{"generated_at":"2026-09-21T15:08:50+00:00","counts":{"registrations":1062,"sites":1046,"import_alert":142,"warning_letter":141,"clean":763,"letters_indexed":3681,"alert_rows_india":461,"firms":711,"tickers":166},"match_rates":{"alert_firms_matched":"73/373","letters_attached":130},"alert_meta":{"99-34":{"title":"DETENTION WITHOUT PHYSICAL EXAMINATION OF DRUGS OR MEDICAL DEVICES FROM FIRMS WITHOUT A VALID DRUG OR MEDICAL DEVICE REGISTRATION AND/OR LISTING","reason":"","url":"https://www.accessdata.fda.gov/cms_ia/importalert_1125.html","observed_at":"2026-09-21T10:10:30+00:00"},"66-76":{"title":"Import Alert 66-76","reason":"","url":"https://www.accessdata.fda.gov/cms_ia/importalert_1155.html","observed_at":"2026-09-21T10:10:32+00:00"},"66-79":{"title":"Import Alert 66-79","reason":"NOTE: The revision of this Import Alert, dated 12/10/2024, updates the reason for alert section, Agency contacts, and includes additional guidance on exemptions covered under detention without physical examination. Changes are bracketed by asterisks (***). REASON FOR ALERT: As part of FDA's activities intended to protect the health and safety of US consumers, FDA often conducts establishment inspections ***and remote regulatory assessments*** of foreign drug manufacturers who produce FDA-regulated articles intended for sale in the US. As part of FDA's foreign inspection process, the Agency may","url":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","observed_at":"2026-09-21T10:10:27+00:00"},"66-40":{"title":"Import Alert 66-40","reason":"NOTE: The revision to this import alert dated July 15, 2025, updates the name of alert, reason for alert, guidance section, program and center contacts and PAC code. Changes are noted and bracketed by three asterisks (***). ***As part of FDA's activities intended to protect the health and safety of US consumers, FDA performs foreign inspections and remote regulatory assessments of pharmaceutical establishments engaged in the manufacture, processing, packing, or holding of drugs or drug products intended for sale in the US. Detention without physical examination may be appropriate when informat","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","observed_at":"2026-09-21T10:10:23+00:00"},"66-41":{"title":"Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.","reason":"NOTE: The revision of this Import Alert, dated 05/19/2026, updates the guidance section, including Agency contacts. Changes to the import alert are bracketed by asterisks (***). Unapproved new drugs present public health and safety risks because they have not been reviewed by FDA for safety or effectiveness. Without FDA review, there is no way to know if these drugs are safe and effective for their intended use, whether they are manufactured in a way that ensures consistent drug quality, or whether their labels are complete and accurate. Unapproved new drugs have resulted in patient harm, and ","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","observed_at":"2026-09-21T10:10:43+00:00"},"66-66":{"title":"Import Alert 66-66","reason":"","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","observed_at":"2026-09-21T10:10:38+00:00"}},"provenance":[{"what":"Establishment registrations (DECRS)","observations":3,"retrieved":"2026-09-21","sha256":["976c10c94309","a9bf7b6b310a","7cbf0e2e6654"],"url":"https://www.accessdata.fda.gov/cder/drls_excluded.zip"},{"what":"Import alert pages","observations":9,"retrieved":"2026-09-21","sha256":["101e848dd9c0","93776b8f7570","c7bc3532a274","55d78e3515bc"],"url":"https://www.accessdata.fda.gov/cms_ia/ialist.html"},{"what":"Warning letter index","observations":8,"retrieved":"2026-09-21","sha256":["e5c00ba692a2","d79720d5bcab","bee65d27aa15","01bade8d71e2"],"url":"https://www.fda.gov/datatables/views/ajax?_drupal_ajax=1&_wrapper_format=drupal_ajax&pager_element=0&view_args=&view_base_path=inspections-compliance-enforcement-and-criminal-investigations%2Fcompliance-actions-and-activities%2Fwarning-letters%2Fdatatables-data&view_display_id=warning_letter_solr_block&view_dom_id=a40dbe3b34fbe5fbb9689f4d9eb6ce2a14e1ece68ec45e17b2dd0be305497af1&view_name=warning_letter_solr_index&view_path=%2Finspections-compliance-enforcement-and-criminal-investigations%2Fcompliance-actions-and-activities%2Fwarning-letters&draw=1&start=0&length=500"},{"what":"India state boundaries","observations":2,"retrieved":"2026-09-21","sha256":["4c63fe43294a","c694a090b753"],"url":"https://media.githubusercontent.com/media/wmgeolab/geoBoundaries/9469f09592ced973a3448cf66b6100b741b64c0d/releaseData/gbOpen/IND/ADM1/geoBoundaries-IND-ADM1_simplified.geojson"},{"what":"Geocoding responses","observations":478,"retrieved":"2026-09-21","sha256":["b6366de690b9","12c57a660d67","c645683f1314","0cf459609434"],"url":"https://nominatim.openstreetmap.org/search?postalcode=110007&country=India&format=jsonv2&limit=1"}],"precision_note":"Coordinates are PIN-code or city centroids from OpenStreetMap Nominatim, not surveyed plant locations. Every point publishes its own precision.","sites":[{"id":"3031662558","fei":"3031662558","duns":"756052829","firm":"ABANI LABS PRIVATE LIMITED","registrant":"ABANI LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"# 5-5-35/169/1, Plot No-19, Ground floor, Prashanth Nagar, I.E. Kukatpally Nagar, Hyderabad, Telangana 500072, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500072","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.49046,"lon":78.40127,"prec":"postcode","geo":"500072, Ward 115 Balaji Nagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Kukatpally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3037730318","3030171758","3017524864","3016445311","3009887324","3027666582","3015443248","3030396086","3038110405"]},{"id":"3005587313","fei":"3005587313","duns":"725584960","firm":"Mylan Laboratories Limited","registrant":"Viatris Inc.","parent":null,"ticker":null,"addr":"(FDF-1), F-4 and F-12, Malegaon MIDC, Sinnar, Nasik District, Nashik, Maharashtra 422113, India (IND)","city":"Nashik","state":"Maharashtra","pin":"422113","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":20.55228,"lon":74.51626,"prec":"tail3","geo":"State Bank of India (SBI), SH19, Malegaon, Malegaon Taluka, Nashik, Maharashtra, 423203, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"12/19/2024","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/19/2024"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"12/19/2024"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/19/2024"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"}],"firm_as_published":"Mylan Laboratories Limited","address_as_published":"(FDF-3) Plot Nos. 11, 12, 13, Indore SEZ , Pharma Zone, Phase II, Sector III , Pithampur, District Dhar, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2024-12-19","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2024-12-19","last":"2024-12-19","sibs":["3008316970","3010453141","3007512701","3006355432","3008255419","3007720135","3007648351"],"colo":[]},{"id":"3008316970","fei":"3008316970","duns":"863996098","firm":"Mylan Laboratories Limited","registrant":"Viatris Inc.","parent":null,"ticker":null,"addr":"(FDF-2) H-12 & H-13, MIDC, Waluj, Chhatrapati Sambhajinagar, Maharashtra State 431136, India (IND)","city":"Chhatrapati Sambhajinagar","state":"Maharashtra","pin":"431136","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.83683,"lon":75.25441,"prec":"postcode","geo":"431136, Chhatrapati Sambhajinagar, Maharashtra, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"12/19/2024","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/19/2024"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"12/19/2024"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/19/2024"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"}],"firm_as_published":"Mylan Laboratories Limited","address_as_published":"(FDF-3) Plot Nos. 11, 12, 13, Indore SEZ , Pharma Zone, Phase II, Sector III , Pithampur, District Dhar, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2024-12-19","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2024-12-19","last":"2024-12-19","sibs":["3005587313","3010453141","3007512701","3006355432","3008255419","3007720135","3007648351"],"colo":["3003204330","3038105724","3007542588","3008580576","3009227929","3003983454"]},{"id":"3010453141","fei":"3010453141","duns":"859649433","firm":"Mylan Laboratories Limited","registrant":"Viatris Inc.","parent":null,"ticker":null,"addr":"(FDF-3) Plot No. 11, 12 &13, Indore Special Economic Zone Pharma Zone, Phase II, Sector III Pithampur, District - Dhar, Madhya Pradesh 454775, India (IND)","city":"District - Dhar","state":"Madhya Pradesh","pin":"454775","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"12/19/2024","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/19/2024"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"12/19/2024"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/19/2024"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"}],"firm_as_published":"Mylan Laboratories Limited","address_as_published":"(FDF-3) Plot Nos. 11, 12, 13, Indore SEZ , Pharma Zone, Phase II, Sector III , Pithampur, District Dhar, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2024-12-19","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2024-12-19","last":"2024-12-19","sibs":["3005587313","3008316970","3007512701","3006355432","3008255419","3007720135","3007648351"],"colo":["3007574780","3016480976","3006456888","3008565058","3005259207","3008581988","3005594847","3038913994","3016268582","3014281041","3008861587","3043782814"]},{"id":"3007512701","fei":"3007512701","duns":"676159830","firm":"Mylan Laboratories Limited","registrant":"Viatris Inc.","parent":null,"ticker":null,"addr":"(OTL), Plot No. 284-B, Bommasandra Jigani Link Road, Industrial Area, Anekal Taluk, Bangalore, Karnataka 560105, India (IND)","city":"Bangalore","state":"Karnataka","pin":"560105","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":12.78642,"lon":77.63458,"prec":"postcode","geo":"560105, Jigani, Anekal, Bengaluru Urban, Karnataka, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"12/19/2024","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/19/2024"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"12/19/2024"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/19/2024"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"}],"firm_as_published":"Mylan Laboratories Limited","address_as_published":"(FDF-3) Plot Nos. 11, 12, 13, Indore SEZ , Pharma Zone, Phase II, Sector III , Pithampur, District Dhar, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2024-12-19","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2024-12-19","last":"2024-12-19","sibs":["3005587313","3008316970","3010453141","3006355432","3008255419","3007720135","3007648351"],"colo":["3005857289","3003560263","3009882550","3015345916","3009609358","3004939494","3003768909"]},{"id":"3003937580","fei":"3003937580","duns":"916568827","firm":"AURORE PHARMACEUTICALS PRIVATE LIMITED","registrant":"Aurore Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"(Unit-I), Plot Nos. 35,36,38 to 40, 49 to 51, Phase IV, IDA, Jeedimetla,, Hyderabad, Telangana 500055, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500055","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869","3018694293"]},{"id":"3009996280","fei":"3009996280","duns":"650739183","firm":"Honour Lab Limited","registrant":"Honour Lab Limited","parent":null,"ticker":null,"addr":"(Unit-I), Survey Nos. 200, 202, 203E, 204, 206, 206A & 217, Bonthapally Village, Gummadidala Mandal, Sangareddy, Telangana 502313, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502313","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011766778","3010828439","3021257926"],"colo":["3014539030","3003723146","3029798246","3006744199","3032314066","3012234942","3013944676","3007164063","3003510514","3042223406","3003289270","3007931994"]},{"id":"3011766778","fei":"3011766778","duns":"650963619","firm":"Honour Lab Limited","registrant":"Honour Lab Limited","parent":null,"ticker":null,"addr":"(Unit-V), Gundlamachnoor (Village), Hathnoora (Mandal), Sangareddy, Telangana 502296, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502296","ops":["API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":17.68077,"lon":78.19935,"prec":"postcode","geo":"502296, Hathnoora mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009996280","3010828439","3021257926"],"colo":["3004590215","3004021253","3006370489"]},{"id":"3046619098","fei":"3046619098","duns":"930130941","firm":"Dabur India Limited","registrant":"Dabur India Limited","parent":null,"ticker":null,"addr":"-greenfield unit, Greenfield Unit Tehsil-baddi, Manakpur, Solan, Himachal Pradesh 174101, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"174101","ops":["LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":31.06505,"lon":76.69603,"prec":"postcode","geo":"174101, Nalagarh, Solan, Himachal Pradesh, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/05/2026","notes":"All Drug and Drug Products","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"06/05/2026"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"06/05/2026"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"06/05/2026"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"06/05/2026"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"06/05/2026"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/05/2026"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"06/05/2026"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"06/05/2026"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"}],"firm_as_published":"Dabur India Limited","address_as_published":"225 - 4 - 1 Saily Village , Survey No , Dadra And Nagar Haveli, Dadra and Nagar Haveli And Dam INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-41","list":"red","since":"08/26/2025","notes":"","charges":[{"code":"33","notes":"","product":"Candy W/O Chocolate/Candy Specialties/Chewing Gums","published":"08/26/2025"},{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"08/26/2025"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"08/26/2025"},{"code":"60 S - - 99","notes":"","product":"Antacid, N.E.C.","published":"08/26/2025"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/26/2025"}],"firm_as_published":"DABUR INDIA LIMITED","address_as_published":"45 46 47 Plot No 44 , And 97; Smart Industrial Park , Pithampur, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"11/01/2021","notes":"All skin creams or lotions that list �bleach or skin bleaching� in the name of the product or �bleach or skin bleaching� in the product�s intended use are subject to DWPE under this listing.","charges":[{"code":"41 Y - - 99","notes":"","product":"Dietary Conventional Foods, N.E.C.","published":"08/09/2024"},{"code":"53 L D - 01","notes":"","product":"Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Liquid, Lotion","published":"08/02/2024"},{"code":"53 L - - 01","notes":"","product":"Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)","published":"08/02/2024"},{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"11/01/2021"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"08/09/2024"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"11/01/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"11/01/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/02/2024"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/09/2024"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/02/2024"}],"firm_as_published":"Dabur India","address_as_published":"Lane no. 3, phase-2 , SIDCO Industrial Complex, Bari Brahmana , Jammu, Jammu and Kashmir INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"02/28/2020","notes":"The product appears to be an unapproved new drug as the product label and promotional website include claims such as (not an all-inclusive list): Label - 'Helps keep you fit by protecting from day to day elements like cough & cold.'; Website - 'Dabur Chyawanprash is a time-tested Ayurvedic formulation of more than 41 Ayurvedic herbs that aid in boosting the immune system, thereby protecting the body from everyday infections like cough & cold etc. caused by bacteria, viruses, dust and weather change.'.","charges":[{"code":"22 C - - 99","notes":"","product":"Vine Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.","published":"02/28/2020"},{"code":"27 Y - - 99","notes":"","product":"Condiments, N.E.C.","published":"02/28/2020"},{"code":"37 K - - 99","notes":"","product":"Pastes, n.e.c.","published":"02/28/2020"},{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"04/03/2020"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"04/03/2020"},{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"02/26/2024"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"02/28/2020"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"02/26/2024"},{"code":"60 S - - 99","notes":"","product":"Antacid, N.E.C.","published":"02/26/2024"},{"code":"63 R","notes":"","product":"Dental Caries Prophyl","published":"04/03/2020"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"02/26/2024"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"02/28/2020"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"04/03/2020"}],"firm_as_published":"Dabur India","address_as_published":"Honey Unit, Tehsil Baddi , Manakpur , Solan, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"09/13/2019","notes":"5/4/2006","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"09/13/2019"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"09/13/2019"}],"firm_as_published":"Dabur India Limited","address_as_published":"P.O. Daburgram , Bihar, INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"11/01/2021","notes":"A labeling statement documenting the intended use of the product includes, but may not be limited to the following: �Ayurvedic Medicine� Indications:� � useful for gout and arthritis, and helps purify blood�.","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"11/01/2021"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"11/01/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"11/01/2021"}],"firm_as_published":"Dabur India Limited","address_as_published":"SP -C 162 , Matsya Industrial Area , Alwar, Rajasthan INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"11/22/2010","notes":"India","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"11/22/2010"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"11/22/2010"},{"code":"63 R - - 06","notes":"","product":"Stannous Fluoride (Dental Caries Prophylactic)","published":"11/22/2010"},{"code":"63 S - - 99","notes":"","product":"Dental Protectant N.E.C.","published":"11/22/2010"}],"firm_as_published":"Dabur India Limited","address_as_published":"60 Maiku Majra , Malku Majra Road; Nalagarth Road , Baddi, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"06/13/2013","notes":"06/13/2013","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"06/13/2013"},{"code":"53 L - - 03","notes":"","product":"Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)","published":"01/27/2021"},{"code":"53 L - - 03","notes":"","product":"Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)","published":"01/27/2021"}],"firm_as_published":"Dabur India Limited","address_as_published":"Village Billanwali Lavana, Baddi , Solan, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"10/14/2012","notes":"The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): �antiplaque & whitening��.","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"05/16/2025"},{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"10/14/2012"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"10/14/2012"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"05/16/2025"},{"code":"63 R - - 06","notes":"","product":"Stannous Fluoride (Dental Caries Prophylactic)","published":"10/14/2012"},{"code":"63 R - - 99","notes":"","product":"Dental Caries Prophylactic N.E.C.","published":"05/16/2025"},{"code":"63 S - - 99","notes":"","product":"Dental Protectant N.E.C.","published":"10/14/2012"},{"code":"63 U - - 99","notes":"","product":"Dentin Desensitizer N.E.C.","published":"10/14/2012"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"05/16/2025"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"10/14/2012"}],"firm_as_published":"Dabur India Limited","address_as_published":"225 - 4 - 1 Saily Village , Survey No , Dadra And Nagar Haveli, Dadra and Nagar Haveli And Dam INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"05/29/2014","notes":"","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"05/29/2014"}],"firm_as_published":"Dabur India Limited","address_as_published":"86 A, Kheda Industrial Area, Pithampur , Dhar, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"02/04/2020","notes":"","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"02/04/2020"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"02/04/2020"},{"code":"63 R","notes":"","product":"Dental Caries Prophyl","published":"02/04/2020"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"02/04/2020"}],"firm_as_published":"Dabur India Limited","address_as_published":"Sanitpur , Garaimari, Assam INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"02/04/2020","notes":"Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: \"Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory\". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"01/27/2021"},{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"04/03/2020"},{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"02/04/2020"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"04/03/2020"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"01/27/2021"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"02/04/2020"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"01/27/2021"},{"code":"63 R - - 06","notes":"","product":"Stannous Fluoride (Dental Caries Prophylactic)","published":"01/27/2021"},{"code":"63 R - - 99","notes":"","product":"Dental Caries Prophylactic N.E.C.","published":"01/27/2021"},{"code":"63 R","notes":"","product":"Dental Caries Prophyl","published":"04/03/2020"},{"code":"63 R","notes":"","product":"Dental Caries Prophyl","published":"02/04/2020"},{"code":"63 S - - 99","notes":"","product":"Dental Protectant N.E.C.","published":"01/27/2021"},{"code":"63 U - - 99","notes":"","product":"Dentin Desensitizer N.E.C.","published":"01/27/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"02/04/2020"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"01/27/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"04/03/2020"}],"firm_as_published":"Dabur India Limited (Unit-2)","address_as_published":"Integrated Industrial Estate, Plot No 4, Sec-2, Pant Nagar, Distt. Udham Singh Nagar , Udham Singh Nagar, Uttaranchal INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"01/10/2017","notes":"Medical claims made on product label","charges":[{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"01/10/2017"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"01/10/2017"}],"firm_as_published":"Dabur India Ltd","address_as_published":"8/3 Asaf Ali Road , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"10/14/2015","notes":"","charges":[{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"10/14/2015"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"10/14/2015"}],"firm_as_published":"Dabur India Ltd","address_as_published":"109 Hpsidc Industrial Area , Baddi, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[{"date":"2026-07-24T04:00:00Z","posted":"2026-08-04T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dabur-india-limited-728828-07242026","company_as_published":"Dabur India Limited","match":"exact"}],"events":[{"d":"2026-07-24","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dabur-india-limited-728828-07242026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2026-06-05","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"},{"d":"2025-08-26","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2025-05-16","k":"charge","t":"66-41 charge 53 I - - 01 — Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2025-05-16","k":"charge","t":"66-41 charge 53 I - - 99 — Other Oral Hygiene Products, without Fluoride, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2025-05-16","k":"charge","t":"66-41 charge 63 R - - 99 — Dental Caries Prophylactic N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2025-05-16","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-09","k":"charge","t":"66-41 charge 41 Y - - 99 — Dietary Conventional Foods, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-09","k":"charge","t":"66-41 charge 54 Y - - 99 — Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-09","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-02","k":"charge","t":"66-41 charge 53 L D - 01 — Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Liquid, Lotion","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-02","k":"charge","t":"66-41 charge 53 L - - 01 — Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-02","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-02","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-02-26","k":"charge","t":"66-41 charge 54 F - - 99 — Herbals & Botanicals (not Teas), N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-02-26","k":"charge","t":"66-41 charge 54 Y - - 99 — Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-02-26","k":"charge","t":"66-41 charge 60 S - - 99 — Antacid, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-02-26","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-11-01","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"All skin creams or lotions that list �bleach or skin bleaching� in the name of the product or �bleach or skin bleaching� in the product�s intended use are subject to DWPE under this listing."},{"d":"2021-11-01","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"A labeling statement documenting the intended use of the product includes, but may not be limited to the following: �Ayurvedic Medicine� Indications:� � useful for gout and arthritis, and helps purify blood�."},{"d":"2021-01-27","k":"charge","t":"66-41 charge 53 L - - 03 — Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 53 L - - 03 — Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 53 I - - 01 — Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 53 I - - 99 — Other Oral Hygiene Products, without Fluoride, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 54 Y - - 99 — Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 63 R - - 06 — Stannous Fluoride (Dental Caries Prophylactic)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 63 R - - 99 — Dental Caries Prophylactic N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 63 S - - 99 — Dental Protectant N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 63 U - - 99 — Dentin Desensitizer N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 53 I - - 01 — Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 53 I - - 99 — Other Oral Hygiene Products, without Fluoride, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 63 R — Dental Caries Prophyl","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 53 I - - 01 — Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 53 I - - 99 — Other Oral Hygiene Products, without Fluoride, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 63 R — Dental Caries Prophyl","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-02-28","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"The product appears to be an unapproved new drug as the product label and promotional website include claims such as (not an all-inclusive list): Label - 'Helps keep you fit by protecting from day to day elements like cough & cold.'; Website - 'Dabur Chyawanprash is a time-tested Ayurvedic formulation of more than 41 Ayurvedic herbs that aid in boosting the immune system, thereby protecting the body from everyday infections like cough & cold etc. caused by bacteria, viruses, dust and weather change.'."},{"d":"2020-02-04","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-02-04","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: \"Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory\". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020"},{"d":"2019-09-13","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"5/4/2006"},{"d":"2017-01-10","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Medical claims made on product label"},{"d":"2015-10-14","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2013-06-13","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"06/13/2013"},{"d":"2012-10-14","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): �antiplaque & whitening��."},{"d":"2010-11-22","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"India"}],"first":"2010-11-22","last":"2026-07-24","sibs":["3001413302"],"colo":["3016859498","3013744962","3012112224","3031080212","3008250236","3014210753","3010868532","3007517881"]},{"id":"3007574780","fei":"3007574780","duns":"677600550","firm":"Ipca Laboratories Limited","registrant":"Ipca Laboratories Limited","parent":"Ipca Laboratories","ticker":"IPCALAB","addr":"1, Pharma Zone, SEZ, Indore, Pithampur, Dhar, Madhya Pradesh 454775, India (IND)","city":"Dhar","state":"Madhya Pradesh","pin":"454775","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"09/30/2009","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","charges":[{"code":"66 V - - 99","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","product":"Miscellaneous Patent Medicines, Etc.","published":"09/30/2009"}],"firm_as_published":"Ipca Laboratories Limited","address_as_published":"P.O. Sejavta , Ratlam, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug."}],"first":"2009-09-30","last":"2009-09-30","sibs":["3027770072","3002807297","3027770075","3005977675","3006057101","3009227929"],"colo":["3010453141","3016480976","3006456888","3008565058","3005259207","3008581988","3005594847","3038913994","3016268582","3014281041","3008861587","3043782814"]},{"id":"3002957101","fei":"3002957101","duns":"677319965","firm":"AUROLAB TRUST DBA Aurolab","registrant":"Aurolab","parent":null,"ticker":null,"addr":"1, Sivagangai Main Road, Veerapanjan, Madurai, Tamil Nadu 625020 India, India (IND)","city":"Madurai","state":"Tamil Nadu","pin":"625020","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":9.95321,"lon":78.15875,"prec":"postcode","geo":"625020, Madurai, Madurai South, Madurai, Tamil Nadu, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"08/28/2026","notes":"","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"08/28/2026"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"08/28/2026"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"08/28/2026"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"08/28/2026"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"08/28/2026"},{"code":"55","notes":"","product":"Pharm Necess & Ctnr For Drug/Bio","published":"08/28/2026"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"08/28/2026"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"08/28/2026"},{"code":"60","notes":"","product":"Human and Animal Drugs","published":"08/28/2026"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"08/28/2026"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"08/28/2026"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"08/28/2026"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"08/28/2026"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"08/28/2026"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"08/28/2026"}],"firm_as_published":"Aurolab Trust","address_as_published":"1 Sivagangai Main Road , Madurai, Tamil Nadu INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"}],"letters":[],"events":[{"d":"2026-08-28","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""}],"first":"2026-08-28","last":"2026-08-28","sibs":[],"colo":[]},{"id":"3038105776","fei":"3038105776","duns":"854322693","firm":"APTA LABS PRIVATE LIMITED","registrant":"APTA LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"1-450/AGG/ W1/805,Plot No 805, Ganga Grandeur,Athvelly Village,Medchal Mandal, Rangareddy, Telangana 501401, India (IND)","city":"Rangareddy","state":"Telangana","pin":"501401","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.62984,"lon":78.48653,"prec":"postcode","geo":"501401, Medchal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004443761","3003802255","3014529730","3022190657"]},{"id":"3018030137","fei":"3018030137","duns":"771744626","firm":"AUDI PHARMA INGREDIENTS","registrant":"AUDI PHARMA INGREDIENTS","parent":null,"ticker":null,"addr":"1/300F, Cheranmahadevi Main Road, Kondanagaram, Tirunelveli, TAMIL NADU 627010, India (IND)","city":"Tirunelveli","state":"Tamil Nadu","pin":"627010","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":8.7161,"lon":77.61903,"prec":"postcode","geo":"627010, Tirunelveli, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3009857729","fei":"3009857729","duns":"913463107","firm":"INTERVEIN RESEARCH LABS PRIVATE LIMITED","registrant":"INTERVEIN RESEARCH LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"101-106, 501-504 & 506 Shapath-IV, Tower B, Prahlad Nagar Opp. Karnavati Club, S G Highway, Ahmedabad, Gujarat 380015, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"380015","ops":["ANALYSIS"],"expires":"12/31/2026","lat":23.02223,"lon":72.52801,"prec":"postcode","geo":"380015, Vejalpur Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3042700568","House No. 5, Ground Floor, First Floor, Second Floor and Third floor, Magnet Corporate Park, Near Thaltej Cross Road, SG Highway,, Ahmedabad, Gujarat 380015, India (IND)","3008355986"]},{"id":"3009310198","fei":"3009310198","duns":"677600482","firm":"Micro Labs Limited","registrant":"Micro Labs Limited","parent":null,"ticker":null,"addr":"113-116, IV Phase, Jigani Link Road, KIADB, Bommasandra Industrial Area, Bengaluru, Karnataka 560099, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560099","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.83934,"lon":77.70554,"prec":"postcode","geo":"560099, Singena Agrahara, Anekal, Bengaluru Urban, Karnataka, India","status":1,"alerts":[],"letters":[{"date":"2024-09-10T04:00:00Z","posted":"2024-11-08T19:00:00Z","subject":"CGMP/QSR/Medical Devices/Adulterated","office":"Center for Devices and Radiological Health","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-x-ltd-692084-09102024","company_as_published":"Micro-X Ltd.","match":"token"},{"date":"2024-12-03T05:00:00Z","posted":"2024-12-17T14:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-orgo-chem-686458-12032024","company_as_published":"Micro Orgo Chem","match":"token"}],"events":[{"d":"2024-12-03","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-orgo-chem-686458-12032024","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-09-10","k":"letter","t":"CGMP/QSR/Medical Devices/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-x-ltd-692084-09102024","x":"Center for Devices and Radiological Health"}],"first":"2024-09-10","last":"2024-12-03","sibs":["3004495158","3004939494","3017157902","3005210225"],"colo":["3003600340","3043619916","3007078919","3003981475","3008300442","3006076314","3013637926","3010164491","3035152598"]},{"id":"3004094136","fei":"3004094136","duns":"862312449","firm":"GLOBAL CALCIUM PRIVATE LIMITED","registrant":"GLOBAL CALCIUM PRIVATE LIMITED","parent":null,"ticker":null,"addr":"124,125,126 Sipcot Industrial Complex Phase I, HOSUR, TAMIL NADU 635126, India (IND)","city":"HOSUR","state":"Tamil Nadu","pin":"635126","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":12.75781,"lon":77.81407,"prec":"postcode","geo":"635126, Hosur, Krishnagiri, Tamil Nadu, India","status":1,"alerts":[],"letters":[{"date":"2025-01-16T05:00:00Z","posted":"2025-02-04T05:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"07/30/2026","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-calcium-pvt-limited-692000-01162025","company_as_published":"Global Calcium Pvt. Limited","match":"exact"}],"events":[{"d":"2025-01-16","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-calcium-pvt-limited-692000-01162025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-01-16","last":"2025-01-16","sibs":[],"colo":["3014362214"]},{"id":"3031661712","fei":"3031661712","duns":"930038154","firm":"DEEPAK PHENOLICS LIMITED","registrant":"DEEPAK PHENOLICS LIMITED","parent":null,"ticker":null,"addr":"12b/1, Gidc, Dahej Industrial Estate, Dahej, Bharuch, Gujarat 392110, India (IND)","city":"Bharuch","state":"Gujarat","pin":"392110","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.98465,"lon":72.85953,"prec":"postcode","geo":"392110, Amod Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"1000212072","fei":"1000212072","duns":"915312748","firm":"Capri Aromatics Pvt Ltd","registrant":"Capri Aromatics Pvt Ltd","parent":null,"ticker":null,"addr":"13 Amrit Apartments, Mumbai, Maharashtra 400052, India (IND)","city":"Mumbai","state":"Maharashtra","pin":"400052","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.07404,"lon":72.83165,"prec":"postcode","geo":"400052, H/W Ward, Mumbai Zone 3, Mumbai, Mumbai Suburban District, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3045048982","fei":"3045048982","duns":"771496867","firm":"CHEMGENIX LABORATORIES PRIVATE LIMITED","registrant":"VILIN BIO MED LIMITED","parent":null,"ticker":null,"addr":"13, COMMERCIAL HUB, RAMKY PHARMACITY LTD, ROAD NO 13, JNPC, PARWADA MANDAL, VISAKAPATNAM, ANDRAPRADESH 531019, India (IND)","city":"VISAKAPATNAM","state":null,"pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397","3019853340"]},{"id":"3017000602","fei":"3017000602","duns":"862584260","firm":"AKRON FORMULATIONS INDIA PRIVATE LIMITED","registrant":"AKRON FORMULATIONS INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"134 - B, IDA, Bollaram, Jinnaram Mandal, Medak, Hyderabad, Telangana 502325, India (IND)","city":"Hyderabad","state":"Telangana","pin":"502325","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.55317,"lon":78.34216,"prec":"postcode","geo":"502325, Jinnaram mandal, Sangareddy, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"11/26/2024","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"11/26/2024"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"11/26/2024"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"11/26/2024"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"}],"firm_as_published":"AKRON FORMULATIONS INDIA PRIVATE LIMITED","address_as_published":"134 - B, Ida Bollaram, Jinnaram Mandal, Medak , Hyderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2024-12-17T05:00:00Z","posted":"2024-12-24T14:20:00Z","subject":"CGMP/Finished Pharmaceutical/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/akron-formulations-india-private-limited-693938-12172024","company_as_published":"Akron Formulations India Private Limited","match":"exact"}],"events":[{"d":"2024-12-17","k":"letter","t":"CGMP/Finished Pharmaceutical/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/akron-formulations-india-private-limited-693938-12172024","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-11-26","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2024-11-26","last":"2024-12-17","sibs":["3041729025"],"colo":["3008408466","3002806851","3007136165","3008479404","3009609117","3007720135","3005818804","3008932115","3005301950"]},{"id":"3041729025","fei":"3041729025","duns":"855511769","firm":"AKRON FORMULATIONS INDIA PRIVATE LIMITED","registrant":"AKRON FORMULATIONS INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"134B, Block-B, Bollaram, Jinnaram Mandal, Medak, Hyderabad, Telangana 502325, India (IND)","city":"Hyderabad","state":"Telangana","pin":"502325","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.55317,"lon":78.34216,"prec":"postcode","geo":"502325, Jinnaram mandal, Sangareddy, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"11/26/2024","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"11/26/2024"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"11/26/2024"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"11/26/2024"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2024"}],"firm_as_published":"AKRON FORMULATIONS INDIA PRIVATE LIMITED","address_as_published":"134 - B, Ida Bollaram, Jinnaram Mandal, Medak , Hyderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2024-12-17T05:00:00Z","posted":"2024-12-24T14:20:00Z","subject":"CGMP/Finished Pharmaceutical/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/akron-formulations-india-private-limited-693938-12172024","company_as_published":"Akron Formulations India Private Limited","match":"exact"}],"events":[{"d":"2024-12-17","k":"letter","t":"CGMP/Finished Pharmaceutical/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/akron-formulations-india-private-limited-693938-12172024","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-11-26","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2024-11-26","last":"2024-12-17","sibs":["3017000602"],"colo":["3008408466","3002806851","3007136165","3008479404","3009609117","3007720135","3005818804","3008932115","3005301950"]},{"id":"3005818763","fei":"3005818763","duns":"650484991","firm":"THE MADRAS PHARMACEUTICALS","registrant":"THE MADRAS PHARMACEUTICALS","parent":null,"ticker":null,"addr":"137-B, Old Mahabalipuram Road,Karapakkam, Chennai, Tamilnadu 600096, India (IND)","city":"Chennai","state":null,"pin":"600096","ops":["LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.95939,"lon":80.24276,"prec":"postcode","geo":"600096, Zone 14 Perungudi, Chennai Corporation, Sholinganallur, Chennai, Tamil Nadu, India","status":1,"alerts":[],"letters":[{"date":"2022-03-28T04:00:00Z","posted":"2022-05-03T13:20:00Z","subject":"Foreign Supplier Verification Program (FSVP)","office":"Division of West Coast Imports","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/madras-groceries-626403-03282022","company_as_published":"Madras Groceries","match":"token"}],"events":[{"d":"2022-03-28","k":"letter","t":"Foreign Supplier Verification Program (FSVP)","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/madras-groceries-626403-03282022","x":"Division of West Coast Imports"}],"first":"2022-03-28","last":"2022-03-28","sibs":[],"colo":[]},{"id":"3007684569","fei":"3007684569","duns":"918451696","firm":"Cadila Pharmaceuticals Limited","registrant":"Cadila Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"1389, Trasad Road, Dholka, Ahmedabad, Gujarat 382225, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382225","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.72227,"lon":72.45136,"prec":"postcode","geo":"382225, Dholka Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3014078015","3002806711"],"colo":["3012520698","3004126703"]},{"id":"3011445120","fei":"3011445120","duns":"650600778","firm":"T M Thakore Pharmaceutical Laboratories LLP","registrant":"T M Thakore Pharmaceutical Laboratories LLP","parent":null,"ticker":null,"addr":"15-A Caves Road Premsons Industrial Estate, Jogeshwari E, Mumbai,  400060, India (IND)","city":"Mumbai","state":null,"pin":"400060","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.13621,"lon":72.85635,"prec":"postcode","geo":"400060, K/E Ward, Mumbai Zone 3, Mumbai, Mumbai Suburban District, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3004293613","fei":"3004293613","duns":"915346860","firm":"MENTHA AND ALLIED PRODUCTS PRIVATE LIMITED","registrant":"Mentha & Allied Products Private Limited","parent":null,"ticker":null,"addr":"16 K M, Rampur-Swar Road, Rampur, Uttar Pradesh 244901, India (IND)","city":"Rampur","state":"Uttar Pradesh","pin":"244901","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":28.78175,"lon":79.03374,"prec":"postcode","geo":"244901, Rampur, Uttar Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2025-04-16T04:00:00Z","posted":"2025-05-13T04:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mentha-allied-products-private-ltd-700242-04162025","company_as_published":"Mentha & Allied Products Private Ltd.","match":"exact"}],"events":[{"d":"2025-04-16","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mentha-allied-products-private-ltd-700242-04162025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-04-16","last":"2025-04-16","sibs":[],"colo":["3006535724","3002899365"]},{"id":"3027513144","fei":"3027513144","duns":"871625470","firm":"APAR INDUSTRIES LIMITED","registrant":"APAR INDUSTRIES LIMITED","parent":null,"ticker":null,"addr":"18, Tt.c.m.i.d.c. Indl. Area, Near Rabale Telephone. Exchange, thane Belapur Road, Rabale, Navi Mumbai, MAHARASHTRA 400701, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400701","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.11985,"lon":73.00488,"prec":"postcode","geo":"400701, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009510975","3006620783","3003484180","3024731845","3007026867","3005502733","3011560035","3030219467","3013153296"]},{"id":"3002808145","fei":"3002808145","duns":"650067093","firm":"SHRIRAM INSTITUTE FOR INDUSTRIAL RESEARCH","registrant":"SHRIRAM INSTITUTE FOR INDUSTRIAL RESEARCH","parent":null,"ticker":null,"addr":"19, UNIVERSITY ROAD, DELHI, DELHI 110007, India (IND)","city":"UNIVERSITY ROAD","state":"Delhi","pin":"110007","ops":["ANALYSIS"],"expires":"12/31/2026","lat":28.68417,"lon":77.20557,"prec":"postcode","geo":"110007, North Campus, Civil Lines, Delhi, North Delhi, Delhi, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3037730318","fei":"3037730318","duns":"772642642","firm":"NAYAS LABORATORIES PRIVATE LIMITED","registrant":"NAYAS LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"1st Floor, 5-35/178(Old 5-36/26/B), Plot No.26, Prasanth Nagar, Balanagar, Kukatpally, Hyderabad, Telangana 500072, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500072","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.49046,"lon":78.40127,"prec":"postcode","geo":"500072, Ward 115 Balaji Nagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Kukatpally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031662558","3030171758","3017524864","3016445311","3009887324","3027666582","3015443248","3030396086","3038110405"]},{"id":"3016067081","fei":"3016067081","duns":"675487254","firm":"Arktek Labs","registrant":"Arktek Labs","parent":null,"ticker":null,"addr":"1st Flr, Plot No. 32, H No. 11-6-29/8, Venkateswara Co-op. Estate, Hyderabad,  500037, India (IND)","city":"Hyderabad","state":null,"pin":"500037","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.47821,"lon":78.44338,"prec":"postcode","geo":"500037, Ward 120 Balanagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Balanagar mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3012278124","3017146711","3014798074","3031055543","3009883190","3013495798","3014683316","3015069609"]},{"id":"3030171758","fei":"3030171758","duns":"738057666","firm":"Dr Rao's Life Sciences Pvt Ltd","registrant":"Dr Rao's Life Sciences Pvt Ltd","parent":null,"ticker":null,"addr":"2&3 RD FLOOR H NO 5-35/152 PLOT NO 95 PRASHANTHI NAGAR, Kukatpally, Medchal Malkjgiri Dist, Hyderabad, Telangana 500072, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500072","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.49046,"lon":78.40127,"prec":"postcode","geo":"500072, Ward 115 Balaji Nagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Kukatpally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031662558","3037730318","3017524864","3016445311","3009887324","3027666582","3015443248","3030396086","3038110405"]},{"id":"3011571416","fei":"3011571416","duns":"650863256","firm":"MOLCLONE LABS PRIVATE LIMITED","registrant":"MOLCLONE LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"2/220, Kundru Medu Street, Sirumathur Village, Padappai, Sriperumbudur Taluk, Kanchipuram District, Chennai, Tamil Nadu 601301, India (IND)","city":"Chennai","state":"Tamil Nadu","pin":"601301","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":12.87958,"lon":80.01653,"prec":"postcode","geo":"601301, Sriperumbudur, Kanchipuram, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021389808"]},{"id":"3003882508","fei":"3003882508","duns":"918527511","firm":"Supriya Lifescience Limited","registrant":"Supriya Lifescience Limited","parent":null,"ticker":null,"addr":"207/208, Udyog Bhavan, Sonawala Lane, Goregaon (East),, Mumbai, Maharashtra 400063, India (IND)","city":"Mumbai","state":"Maharashtra","pin":"400063","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.16917,"lon":72.86179,"prec":"postcode","geo":"400063, P/S Ward, Mumbai Zone 4, Mumbai, Mumbai Suburban District, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3007497376","3032073298"],"colo":["3012255151"]},{"id":"1000172912","fei":"1000172912","duns":"650173537","firm":"Biocon Limited","registrant":"Biocon Limited","parent":"Biocon","ticker":"BIOCON","addr":"20th KM, Hosur Road, Electronics City, Bengaluru, Karnataka 560100, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560100","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":12.84601,"lon":77.66127,"prec":"postcode","geo":"560100, Bangalore South, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004956855","3006400591","3010164491"],"colo":["3015283245","3004495158","3007907068"]},{"id":"3006949803","fei":"3006949803","duns":"861475339","firm":"ADGYL LIFESCIENCES PRIVATE LIMITED","registrant":"ADGYL LIFESCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"21 & 22 PHASE II PEENYA INDUSTRIAL AREA, BENGALURU, KARNATAKA 560058, India (IND)","city":"BENGALURU","state":"Karnataka","pin":"560058","ops":["ANALYSIS"],"expires":"12/31/2026","lat":13.02329,"lon":77.51356,"prec":"postcode","geo":"560058, Parvathi Nagar, Bengaluru West City Corporation, Bengaluru, Bangalore North, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3022528084","3013697420","3013200240"]},{"id":"3022528084","fei":"3022528084","duns":"861468633","firm":"EUROFINS ADVINUS BIOPHARMA SERVICES INDIA PRIVATE LIMITED","registrant":"EUROFINS ADVINUS BIOPHARMA SERVICES INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"21 & 22 PHASE II PEENYA INDUSTRIAL AREA, BENGALURU, KARNATAKA 560058, India (IND)","city":"BENGALURU","state":"Karnataka","pin":"560058","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":13.02329,"lon":77.51356,"prec":"postcode","geo":"560058, Parvathi Nagar, Bengaluru West City Corporation, Bengaluru, Bangalore North, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3021329253"],"colo":["3006949803","3013697420","3013200240"]},{"id":"3020223359","fei":"3020223359","duns":"878533233","firm":"SERUM INSTITUTE OF INDIA PRIVATE LIMITED","registrant":"SERUM INSTITUTE OF INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"S. No. 105-110, Manjari BK, Pune Zone 3, Pune, MAHARASHTRA 412307, India (IND)","city":"Pune","state":"Maharashtra","pin":"412307","ops":["ANALYSIS","API MANUFACTURE","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.50914,"lon":73.97019,"prec":"postcode","geo":"412307, Haveli Subdistrict, Pune, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3014372507","fei":"3014372507","duns":"860390184","firm":"INVITRO RESEARCH SOLUTIONS PRIVATE LIMITED","registrant":"INVITRO RESEARCH SOLUTIONS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal, Bangalore, Karnataka 560092, India (IND)","city":"Bangalore","state":"Karnataka","pin":"560092","ops":["ANALYSIS"],"expires":"12/31/2026","lat":13.06173,"lon":77.59288,"prec":"postcode","geo":"560092, Byatarayanapura, Bengaluru North City Corporation, Bengaluru, Yelahanka taluku, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3003310718","fei":"3003310718","duns":"862621692","firm":"Alchem International Private Ltd","registrant":"Alchem International Private Ltd","parent":null,"ticker":null,"addr":"25/2, Main Mathura Road Village Kaili, Ballabgarh, Faridabad, Haryana 121004, India (IND)","city":"Faridabad","state":"Haryana","pin":"121004","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":28.34355,"lon":77.32658,"prec":"postcode","geo":"121004, Faridabad, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009344588"],"colo":[]},{"id":"3004987008","fei":"3004987008","duns":"650488401","firm":"Alkaloids Private Limited","registrant":"ALKALOIDS BIOACTIVES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"25/3 Gundlapochampally,, Medchal-Malkajgiri District, Telangana 500100, India (IND)","city":"Medchal-Malkajgiri District","state":"Telangana","pin":"500100","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.53513,"lon":78.48305,"prec":"postcode","geo":"500100, Dundigal mandal, Medchal–Malkajgiri, Telangana, India","status":2,"alerts":[{"alert":"66-66","list":"red","since":"01/22/2010","notes":"","charges":[{"code":"61 T C S 29","notes":"","product":"Scopolamine (Anti-Emetic/Nauseant), Human - Rx/Single Ingredient, Active Pharm Ingred/Chems for Further Manuf","published":"01/22/2010"}],"firm_as_published":"Alkaloids Private Limited","address_as_published":"25/3 Gundla Pochampally , Medchal-Malkajgiri District , Rangareddy, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"},{"alert":"66-66","list":"red","since":"01/22/2010","notes":"","charges":[{"code":"61 T C S 29","notes":"","product":"Scopolamine (Anti-Emetic/Nauseant), Human - Rx/Single Ingredient, Active Pharm Ingred/Chems for Further Manuf","published":"01/22/2010"}],"firm_as_published":"Alkaloids Private Ltd","address_as_published":"834(P) Medchal Shamirpet Road, Medchal Mandal , Medchal-Malkajgiri District , Medchal, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"}],"letters":[],"events":[{"d":"2010-01-22","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2010-01-22","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""}],"first":"2010-01-22","last":"2010-01-22","sibs":[],"colo":["3008243902"]},{"id":"3006254924","fei":"3006254924","duns":"676190180","firm":"CTX Lifesciences Pvt. Ltd.","registrant":"CTX Lifesciences Pvt. Ltd.","parent":null,"ticker":null,"addr":"251-252, Sachin Magdalla Road, GIDC Sachin,, Surat, Gujarat 394230, India (IND)","city":"Surat","state":"Gujarat","pin":"394230","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.08626,"lon":72.86963,"prec":"postcode","geo":"394230, Chorasi Taluka, Surat, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3007026935","3010703501","3008953049"]},{"id":"3005183272","fei":"3005183272","duns":"863182240","firm":"Elysium Pharmaceuticals Ltd","registrant":"ELYSIUM PHARMACEUTICALS LTD","parent":null,"ticker":null,"addr":"253 to 256 and 258, Post: Dabhasa Taluka: Padra, Vadodara, Gujarat 391440, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391440","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.24672,"lon":73.08544,"prec":"postcode","geo":"391440, Padra Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009167769","3009119873","3005906909","3009219197","3006767695","3007836955","3008494993","3008405956","3002806475","3010166818","3038848101"]},{"id":"3003722314","fei":"3003722314","duns":"650477933","firm":"Intas Pharmaceuticals Limited","registrant":"Intas Pharmaceuticals Limited","parent":"Intas (unlisted)","ticker":null,"addr":"2702/A, GIDC Industrial Estate, District Bharuch, Ankleshwar, Gujarat 393002, India (IND)","city":"Ankleshwar","state":"Gujarat","pin":"393002","ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/01/2023","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"11/15/2024"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"11/15/2024"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"11/15/2024"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"11/15/2024"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"11/15/2024"},{"code":"55","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/01/2023"},{"code":"56","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Antibiotics (Human/Animal)","published":"06/01/2023"},{"code":"58","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"06/01/2023"},{"code":"60","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"61","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"62","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"63","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"64","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"65","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"66","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"}],"firm_as_published":"Intas Pharmaceuticals Limited","address_as_published":"Pharmez Plot No 5-14 , Near Village Matoda; Sarkhej-Bavla Highway No 8-A , Sanand, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"11/14/2023","notes":"These products are excluded from DWPE: Azacitidine Injection 62I[][]99 Clonazepam Tablet 61M[][]06 Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"04/09/2024"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"04/09/2024"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"04/09/2024"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"04/09/2024"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"04/09/2024"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"11/14/2023"},{"code":"56","notes":"All Drug and Drug Products;","product":"Antibiotics (Human/Animal)","published":"11/14/2023"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"11/14/2023"},{"code":"60","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"61","notes":"All Drug and Drug Products; These products are excluded from DWPE: Clonazepam Tablet 61M[][]06","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"62","notes":"All Drug and Drug Products; These products are excluded from DWPE: Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95 Azacitidine Injection 62I[][]99","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"63","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"64","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/14/2023"}],"firm_as_published":"Intas Pharmaceuticals Limited","address_as_published":"Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi , Sarkhej-Bavla Highway, Taluka-Sanand, Matoda , Ahmedabad, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2023-07-28T04:00:00Z","posted":"2023-08-01T14:31:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"},{"date":"2023-11-21T05:00:00Z","posted":"2023-11-28T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"},{"date":"2026-03-30T04:00:00Z","posted":"2026-04-28T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"}],"events":[{"d":"2026-03-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2023-11-21","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-11-14","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE: Azacitidine Injection 62I[][]99 Clonazepam Tablet 61M[][]06 Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95"},{"d":"2023-07-28","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-06-01","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32"}],"first":"2023-06-01","last":"2026-03-30","sibs":["3005890633","3007277149","3003157498","3004011473","3011743992"],"colo":["3003696998","3014078015","3003650383","3010079586","3006851796","3030461518","3004086396","3006509185","3002806711","3008314161","3004006229","3012032037"]},{"id":"3005857289","fei":"3005857289","duns":"650442440","firm":"CIPLA LIMITED","registrant":"CIPLA LIMITED","parent":"Cipla","ticker":"CIPLA","addr":"285, 286, 287, KIADB, IV Phase, Industrial area Bommasandra-Jigani Link Road, Bengaluru, Karnataka 560105, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560105","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":12.78642,"lon":77.63458,"prec":"postcode","geo":"560105, Jigani, Anekal, Bengaluru Urban, Karnataka, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"03/14/2017","notes":"","charges":[{"code":"66 S - - 51","notes":"","product":"Tadalafil","published":"03/14/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"03/14/2017"}],"firm_as_published":"Cipla LTD","address_as_published":"Khasra No. 509/1-2 & 520 , Vii-Bhagwanpur , Bhagwanpur, Uttaranchal INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-66","list":"red","since":"10/09/2013","notes":"","charges":[{"code":"60 W - - 16","notes":"","product":"Mebendazole (Anthelmintic)","published":"10/09/2013"}],"firm_as_published":"Cipla Limited","address_as_published":"Patalganga Industrial Area , Plot No A-2, A-33, A-37/2/2, A-42 , Raigad, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"},{"alert":"66-66","list":"red","since":"10/18/2010","notes":"","charges":[{"code":"64 U C S 06","notes":"","product":"Finasteride (Inhibitor (Decarboxylase)), Human - Rx/Single Ingredient, Active Pharm Ingred/Chems for Further Manuf","published":"10/18/2010"}],"firm_as_published":"Cipla, Ltd.","address_as_published":"Plots D-7, D-22, D-27 , M.I.D.C. Industrial Area, Taluka-Daund , Kurkumbh Village, Dist. Pune, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"}],"letters":[{"date":"2023-11-17T05:00:00Z","posted":"2023-11-21T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-660904-11172023","company_as_published":"Cipla Limited","match":"exact"}],"events":[{"d":"2023-11-17","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-660904-11172023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2017-03-14","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2013-10-09","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2010-10-18","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""}],"first":"2010-10-18","last":"2023-11-17","sibs":["3004081307","3002806702","3008581988","3002806710","3002806691"],"colo":["3007512701","3003560263","3009882550","3015345916","3009609358","3004939494","3003768909","3007648351"]},{"id":"3041703540","fei":"3041703540","duns":"854317926","firm":"AAL BIOSCIENCES RESEARCH PRIVATE LIMITED","registrant":"AAL BIOSCIENCES RESEARCH PRIVATE LIMITED","parent":null,"ticker":null,"addr":"287, Plot No 287, Phase 1, HSIIDC Alipur, Barwala, Panchkula, Haryana 134118, India (IND)","city":"Panchkula","state":"Haryana","pin":"134118","ops":["ANALYSIS"],"expires":"12/31/2026","lat":30.57058,"lon":76.94024,"prec":"postcode","geo":"134118, Barwala, Panchkula, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3024206690"]},{"id":"3003696998","fei":"3003696998","duns":"918596206","firm":"ZYDUS LIFESCIENCES LIMITED","registrant":"ZYDUS LIFESCIENCES LIMITED","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"291, G.I.D.C. ESTATE, Ankleshwar, Gujarat 393002, India (IND)","city":"Ankleshwar","state":"Gujarat","pin":"393002","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2024-08-29T04:00:00Z","posted":"2024-09-10T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"12/16/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","company_as_published":"Zydus Lifesciences Limited","match":"exact"},{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","company_as_published":"Zydus Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-29","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-29","last":"2026-06-02","sibs":["3006595385","3008957483","3007938603","3007621329","3006809732","3006026405","3002806475","3012977526","3002984011","3013712903","3005430968"],"colo":["3003722314","3014078015","3003650383","3010079586","3006851796","3030461518","3004086396","3006509185","3002806711","3008314161","3004006229","3012032037"]},{"id":"3048143097","fei":"3048143097","duns":"581789137","firm":"VINNER LABS PRIVATE LIMITED","registrant":"VINNER LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"2nd Floor, Plot No. 6/1, Road No. 2, IDA Nacharam, Medchal Malkajgiri, Hyderabad, Telangana 500076, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500076","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.43874,"lon":78.56145,"prec":"postcode","geo":"500076, Ward 6 Nacharam, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003504071","3006493505","3011573185","3007308467","3005851210","3011823550","3008311641","3008768274","3024919921","3019773458"]},{"id":"3011063130","fei":"3011063130","duns":"922557876","firm":"STARTECH LABS PRIVATE LIMITED","registrant":"STARTECH LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"2nd Floor, SMR Chambers, H.No 1-58/7, Madinaguda,, Hyderabad, Telangana 500050, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500050","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.49573,"lon":78.33327,"prec":"postcode","geo":"500050, Ward 110 Chandanagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Serilingampalle mandal, Ranga Reddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3039358445"],"colo":[]},{"id":"3030461061","fei":"3030461061","duns":"644903923","firm":"Amneal Pharmaceuticals Private Limited","registrant":"Amneal Pharmaceuticals of New York, LLC","parent":null,"ticker":null,"addr":"2nd Floor, W-1, Ambli Road, New York Timber Street, Opp PSP House, S.G. Highway, Ahmedabad, Gujarat 380053, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"380053","ops":["ANALYSIS"],"expires":"12/31/2026","lat":23.02154,"lon":72.58006,"prec":"tail2","geo":"Ahmedabad, Gujarat, 380001, India","status":1,"alerts":[],"letters":[{"date":"2025-08-27T04:00:00Z","posted":"2025-09-02T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","company_as_published":"Amneal Pharmaceuticals, LLC","match":"exact"}],"events":[{"d":"2025-08-27","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-27","last":"2025-08-27","sibs":["3010661577","3010254278","3029456823","3017573557","3018907202","3008223599"],"colo":[]},{"id":"3038430488","fei":"3038430488","duns":"930270205","firm":"PROANTEK RESEARCH LABORATORIES PRIVATE LIMITED","registrant":"PROANTEK RESEARCH LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"2nd Flr, Off. No-2034 K-Wing Plot No.03, Sector 25, Akshar Business Park, Vashi Kopar Khairane Road, Navi Mumbai, MAHARASHTRA 400703, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400703","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.07638,"lon":73.00446,"prec":"postcode","geo":"400703, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008763768","3005972980"]},{"id":"3007112162","fei":"3007112162","duns":"650654655","firm":"AnaCipher CLINICAL RESEARCH ORGANIZATION","registrant":"Indoco Remedies Limited","parent":null,"ticker":null,"addr":"2nd, 3rd and 4th Floor, Mirrakamshetty Mall, Ramanthapur, Medchal-Malkajgiri District, Hyderabad, Telangana 500 013, India (IND)","city":"Hyderabad","state":"Telangana","pin":null,"ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.40212,"lon":78.55854,"prec":"tail3","geo":"near union bank of india, Habsiguda, Ward 8 Habsiguda, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, 500039, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3010960741","fei":"3010960741","duns":"650801215","firm":"MEGSAN LABS PRIVATE LIMITED","registrant":"MEGSAN LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"3-31/33, Plot No. 33, Part Sy. No. S - 123, 124, 125 & 142, Kompally, Quthbullapur, Hyderabad, Telangana 500014, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500014","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.54389,"lon":78.47182,"prec":"postcode","geo":"500014, Dundigal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3023813135","fei":"3023813135","duns":"854315576","firm":"VITELY CORP PRIVATE LIMITED","registrant":"VITELY CORP PRIVATE LIMITED","parent":null,"ticker":null,"addr":"3/4th Floor, Commerce House II, Opposite Pushparaj Tow Judges Bungalows Road, Bodakdev, Ahmedabad, Gujarat 380054, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"380054","ops":["ANALYSIS"],"expires":"12/31/2026","lat":23.04586,"lon":72.52619,"prec":"postcode","geo":"380054, Ghatlodiya Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3008117347","fei":"3008117347","duns":"915846619","firm":"Unimark Remedies Limited","registrant":"Unimark Remedies Limited","parent":null,"ticker":null,"addr":"300, Kerala Nalsarovar Road, Village: Kerala, Tal: Bavla, AHMEDABAD, GUJARAT 382220, India (IND)","city":"AHMEDABAD","state":"Gujarat","pin":"382220","ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.85878,"lon":72.34332,"prec":"postcode","geo":"382220, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004414652"],"colo":["3036572523","3035187076","3033035639","3004161218","3044181625","3008223599"]},{"id":"3041646841","fei":"3041646841","duns":"644969113","firm":"ANTALYA ANALYTICAL SOLUTIONS LLP","registrant":"Antalya Analytical Solutions LLP","parent":null,"ticker":null,"addr":"301-305 Tulsi Industrial Estate And Plaza, Opp Bhagyoday Hotel, Sarkhej-Changodar Highway, Moraiya, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["ANALYSIS"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3036725850","3043068534","3017085815","3010661577","3007277149","3008957483","3007938603","3010254278","3029456823","3007621329","3008725987","3004011473"]},{"id":"3036230268","fei":"3036230268","duns":"756121925","firm":"NeoAnthem Lifesciences Private Limited","registrant":"NeoAnthem Lifesciences Private Limited","parent":null,"ticker":null,"addr":"313-P, 314-P, 318P, Bannikuppe Road Harohalli Industrial Area, Phase II, Harohalli Taluk, Bengaluru South District, Bengaluru South District, Karnataka 562112, India (IND)","city":"Bengaluru South District","state":"Karnataka","pin":"562112","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":12.68682,"lon":77.50493,"prec":"postcode","geo":"562112, Harohalli taluk, Bengaluru South, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3017542362","3014463103","3035948306","3013884349"]},{"id":"3027227554","fei":"3027227554","duns":"955475393","firm":"Eureka Analytical Services Private Limited","registrant":"Eureka Analytical Services Private Limited","parent":null,"ticker":null,"addr":"31St Milestone, Main Gt Road, Beside Amr Mall, Kundli, Sonepat, Haryana 131028, India (IND)","city":"Sonepat","state":"Haryana","pin":"131028","ops":["ANALYSIS"],"expires":"12/31/2026","lat":28.87502,"lon":77.12227,"prec":"postcode","geo":"131028, Sonipat, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3014078015","fei":"3014078015","duns":"916011454","firm":"Cadila Pharmaceuticals Limited","registrant":"Cadila Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"3203, G.I.D.C. Industrial Estate, Ankleshwar, Gujarat 393002, India (IND)","city":"Ankleshwar","state":"Gujarat","pin":"393002","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3007684569","3002806711"],"colo":["3003722314","3003696998","3003650383","3010079586","3006851796","3030461518","3004086396","3006509185","3008314161","3004006229","3012032037","3004390840"]},{"id":"3012255151","fei":"3012255151","duns":"915358204","firm":"SAMANTA ORGANICS PRIVATE LIMITED","registrant":"SAMANTHA ORGANICS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"321, Durian Estate, Goregaon-Mulund Link Road, Goregaon (East), Mumbai, Maharashtra 400063, India (IND)","city":"Mumbai","state":"Maharashtra","pin":"400063","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.16917,"lon":72.86179,"prec":"postcode","geo":"400063, P/S Ward, Mumbai Zone 4, Mumbai, Mumbai Suburban District, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3018369072"],"colo":["3003882508"]},{"id":"3015077059","fei":"3015077059","duns":"871418313","firm":"Bajaj Nutraceuticals","registrant":"Bajaj Nutraceuticals","parent":null,"ticker":null,"addr":"328M, Raipur Industrial Area, Bhagwanpur, Roorkee, Uttarakhand 247661, India (IND)","city":"Roorkee","state":"Uttarakhand","pin":"247661","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":29.97104,"lon":77.79879,"prec":"postcode","geo":"247661, Roorkee, Haridwar, Uttarakhand, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3012020703","Tehsil Bhagwanpur, Khasra No 189/3, 189/4, 190, 190/1, Haridwar, UT 247661, India (IND)","3006895982"]},{"id":"3003520162","fei":"3003520162","duns":"650540680","firm":"SHASHI PHYTOCHEMICAL INDUSTRIES","registrant":"SHASHI PHYTOCHEMICAL INDUSTRIES","parent":null,"ticker":null,"addr":"329, DELHI ROAD, ALWAR, RAJASTHAN 301001, India (IND)","city":"ALWAR","state":"Rajasthan","pin":"301001","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":27.57411,"lon":76.60871,"prec":"postcode","geo":"301001, Alwar, Alwar Tehsil, Alwar, Rajasthan, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3037699325","fei":"3037699325","duns":"873680325","firm":"ATHULITHA LABORATORIES PRIVATE LIMITED","registrant":"ATHULITHA LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"34/A, SVCIE, IDA, Jeedimetla, Medchal-Malkajgiri, Telangana 500055, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500055","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003937580","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869","3018694293"]},{"id":"36P & 37 Saidapur Road, Yadgir, Karnataka 585201, India (IND)","fei":"","duns":"644876223","firm":"Synnova Intermediates Private Limited","registrant":"Synnova Intermediates Private Limited","parent":null,"ticker":null,"addr":"36P & 37 Saidapur Road, Yadgir, Karnataka 585201, India (IND)","city":"Yadgir","state":"Karnataka","pin":"585201","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.76071,"lon":77.13537,"prec":"postcode","geo":"585201, Yadagiri taluku, Yadgir, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3009167769","fei":"3009167769","duns":"650543262","firm":"Kumar Organic Products Limited","registrant":"Kumar Organic Products Limited","parent":null,"ticker":null,"addr":"379, Canal Road, Village Luna Taluka Padra, Vadodara, Gujarat 391440, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391440","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.24672,"lon":73.08544,"prec":"postcode","geo":"391440, Padra Taluka, Vadodara, Gujarat, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"08/01/2012","notes":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).India","charges":[{"code":"53 E - - 01","notes":"","product":"Hair Conditioners (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 07","notes":"","product":"Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 99","notes":"","product":"Other Hair Preparations, Non-coloring), N.E.C.","published":"08/01/2012"},{"code":"62 C - - 41","notes":"","product":"Minoxidil (Anti-Hypertensive)","published":"08/01/2012"},{"code":"62 C - - 99","notes":"","product":"Anti-Hypertensive N.E.C.","published":"08/01/2012"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/01/2012"}],"firm_as_published":"Kumar Organic Products Limited","address_as_published":"Plot 94P, 103 & 104, Pharma Sez, HN Pura Road, KIADB Industrial Area , Hassan, Karnataka INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"08/01/2012","notes":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India","charges":[{"code":"53 E - - 01","notes":"","product":"Hair Conditioners (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 07","notes":"","product":"Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 99","notes":"","product":"Other Hair Preparations, Non-coloring), N.E.C.","published":"08/01/2012"},{"code":"62 C - - 41","notes":"","product":"Minoxidil (Anti-Hypertensive)","published":"08/01/2012"},{"code":"62 C - - 99","notes":"","product":"Anti-Hypertensive N.E.C.","published":"08/01/2012"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/01/2012"}],"firm_as_published":"Kumar Organic Products Ltd.","address_as_published":"Plot No. 60&65, Road No.3, Jigani Industrial Area, Jigani, , Anekal Taluk, Bengaluru, Karnataka INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"08/01/2012","notes":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India","charges":[{"code":"53 E - - 01","notes":"","product":"Hair Conditioners (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 07","notes":"","product":"Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 99","notes":"","product":"Other Hair Preparations, Non-coloring), N.E.C.","published":"08/01/2012"},{"code":"62 C - - 41","notes":"","product":"Minoxidil (Anti-Hypertensive)","published":"08/01/2012"},{"code":"62 C - - 99","notes":"","product":"Anti-Hypertensive N.E.C.","published":"08/01/2012"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/01/2012"}],"firm_as_published":"Kumar Organic Products Ltd.","address_as_published":"Anekai Taluk , S No 49; Bannerghatta Road , Bengaluru, Karnataka INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2012-08-01","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).India"},{"d":"2012-08-01","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India"},{"d":"2012-08-01","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India"}],"first":"2012-08-01","last":"2012-08-01","sibs":["3008957541","3003768909"],"colo":["3005183272","3009119873","3005906909","3009219197","3006767695","3007836955","3008494993","3008405956","3002806475","3010166818","3038848101"]},{"id":"3038789880","fei":"3038789880","duns":"932605938","firm":"Wexford Laboratories Private Limited","registrant":"Wexford Laboratories Private Limited","parent":null,"ticker":null,"addr":"37B 37C, Vasanthanarasapura Industrial Area Phase 1, Kora Hobli, Tumakuru, KARNATAKA 572201, India (IND)","city":"Tumakuru","state":"Karnataka","pin":"572201","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":13.25032,"lon":76.48258,"prec":"postcode","geo":"572201, Tipaturu taluk, Tumakuru, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3005122933","fei":"3005122933","duns":"650328805","firm":"Symbiotec Pharmalab Limited","registrant":"Symbiotec Pharmalab Limited","parent":null,"ticker":null,"addr":"385/2, Pigdamber, Rau, Mhow, Indore, Madhya Pradesh 453331, India (IND)","city":"Indore","state":"Madhya Pradesh","pin":"453331","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.62244,"lon":75.80397,"prec":"postcode","geo":"453331, Pigdambar, Pigdamber, Rau Tahsil, Indore, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009298759"],"colo":["3015348439","3025817290"]},{"id":"3014595540","fei":"3014595540","duns":"876817152","firm":"Hazelo Lab Private Limited","registrant":"Hazelo Lab Private Limited","parent":null,"ticker":null,"addr":"3rd Floor, A Wing, H No 4-166 SY No 242, 247, 248 and 249, Dothigudem Village, Jablakpally, B Pochampally Mandal,, Yadadri Bhuvanagiri, Telangana 508284, India (IND)","city":"Yadadri Bhuvanagiri","state":"Telangana","pin":"508284","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.35845,"lon":78.85712,"prec":"postcode","geo":"508284, B. Pochampally mandal, Yadadri Bhuvanagiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3010419177"]},{"id":"3037008841","fei":"3037008841","duns":"772673818","firm":"COTECNA LIFE SCIENCES INDIA PRIVATE LIMITED","registrant":"COTECNA LIFE SCIENCES INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"3rd Floor, Plot No.39, Ganpati Pada, TTC Industrial Estate, MIDC, Kalwa, Navi Mumbai, Maharashtra 400605, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400605","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.20227,"lon":73.00279,"prec":"postcode","geo":"400605, Thane, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3048141588","fei":"3048141588","duns":"860251527","firm":"Auro Central Testing Laboratory","registrant":"Aurobindo Pharma Limited","parent":"Aurobindo Pharma","ticker":"AUROPHARMA","addr":"3rd Floor, Survey Nos. 71 & 72, Indrakaran Village, Kandi Mandal, Sangareddy, Telangana 502329, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502329","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.55007,"lon":78.16544,"prec":"postcode","geo":"502329, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3010923869","3008765247","3005254981"]},{"id":"3005202412","fei":"3005202412","duns":"676244169","firm":"InterMed Laboratories Private Limited","registrant":"InterMed Laboratories Private Limited","parent":null,"ticker":null,"addr":"4, G.k. Industrial Estate, Alapakkam, Tiruvallur Arcot Road, Porur, CHENNAI, Tamil Nadu 600116, India (IND)","city":"CHENNAI","state":"Tamil Nadu","pin":"600116","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":13.03267,"lon":80.16048,"prec":"postcode","geo":"600116, Zone 11 Valasaravakkam, Maduravoyal, Chennai Corporation, Ambattur, Thiruvallur, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3006033094","fei":"3006033094","duns":"918535225","firm":"Halcyon Labs Private Limited","registrant":"Halcyon Labs Private Limited","parent":null,"ticker":null,"addr":"405-408 Navbharat Estates Zakaria Bunder Road, Sewri (West), Mumbai,  400015, India (IND)","city":"Mumbai","state":null,"pin":"400015","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.00046,"lon":72.85179,"prec":"postcode","geo":"400015, F/S Ward, Mumbai Zone 2, Mumbai City District, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3004414652","fei":"3004414652","duns":"918458725","firm":"Unimark Remedies Limited","registrant":"Unimark Remedies Limited","parent":null,"ticker":null,"addr":"41/42, GIDC Industrial Estate, 1st Phase, Dist: Valsad, Vapi, Gujurat 396195, India (IND)","city":"Vapi","state":null,"pin":"396195","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":20.36447,"lon":72.9263,"prec":"postcode","geo":"396195, Vapi Taluka, Valsad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008117347"],"colo":["3006688078","3009765202","3004810446","3007850324","3008460260","3034419392"]},{"id":"3009882448","fei":"3009882448","duns":"725929124","firm":"Indena India Private Limited","registrant":"Indena SpA","parent":null,"ticker":null,"addr":"43/3 Shivapura Post, Ranganathpur Dodaballapur, BENGALURU, KAR 562163, India (IND)","city":"BENGALURU","state":null,"pin":"562163","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.27389,"lon":77.56344,"prec":"postcode","geo":"562163, Doddaballapura taluk, Bengaluru North, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3038164496","fei":"3038164496","duns":"771664688","firm":"ATERNA LABS PRIVATE LIMITED","registrant":"ATERNA LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"47/1A, 47/1B1, 47/1B2 & 48, Dondapadu Road, The KCP Limited, Mukteswarapuram, N.T.R, 521 457, Andhra Pradesh, India, Jaggaiapet, Andhra Pradesh 521 457, India (IND)","city":"521 457","state":"Andhra Pradesh","pin":null,"ops":["MANUFACTURE"],"expires":"12/31/2026","lat":15.92409,"lon":80.18638,"prec":"state","geo":"Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3043513108","fei":"3043513108","duns":"932793654","firm":"JOHNSON & SMITH COMPANY","registrant":"JOHNSON SMITH COMPANY","parent":null,"ticker":null,"addr":"4j-4k Dobaspet Industrial Area Nelamangala, Bengaluru Rural,  562123, India (IND)","city":"Bengaluru Rural","state":null,"pin":"562123","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":13.11741,"lon":77.38033,"prec":"postcode","geo":"562123, Vishveshwarapura, Mallapura, Nelamangala taluk, Bengaluru North, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003821988","3009150119","3023352430"]},{"id":"3006211400","fei":"3006211400","duns":"650392637","firm":"Actimus Biosciences Private Limited","registrant":"Actimus Biosciences Private Limited","parent":null,"ticker":null,"addr":"4th Floor, Varun Towers, 7-8-1/3, VISAKHAPATNAM,  530003, India (IND)","city":"VISAKHAPATNAM","state":null,"pin":"530003","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.72402,"lon":83.31855,"prec":"postcode","geo":"530003, Visakhapatnam Urban, Visakhapatnam, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3007078752"],"colo":[]},{"id":"3008449456","fei":"3008449456","duns":"862170057","firm":"OMNI LENS PRIVATE LIMITED","registrant":"OMNI LENS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"5 Samrudddhi Ground Floor, Near Sattar Taluka Society, Navrangpura, Ahmedabad, Gujrat 380014, India (IND)","city":"Ahmedabad","state":null,"pin":"380014","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":23.04135,"lon":72.5618,"prec":"postcode","geo":"380014, SabarmatiTaluka, Ahmedabad, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/27/2024","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/27/2024"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"09/27/2024"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"09/27/2024"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"09/27/2024"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"09/27/2024"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"09/27/2024"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"09/27/2024"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"09/27/2024"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"09/27/2024"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"09/27/2024"}],"firm_as_published":"Omni Lens Private Limited","address_as_published":"5 Samrudddhi Ground Floor, Near Sattar Taluka Society, Navrangpura , Ahmedabad, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2024-10-02T04:00:00Z","posted":"2024-10-22T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/omni-lens-pvt-ltd-688151-10022024","company_as_published":"Omni Lens Pvt. Ltd.","match":"exact"}],"events":[{"d":"2024-10-02","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/omni-lens-pvt-ltd-688151-10022024","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-09-27","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2024-09-27","last":"2024-10-02","sibs":[],"colo":[]},{"id":"3038416771","fei":"3038416771","duns":"930273802","firm":"Hexagon Analytical Solutions Private Limited","registrant":"Hexagon Analytical Solutions Private Limited","parent":null,"ticker":null,"addr":"511-512, Naroda Icon, Near Naroda Toll Plaza, S P Ring Road, Opp Darshan Hotel, Naroda, Ahmedabad, Gujarat 382330, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382330","ops":["ANALYSIS"],"expires":"12/31/2026","lat":23.08459,"lon":72.68392,"prec":"postcode","geo":"382330, Asarva Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["1000607691"]},{"id":"3013455974","fei":"3013455974","duns":"876817087","firm":"KALINTIS HEALTHCARE PRIVATE LIMITED","registrant":"KALINTIS HEALTHCARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"52A, JAROD SAMLAYA ROAD PO GARDHIYA, TALUKA - SAVLI GA, Vadodara, Gujarat 391520, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391520","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":22.52534,"lon":73.28682,"prec":"postcode","geo":"391520, Savli Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3004462816","fei":"3004462816","duns":"876818924","firm":"Sbl (india) Private Limited","registrant":"Bakson Drugs and Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"533, Sitapura Industrial Area, Jaipur,  302022, India (IND)","city":"Jaipur","state":null,"pin":"302022","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":26.7736,"lon":75.83811,"prec":"postcode","geo":"302022, Sanganer Tehsil, Jaipur, Rajasthan, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"12/22/2023","notes":"","charges":[{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"12/22/2023"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"12/22/2023"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"01/23/2026"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"01/23/2026"}],"firm_as_published":"SBL Private Limited","address_as_published":"Sbl House , 2, Commercial Complex, Shrestha Vihar , East Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[],"events":[{"d":"2026-01-23","k":"charge","t":"66-41 charge 66 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2026-01-23","k":"charge","t":"66-41 charge 66 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2023-12-22","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""}],"first":"2023-12-22","last":"2026-01-23","sibs":[],"colo":["3003925108"]},{"id":"3003821988","fei":"3003821988","duns":"677236695","firm":"Somerset Therapeutics Private Limited","registrant":"Somerset Therapeutics Private Limited","parent":null,"ticker":null,"addr":"54/1, Boodihal Village Nelamangala Taluk, Bengaluru, Karnataka 562123, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"562123","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":13.11741,"lon":77.38033,"prec":"postcode","geo":"562123, Vishveshwarapura, Mallapura, Nelamangala taluk, Bengaluru North, Karnataka, India","status":1,"alerts":[],"letters":[{"date":"2025-09-04T04:00:00Z","posted":"2025-09-16T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/somerset-therapeutics-private-limited-711340-09042025","company_as_published":"Somerset Therapeutics Private Limited","match":"exact"}],"events":[{"d":"2025-09-04","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/somerset-therapeutics-private-limited-711340-09042025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-09-04","last":"2025-09-04","sibs":[],"colo":["3043513108","3009150119","3023352430"]},{"id":"3003496619","fei":"3003496619","duns":"650564870","firm":"Coral Drugs Private Limited","registrant":"Coral Drugs Private Limited","parent":null,"ticker":null,"addr":"55-56-57 HSIIDC Industrial Estate Murthal, Sonipat,  131039, India (IND)","city":"Sonipat","state":null,"pin":"131039","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":29.03187,"lon":77.06055,"prec":"postcode","geo":"131039, Sonipat, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3015348439","fei":"3015348439","duns":"932612007","firm":"PIOUS LABORATORIES PRIVATE LIMITED","registrant":"Pious Laboratories Private Limited","parent":null,"ticker":null,"addr":"57, Confectionery Park, Rangwasa, Rau, Indore, Madhya Pradesh 453331, India (IND)","city":"Indore","state":"Madhya Pradesh","pin":"453331","ops":["ANALYSIS"],"expires":"12/31/2026","lat":22.62244,"lon":75.80397,"prec":"postcode","geo":"453331, Pigdambar, Pigdamber, Rau Tahsil, Indore, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005122933","3025817290"]},{"id":"3011212532","fei":"3011212532","duns":"871403710","firm":"AVANTOR PERFORMANCE MATERIALS INDIA LIMITED","registrant":"Avantor Performance Materials, LLC","parent":null,"ticker":null,"addr":"5th Floor, Tiffeny Building, Hiranandani Business Park Off Ghodbunder Road,Hiranandani Estate, Thane (West), Maharashtra 400607, India (IND)","city":"Thane (West)","state":"Maharashtra","pin":"400607","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.24448,"lon":72.9963,"prec":"postcode","geo":"400607, Thane, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3015612053","fei":"3015612053","duns":"675485901","firm":"Felix Generics Private Limited","registrant":"Felix Pharmaceuticals PVT Limited","parent":null,"ticker":null,"addr":"5th Floor, Wegmans Business Park, Sector Knowledge Park III, Noida, Uttar Pradesh 201308, India (IND)","city":"Noida","state":"Uttar Pradesh","pin":"201308","ops":["ANALYSIS"],"expires":"12/31/2026","lat":28.49057,"lon":77.49641,"prec":"postcode","geo":"201308, Gautam Buddha Nagar, Uttar Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3038913994","3014281041"],"colo":[]},{"id":"3004790309","fei":"3004790309","duns":"858363058","firm":"TYCHE INDUSTRIES LIMITED","registrant":"TYCHE INDUSTRIES LIMITED","parent":null,"ticker":null,"addr":"6/223, SARPAVARAM, KAKINADA, ANDHRA PRADESH 533005, India (IND)","city":"KAKINADA","state":"Andhra Pradesh","pin":"533005","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.03848,"lon":82.20595,"prec":"postcode","geo":"533005, Samalkota, Kakinada, Andhra Pradesh, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"01/02/2025","notes":"All Drug and Drug Products","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"01/02/2025"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"01/02/2025"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"01/02/2025"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"01/02/2025"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"01/02/2025"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"01/02/2025"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"01/02/2025"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"01/02/2025"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/02/2025"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/02/2025"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/02/2025"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/02/2025"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/02/2025"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/02/2025"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/02/2025"}],"firm_as_published":"Tyche Industries Ltd.","address_as_published":"6 - 223 Sarpavaram (V) , Kakinada, Andhra Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2025-02-06T05:00:00Z","posted":"2025-02-18T05:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tyche-industries-ltd-693081-02062025","company_as_published":"Tyche Industries Ltd","match":"exact"}],"events":[{"d":"2025-02-06","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tyche-industries-ltd-693081-02062025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2025-01-02","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2025-01-02","last":"2025-02-06","sibs":[],"colo":[]},{"id":"3022553857","fei":"3022553857","duns":"871599331","firm":"ANANTA MEDICARE LIMITED","registrant":"ANANTA MEDICARE LIMITED","parent":null,"ticker":null,"addr":"621, RING ROAD MALL, SECTOR 3, ROHINI, DELHI, DELHI 110085, India (IND)","city":"ROHINI","state":"Delhi","pin":"110085","ops":["LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":28.71903,"lon":77.11611,"prec":"postcode","geo":"110085, Rohini, Delhi, North West Delhi, Delhi, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3030554615","fei":"3030554615","duns":"932464248","firm":"AMGIS LIFESCIENCE LIMITED","registrant":"AMGIS LIFESCIENCE LIMITED","parent":null,"ticker":null,"addr":"631 To 639, 654 To 656, 2019 To 2027/2, Amardeep Chemical Industries Pvt Ltd, Gidc Estate, Panoli, Bharuch, Gujarat 394116, India (IND)","city":"Bharuch","state":"Gujarat","pin":"394116","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.53479,"lon":72.95568,"prec":"postcode","geo":"394116, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038149173","3003952717","3003053502","3015776899","3013151303","3009627283","3004196193"]},{"id":"3007676986","fei":"3007676986","duns":"915896189","firm":"Sujanil Chemo Industries","registrant":"Sujanil Chemo Industries","parent":null,"ticker":null,"addr":"69/1-A/1-B, Wanawadi Industrial Area, Pune, MH 411040, India (IND)","city":"Pune","state":null,"pin":"411040","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":18.49142,"lon":73.89914,"prec":"postcode","geo":"411040, Pune City Subdistrict, Pune, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3003560263","fei":"3003560263","duns":"918602129","firm":"Hikal Limited","registrant":"Hikal Limited","parent":null,"ticker":null,"addr":"72 & 82/A, KIADB Industrial Area Jigani, Anekal Taluk, Bengaluru, Karnataka 560105, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560105","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":12.78642,"lon":77.63458,"prec":"postcode","geo":"560105, Jigani, Anekal, Bengaluru Urban, Karnataka, India","status":1,"alerts":[],"letters":[{"date":"2025-08-20T04:00:00Z","posted":"2025-09-09T04:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hikal-limited-709370-08202025","company_as_published":"Hikal Limited","match":"exact"}],"events":[{"d":"2025-08-20","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hikal-limited-709370-08202025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-20","last":"2025-08-20","sibs":["3009627283"],"colo":["3007512701","3005857289","3009882550","3015345916","3009609358","3004939494","3003768909","3007648351"]},{"id":"3009882550","fei":"3009882550","duns":"916512426","firm":"Cdymax (India) Pharma Private Limited","registrant":"Cdymax (India) Pharma Private Limited","parent":null,"ticker":null,"addr":"77D & 116/117, KIADB Industrial Area Jigani, 2nd Phase, Bengaluru, Karnataka 560105, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560105","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":12.78642,"lon":77.63458,"prec":"postcode","geo":"560105, Jigani, Anekal, Bengaluru Urban, Karnataka, India","status":1,"alerts":[],"letters":[{"date":"2025-11-13T05:00:00Z","posted":"2025-11-18T05:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cdymax-india-pharma-private-limited-715022-11132025","company_as_published":"Cdymax India Pharma Private Limited","match":"exact"}],"events":[{"d":"2025-11-13","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cdymax-india-pharma-private-limited-715022-11132025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-11-13","last":"2025-11-13","sibs":["3030133758"],"colo":["3007512701","3005857289","3003560263","3015345916","3009609358","3004939494","3003768909","3007648351"]},{"id":"3038945565","fei":"3038945565","duns":"877230216","firm":"DEFT ORGANICS LIMITED","registrant":"Deft Organics Limited","parent":null,"ticker":null,"addr":"79-100, Sector-a, Bhind Road, Maharajpura Industrial Area, Gwalior, MP 474020, India (IND)","city":"Gwalior","state":null,"pin":"474020","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":26.25882,"lon":78.21412,"prec":"postcode","geo":"474020, Gwalior, Gird Tahsil, Gwalior, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3002780785","fei":"3002780785","duns":"650474468","firm":"MALLADI DRUGS AND PHARMACEUTICALS LIMITED","registrant":"Malladi Drugs & Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"7B & 7C, Sipcot Industrial Complex, Ranipet, Tamil Nadu 632403, India (IND)","city":"Ranipet","state":"Tamil Nadu","pin":"632403","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":12.95652,"lon":79.30426,"prec":"postcode","geo":"632403, Wallajah, Ranipet, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005115135","3004896422"],"colo":[]},{"id":"3009456513","fei":"3009456513","duns":"916631491","firm":"Ami Lifesciences Private Limited","registrant":"Ami Lifesciences Private Limited","parent":null,"ticker":null,"addr":"82/B, ECP Road, At & post Karakhadi-Taluka: Padra, District: Vadodara,., Vadodara, Gujarat 391450, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391450","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.21881,"lon":72.98271,"prec":"postcode","geo":"391450, Padra Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3007501748","3013826490","3015685305"]},{"id":"3004443761","fei":"3004443761","duns":"677600521","firm":"ALKALOIDS BIOACTIVES PRIVATE LIMITED","registrant":"ALKALOIDS BIOACTIVES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"834 (P) Medchal Shamirpet Road, Medchal Mandal,, Medchal-Malkajgiri, Telangana 501401, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"501401","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62984,"lon":78.48653,"prec":"postcode","geo":"501401, Medchal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038105776","3003802255","3014529730","3022190657"]},{"id":"3015621300","fei":"3015621300","duns":"873673519","firm":"Ocean Healthcare Pvt Ltd","registrant":"Sidharth Baid","parent":null,"ticker":null,"addr":"86 /1-6 Orathur Village, Thiruporur Taluk, Chengalpattu, Tamil Nadu 603105, India (IND)","city":"Chengalpattu","state":"Tamil Nadu","pin":"603105","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":12.71995,"lon":80.18724,"prec":"postcode","geo":"603105, Tiruporur, Chengalpattu, Tamil Nadu, India","status":1,"alerts":[],"letters":[{"date":"2024-04-17T04:00:00Z","posted":"2024-05-14T13:20:00Z","subject":"Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ocean-group-inc-675713-04172024","company_as_published":"Ocean Group Inc.","match":"token"},{"date":"2026-03-03T05:00:00Z","posted":"2026-04-14T04:00:00Z","subject":"Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions","office":"Human Foods Program","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ocean-group-inc-715467-03032026","company_as_published":"Ocean Group Inc.","match":"token"}],"events":[{"d":"2026-03-03","k":"letter","t":"Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ocean-group-inc-715467-03032026","x":"Human Foods Program"},{"d":"2024-04-17","k":"letter","t":"Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ocean-group-inc-675713-04172024","x":"Division of Human and Animal Food Operations West V"}],"first":"2024-04-17","last":"2026-03-03","sibs":[],"colo":["3041045488"]},{"id":"3007027193","fei":"3007027193","duns":"676159161","firm":"Par Formulations Private Limited","registrant":"Par Health USA, LLC","parent":null,"ticker":null,"addr":"9/215, Pudupakkam-Vandalur Main Road, Pudupakkam, Kelambakkam,,, Chennai, Tamil Nadu 603103, India (IND)","city":"Chennai","state":"Tamil Nadu","pin":"603103","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.81951,"lon":80.22035,"prec":"postcode","geo":"603103, Tiruporur, Chengalpattu, Tamil Nadu, India","status":1,"alerts":[],"letters":[{"date":"2026-04-15T04:00:00Z","posted":"2026-04-21T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/par-health-usa-llc-endo-usa-inc-722121-04152026","company_as_published":"Par Health USA, LLC & Endo USA, Inc.","match":"token"}],"events":[{"d":"2026-04-15","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/par-health-usa-llc-endo-usa-inc-722121-04152026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-04-15","last":"2026-04-15","sibs":["3014425346","3016268582"],"colo":["3006381009"]},{"id":"3002911411","fei":"3002911411","duns":"650578565","firm":"Global Dent Aids Private Limited","registrant":"GLOBAL DENT AIDS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"91, NSEZ, Gautam Buddha Nagar, Noida, Uttar Pradesh 201305, India (IND)","city":"Noida","state":"Uttar Pradesh","pin":"201305","ops":["PACK","REPACK"],"expires":"12/31/2026","lat":28.52353,"lon":77.41648,"prec":"postcode","geo":"201305, Noida, Dadri, Gautam Buddha Nagar, Uttar Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3026324208"]},{"id":"3006688078","fei":"3006688078","duns":"925626983","firm":"Megafine Pharma (P) Limited","registrant":"Megafine Pharma (P) Limited","parent":null,"ticker":null,"addr":"911 & 912, GIDC, III Phase,, Vapi,  396195, India (IND)","city":"Vapi","state":null,"pin":"396195","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":20.36447,"lon":72.9263,"prec":"postcode","geo":"396195, Vapi Taluka, Valsad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005694111"],"colo":["3004414652","3009765202","3004810446","3007850324","3008460260","3034419392"]},{"id":"3009326970","fei":"3009326970","duns":"917997967","firm":"GULKAS PHARMA PRIVATE LIMITED","registrant":"GULKAS PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"914/1 Gidc Est, Gandhinagar, Gujarat 382729, India (IND)","city":"Gandhinagar","state":"Gujarat","pin":"382729","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":23.29313,"lon":72.43882,"prec":"postcode","geo":"382729, Kalol Taluka, Gandhinagar, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3012740315"]},{"id":"3029943792","fei":"3029943792","duns":"877268068","firm":"CHROMO HEALTH CARE PRIVATE LIMITED","registrant":"Chromo Healthcare Private Limited","parent":null,"ticker":null,"addr":"94/95, EPIP, Pashamylaram, Patancheru Mandal, Sangareddy District, Telangana 502307, India (IND)","city":"Sangareddy District","state":"Telangana","pin":"502307","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2025-08-06T04:00:00Z","posted":"2025-08-12T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","company_as_published":"K & Care Organics","match":"token"}],"events":[{"d":"2025-08-06","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-06","last":"2025-08-06","sibs":[],"colo":["3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167","3005075182"]},{"id":"3008909227","fei":"3008909227","duns":"915388904","firm":"Bharat Explosives Limited","registrant":"Bharat Pharma (A Unit of Bharat Explosives Limited)","parent":null,"ticker":null,"addr":"9KM, Lalitpur Jhansi Road, Lalitpur, UP 284403, India (IND)","city":"Lalitpur","state":null,"pin":"284403","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":24.67034,"lon":78.4481,"prec":"postcode","geo":"284403, Lalitpur Tehsil, Lalitpur, Uttar Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3003227148","fei":"3003227148","duns":"915259324","firm":"Wanbury Limited","registrant":"Wanbury Limited","parent":null,"ticker":null,"addr":"A - 15, M.I.D.C. Industrial Area, Patalganga, Dist-Raigad, Maharashtra 410220, India (IND)","city":"Dist-Raigad","state":"Maharashtra","pin":"410220","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":18.86792,"lon":73.16278,"prec":"postcode","geo":"410220, Panvel Subdistrict, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002980818"],"colo":["3006784730","3010437486","3002806710"]},{"id":"3007497376","fei":"3007497376","duns":"650542744","firm":"Supriya Lifescience Limited","registrant":"Supriya Lifescience Limited","parent":null,"ticker":null,"addr":"A - 5 / 2, Lote Parshuram Industrial Area, Ratnagiri, Maharashtra 415722, India (IND)","city":"Ratnagiri","state":"Maharashtra","pin":"415722","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.57724,"lon":73.52335,"prec":"postcode","geo":"415722, Khed Taluka, Ratnagiri, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003882508","3032073298"],"colo":["3027337476"]},{"id":"3004995645","fei":"3004995645","duns":"862272739","firm":"LUPIN LIMITED","registrant":"LUPIN LIMITED","parent":"Lupin","ticker":"LUPIN","addr":"A 28-1, MIDC Industrial Area, Chikalthana, Chhatrapati Sambhajinagar, Maharashtra 431210, India (IND)","city":"Chhatrapati Sambhajinagar","state":"Maharashtra","pin":"431210","ops":["MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.87241,"lon":75.38755,"prec":"postcode","geo":"431210, Chhatrapati Sambhajinagar, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2021-06-11T04:00:00Z","posted":"2021-06-29T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Office of Pharmaceutical Quality Operations Division I","response":"","closeout":"04/19/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","company_as_published":"Novel Laboratories, Inc. d.b.a LUPIN","match":"token"},{"date":"2022-09-27T04:00:00Z","posted":"2022-11-01T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","company_as_published":"Lupin Limited","match":"exact"}],"events":[{"d":"2022-09-27","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-06-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","x":"Office of Pharmaceutical Quality Operations Division I"}],"first":"2021-06-11","last":"2022-09-27","sibs":["3010977634","3004819820","3002807510","3002807512","3002807511","3009843207","3009831799","3007756473","3015392060","3007549629","3009107538"],"colo":[]},{"id":"3009765202","fei":"3009765202","duns":"650621472","firm":"Swati Spentose Private Limited","registrant":"Swati Spentose Pvt. Ltd.","parent":null,"ticker":null,"addr":"A-1/2102, 2103 & A2/2120, Phase III, GIDC, Vapi, Gujarat 396195, India (IND)","city":"Vapi","state":"Gujarat","pin":"396195","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":20.36447,"lon":72.9263,"prec":"postcode","geo":"396195, Vapi Taluka, Valsad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004414652","3006688078","3004810446","3007850324","3008460260","3034419392"]},{"id":"3003585876","fei":"3003585876","duns":"650564045","firm":"Solara Active Pharma Sciences Limited","registrant":"SOLARA ACTIVE PHARMA SCIENCES LIMITED","parent":null,"ticker":null,"addr":"A-1/B, Sipcot Industrial Complex, Kudikadu Village, Cuddalore, Tamil Nadu 607005, India (IND)","city":"Cuddalore","state":"Tamil Nadu","pin":"607005","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":11.52021,"lon":79.33964,"prec":"tail2","geo":"Cuddalore, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008374690","3016965485","3008252997","3002808058","3011856449"],"colo":["3030840962"]},{"id":"3004101736","fei":"3004101736","duns":"650446276","firm":"HARMAN FINOCHEM LIMITED","registrant":"HARMAN FINOCHEM LIMITED","parent":null,"ticker":null,"addr":"A-100, A-100/1, A-100/2, A-120 & D-1, M.I.D.C Industrial Area, Shendra, Chhatrapati Sambhajinagar, Maharashtra 431154, India (IND)","city":"Chhatrapati Sambhajinagar","state":"Maharashtra","pin":"431154","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":19.87228,"lon":75.47133,"prec":"tail3","geo":"Shendra, Chhatrapati Sambhajinagar, Maharashtra, 431201, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3015838038","3041504075","3003130103"],"colo":["3034735246","3009915929","3009278506"]},{"id":"3015838038","fei":"3015838038","duns":"675487429","firm":"HARMAN FINOCHEM LIMITED","registrant":"HARMAN FINOCHEM LIMITED","parent":null,"ticker":null,"addr":"A-100/1 Finished Dosage Form (FDF), M.I.D.C. Industrial Area, Shendra, Chhatrapati Sambhajinagar, Maharashtra 431154, India (IND)","city":"Chhatrapati Sambhajinagar","state":"Maharashtra","pin":"431154","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":19.87228,"lon":75.47133,"prec":"tail3","geo":"Shendra, Chhatrapati Sambhajinagar, Maharashtra, 431201, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004101736","3041504075","3003130103"],"colo":["3034735246","3009915929","3009278506"]},{"id":"3014207480","fei":"3014207480","duns":"675471888","firm":"Nalanda Research Laboratories","registrant":"Nalanda Research Laboratories","parent":null,"ticker":null,"addr":"A-117, SILVER SPRINGS, PANVEL, TALOJA MIDC, PLOT NO. 6, OPPOSITE DENA BANK, Raigad, Maharashtra 410208, India (IND)","city":"Raigad","state":"Maharashtra","pin":"410208","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.06884,"lon":73.11504,"prec":"postcode","geo":"410208, Panvel, Panvel Subdistrict, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008177314","3009934288","3044141181","3005048741","3004947391","3027545288","3004455093","3015986431","3025922195","3003908605"]},{"id":"3005216842","fei":"3005216842","duns":"862636623","firm":"Alchymars ICM SM Private Limited","registrant":"Alchymars ICM SM Private Limited","parent":null,"ticker":null,"addr":"A-14 & 20, SIDCO Pharmaceutical Complex, Alathur, Chengalpattu District, Tamil Nadu 603110, India (IND)","city":"Chengalpattu District","state":"Tamil Nadu","pin":"603110","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":12.71867,"lon":80.09467,"prec":"postcode","geo":"603110, Chengalpattu, Tamil Nadu, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"05/19/2026","notes":"All Drugs and Drug Products","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"05/19/2026"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"05/19/2026"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"05/19/2026"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"05/19/2026"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"05/19/2026"},{"code":"55","notes":"All Drugs and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"05/19/2026"},{"code":"56","notes":"All Drugs and Drug Products","product":"Antibiotics (Human/Animal)","published":"05/19/2026"},{"code":"58","notes":"All Drugs and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/19/2026"},{"code":"60","notes":"All Drugs and Drug Products","product":"Human and Animal Drugs","published":"05/19/2026"},{"code":"61","notes":"All Drugs and Drug Products","product":"Human and Animal Drugs","published":"05/19/2026"},{"code":"62","notes":"All Drugs and Drug Products","product":"Human and Animal Drugs","published":"05/19/2026"},{"code":"63","notes":"All Drugs and Drug Products","product":"Human and Animal Drugs","published":"05/19/2026"},{"code":"64","notes":"All Drugs and Drug Products","product":"Human and Animal Drugs","published":"05/19/2026"},{"code":"65","notes":"All Drugs and Drug Products","product":"Human and Animal Drugs","published":"05/19/2026"},{"code":"66","notes":"All Drugs and Drug Products","product":"Human and Animal Drugs","published":"05/19/2026"}],"firm_as_published":"Alchymars ICM SM Private Limited","address_as_published":"A - 14 & 20 Sidco Pharmaceutical Complex , Alathur, Tamil Nadu INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2026-05-21T04:00:00Z","posted":"2026-05-26T04:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alchymars-icm-sm-private-limited-724429-05212026","company_as_published":"Alchymars ICM SM Private Limited","match":"exact"}],"events":[{"d":"2026-05-21","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/alchymars-icm-sm-private-limited-724429-05212026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2026-05-19","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs and Drug Products"}],"first":"2026-05-19","last":"2026-05-21","sibs":[],"colo":["3011361515","3005151016","3005782924","3003597293","3020342635","3003747558","3009042530"]},{"id":"3004644745","fei":"3004644745","duns":"917997541","firm":"VAMSI LABS LIMITED","registrant":"Vamsi Labs Limited","parent":null,"ticker":null,"addr":"A-14, A-15, A-31, A-32, A-33 & A-34 MIDC Area, Chincholi, Tal-Mohol, Solapur, MAHARASHTRA 413255, India (IND)","city":"Solapur","state":"Maharashtra","pin":"413255","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.75603,"lon":75.81399,"prec":"postcode","geo":"413255, Mohol, Solapur, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3016480976","fei":"3016480976","duns":"771793568","firm":"Rubicon Research Limited","registrant":"Rubicon Research Limited","parent":null,"ticker":null,"addr":"A-17, ISEZ, Phase II, Sector 3, Pithampur, Dhar, Dhar, Madhya Pradesh 454775, India (IND)","city":"Dhar","state":"Madhya Pradesh","pin":"454775","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006559899","3012953979","3008252295"],"colo":["3010453141","3007574780","3006456888","3008565058","3005259207","3008581988","3005594847","3038913994","3016268582","3014281041","3008861587","3043782814"]},{"id":"3003504071","fei":"3003504071","duns":"650673932","firm":"SALICYLATES & CHEMICALS PRIVATE LIMITED","registrant":"SALICYLATES & CHEMICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"A-25, Road No 18, lDA, Nacharam, Hyderabad, Telangana 500076, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500076","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.43874,"lon":78.56145,"prec":"postcode","geo":"500076, Ward 6 Nacharam, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3039378398"],"colo":["3048143097","3006493505","3011573185","3007308467","3005851210","3011823550","3008311641","3008768274","3024919921","3019773458"]},{"id":"3006784730","fei":"3006784730","duns":"650455566","firm":"INDOCO REMEDIES LIMITED","registrant":"Indoco Remedies Limited","parent":null,"ticker":null,"addr":"A-26, A-27, A-28/1, A-28/2, M.I.D.C. Industrial Area, Patalganga, Village Kaire, Taluka Khalapur, Dist. Raigad, Raigad, Maharashtra 410220, India (IND)","city":"Raigad","state":"Maharashtra","pin":"410220","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":18.86792,"lon":73.16278,"prec":"postcode","geo":"410220, Panvel Subdistrict, Raigad, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2024-12-16T05:00:00Z","posted":"2025-01-07T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indoco-remedies-limited-691594-12162024","company_as_published":"Indoco Remedies Limited","match":"exact"}],"events":[{"d":"2024-12-16","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indoco-remedies-limited-691594-12162024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-12-16","last":"2024-12-16","sibs":["3006644152","3005124189","3006620783","3038105724"],"colo":["3003227148","3010437486","3002806710"]},{"id":"3007317099","fei":"3007317099","duns":"915827852","firm":"MADHU INSTRUMENTS PRIVATE LIMITED","registrant":"MADHU INSTRUMENTS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"A-260, Okhla Industrial Area Phase-1, New Deli,  110020, India (IND)","city":"New Deli","state":null,"pin":"110020","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":28.44705,"lon":77.44527,"prec":"postcode","geo":"110020, Noida, Dadri, Gautam Buddha Nagar, Uttar Pradesh, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"05/31/2023","notes":"All Drug and Drug Products","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"07/17/2025"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"07/17/2025"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"07/17/2025"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"07/17/2025"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"07/17/2025"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"05/31/2023"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"05/31/2023"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/31/2023"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/31/2023"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/31/2023"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/31/2023"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/31/2023"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/31/2023"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/31/2023"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/31/2023"},{"code":"86 H","notes":"","product":"Portion of device code","published":"05/31/2023"},{"code":"86 K","notes":"","product":"Portion of device code","published":"05/31/2023"}],"firm_as_published":"Madhu Instruments Private Limited","address_as_published":"A - 260 Okhla Industrial Area Phase 1'St Road , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2024-02-01T05:00:00Z","posted":"2024-02-13T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/madhu-instruments-private-limited-659694-02012024","company_as_published":"Madhu Instruments Private Limited","match":"exact"}],"events":[{"d":"2025-07-17","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-07-17","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-07-17","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-07-17","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-07-17","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-02-01","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/madhu-instruments-private-limited-659694-02012024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-05-31","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2023-05-31","last":"2025-07-17","sibs":[],"colo":[]},{"id":"3003227153","fei":"3003227153","duns":"862278942","firm":"Sun Pharmaceutical Industries Limited","registrant":"Sun Pharmaceutical Industries Limited","parent":"Sun Pharmaceutical Industries","ticker":"SUNPHARMA","addr":"A-7 & A-8, MIDC Industrial Area, Ahilyanagar, Maharashtra 414111, India (IND)","city":"Ahilyanagar","state":"Maharashtra","pin":"414111","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":19.17622,"lon":74.6921,"prec":"postcode","geo":"414111, Nagar Subdistrict, Ahilyanagar District, Maharashtra, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs.","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs.","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs.","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"Village Ganguwala , Tehsil-Paonta Sahib , Sirmaur, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs.","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"3 Industrial Area , Dewas, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"03/12/2014","notes":"","charges":[{"code":"60","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"}],"firm_as_published":"Sun Pharmaceutical Industries Limited - Karkhadi","address_as_published":"A Plot No 817 , Village Karkhadi , Padra, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"12/07/2022","notes":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","charges":[{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"05/12/2025"},{"code":"55","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/07/2022"},{"code":"56","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Antibiotics (Human/Animal)","published":"12/07/2022"},{"code":"58","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/07/2022"},{"code":"60","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"61","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"62","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"63","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"64","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"65","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"66","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"}],"firm_as_published":"Sun Pharmaceutical Industries Ltd.","address_as_published":"Halol - Baroda Highway , Halol, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-06-08T04:00:00Z","posted":"2022-07-19T13:20:00Z","subject":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","office":"Office of Human and Animal Foods- East Division 3","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","company_as_published":"New Sun Inc.","match":"token"},{"date":"2022-08-17T04:00:00Z","posted":"2022-09-06T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Office of Human and Animal Food Operations – West Division 5","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","company_as_published":"Sun Sen Co., Inc.","match":"token"},{"date":"2023-04-07T04:00:00Z","posted":"2023-08-15T13:20:00Z","subject":"Unapproved New Drugs/Misbranded","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","company_as_published":"STPCA Inc. dba Sun Ten Laboratories","match":"token"},{"date":"2023-05-10T04:00:00Z","posted":"2023-05-30T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations West II","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","company_as_published":"Rhodes Legacy Inc DBA Sun Sprouts","match":"token"},{"date":"2023-10-16T04:00:00Z","posted":"2023-10-16T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","company_as_published":"Sun Pharmaceutical Industries Ltd.","match":"exact"},{"date":"2024-06-18T04:00:00Z","posted":"2024-07-02T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","company_as_published":"Sun Pharmaceutical Industries Limited","match":"exact"},{"date":"2025-03-12T04:00:00Z","posted":"2025-03-18T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","company_as_published":"Waxhead Sun Defense Company","match":"token"}],"events":[{"d":"2025-05-12","k":"charge","t":"66-40 charge 54 — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-03-12","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-06-18","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-10-16","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-05-10","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","x":"Division of Human and Animal Food Operations West II"},{"d":"2023-04-07","k":"letter","t":"Unapproved New Drugs/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","x":"Division of Human and Animal Food Operations West V"},{"d":"2022-12-07","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24"},{"d":"2022-08-17","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","x":"Office of Human and Animal Food Operations – West Division 5"},{"d":"2022-06-08","k":"letter","t":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","x":"Office of Human and Animal Foods- East Division 3"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2014-03-12","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs."},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs"}],"first":"2009-09-10","last":"2025-05-12","sibs":["3004520113","3003892973","3002809586","3003952717","3012032037","3002807979","3010027135","3002871444","3007627683","3004561553"],"colo":[]},{"id":"3043564365","fei":"3043564365","duns":"771725224","firm":"KIIOR PHARMA PRIVATE LIMITED","registrant":"KIIOR PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"A/10 44/alok/v Nr Arpan, School Nirant Char Rasta, Vastral, Daskroi, Ahmedabad, Gujarat 382418, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382418","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":23.00802,"lon":72.64384,"prec":"postcode","geo":"382418, Vatva Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3009565091","fei":"3009565091","duns":"858030888","firm":"GOPALDAS VISRAM AND COMPANY LIMITED","registrant":"GOPALDAS VISRAM AND COMPANY LIMITED","parent":null,"ticker":null,"addr":"A/327, TTC Industrial Area, MIDC Mahape, Navi Mumbai, Maharashtra 400710, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400710","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":19.10848,"lon":73.02077,"prec":"postcode","geo":"400710, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"02/09/2021","notes":"The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory'.","charges":[{"code":"56 D - - 41","notes":"","product":"Neomycin Sulfate (Aminoglycosides)","published":"02/09/2021"},{"code":"56 G - - 99","notes":"","product":"Antifungal N.E.C.","published":"02/09/2021"},{"code":"61 W - - 04","notes":"","product":"Clotrimazole (Anti-Fungal) (Not Antibiotic)","published":"02/09/2021"},{"code":"61 W - - 99","notes":"","product":"A-Fungal N.E.C.","published":"02/09/2021"},{"code":"64 L - - 06","notes":"","product":"Betamethasone Dipropionate (Glucocorticoid)","published":"02/09/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"02/09/2021"}],"firm_as_published":"GOPALDAS VISRAM","address_as_published":"A - 590/591 Ttc Ind Area , Navi , Navi Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"08/16/2019","notes":"�Super Apeti Plus Syrup� appears to be a �new drug� as defined by section 201(p) of the FD&C Act, because it is not generally recognized as safe and effective for its labeled uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the FD&C Act. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. There are no FDA-approved applications in effect for �Super Apeti Plus Syrup.� Therefore, its introduction and delivery for introduction into interstate commerce appears to violate section 505(a) of the FD&C Act.","charges":[{"code":"56 G - - 99","notes":"","product":"Antifungal N.E.C.","published":"08/16/2019"},{"code":"61 W - - 18","notes":"","product":"Miconazole Nitrate (Anti-Fungal) (Not Antibiotic)","published":"08/16/2019"},{"code":"61 X - - 14","notes":"","product":"Cyproheptadine HCl (Anti-Histaminic)","published":"11/16/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/16/2019"}],"firm_as_published":"Gopaldas Visram & Company Ltd.","address_as_published":"A/327, TTC Industrial Area, MIDC Mahape , Navi Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"CGMP/OTC Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gopaldas-visram-co-ltd-721755-06022026","company_as_published":"Gopaldas Visram & Co., Ltd.","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"CGMP/OTC Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gopaldas-visram-co-ltd-721755-06022026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2021-11-16","k":"charge","t":"66-41 charge 61 X - - 14 — Cyproheptadine HCl (Anti-Histaminic)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-02-09","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"The product appears to be an unapproved new drug as the product's label includes claims such as (not an all-inclusive list): 'Antifungal, Anibacterial, Anti-inflammatory'."},{"d":"2019-08-16","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"�Super Apeti Plus Syrup� appears to be a �new drug� as defined by section 201(p) of the FD&C Act, because it is not generally recognized as safe and effective for its labeled uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the FD&C Act. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. There are no FDA-approved applications in effect for �Super Apeti Plus Syrup.� Therefore, its introduction and delivery for introduction into interstate commerce appears to violate section 505(a) of the FD&C Act."}],"first":"2019-08-16","last":"2026-06-02","sibs":[],"colo":["3010408344","3008763840","3027402875"]},{"id":"3010437486","fei":"3010437486","duns":"872184819","firm":"Bakul Aromatics and Chemicals Private Limited","registrant":"Bakul Aromatics and Chemicals Private Limited","parent":null,"ticker":null,"addr":"A/6 Midc Patalganga Ind Area, Kaire, Dist Raigad, Maharashtra 410220, India (IND)","city":"Dist Raigad","state":"Maharashtra","pin":"410220","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":18.86792,"lon":73.16278,"prec":"postcode","geo":"410220, Panvel Subdistrict, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003227148","3006784730","3002806710"]},{"id":"3009119873","fei":"3009119873","duns":"871408842","firm":"BDR LIFESCIENCES PRIVATE LIMITED","registrant":"BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED","parent":null,"ticker":null,"addr":"API CYTOTOXIC BLOCK, R.S No-578, Near effluent Channel road, Vill-Luna, Tal-Padra, Vadodara, Gujarat 391440, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391440","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.24672,"lon":73.08544,"prec":"postcode","geo":"391440, Padra Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005183272","3009167769","3005906909","3009219197","3006767695","3007836955","3008494993","3008405956","3002806475","3010166818","3038848101"]},{"id":"3007501748","fei":"3007501748","duns":"650574697","firm":"Alembic Pharmaceuticals Limited","registrant":"Alembic Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"API Division, Plot No 842-843, Village Karakhadi, Padra Taluka, VADODARA, GUJARAT 391450, India (IND)","city":"VADODARA","state":"Gujarat","pin":"391450","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.21881,"lon":72.98271,"prec":"postcode","geo":"391450, Padra Taluka, Vadodara, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2026-07-10T04:00:00Z","posted":"2026-07-21T04:00:00Z","subject":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","company_as_published":"Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.","match":"token"}],"events":[{"d":"2026-07-10","k":"letter","t":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-07-10","last":"2026-07-10","sibs":["3003821360","3013826490","3015685305","3016088083","3004956904","3014866088"],"colo":["3009456513"]},{"id":"3003821360","fei":"3003821360","duns":"650574705","firm":"Alembic Pharmaceuticals Limited","registrant":"Alembic Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"API Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol,, PANCHMAHAL, GUJARAT 389350, India (IND)","city":"PANCHMAHAL","state":"Gujarat","pin":"389350","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.51554,"lon":73.46023,"prec":"postcode","geo":"389350, Halol Taluka, Panchmahal, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2026-07-10T04:00:00Z","posted":"2026-07-21T04:00:00Z","subject":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","company_as_published":"Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.","match":"token"}],"events":[{"d":"2026-07-10","k":"letter","t":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-07-10","last":"2026-07-10","sibs":["3007501748","3013826490","3015685305","3016088083","3004956904","3014866088"],"colo":["3002809586","3012075440","3014447455","3002957541"]},{"id":"3003650383","fei":"3003650383","duns":"915838074","firm":"Cohance Lifesciences Limited","registrant":"Cohance Lifesciences Limited","parent":null,"ticker":null,"addr":"API Unit-III, 3102/B, GIDC, Ankleshwar, Gujarat 393002, India (IND)","city":"Ankleshwar","state":"Gujarat","pin":"393002","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2026-01-30T05:00:00Z","posted":"2026-02-03T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cohance-lifesciences-limited-718812-01302026","company_as_published":"Cohance Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-01-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cohance-lifesciences-limited-718812-01302026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-01-30","last":"2026-01-30","sibs":["3006493505","3008768274","1000623515","3005554260","3019037664"],"colo":["3003722314","3003696998","3014078015","3010079586","3006851796","3030461518","3004086396","3006509185","3002806711","3008314161","3004006229","3012032037"]},{"id":"3006493505","fei":"3006493505","duns":"675623773","firm":"Cohance Lifesciences Limited","registrant":"Cohance Lifesciences Limited","parent":null,"ticker":null,"addr":"API Unit-IV, Plot No. A-21, road No.10, IDA Nacharam, Uppal Mandal,, Medchal-Malkajgiri, Telangana 500076, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500076","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.43874,"lon":78.56145,"prec":"postcode","geo":"500076, Ward 6 Nacharam, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2026-01-30T05:00:00Z","posted":"2026-02-03T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cohance-lifesciences-limited-718812-01302026","company_as_published":"Cohance Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-01-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cohance-lifesciences-limited-718812-01302026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-01-30","last":"2026-01-30","sibs":["3003650383","3008768274","1000623515","3005554260","3019037664"],"colo":["3048143097","3003504071","3011573185","3007308467","3005851210","3011823550","3008311641","3024919921","3019773458"]},{"id":"3003978209","fei":"3003978209","duns":"916648541","firm":"Vista Pharmaceuticals Limited","registrant":"Vista Pharmaceuticals, Limited.","parent":null,"ticker":null,"addr":"APIIC Industrial Estate, Gopalaipalli Village,, Nalgonda, Telangana 508254, India (IND)","city":"Nalgonda","state":"Telangana","pin":"508254","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.23151,"lon":79.15116,"prec":"postcode","geo":"508254, Chityal mandal, Nalgonda, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"05/22/2018","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"05/22/2018"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"05/22/2018"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2018"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2018"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2018"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2018"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2018"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2018"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2018"}],"firm_as_published":"Vista Pharmaceuticals Limited","address_as_published":"Apiic Industrial Estate , Gopalaipalli Village , Nalgonda District, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2021-09-08T04:00:00Z","posted":"2021-09-14T13:20:00Z","subject":"Foreign Supplier Verification Program (FSVP)","office":"Division of Northern Border Imports","response":"","closeout":"02/24/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chula-vista-imports-ltd-614758-09082021","company_as_published":"Chula Vista Imports Ltd.","match":"token"},{"date":"2023-09-26T04:00:00Z","posted":"2023-10-10T13:20:00Z","subject":"Clinical Investigator","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/antonio-e-blanco-mdvista-health-research-llc-668519-09262023","company_as_published":"Antonio E. Blanco, M.D./Vista Health Research, LLC","match":"token"}],"events":[{"d":"2023-09-26","k":"letter","t":"Clinical Investigator","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/antonio-e-blanco-mdvista-health-research-llc-668519-09262023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2021-09-08","k":"letter","t":"Foreign Supplier Verification Program (FSVP)","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chula-vista-imports-ltd-614758-09082021","x":"Division of Northern Border Imports"},{"d":"2018-05-22","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2018-05-22","last":"2023-09-26","sibs":[],"colo":[]},{"id":"3002949085","fei":"3002949085","duns":"650443430","firm":"DR. REDDY'S LABORATORIES LIMITED","registrant":"Dr. Reddy's Laboratories Limited","parent":"Dr. Reddy's Laboratories","ticker":"DRREDDY","addr":"APIIC Industrial Estate, Pydibhimavaram, Ranasthalam Mandal, Srikakulam, Andhra Pradesh 532409, India (IND)","city":"Srikakulam","state":"Andhra Pradesh","pin":"532409","ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.15105,"lon":83.65614,"prec":"postcode","geo":"532409, Ranastalam, Srikakulam, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3014250111","3005336882","3011171511","3009193040","3012414462","3006549835","3005447965","3005448030","3002806851","3003184497","3002949099","3009483004"],"colo":["3008430469","3013791804","3012390454","3030708811","3004611182"]},{"id":"3005029956","fei":"3005029956","duns":"916488547","firm":"Torrent Pharmaceuticals Limited","registrant":"Torrent Pharma, Inc.","parent":"Torrent Pharmaceuticals","ticker":"TORNTPHARM","addr":"Ahmedabad-Mehsana Highway, Indrad, Taluka-Kadi, Dist. Mehsana, Indrad, Gujarat 382721, India (IND)","city":"Indrad","state":"Gujarat","pin":"382721","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":23.22926,"lon":72.50863,"prec":"postcode","geo":"382721, Kalol Taluka, Gandhinagar, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3010228235","3008861587","3006763261","3012740315"],"colo":["3043513089","3007623760"]},{"id":"3011573185","fei":"3011573185","duns":"756140078","firm":"Aragen Life Sciences Limited","registrant":"Aragen Life Sciences Limited","parent":null,"ticker":null,"addr":"Plot No. 125(PART), 126, IDA Mallapur, Mallapur Village, Uppal Mandal, Medchal Malkajgiri, Telangana 500076, India (IND)","city":"Medchal Malkajgiri","state":"Telangana","pin":"500076","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.43874,"lon":78.56145,"prec":"postcode","geo":"500076, Ward 6 Nacharam, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005851210","3014738606"],"colo":["3048143097","3003504071","3006493505","3007308467","3011823550","3008311641","3008768274","3024919921","3019773458"]},{"id":"3014539030","fei":"3014539030","duns":"675467675","firm":"TCG GREENCHEM MANUFACTURING PRIVATE LIMITED","registrant":"TCG GREENCHEM MANUFACTURING PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Anantaram (Village), Gummdidhala (Mandal) Sangareddy District, Hyderabad,  502313, India (IND)","city":"Hyderabad","state":null,"pin":"502313","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009996280","3003723146","3029798246","3006744199","3032314066","3012234942","3013944676","3007164063","3003510514","3042223406","3003289270","3007931994"]},{"id":"3008616840","fei":"3008616840","duns":"915038921","firm":"EVEREST ORGANICS LIMITED","registrant":"EVEREST ORGANICS LIMITED","parent":null,"ticker":null,"addr":"Aroor Village,Sadasivpet Mandal, Sangareddy, Telangana 502291, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502291","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.61837,"lon":77.97063,"prec":"postcode","geo":"502291, Sadasivpet mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3022699158"]},{"id":"2000011033","fei":"2000011033","duns":"862179848","firm":"Atul Ltd.","registrant":"Atul Ltd.","parent":null,"ticker":null,"addr":"Atul Ltd., Pharmaceuticals and Intermediates Business, North Site, Atu, Valsad, Gujarat 396020, India (IND)","city":"Valsad","state":"Gujarat","pin":"396020","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":20.55553,"lon":72.91589,"prec":"postcode","geo":"396020, Valsad Taluka, Valsad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3005658262","fei":"3005658262","duns":"651010907","firm":"Analytical Solutions","registrant":"ANALYTICAL SOLUTIONS","parent":null,"ticker":null,"addr":"B--22, MIDC, TTC Ind. Area, Navi Mumbai, Maharashtra 400708, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400708","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.16979,"lon":73.00462,"prec":"postcode","geo":"400708, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2021-08-17T04:00:00Z","posted":"2021-11-09T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Division of Pharmaceutical Quality Operations IV","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/adamson-analytical-laboratories-inc-614644-08172021","company_as_published":"Adamson Analytical Laboratories, Inc.","match":"token"},{"date":"2021-09-30T04:00:00Z","posted":"2021-10-12T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Division of Pharmaceutical Quality Operations III","response":"","closeout":"10/15/2024","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/missouri-analytical-laboratories-inc-615319-09302021","company_as_published":"Missouri Analytical Laboratories Inc","match":"token"},{"date":"2022-08-19T04:00:00Z","posted":"2022-08-30T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Division of Pharmaceutical Quality Operations IV","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-wave-analytical-llc-630965-08192022","company_as_published":"Green Wave Analytical, LLC","match":"token"},{"date":"2024-10-10T04:00:00Z","posted":"2024-11-05T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/analytical-food-laboratories-inc-687513-10102024","company_as_published":"Analytical Food Laboratories, Inc.","match":"token"},{"date":"2025-08-20T04:00:00Z","posted":"2025-09-02T04:00:00Z","subject":"CGMP/Finished Pharmaceutical/API/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chromatography-institute-america-dba-compounders-international-analytical-laboratory-708944-08202025","company_as_published":"Chromatography Institute of America dba Compounder’s International Analytical Laboratory","match":"token"},{"date":"2025-09-17T04:00:00Z","posted":"2025-10-21T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/brs-analytical-services-llc-711133-09172025","company_as_published":"BRS Analytical Services, LLC","match":"token"},{"date":"2025-11-12T05:00:00Z","posted":"2025-12-02T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhyz-analytical-labs-715298-11122025","company_as_published":"Rhyz Analytical Labs","match":"token"}],"events":[{"d":"2025-11-12","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhyz-analytical-labs-715298-11122025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2025-09-17","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/brs-analytical-services-llc-711133-09172025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2025-08-20","k":"letter","t":"CGMP/Finished Pharmaceutical/API/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chromatography-institute-america-dba-compounders-international-analytical-laboratory-708944-08202025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-10-10","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/analytical-food-laboratories-inc-687513-10102024","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2022-08-19","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-wave-analytical-llc-630965-08192022","x":"Division of Pharmaceutical Quality Operations IV"},{"d":"2021-09-30","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/missouri-analytical-laboratories-inc-615319-09302021","x":"Division of Pharmaceutical Quality Operations III"},{"d":"2021-08-17","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/adamson-analytical-laboratories-inc-614644-08172021","x":"Division of Pharmaceutical Quality Operations IV"}],"first":"2021-08-17","last":"2025-11-12","sibs":[],"colo":["3009890383","3004944629","3014425346","3027620173"]},{"id":"3002977798","fei":"3002977798","duns":"918456588","firm":"USV Private Limited","registrant":"USV Private Limited","parent":null,"ticker":null,"addr":"B-1/8, MIDC, Lote Parshuram Industrial Area, Taluka Khed, Ratnagiri, Maharashtra 415 722, India (IND)","city":"Ratnagiri","state":"Maharashtra","pin":null,"ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":17.73349,"lon":73.43643,"prec":"tail3","geo":"Khed Taluka, Ratnagiri, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004086192","3027308441"],"colo":[]},{"id":"3012278124","fei":"3012278124","duns":"650992501","firm":"JEEVAN SCIENTIFIC TECHNOLOGY LIMITED","registrant":"Jeevan Scientific Technology Limited","parent":null,"ticker":null,"addr":"B-17, TIE Phase II,Balanagar, Hyderabad, Telangana 500037, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500037","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.47821,"lon":78.44338,"prec":"postcode","geo":"500037, Ward 120 Balanagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Balanagar mandal, Medchal–Malkajgiri, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2024-07-09T04:00:00Z","posted":"2024-07-23T13:20:00Z","subject":"New Drugs/Dietary Supplements/Food Labeling/Misbranded","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/formulation-technology-inc-672905-07092024","company_as_published":"Formulation Technology, Inc.","match":"token"}],"events":[{"d":"2024-07-09","k":"letter","t":"New Drugs/Dietary Supplements/Food Labeling/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/formulation-technology-inc-672905-07092024","x":"Division of Human and Animal Food Operations West V"}],"first":"2024-07-09","last":"2024-07-09","sibs":["3011452148"],"colo":["3016067081","3017146711","3014798074","3031055543","3009883190","3013495798","3014683316","3015069609"]},{"id":"3016710326","fei":"3016710326","duns":"861512375","firm":"ORTIV-Q3 RESEARCH PRIVATE LIMITED","registrant":"ORTIV-Q3 RESEARCH PRIVATE LIMITED","parent":null,"ticker":null,"addr":"B-202-207, Ratna Business Hub, Survey No. 439 Village Navapura, Sanand, Ahmedabad, Gujarat 382210, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382210","ops":["ANALYSIS"],"expires":"12/31/2026","lat":22.96445,"lon":72.4238,"prec":"postcode","geo":"382210, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3006595385","3003157498","3006026405","3023491920","3002984011"]},{"id":"3011361515","fei":"3011361515","duns":"918597266","firm":"APEX LABORATORIES PRIVATE LIMITED","registrant":"APEX LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"B-23, SIDCO Pharmaceutical Complex, Alathur, Thiruporur, Kanchipuram, Tamil Nadu 603110, India (IND)","city":"Kanchipuram","state":"Tamil Nadu","pin":"603110","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":12.71867,"lon":80.09467,"prec":"postcode","geo":"603110, Chengalpattu, Tamil Nadu, India","status":1,"alerts":[],"letters":[{"date":"2023-08-23T04:00:00Z","posted":"2023-08-23T15:00:00Z","subject":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","office":"Center for Tobacco Products","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apex-vape-inc-665306-08232023","company_as_published":"Apex Vape, Inc","match":"token"}],"events":[{"d":"2023-08-23","k":"letter","t":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apex-vape-inc-665306-08232023","x":"Center for Tobacco Products"}],"first":"2023-08-23","last":"2023-08-23","sibs":[],"colo":["3005216842","3005151016","3005782924","3003597293","3020342635","3003747558","3009042530"]},{"id":"3009890383","fei":"3009890383","duns":"675467077","firm":"Doctors' Analytical Laboratories Private Limited","registrant":"Doctors' Analytical Laboratories Private Limited","parent":null,"ticker":null,"addr":"B-49, C/o Shruti Flexipack Pvt.Ltd. MIDC Road TTC Industrial Area, Airoli, Navi Mumbai, Maharashtra 400708, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400708","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.16979,"lon":73.00462,"prec":"postcode","geo":"400708, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005658262","3004944629","3014425346","3027620173"]},{"id":"3006785788","fei":"3006785788","duns":"918594859","firm":"Ajanta Pharma Limited","registrant":"Ajanta Pharma Limited","parent":"Ajanta Pharma","ticker":"AJANTPHARM","addr":"B-4\\5\\6, MIDC Area, Paithan, Chhatrapati Sambhajinagar, Maharashtra 431148, India (IND)","city":"Chhatrapati Sambhajinagar","state":"Maharashtra","pin":"431148","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":19.54941,"lon":75.38207,"prec":"postcode","geo":"431148, Paithan, Chhatrapati Sambhajinagar, Maharashtra, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"12/17/2010","notes":"India","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"12/17/2010"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"12/17/2010"},{"code":"64 H - - 99","notes":"","product":"Expectorant N.E.C.","published":"12/17/2010"}],"firm_as_published":"Ajanta Medicals PVT.LTD.","address_as_published":"71 , Ponda, Goa INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"09/30/2009","notes":"Kamagra 100mg oral tablet; 4/4/2003","charges":[{"code":"65 P D - 02","notes":"Kamagra 100mg oral tablet; 4/4/2003","product":"Sildenafil Citrate (Regulator), Human - Rx/Combination Ingredient","published":"09/13/2019"}],"firm_as_published":"Ajanta Pharma Limited","address_as_published":"318 Linking Road , Mumbai, INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"01/20/2017","notes":"Product contains Sildenafil Citrate","charges":[{"code":"65 P - - 02","notes":"","product":"Sildenafil Citrate (Regulator)","published":"01/20/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"01/20/2017"}],"firm_as_published":"Ajanta Pharma Ltd.","address_as_published":"B-4/5/6 Midc Industrial Area , District - Aurangabad , Paithan, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2019-09-13","k":"charge","t":"66-41 charge 65 P D - 02 — Sildenafil Citrate (Regulator), Human - Rx/Combination Ingredient","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Kamagra 100mg oral tablet; 4/4/2003"},{"d":"2017-01-20","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Product contains Sildenafil Citrate"},{"d":"2010-12-17","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"India"},{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Kamagra 100mg oral tablet; 4/4/2003"}],"first":"2009-09-30","last":"2019-09-13","sibs":["3012664809"],"colo":[]},{"id":"3021189141","fei":"3021189141","duns":"859661918","firm":"RAHUL ENTERPRISES","registrant":"RAHUL ENTERPRISES","parent":null,"ticker":null,"addr":"B-67, Additional MIDC, Anand Ngr, THANE, MH 421506, India (IND)","city":"THANE","state":null,"pin":"421506","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009887190","3008232264","3013999816","3018052045","3016575313","3006599894","3006809732","3027577650","3010166801","3032073298","3008374690","3009051788"]},{"id":"3006559899","fei":"3006559899","duns":"918629544","firm":"Rubicon Research Limited","registrant":"Rubicon Research Limited","parent":null,"ticker":null,"addr":"B-75, Medone House, Road No. 33, Wagale Industrial Estate, Thane, Maharashtra 400604, India (IND)","city":"Thane","state":"Maharashtra","pin":"400604","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.19187,"lon":72.95459,"prec":"postcode","geo":"400604, Thane, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3016480976","3012953979","3008252295"],"colo":["3006121542"]},{"id":"3003204330","fei":"3003204330","duns":"862267994","firm":"FDC LIMITED","registrant":"FDC Limited","parent":null,"ticker":null,"addr":"B-8,MIDC Industrial Area,Waluj,, Chhatrapati Sambhajinagar, Maharashtra 431136, India (IND)","city":"Chhatrapati Sambhajinagar","state":"Maharashtra","pin":"431136","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.83683,"lon":75.25441,"prec":"postcode","geo":"431136, Chhatrapati Sambhajinagar, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2021-02-18T05:00:00Z","posted":"2021-02-19T17:00:00Z","subject":"New Drug/Misbranded","office":"Center for Food Safety and Applied Nutrition (CFSAN)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fdc-nutrition-inc-612264-02182021","company_as_published":"FDC Nutrition Inc.","match":"token"}],"events":[{"d":"2021-02-18","k":"letter","t":"New Drug/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fdc-nutrition-inc-612264-02182021","x":"Center for Food Safety and Applied Nutrition (CFSAN)"}],"first":"2021-02-18","last":"2021-02-18","sibs":["3008524952","3002806958","3004738570"],"colo":["3008316970","3038105724","3007542588","3008580576","3009227929","3003983454"]},{"id":"3006535724","fei":"3006535724","duns":"917995797","firm":"Aggarwwal Exports","registrant":"Aggarwwal Exports","parent":null,"ticker":null,"addr":"B/6-9, Roshan Bagh lndustrial Estate, Rampur,  244901, India (IND)","city":"Rampur","state":null,"pin":"244901","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":28.78175,"lon":79.03374,"prec":"postcode","geo":"244901, Rampur, Uttar Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004293613","3002899365"]},{"id":"3007016503","fei":"3007016503","duns":"862887797","firm":"Seema International","registrant":"Seema International","parent":null,"ticker":null,"addr":"BT-3/211, PHASE 1, MANGOLPURI INDUSTRIAL AREA, New Delhi,  110083, India (IND)","city":"MANGOLPURI INDUSTRIAL AREA","state":"Delhi","pin":"110083","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":28.69251,"lon":77.08811,"prec":"postcode","geo":"110083, Mangolpuri Colony, Rohini, Delhi, North West Delhi, Delhi, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/18/2025","notes":"","charges":[{"code":"53","notes":"","product":"Cosmetics","published":"09/18/2025"},{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"09/18/2025"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"09/18/2025"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"09/18/2025"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"09/18/2025"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"09/18/2025"},{"code":"55","notes":"","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/18/2025"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"09/18/2025"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"09/18/2025"},{"code":"60","notes":"","product":"Human and Animal Drugs","published":"09/18/2025"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"09/18/2025"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"09/18/2025"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"09/18/2025"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"09/18/2025"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"09/18/2025"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"09/18/2025"}],"firm_as_published":"Seema International","address_as_published":"Bt-3/211, Phase 1, Mangolpuri Industrial Area , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2025-11-13T05:00:00Z","posted":"2025-11-18T05:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/seema-international-716072-11132025","company_as_published":"Seema International","match":"exact"}],"events":[{"d":"2025-11-13","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/seema-international-716072-11132025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2025-09-18","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""}],"first":"2025-09-18","last":"2025-11-13","sibs":[],"colo":[]},{"id":"3002899365","fei":"3002899365","duns":"915999668","firm":"Swati menthol & Allied Chemicals Ltd","registrant":"Swati Menthol & Allied Chemicals Ltd","parent":null,"ticker":null,"addr":"Bareilly Road, Opp. Akashwani, Rampur, Uttar Pradesh 244901, India (IND)","city":"Rampur","state":"Uttar Pradesh","pin":"244901","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":28.78175,"lon":79.03374,"prec":"postcode","geo":"244901, Rampur, Uttar Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004293613","3006535724"]},{"id":"3005652193","fei":"3005652193","duns":"650391548","firm":"ONESOURCE SPECIALTY PHARMA LIMITED","registrant":"ONESOURCE SPECIALTY PHARMA LIMITED","parent":null,"ticker":null,"addr":"Beta Lactam Division, 152/6 & 154/16, Doresanipalya, Bilekahalli, Bannerghatta Road,, Bengaluru, Karnataka 560076, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560076","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":12.88064,"lon":77.60387,"prec":"postcode","geo":"560076, Hulimavu, Bengaluru South City Corporation, Bengaluru, Bangalore South, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3017501030","3003813519"],"colo":["3041525876"]},{"id":"3004497364","fei":"3004497364","duns":"860184986","firm":"CENTRIENT PHARMACEUTICALS INDIA PRIVATE LIMITED","registrant":"Centrient Pharmaceuticals Netherlands B.V.","parent":null,"ticker":null,"addr":"Bhai Mohan Singh Nagar,Toansa, District SBS Nagar, Nawanshahr, PB 144533, India (IND)","city":"Nawanshahr","state":null,"pin":"144533","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":30.99742,"lon":76.4641,"prec":"postcode","geo":"144533, Balachaur Tahsil, Shaheed Bhagat Singh Nagar, Punjab, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"11/21/2022","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"11/21/2022"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"11/21/2022"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"11/21/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/21/2022"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/21/2022"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/21/2022"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/21/2022"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/21/2022"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/21/2022"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/21/2022"}],"firm_as_published":"Centrient Pharmaceuticals India Private Limited","address_as_published":"Bhai Mohan Singh Nagar , Village Toansa, District Sbs Nagar , Nawashahr, Punjab INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-12-07T05:00:00Z","posted":"2022-12-13T14:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centrient-pharmaceuticals-india-private-limited-640196-12072022","company_as_published":"Centrient Pharmaceuticals India Private Limited","match":"exact"}],"events":[{"d":"2022-12-07","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centrient-pharmaceuticals-india-private-limited-640196-12072022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2022-11-21","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2022-11-21","last":"2022-12-07","sibs":[],"colo":[]},{"id":"3003600340","fei":"3003600340","duns":"915833842","firm":"SYNGENE INTERNATIONAL LIMITED","registrant":"Syngene International Limited","parent":"Syngene International","ticker":"SYNGENE","addr":"Biocon SEZ, Biocon Park, Plot No. 2, 3, 4 & 5, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka 560099, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560099","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":12.83934,"lon":77.70554,"prec":"postcode","geo":"560099, Singena Agrahara, Anekal, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012608389","3007907068","3035152598"],"colo":["3009310198","3043619916","3007078919","3003981475","3008300442","3006076314","3013637926","3010164491"]},{"id":"3043619916","fei":"3043619916","duns":"771648898","firm":"Biocon Biosphere Limited","registrant":"Biocon Biosphere Limited","parent":"Biocon","ticker":"BIOCON","addr":"Biocon Special Economic Zone, Block F2, Plot no. 5, Phase IV, Bommasandra - Jigani link Road, Bommasandra Post, Bengaluru, Karnataka 560099, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560099","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.83934,"lon":77.70554,"prec":"postcode","geo":"560099, Singena Agrahara, Anekal, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3022125340"],"colo":["3009310198","3003600340","3007078919","3003981475","3008300442","3006076314","3013637926","3010164491","3035152598"]},{"id":"3007078919","fei":"3007078919","duns":"650081412","firm":"Apotex Research Private Limited","registrant":"Apotex Inc.","parent":null,"ticker":null,"addr":"Bioequivalence Center, Site No. 2, Bommasandra Industrial Area, Phase IV, Jigani Link Road, Bangalore, Karnataka 560099, India (IND)","city":"Bangalore","state":"Karnataka","pin":"560099","ops":["ANALYSIS"],"expires":"12/31/2026","lat":12.83934,"lon":77.70554,"prec":"postcode","geo":"560099, Singena Agrahara, Anekal, Bengaluru Urban, Karnataka, India","status":1,"alerts":[],"letters":[{"date":"2025-10-31T04:00:00Z","posted":"2025-11-04T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apotex-inc-714137-10312025","company_as_published":"Apotex Inc.","match":"token"}],"events":[{"d":"2025-10-31","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apotex-inc-714137-10312025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-10-31","last":"2025-10-31","sibs":["3006076314"],"colo":["3009310198","3003600340","3043619916","3003981475","3008300442","3013637926","3010164491","3035152598"]},{"id":"3014250111","fei":"3014250111","duns":"918608167","firm":"DR.REDDY'S LABORATORIES LIMITED","registrant":"DR.REDDY'S LABORATORIES LIMITED","parent":"Dr. Reddy's Laboratories","ticker":"DRREDDY","addr":"Biologics, Survey No. 47 and 44 (Part), Bachupally Village, Medchal-Malkajgiri, TS 500090, India (IND)","city":"Medchal-Malkajgiri","state":null,"pin":"500090","ops":["API MANUFACTURE","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.53062,"lon":78.38101,"prec":"postcode","geo":"500090, Bachupally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002949085","3005336882","3011171511","3009193040","3012414462","3006549835","3005447965","3005448030","3002806851","3003184497","3002949099","3009483004"],"colo":["3026584977","3013593602","3013758337","3008569405","3013580504","3027524740","3017981159","3003971663","3004021229","3004446312"]},{"id":"3006627482","fei":"3006627482","duns":"651030913","firm":"TCG Lifesciences Private Limited","registrant":"TCG Lifesciences Private Limited","parent":null,"ticker":null,"addr":"Bipl, Block Ep & Gp, Salt Lake Electronics Complex, Kolkata, West Bengal 700091, India (IND)","city":"Kolkata","state":"West Bengal","pin":"700091","ops":["ANALYSIS"],"expires":"12/31/2026","lat":22.57689,"lon":88.43012,"prec":"postcode","geo":"700091, Bidhannagar, Kolkata Metropolitan Area, Rajarhat, North 24 Parganas, West Bengal, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3005906909","fei":"3005906909","duns":"863842112","firm":"LUPIN MANUFACTURING SOLUTIONS LIMITED","registrant":"LUPIN MANUFACTURING SOLUTIONS LIMITED","parent":"Lupin","ticker":"LUPIN","addr":"Block - 21, At & Post, Dabhasa, Taluka Padra, Vadodara, Gujarat 391440, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391440","ops":["API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.24672,"lon":73.08544,"prec":"postcode","geo":"391440, Padra Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3013127166"],"colo":["3005183272","3009167769","3009119873","3009219197","3006767695","3007836955","3008494993","3008405956","3002806475","3010166818","3038848101"]},{"id":"3017542362","fei":"3017542362","duns":"854220556","firm":"Anthem Biosciences Limited","registrant":"Anthem Biosciences Limited","parent":"Anthem Biosciences","ticker":"ANTHEMBIO","addr":"Block AH12BG2, Plot No. 276-P & 277-P, SY No. 20, Bannikuppe Road, Harohalli Industrial Area, Phase–II, Kanakapura Taluk, Ramanagara District, Bengaluru, Karnataka 562112, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"562112","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":12.68682,"lon":77.50493,"prec":"postcode","geo":"562112, Harohalli taluk, Bengaluru South, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008300442","3013884349"],"colo":["3036230268","3014463103","3035948306"]},{"id":"3009219197","fei":"3009219197","duns":"916830251","firm":"Exemed Pharmaceuticals","registrant":"Exemed Pharmaceuticals","parent":null,"ticker":null,"addr":"Block NO. 628 A & B ECP Canal Road, AT. & PO. Luna, Taluka: Padra, District Vadodara, Vadodara, Gujarat 391440, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391440","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":22.24672,"lon":73.08544,"prec":"postcode","geo":"391440, Padra Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005183272","3009167769","3009119873","3005906909","3006767695","3007836955","3008494993","3008405956","3002806475","3010166818","3038848101"]},{"id":"3005751252","fei":"3005751252","duns":"863318468","firm":"PRAVEEN LABORATORIES PRIVATE LIMITED","registrant":"Praveen Laboratories Private Limited","parent":null,"ticker":null,"addr":"Block No 206, Moje Jolwa, Tal Palsana, Surat, Gujarat 394305, India (IND)","city":"Surat","state":"Gujarat","pin":"394305","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":21.14391,"lon":72.92218,"prec":"postcode","geo":"394305, Chorasi Taluka, Surat, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3003981475","fei":"3003981475","duns":"650501997","firm":"Biocon Biologics Limited","registrant":"Biocon Biologics Limited","parent":"Biocon","ticker":"BIOCON","addr":"Block No, B1,B2, B3, B5, Q13 of Q1 and W20 & Unit S18,1st Floor,Block B4, SEZ, Plot No.2,3,4&5, Phase IV, Bommasandra-Jigani Link Road, Bengaluru, Karnataka 560099, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560099","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.83934,"lon":77.70554,"prec":"postcode","geo":"560099, Singena Agrahara, Anekal, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3015283245"],"colo":["3009310198","3003600340","3043619916","3007078919","3008300442","3006076314","3013637926","3010164491","3035152598"]},{"id":"3027770072","fei":"3027770072","duns":"957246602","firm":"Ipca Laboratories Limited","registrant":"Ipca Laboratories Limited","parent":"Ipca Laboratories","ticker":"IPCALAB","addr":"Block No. 132, Village Ranu Taluka Padra, Vadodara, Gujarat 391445, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391445","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.29731,"lon":73.19426,"prec":"tail2","geo":"Vadodara, Vadodara Rural Taluka, Vadodara, Gujarat, 390001, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"09/30/2009","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","charges":[{"code":"66 V - - 99","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","product":"Miscellaneous Patent Medicines, Etc.","published":"09/30/2009"}],"firm_as_published":"Ipca Laboratories Limited","address_as_published":"P.O. Sejavta , Ratlam, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug."}],"first":"2009-09-30","last":"2009-09-30","sibs":["3007574780","3002807297","3027770075","3005977675","3006057101","3009227929"],"colo":[]},{"id":"3035575633","fei":"3035575633","duns":"877180262","firm":"TROIKAA PHARMACEUTICALS LIMITED","registrant":"TROIKAA PHARMACEUTICALS LIMITED","parent":null,"ticker":null,"addr":"Block No. 2019, 2022, 2023, Village Virochannagar Tal-Sanand, Ahmedabad, Gujarat 382170, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382170","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.91651,"lon":72.1325,"prec":"postcode","geo":"382170, Viramgam Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3006767695","fei":"3006767695","duns":"676248879","firm":"APICORE PHARMACEUTICALS PRIVATE LIMITED","registrant":"APICORE PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Block No. 252-253, Village - Dhobikuva, Opposite Jain Irrigation, Padra - Jambusar Highway, Tal. Padra., Vadodara, Gujarat 391440, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391440","ops":["ANALYSIS","API MANUFACTURE","RELABEL","REPACK","STERILIZE"],"expires":"12/31/2026","lat":22.24672,"lon":73.08544,"prec":"postcode","geo":"391440, Padra Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3007136165","3012575874"],"colo":["3005183272","3009167769","3009119873","3005906909","3009219197","3007836955","3008494993","3008405956","3002806475","3010166818","3038848101"]},{"id":"3006595385","fei":"3006595385","duns":"650478121","firm":"ZYDUS LIFESCIENCES LIMITED","registrant":"ZYDUS LIFESCIENCES LIMITED","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Block No. 265, 266, 267, Opp. Laxminarayan Petrol Pump, Sarkhej-Bavla National Highway, Changodar, Ahmedabad, Gujarat 382210, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382210","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":22.96445,"lon":72.4238,"prec":"postcode","geo":"382210, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2024-08-29T04:00:00Z","posted":"2024-09-10T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"12/16/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","company_as_published":"Zydus Lifesciences Limited","match":"exact"},{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","company_as_published":"Zydus Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-29","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-29","last":"2026-06-02","sibs":["3003696998","3008957483","3007938603","3007621329","3006809732","3006026405","3002806475","3012977526","3002984011","3013712903","3005430968"],"colo":["3016710326","3003157498","3023491920"]},{"id":"3007836955","fei":"3007836955","duns":"918610077","firm":"Amoli Organics (A Division of Umedica Laboratories Pvt.Ltd.)","registrant":"Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)","parent":null,"ticker":null,"addr":"Block No. 422, ECP Canal Road Village-Luna, Taluka-Padra, Vadodara, Gujarat 391440, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391440","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":22.24672,"lon":73.08544,"prec":"postcode","geo":"391440, Padra Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004810446"],"colo":["3005183272","3009167769","3009119873","3005906909","3009219197","3006767695","3008494993","3008405956","3002806475","3010166818","3038848101"]},{"id":"3033605590","fei":"3033605590","duns":"918312059","firm":"VIRDEV INTERMEDIATES PRIVATE LIMITED","registrant":"VIRDEV INTERMEDIATES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Block No. 46-47, Plot No.2 Village Palsana, Taluka Palsana Surat 394315 Gujarat India, Surat, Gujarat 394 315, India (IND)","city":"Plot No.2 Village Palsana","state":"Gujarat","pin":"394315","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":21.10608,"lon":72.98741,"prec":"postcode","geo":"394315, Palsana Taluka, Surat, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3008087189","fei":"3008087189","duns":"677567260","firm":"Bajaj Healthcare Ltd","registrant":"Bajaj Healthcare Ltd","parent":null,"ticker":null,"addr":"Block No. 588, Savli-karachia Road At & Post Gothada, Tal. Savli Vadodara, Gujarat, 391776, IN, Vadodara, Gujarat 391776, India (IND)","city":"Tal. Savli Vadodara","state":"Gujarat","pin":"391776","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.31081,"lon":73.16578,"prec":"tail3","geo":"Compucare India Pvt Ltd, 203-210, RC Dutt Road, Alkapuri, Vadodara, Vadodara Rural Taluka, Vadodara, Gujarat, 390007, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003336449"],"colo":[]},{"id":"3039259640","fei":"3039259640","duns":"861502593","firm":"Rebase Lifescience Private Limited","registrant":"Rebase Lifescience Private Limited","parent":null,"ticker":null,"addr":"Block No. 6, Plot No. 11 & 12, Nr. Amrut Dairy, Lalpur, Daskroi Ahmedabad, Gujarat 382430, India (IND)","city":"Daskroi Ahmedabad","state":"Gujarat","pin":"382430","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":23.02724,"lon":72.7169,"prec":"postcode","geo":"382430, Daskroi Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3015283245","fei":"3015283245","duns":"675486243","firm":"Biocon Biologics Limited","registrant":"Biocon Biologics Limited","parent":"Biocon","ticker":"BIOCON","addr":"Block No. M1, M2 and M6, Q1 (QC3 and QC10) and W3, 20th KM Hosur Road, Electronics City, Bengaluru, Karnataka 560100, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560100","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.84601,"lon":77.66127,"prec":"postcode","geo":"560100, Bangalore South, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003981475"],"colo":["1000172912","3004495158","3007907068"]},{"id":"3018899465","fei":"3018899465","duns":"854198171","firm":"BROOKS STERISCIENCE LIMITED","registrant":"BROOKS STERISCIENCE LIMITED","parent":"Eris Lifesciences","ticker":"ERIS","addr":"Block No. Survey No. 61/62, Manglej village, Nareshwar Road, Karjan Taluka,, Vadodara, Gujarat 391243, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391243","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":22.13388,"lon":73.18071,"prec":"postcode","geo":"391243, Vadodara Rural Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3017001542","3032592163"]},{"id":"3016579947","fei":"3016579947","duns":"876730408","firm":"Apnar Pharma Private Limited","registrant":"Apnar Pharma Private Limited","parent":null,"ticker":null,"addr":"Block No.102, At And Post Gavasad Padra Jambusar Road, Taluka Padra, Vadodara, Gujarat 391430, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391430","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.13652,"lon":72.96596,"prec":"postcode","geo":"391430, Padra Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3023674245","fei":"3023674245","duns":"930653342","firm":"MEDILANE HEALTHCARE PRIVATE LIMITED","registrant":"MEDILANE HEALTHCARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Block No.1146, Sub Plot No 04, Kim Mandvi Road, Near Vatsalya Paper Ind, Tadkeshwar, Tal-Mandvi, Surat, Gujarat 394170, India (IND)","city":"Surat","state":"Gujarat","pin":"394170","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.3501,"lon":73.08211,"prec":"postcode","geo":"394170, Mandvi Taluka, Surat, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3038200383","fei":"3038200383","duns":"771573088","firm":"SHOOLIN PHARMA CHEM LLP","registrant":"SHOOLIN PHARMA CHEM LLP","parent":null,"ticker":null,"addr":"Block/Survey No.- 408, B/H Ratnamani Tubes, Nr,Maruti Inox, Indira, Kadi, Mehsana, Gujarat 382715, India (IND)","city":"Mehsana","state":"Gujarat","pin":"382715","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":23.29798,"lon":72.33217,"prec":"postcode","geo":"382715, Kadi Taluka, Mahesana, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"08/11/2026","notes":"All drugs and drug products manufactured by Shoolin Pharma Chem LLP","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"08/11/2026"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"08/11/2026"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"08/11/2026"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"08/11/2026"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"08/11/2026"},{"code":"55","notes":"All drugs and drug products manufactured by Shoolin Pharma Chem LLP","product":"Pharm Necess & Ctnr For Drug/Bio","published":"08/11/2026"},{"code":"56","notes":"All drugs and drug products manufactured by Shoolin Pharma Chem LLP","product":"Antibiotics (Human/Animal)","published":"08/11/2026"},{"code":"58","notes":"All drugs and drug products manufactured by Shoolin Pharma Chem LLP","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"08/11/2026"},{"code":"60","notes":"All drugs and drug products manufactured by Shoolin Pharma Chem LLP","product":"Human and Animal Drugs","published":"08/11/2026"},{"code":"61","notes":"All drugs and drug products manufactured by Shoolin Pharma Chem LLP","product":"Human and Animal Drugs","published":"08/11/2026"},{"code":"62","notes":"All drugs and drug products manufactured by Shoolin Pharma Chem LLP","product":"Human and Animal Drugs","published":"08/11/2026"},{"code":"63","notes":"All drugs and drug products manufactured by Shoolin Pharma Chem LLP","product":"Human and Animal Drugs","published":"08/11/2026"},{"code":"64","notes":"All drugs and drug products manufactured by Shoolin Pharma Chem LLP","product":"Human and Animal Drugs","published":"08/11/2026"},{"code":"65","notes":"All drugs and drug products manufactured by Shoolin Pharma Chem LLP","product":"Human and Animal Drugs","published":"08/11/2026"},{"code":"66","notes":"All drugs and drug products manufactured by Shoolin Pharma Chem LLP","product":"Human and Animal Drugs","published":"08/11/2026"}],"firm_as_published":"Shoolin Pharma Chem LLP","address_as_published":"408 B/H Ratnamani Tubes , Block/Survey No; Nr Maruti Inox , Kadi, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2026-08-18T04:00:00Z","posted":"2026-09-01T04:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shoolin-pharma-chem-llp-734100-08182026","company_as_published":"Shoolin Pharma Chem LLP","match":"exact"}],"events":[{"d":"2026-08-18","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shoolin-pharma-chem-llp-734100-08182026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2026-08-11","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All drugs and drug products manufactured by Shoolin Pharma Chem LLP"}],"first":"2026-08-11","last":"2026-08-18","sibs":[],"colo":["3027756269"]},{"id":"3011062091","fei":"3011062091","duns":"864237541","firm":"FINOSO PHARMA PRIVATE LIMITED","registrant":"FINOSO PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Building 450, MN Science and Technology Park, Turkapally, Shamirpet, Hyderabad, Telangana 500078, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500078","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.58696,"lon":78.55137,"prec":"postcode","geo":"500078, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3046312775","3025926685","3012071812","3038847754","3012796281","3008377265","3004602077"]},{"id":"3013697420","fei":"3013697420","duns":"860479936","firm":"BioMylz Pvt. Ltd.","registrant":"BioMylz Pvt Ltd.","parent":null,"ticker":null,"addr":"Building No.1, #21-D, 2nd Phase, Peenya Industrial Area, Bengaluru,  560058, India (IND)","city":"Bengaluru","state":null,"pin":"560058","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":13.02329,"lon":77.51356,"prec":"postcode","geo":"560058, Parvathi Nagar, Bengaluru West City Corporation, Bengaluru, Bangalore North, Bengaluru Urban, Karnataka, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"04/24/2024","notes":"","charges":[{"code":"54 E - - 99","notes":"","product":"Herbals & Botanical Teas, N.E.C.","published":"04/24/2024"},{"code":"54 E - - 99","notes":"","product":"Herbals & Botanical Teas, N.E.C.","published":"04/24/2024"},{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"04/24/2024"},{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"04/24/2024"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"04/24/2024"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"04/24/2024"}],"firm_as_published":"BioMylz Pvt. Ltd.","address_as_published":"Building No.1, #21-D, 2nd Phase, Peenya Industrial Area , Bengaluru, Karnataka INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[{"date":"2026-07-13T04:00:00Z","posted":"2026-07-21T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated/Misbranded","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biomylz-pvt-ltd-729483-07132026","company_as_published":"BioMylz Pvt. Ltd.","match":"exact"}],"events":[{"d":"2026-07-13","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biomylz-pvt-ltd-729483-07132026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-04-24","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""}],"first":"2024-04-24","last":"2026-07-13","sibs":[],"colo":["3006949803","3022528084","3013200240"]},{"id":"3020879673","fei":"3020879673","duns":"854247369","firm":"CHEMOTEST LABORATORY","registrant":"CHEMOTEST LABORATORY","parent":null,"ticker":null,"addr":"C 258 MIDC Pawane TTC Industrial Area Turbhe, Navi Mumbai, MAHARASHTRA 400705, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400705","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.06727,"lon":73.00917,"prec":"postcode","geo":"400705, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["C 404, TTC Industrial Area MIDC, Pawane, Navi Mumbai,  400705, India (IND)","3010585824","3006441076","3011103533"]},{"id":"3039906804","fei":"3039906804","duns":"771654466","firm":"VALENS PHARMACHEM PRIVATE LIMITED","registrant":"VALENS PHARMACHEM PRIVATE LIMITED","parent":null,"ticker":null,"addr":"C 3-24, Shriji Agro Industries, Udhhoyog Nagar, Gidc Nadiad, Kheda, Gujarat 387001, India (IND)","city":"Kheda","state":"Gujarat","pin":"387001","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.6891,"lon":72.86637,"prec":"postcode","geo":"387001, Nadlad City Taluka, Kheda, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"C 404, TTC Industrial Area MIDC, Pawane, Navi Mumbai,  400705, India (IND)","fei":"","duns":"650786317","firm":"ANAZEAL ANALYTICALS & RESEARCH PRIVATE LIMITED","registrant":"ANAZEAL ANALYTICALS RESEARCH PRIVATE LIMITED","parent":null,"ticker":null,"addr":"C 404, TTC Industrial Area MIDC, Pawane, Navi Mumbai,  400705, India (IND)","city":"Navi Mumbai","state":null,"pin":"400705","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.06727,"lon":73.00917,"prec":"postcode","geo":"400705, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006441076"],"colo":["3020879673","3010585824","3011103533"]},{"id":"3004293539","fei":"3004293539","duns":"915787037","firm":"Sharp Mint Limited","registrant":"Sharp Mint Limited","parent":null,"ticker":null,"addr":"C-03, SMA Cooperative Industrial Estate, G.T.Karnal Road, New Delhi, Delhi 110033, India (IND)","city":"G.T.Karnal Road","state":"Delhi","pin":"110033","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":28.72732,"lon":77.1698,"prec":"postcode","geo":"110033, Jahangirpuri Colony, Civil Lines, Delhi, North Delhi, Delhi, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3041888751","fei":"3041888751","duns":"862174716","firm":"Vasundhara Rasayans Limited","registrant":"Vasundhara Rasayans Limited","parent":null,"ticker":null,"addr":"C-104 MIDC Industrial Area, Mahad, Raigad, Maharashtra 402309, India (IND)","city":"Raigad","state":"Maharashtra","pin":"402309","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":18.08075,"lon":73.42438,"prec":"tail3","geo":"Mahad, Mahad Taluka, Raigad, Maharashtra, 402300, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["1000283831","3015167570","3031325873"]},{"id":"3004082076","fei":"3004082076","duns":"862383163","firm":"Unichem Laboratories Limited","registrant":"Unichem Laboratories Limited, India","parent":null,"ticker":null,"addr":"C-31, 32 & D-10, Industrial Area, Meerut Road, Ghaziabad, Uttar Pradesh 201003, India (IND)","city":"Ghaziabad","state":"Uttar Pradesh","pin":"201003","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":28.71282,"lon":77.37749,"prec":"postcode","geo":"201003, Ghaziabad, Uttar Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005497507","3006456888","3004373180","3013585679"],"colo":[]},{"id":"3008763768","fei":"3008763768","duns":"650515294","firm":"Piramal Pharma Limited","registrant":"Piramal Pharma Limited","parent":"Piramal Pharma","ticker":"PPLPHARMA","addr":"C-43, MIDC, TTC Industrial Area, Turbhe, off Thane Belapur Road, Navi Mumbai, Maharashtra 400703, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400703","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.07638,"lon":73.00446,"prec":"postcode","geo":"400703, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"10/27/2009","notes":"","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"10/27/2009"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"10/29/2009"}],"firm_as_published":"Piramal Enterprises Ltd","address_as_published":"1 Nirlon Complex , Western Express Highway , Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[],"events":[{"d":"2009-10-29","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2009-10-27","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""}],"first":"2009-10-27","last":"2009-10-29","sibs":["3005259207","3008394466","3003803288"],"colo":["3038430488","3005972980"]},{"id":"3010585824","fei":"3010585824","duns":"918512278","firm":"PADARSH PHARMACEUTICALS PRIVATE LIMITED","registrant":"PADARSH PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"C-45/1,TTC Industrial Area, Village Pawane, Navi Mumbai, Maharashatra 400705, India (IND)","city":"Navi Mumbai","state":null,"pin":"400705","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.06727,"lon":73.00917,"prec":"postcode","geo":"400705, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3020879673","C 404, TTC Industrial Area MIDC, Pawane, Navi Mumbai,  400705, India (IND)","3006441076","3011103533"]},{"id":"3019864868","fei":"3019864868","duns":"854271096","firm":"UCS Wellness Private Limited","registrant":"UCS Wellness Private Limited","parent":null,"ticker":null,"addr":"C-51, SECTOR - 58, NOIDA, GAUTAM BUDDHA NAGAR, Noida, UP 201301, India (IND)","city":"Noida","state":null,"pin":"201301","ops":["MANUFACTURE","TRANSFILL"],"expires":"12/31/2026","lat":28.55404,"lon":77.37956,"prec":"postcode","geo":"201301, Noida, Dadri, Gautam Buddha Nagar, Uttar Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3010165295","fei":"3010165295","duns":"916758275","firm":"Simpex Pharma Pvt. Ltd","registrant":"Simpex Pharma Pvt. Ltd","parent":null,"ticker":null,"addr":"C-7 to C-13 & C-59 to C-64 Siggaddi Growth Center, Sigaddi, Kotdwar, Pauri Garhwal, Uttarakhand 246149, India (IND)","city":"Pauri Garhwal","state":"Uttarakhand","pin":"246149","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":29.74643,"lon":78.51789,"prec":"postcode","geo":"246149, Kotdwara, Pauri Garhwal, Uttarakhand, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3007127164","fei":"3007127164","duns":"650344315","firm":"Actavis Pharma Development Centre Private Limited","registrant":"Actavis Pharma Development Centre Private Limited","parent":null,"ticker":null,"addr":"C/O Ticel Biopark Limited, Taramani Road, Chennai, Tamil nadu 600113, India (IND)","city":"Chennai","state":"Tamil Nadu","pin":"600113","ops":["ANALYSIS"],"expires":"12/31/2026","lat":12.99292,"lon":80.24367,"prec":"postcode","geo":"600113, Zone 13 Adyar, Chennai Corporation, Chennai, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3018807295"]},{"id":"3042700568","fei":"3042700568","duns":"854047348","firm":"SHUKRA PHARMACEUTICALS LIMITED","registrant":"SHUKRA PHARMACEUTICALS LIMITED","parent":null,"ticker":null,"addr":"CAMPS CORNER-1, 3RD FLOOR, NR AUDA GARDEN, PRAHLADNAGAR, Ahmedabad, Gujarat 380015, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"380015","ops":["ANALYSIS"],"expires":"12/31/2026","lat":23.02223,"lon":72.52801,"prec":"postcode","geo":"380015, Vejalpur Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009857729","House No. 5, Ground Floor, First Floor, Second Floor and Third floor, Magnet Corporate Park, Near Thaltej Cross Road, SG Highway,, Ahmedabad, Gujarat 380015, India (IND)","3008355986"]},{"id":"3037647985","fei":"3037647985","duns":"772679277","firm":"Encube Ethicals Limited","registrant":"Encube Ethicals Limited","parent":null,"ticker":null,"addr":"CS No. 59/5, 63/1, 64/1, 64/2,64/3, 64/4, 64/5, 242/5, 242/6, 266/1, 266/2, Village Hedutane, Kalyan,, Thane, Maharashtra 421204, India (IND)","city":"Thane","state":"Maharashtra","pin":"421204","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.1703,"lon":73.09164,"prec":"postcode","geo":"421204, Dombivali, Kalyan Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005669319","3030695079","3007532627"],"colo":["3007005296","3004985767"]},{"id":"3005336882","fei":"3005336882","duns":"858971115","firm":"DR. REDDY'S LABORATORIES LIMITED","registrant":"Dr. Reddy's Laboratories Limited","parent":"Dr. Reddy's Laboratories","ticker":"DRREDDY","addr":"CTO-SEZ Process Unit-01, Sector No's. 28 to 34, 36 to 37, 40, 50 to 53 & 03, Survey No' s. 57 to 58, 60, 72 to 73, 76 to 77 & 80, Devunipalavalasa Village, Ransthalam Mandal, Srikakulam, Andhra Pradesh 532409, India (IND)","city":"Srikakulam","state":"Andhra Pradesh","pin":"532409","ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.15105,"lon":83.65614,"prec":"postcode","geo":"532409, Ranastalam, Srikakulam, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002949085","3014250111","3011171511","3009193040","3012414462","3006549835","3005447965","3005448030","3002806851","3003184497","3002949099","3009483004"],"colo":["3008430469","3013791804","3012390454","3030708811","3004611182"]},{"id":"3005890633","fei":"3005890633","duns":"858328710","firm":"Intas Pharmaceuticals Limited","registrant":"Intas Pharmaceuticals Limited","parent":"Intas (unlisted)","ticker":null,"addr":"Camp Road, Selaqui, Dehradun, Uttarakhand 248011, India (IND)","city":"Dehradun","state":"Uttarakhand","pin":"248011","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":30.36521,"lon":77.85851,"prec":"postcode","geo":"248011, Vikasnagar, Dehradun, Uttarakhand, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/01/2023","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"11/15/2024"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"11/15/2024"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"11/15/2024"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"11/15/2024"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"11/15/2024"},{"code":"55","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/01/2023"},{"code":"56","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Antibiotics (Human/Animal)","published":"06/01/2023"},{"code":"58","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"06/01/2023"},{"code":"60","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"61","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"62","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"63","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"64","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"65","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"66","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"}],"firm_as_published":"Intas Pharmaceuticals Limited","address_as_published":"Pharmez Plot No 5-14 , Near Village Matoda; Sarkhej-Bavla Highway No 8-A , Sanand, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"11/14/2023","notes":"These products are excluded from DWPE: Azacitidine Injection 62I[][]99 Clonazepam Tablet 61M[][]06 Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"04/09/2024"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"04/09/2024"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"04/09/2024"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"04/09/2024"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"04/09/2024"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"11/14/2023"},{"code":"56","notes":"All Drug and Drug Products;","product":"Antibiotics (Human/Animal)","published":"11/14/2023"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"11/14/2023"},{"code":"60","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"61","notes":"All Drug and Drug Products; These products are excluded from DWPE: Clonazepam Tablet 61M[][]06","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"62","notes":"All Drug and Drug Products; These products are excluded from DWPE: Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95 Azacitidine Injection 62I[][]99","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"63","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"64","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/14/2023"}],"firm_as_published":"Intas Pharmaceuticals Limited","address_as_published":"Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi , Sarkhej-Bavla Highway, Taluka-Sanand, Matoda , Ahmedabad, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2023-07-28T04:00:00Z","posted":"2023-08-01T14:31:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"},{"date":"2023-11-21T05:00:00Z","posted":"2023-11-28T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"},{"date":"2026-03-30T04:00:00Z","posted":"2026-04-28T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"}],"events":[{"d":"2026-03-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2023-11-21","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-11-14","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE: Azacitidine Injection 62I[][]99 Clonazepam Tablet 61M[][]06 Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95"},{"d":"2023-07-28","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-06-01","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32"}],"first":"2023-06-01","last":"2026-03-30","sibs":["3003722314","3007277149","3003157498","3004011473","3011743992"],"colo":["3017348002","3008127341"]},{"id":"3014615000","fei":"3014615000","duns":"677605501","firm":"SMS Pharmaceuticals limited","registrant":"SMS Pharmaceuticals Limited (Central laboratory Analytical Services)","parent":null,"ticker":null,"addr":"Central Laboratory Analytical Services Building No 2, First Floor Survey No 186 189 190, Gagillapur (V), Medchal-Malkajgiri, Hyderabad, India 500043, India (IND)","city":"Hyderabad","state":null,"pin":"500043","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.56089,"lon":78.43615,"prec":"postcode","geo":"500043, Dundigal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008654585","3003971663"],"colo":["3002647489","3004097901"]},{"id":"3005656140","fei":"3005656140","duns":"772046267","firm":"Ceph Lifesciences Private Limited","registrant":"Ceph Lifesciences Private Limited","parent":null,"ticker":null,"addr":"Ceph Lifesciences Private Ltd. Unit-2, Haripur Hinduan Sundran Road, Saidpura Bus Stop, Derabassi, Saidpura, SAS Nagar, Punjab 140507, India (IND)","city":"SAS Nagar","state":"Punjab","pin":"140507","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":30.58076,"lon":76.85014,"prec":"postcode","geo":"140507, Dera Bassi Tahsil, Sahibzada Ajit Singh Nagar, Punjab, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3007147039","3015793804","3005895238","3007577941"]},{"id":"3009870595","fei":"3009870595","duns":"677603796","firm":"NATCO PHARMA LIMITED","registrant":"NATCO PHARMA LIMITED","parent":"Natco Pharma","ticker":"NATCOPHARM","addr":"Chemical Division, Chennai, No 74/7B, Vaikkadu TPP Salai, Manali, Chennai, Tamil Nadu 600103, India (IND)","city":"Chennai","state":"Tamil Nadu","pin":"600103","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.2042,"lon":80.26825,"prec":"postcode","geo":"600103, Ponneri, Thiruvallur, Tamil Nadu, India","status":1,"alerts":[],"letters":[{"date":"2024-04-08T04:00:00Z","posted":"2024-04-16T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"09/29/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natco-pharma-limited-672564-04082024","company_as_published":"Natco Pharma Limited","match":"exact"}],"events":[{"d":"2024-04-08","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natco-pharma-limited-672564-04082024","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2024-04-08","last":"2024-04-08","sibs":["3004065860","3004540906","3015380536"],"colo":[]},{"id":"3004065860","fei":"3004065860","duns":"862497174","firm":"NATCO PHARMA LIMITED","registrant":"NATCO PHARMA LIMITED","parent":"Natco Pharma","ticker":"NATCOPHARM","addr":"Chemical Division, Mekaguda Village, Nandigama Mandal, Rangareddy, Telangana 509223, India (IND)","city":"Rangareddy","state":"Telangana","pin":"509223","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.12028,"lon":78.2566,"prec":"tail3","geo":"Nandigama I, Mekaguda road Nandigam, Mohinuddin Guda (U.I), Nandigama, Nandigama mandal, Ranga Reddy, Telangana, 509228, India","status":1,"alerts":[],"letters":[{"date":"2024-04-08T04:00:00Z","posted":"2024-04-16T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"09/29/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natco-pharma-limited-672564-04082024","company_as_published":"Natco Pharma Limited","match":"exact"}],"events":[{"d":"2024-04-08","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natco-pharma-limited-672564-04082024","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2024-04-08","last":"2024-04-08","sibs":["3009870595","3004540906","3015380536"],"colo":[]},{"id":"3006355432","fei":"3006355432","duns":"650438166","firm":"Mylan Laboratories Limited","registrant":"Viatris Inc.","parent":null,"ticker":null,"addr":"Clinical Research Centre, Saradhi Chambers, A-4 Rukminipuri Near Polomi Hospital Main Road, Dr AS Rao Nagar, Hyderabad, Telangana 500062, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500062","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.47931,"lon":78.56395,"prec":"postcode","geo":"500062, Ward 2 Dr A S Rao Nagar, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Kapra mandal, Medchal–Malkajgiri, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"12/19/2024","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/19/2024"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"12/19/2024"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/19/2024"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"}],"firm_as_published":"Mylan Laboratories Limited","address_as_published":"(FDF-3) Plot Nos. 11, 12, 13, Indore SEZ , Pharma Zone, Phase II, Sector III , Pithampur, District Dhar, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2024-12-19","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2024-12-19","last":"2024-12-19","sibs":["3005587313","3008316970","3010453141","3007512701","3008255419","3007720135","3007648351"],"colo":[]},{"id":"3004698222","fei":"3004698222","duns":"650057904","firm":"Colgate-Palmolive India Limited","registrant":"Coglate-Palmolive Company","parent":null,"ticker":null,"addr":"Colgate Research Centre, Main Street, Hiranandani Gardens, Powai, Mumbai, Maharashtra 400076, India (IND)","city":"Mumbai","state":"Maharashtra","pin":"400076","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.12378,"lon":72.91208,"prec":"postcode","geo":"400076, S Ward, Mumbai Zone 6, Mumbai, Mumbai Suburban District, Maharashtra, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"01/12/2018","notes":"","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"01/12/2018"},{"code":"55 R - - 99","notes":"","product":"Pharmaceutic Necessities, N.E.C.","published":"01/12/2018"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"01/12/2018"}],"firm_as_published":"Colgate Palmolive","address_as_published":"Sm - 02 Sanand , Plot , Gujrat, Punjab INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"12/30/2019","notes":"","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"12/30/2019"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"12/30/2019"},{"code":"63 R","notes":"","product":"Dental Caries Prophyl","published":"12/30/2019"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"12/30/2019"}],"firm_as_published":"Colgate-Palmolive (India) Ltd.","address_as_published":"78 Epip Phase I , Plot No , Jhar Majri, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[{"date":"2024-11-05T05:00:00Z","posted":"2024-11-19T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/colgate-palmolivetoms-maine-inc-687043-11052024","company_as_published":"Colgate-Palmolive/Tom's of Maine, Inc.","match":"token"}],"events":[{"d":"2024-11-05","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/colgate-palmolivetoms-maine-inc-687043-11052024","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2019-12-30","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2018-01-12","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""}],"first":"2018-01-12","last":"2024-11-05","sibs":[],"colo":[]},{"id":"3038528882","fei":"3038528882","duns":"931831324","firm":"Prathyak Laboratories Private Limited","registrant":"Prathyak Laboratories Private Limited","parent":null,"ticker":null,"addr":"Cronies Plot No. 4C, MN Sciences Tech, Genome Valley, Synergy Square 1, Phase 1, Medchal,, Hyderabad, Telangana 500101, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500101","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.65514,"lon":78.60618,"prec":"postcode","geo":"500101, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["PLOT NO 4C,MN SC & TECH BIOTECH PARK GENOME VALLEY, TURKAPALLY, SHAMIRPET RANGAREDDY, Hyderabad, Telangana 500101, India (IND)","3006587427","3017754175","3039644403","3039411568","3006527015","3009522832","3012704791","3030495702","3009883135","3011960448"]},{"id":"3005972980","fei":"3005972980","duns":"772679105","firm":"Svizera Labs Private Limited","registrant":"Svizera Labs Private Limited","parent":null,"ticker":null,"addr":"D 16/5-6, TTC Industrial Area, Near Turbhe Telephone Exchange, Govandi West, Thane, Maharashtra 400703, India (IND)","city":"Thane","state":"Maharashtra","pin":"400703","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.07638,"lon":73.00446,"prec":"postcode","geo":"400703, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038430488","3008763768"]},{"id":"3006441076","fei":"3006441076","duns":"756052848","firm":"AnaZeal Analyticals & Research Pvt. Ltd.","registrant":"AnaZeal Analyticals & Research Pvt. Ltd.","parent":null,"ticker":null,"addr":"D 334, TTC Industrial Area, MIDC Turbhe, Navi Mumbai, Thane, Maharashtra 400705, India (IND)","city":"Thane","state":"Maharashtra","pin":"400705","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.06727,"lon":73.00917,"prec":"postcode","geo":"400705, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["C 404, TTC Industrial Area MIDC, Pawane, Navi Mumbai,  400705, India (IND)"],"colo":["3020879673","3010585824","3011103533"]},{"id":"3003447972","fei":"3003447972","duns":"725561927","firm":"KREATIVE ORGANICS PRIVATE LIMITED","registrant":"Kreative Organics Private Limited","parent":null,"ticker":null,"addr":"D-123, Phase III IDA, Jeedimetla, Hyderabad, Telangana 500055, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500055","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003937580","3037699325","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869","3018694293"]},{"id":"3007523885","fei":"3007523885","duns":"650566198","firm":"Wockhardt Limited","registrant":"WOCKHARDT LIMITED","parent":"Wockhardt","ticker":"WOCKPHARMA","addr":"D-4, M.I.D.C. Area, Chikalthana, Aurangabad, Maharashtra 431006, India (IND)","city":"Aurangabad","state":"Maharashtra","pin":"431006","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.87506,"lon":75.37945,"prec":"postcode","geo":"431006, Chhatrapati Sambhajinagar, Maharashtra, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"05/22/2013","notes":"All Drugs and drug products;","charges":[{"code":"55","notes":"All Drugs and drug products;","product":"Pharm Necess & Ctnr For Drug/Bio","published":"05/22/2013"},{"code":"56","notes":"All Drugs and drug products;","product":"Antibiotics (Human/Animal)","published":"05/22/2013"},{"code":"58","notes":"All Drugs and drug products;","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drugs and drug products;","product":"Human and Animal Drugs","published":"05/22/2013"},{"code":"61","notes":"All Drugs and drug products;","product":"Human and Animal Drugs","published":"05/22/2013"},{"code":"62","notes":"All Drugs and drug products","product":"Human and Animal Drugs","published":"05/22/2013"},{"code":"63","notes":"All Drugs and drug products;","product":"Human and Animal Drugs","published":"05/22/2013"},{"code":"64","notes":"All Drugs and drug products","product":"Human and Animal Drugs","published":"05/22/2013"},{"code":"65","notes":"All Drugs and drug products","product":"Human and Animal Drugs","published":"05/22/2013"},{"code":"66","notes":"All Drugs and drug products;","product":"Human and Animal Drugs","published":"05/22/2013"}],"firm_as_published":"Wockhardt Limited","address_as_published":"H - 14/2 Midc Area , Waluj , Aurangabad, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"11/26/2013","notes":"All Drug and Drug Products","charges":[{"code":"50","notes":"","product":"Color Additiv Food/Drug/Cosmetic","published":"09/28/2016"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"11/26/2013"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"09/28/2016"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2013"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2013"},{"code":"62","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/26/2013"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2013"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2013"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2013"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2013"}],"firm_as_published":"Wockhardt Limited","address_as_published":"L-1, MIDC Area, Jalgaon Road 43 , Chikalthana , Aurangabad, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"08/05/2016","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"08/05/2016"},{"code":"56","notes":"All Drug and Drug Products;","product":"Antibiotics (Human/Animal)","published":"08/05/2016"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"}],"firm_as_published":"Wockhardt, Ltd.","address_as_published":"Sf-12 Shrinathji Arcade Plot 138 , Bulk Drug Division; Karmatur Road , Ankleshwar, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs and drug products;"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2016-09-28","k":"charge","t":"66-40 charge 50 — Color Additiv Food/Drug/Cosmetic","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2016-09-28","k":"charge","t":"66-40 charge 56 — Antibiotics (Human/Animal)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2016-08-05","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"},{"d":"2013-11-26","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"},{"d":"2013-05-22","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs and drug products;"}],"first":"2013-05-22","last":"2022-05-26","sibs":["3009278506"],"colo":["3003130103"]},{"id":"3015345351","fei":"3015345351","duns":"871623684","firm":"Zen Chemicals Private Limited","registrant":"Zen Chemicals Private Limited","parent":null,"ticker":null,"addr":"D-5, Midc, Phase-2, Manpada Road, Dombivili,dombivili, Jalna,  421203, India (IND)","city":"Jalna","state":null,"pin":"421203","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.19972,"lon":73.09442,"prec":"postcode","geo":"421203, Dombivali, Kalyan Subdistrict, Thane, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2021-11-29T05:00:00Z","posted":"2021-11-30T20:00:00Z","subject":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","office":"Center for Tobacco Products","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zen-vaper-e-liquids-llc-621466-11292021","company_as_published":"The Zen Vaper E-Liquids, LLC","match":"token"},{"date":"2024-04-18T04:00:00Z","posted":"2024-04-23T13:20:00Z","subject":"Failure to Register and List","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"09/17/2024","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zen-enterprises-llc-678407-04182024","company_as_published":"Zen Enterprises LLC","match":"token"}],"events":[{"d":"2024-04-18","k":"letter","t":"Failure to Register and List","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zen-enterprises-llc-678407-04182024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-11-29","k":"letter","t":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zen-vaper-e-liquids-llc-621466-11292021","x":"Center for Tobacco Products"}],"first":"2021-11-29","last":"2024-04-18","sibs":[],"colo":[]},{"id":"3037146694","fei":"3037146694","duns":"766401589","firm":"CIPLA PHARMACEUTICALS LIMITED","registrant":"CIPLA PHARMACEUTICALS LIMITED","parent":"Cipla","ticker":"CIPLA","addr":"D-8, MIDC ROAD, Kurkumbh MIDC, Pune, Maharashtra 413802, India (IND)","city":"Pune","state":"Maharashtra","pin":"413802","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":18.35405,"lon":74.55832,"prec":"postcode","geo":"413802, Daund, Pune, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3002806702","3005782879"]},{"id":"3015587560","fei":"3015587560","duns":"860320955","firm":"Chromcore Lifesciences LLP","registrant":"CHROMCORE LIFESCIENCES LLP","parent":null,"ticker":null,"addr":"D.no.49-24-56, Cynosure Plaza Plot No.8, 2nd Floor, Madhuranagar, Vishakhapatnam, Andhra Pradesh 530016, India (IND)","city":"Vishakhapatnam","state":"Andhra Pradesh","pin":"530016","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.73253,"lon":83.30189,"prec":"postcode","geo":"530016, Visakhapatnam Urban, Visakhapatnam, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3007078752","fei":"3007078752","duns":"650883916","firm":"Actimus Biosciences Private Limited","registrant":"Actimus Biosciences Private Limited","parent":null,"ticker":null,"addr":"D2 D Block Chandana Plastics, Visakhapatnam,  5300122, India (IND)","city":"Visakhapatnam","state":null,"pin":null,"ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.69355,"lon":83.29213,"prec":"tail2","geo":"Visakhapatnam, Visakhapatnam Urban, Visakhapatnam, Andhra Pradesh, 530001, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006211400"],"colo":[]},{"id":"3007147039","fei":"3007147039","duns":"677318280","firm":"SCL Lifesciences Limited","registrant":"SCL Lifesciences Limited","parent":null,"ticker":null,"addr":"Derabassi-Barwala Road, Village Bhagwanpura, Tehsil Derabassi, Sahibzada Ajit Singh Nagar, Punjab 140507, India (IND)","city":"Sahibzada Ajit Singh Nagar","state":"Punjab","pin":"140507","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":30.58076,"lon":76.85014,"prec":"postcode","geo":"140507, Dera Bassi Tahsil, Sahibzada Ajit Singh Nagar, Punjab, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005656140","3015793804","3005895238","3007577941"]},{"id":"3013826490","fei":"3013826490","duns":"871411532","firm":"Alembic Pharmaceuticals Limited","registrant":"Alembic Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Derma Division, Plot no 779/P and 790/P, Vadodara, Gujarat 391450, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391450","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.21881,"lon":72.98271,"prec":"postcode","geo":"391450, Padra Taluka, Vadodara, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2026-07-10T04:00:00Z","posted":"2026-07-21T04:00:00Z","subject":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","company_as_published":"Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.","match":"token"}],"events":[{"d":"2026-07-10","k":"letter","t":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-07-10","last":"2026-07-10","sibs":["3007501748","3003821360","3015685305","3016088083","3004956904","3014866088"],"colo":["3009456513"]},{"id":"3009995739","fei":"3009995739","duns":"859039595","firm":"BIONEEDS INDIA PRIVATE LIMITED","registrant":"BIONEEDS INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Devarahosahally, Sompura Hobli Nelamangala Taluk, Bengalore Rural, Karnataka 562111, India (IND)","city":"Bengalore Rural","state":"Karnataka","pin":"562111","ops":["ANALYSIS"],"expires":"12/31/2026","lat":13.23559,"lon":77.2605,"prec":"postcode","geo":"562111, Pemmanahalli, Nelamangala taluk, Bengaluru North, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3010619401","3018694237"]},{"id":"3009510975","fei":"3009510975","duns":"650213072","firm":"Reliance Life Sciences Private Limited","registrant":"Reliance Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Dhirubhai Ambani Life Sciences Centre, R-282 Ttc Area of MIDC, Thane Belapur Road, Rabale,, Navi Mumbai, Maharashtra 400701, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400701","ops":["ANALYSIS","API MANUFACTURE","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.11985,"lon":73.00488,"prec":"postcode","geo":"400701, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"07/09/2026","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","charges":[{"code":"54 - D","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"07/09/2026"},{"code":"54 - E","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"07/09/2026"},{"code":"54 - F","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"07/09/2026"},{"code":"54 - G","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"07/09/2026"},{"code":"54 - I","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"07/09/2026"},{"code":"55","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Pharm Necess & Ctnr For Drug/Bio","published":"07/09/2026"},{"code":"56","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Antibiotics (Human/Animal)","published":"07/09/2026"},{"code":"58","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"07/09/2026"},{"code":"60","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Human and Animal Drugs","published":"07/09/2026"},{"code":"61","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Human and Animal Drugs","published":"07/09/2026"},{"code":"62","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Human and Animal Drugs","published":"07/09/2026"},{"code":"63","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Human and Animal Drugs","published":"07/09/2026"},{"code":"64","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Human and Animal Drugs","published":"07/09/2026"},{"code":"65","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Human and Animal Drugs","published":"07/09/2026"},{"code":"66","notes":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited","product":"Human and Animal Drugs","published":"07/09/2026"}],"firm_as_published":"Reliance Life Sciences Private Limited","address_as_published":"Ttc Area Of Midc , R - 282 Dhirubhai Ambani Life Sciences Centre; Thane Belapur Road , Navi Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2023-02-16T05:00:00Z","posted":"2023-03-07T14:20:00Z","subject":"CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations West VI","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/arrow-reliance-inc-644947-02162023","company_as_published":"Arrow Reliance Inc.","match":"token"},{"date":"2026-08-18T04:00:00Z","posted":"2026-09-01T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/reliance-life-sciences-private-limited-730801-08182026","company_as_published":"Reliance Life Sciences Private Limited","match":"exact"}],"events":[{"d":"2026-08-18","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/reliance-life-sciences-private-limited-730801-08182026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2026-07-09","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All drugs and drug products manufactured by Reliance Life Sciences Private Limited"},{"d":"2023-02-16","k":"letter","t":"CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/arrow-reliance-inc-644947-02162023","x":"Division of Human and Animal Food Operations West VI"}],"first":"2023-02-16","last":"2026-08-18","sibs":[],"colo":["3027513144","3006620783","3003484180","3024731845","3007026867","3005502733","3011560035","3030219467","3013153296"]},{"id":"3003445931","fei":"3003445931","duns":"917151029","firm":"VENKAR CHEMICALS PRIVATE LIMITED","registrant":"VENKAR CHEMICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Door No.7-2-1735 & 1813/5/A, Plot No.16 1st Floor, Road No.1A, Czech Colony, Sanathnagar, Hyderabad, Telangana/India 500018, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500018","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.45684,"lon":78.43297,"prec":"postcode","geo":"500018, Ward 101 Erragadda, Greater Hyderabad Municipal Corporation Central Zone, Hyderabad, Ameerpet mandal, Hyderabad, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011960469"],"colo":["3004544153","3009307611"]},{"id":"3009887190","fei":"3009887190","duns":"859047363","firm":"A.V.Processors Pvt. Ltd.","registrant":"AVProcessors Pvt Ltd","parent":null,"ticker":null,"addr":"E - 52, Additional Ambernath MIDC Anand Nagar,, Thane, Maharashtra 421506, India (IND)","city":"Thane","state":"Maharashtra","pin":"421506","ops":["STERILIZE"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"05/29/2014","notes":"","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"05/29/2014"}],"firm_as_published":"Fine Processors Private Ltd.","address_as_published":"D - 27 Sector Ii , Noida, Uttar Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"05/29/2014","notes":"","charges":[{"code":"53 E - - 99","notes":"","product":"Other Hair Preparations, Non-coloring), N.E.C.","published":"05/29/2014"}],"firm_as_published":"Paramount Polish Processors Ltd","address_as_published":"995 1 Camp Road , Central Hope Town, Uttarakhand INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[],"events":[{"d":"2014-05-29","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""}],"first":"2014-05-29","last":"2014-05-29","sibs":[],"colo":["3021189141","3008232264","3013999816","3018052045","3016575313","3006599894","3006809732","3027577650","3010166801","3032073298","3008374690","3009051788"]},{"id":"3001174909","fei":"3001174909","duns":"915041156","firm":"ANUH PHARMA LIMITED","registrant":"Anuh Pharma Ltd.","parent":null,"ticker":null,"addr":"E-17/3 &17/4, E-18 , MIDC, Tarapur Boisar, Thane, Maharashtra 401506, India (IND)","city":"Thane","state":"Maharashtra","pin":"401506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003721861","3006418686","3006057101","3009118300","3016577628","3016790354","3017545500","3003336449","3013633378","3018369072","3003677831","3002807512"]},{"id":"1000283831","fei":"1000283831","duns":"916512449","firm":"Embio Limited","registrant":"Embio Limited","parent":null,"ticker":null,"addr":"E-21, MIDC Industrial Estate,, Mahad, Maharashtra, Raigad 402309, India (IND)","city":"Mahad","state":"Maharashtra","pin":"402309","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":18.08075,"lon":73.42438,"prec":"tail3","geo":"Mahad, Mahad Taluka, Raigad, Maharashtra, 402300, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3041888751","3015167570","3031325873"]},{"id":"3010408344","fei":"3010408344","duns":"650743854","firm":"Phoenix Innovative Healthcare Manufacturers Private Limited","registrant":"Phoenix Innovative Healthcare Manufacturers Private Limited","parent":null,"ticker":null,"addr":"EL-209, Shil Mahape Road, Elec tronic Zone, Navi Mumbai, Maharashtra 400710, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400710","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":19.10848,"lon":73.02077,"prec":"postcode","geo":"400710, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009565091","3008763840","3027402875"]},{"id":"3004520113","fei":"3004520113","duns":"918459363","firm":"Sun Pharmaceutical Industries Limited","registrant":"Sun Pharmaceutical Industries Limited","parent":"Sun Pharmaceutical Industries","ticker":"SUNPHARMA","addr":"F P No. 27, Part Survey No. 27, C.S. No. 1050, TPS No. 24, Village Tandalja, Vadodara, Gujarat 390012, India (IND)","city":"Vadodara","state":"Gujarat","pin":"390012","ops":["ANALYSIS"],"expires":"12/31/2026","lat":22.28337,"lon":73.16077,"prec":"postcode","geo":"390012, Vadodara West Taluka, Vadodara, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs.","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs.","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs.","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"Village Ganguwala , Tehsil-Paonta Sahib , Sirmaur, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs.","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"3 Industrial Area , Dewas, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"03/12/2014","notes":"","charges":[{"code":"60","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"}],"firm_as_published":"Sun Pharmaceutical Industries Limited - Karkhadi","address_as_published":"A Plot No 817 , Village Karkhadi , Padra, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"12/07/2022","notes":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","charges":[{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"05/12/2025"},{"code":"55","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/07/2022"},{"code":"56","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Antibiotics (Human/Animal)","published":"12/07/2022"},{"code":"58","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/07/2022"},{"code":"60","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"61","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"62","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"63","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"64","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"65","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"66","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"}],"firm_as_published":"Sun Pharmaceutical Industries Ltd.","address_as_published":"Halol - Baroda Highway , Halol, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-06-08T04:00:00Z","posted":"2022-07-19T13:20:00Z","subject":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","office":"Office of Human and Animal Foods- East Division 3","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","company_as_published":"New Sun Inc.","match":"token"},{"date":"2022-08-17T04:00:00Z","posted":"2022-09-06T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Office of Human and Animal Food Operations – West Division 5","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","company_as_published":"Sun Sen Co., Inc.","match":"token"},{"date":"2023-04-07T04:00:00Z","posted":"2023-08-15T13:20:00Z","subject":"Unapproved New Drugs/Misbranded","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","company_as_published":"STPCA Inc. dba Sun Ten Laboratories","match":"token"},{"date":"2023-05-10T04:00:00Z","posted":"2023-05-30T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations West II","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","company_as_published":"Rhodes Legacy Inc DBA Sun Sprouts","match":"token"},{"date":"2023-10-16T04:00:00Z","posted":"2023-10-16T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","company_as_published":"Sun Pharmaceutical Industries Ltd.","match":"exact"},{"date":"2024-06-18T04:00:00Z","posted":"2024-07-02T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","company_as_published":"Sun Pharmaceutical Industries Limited","match":"exact"},{"date":"2025-03-12T04:00:00Z","posted":"2025-03-18T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","company_as_published":"Waxhead Sun Defense Company","match":"token"}],"events":[{"d":"2025-05-12","k":"charge","t":"66-40 charge 54 — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-03-12","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-06-18","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-10-16","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-05-10","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","x":"Division of Human and Animal Food Operations West II"},{"d":"2023-04-07","k":"letter","t":"Unapproved New Drugs/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","x":"Division of Human and Animal Food Operations West V"},{"d":"2022-12-07","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24"},{"d":"2022-08-17","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","x":"Office of Human and Animal Food Operations – West Division 5"},{"d":"2022-06-08","k":"letter","t":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","x":"Office of Human and Animal Foods- East Division 3"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2014-03-12","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs."},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs"}],"first":"2009-09-10","last":"2025-05-12","sibs":["3003227153","3003892973","3002809586","3003952717","3012032037","3002807979","3010027135","3002871444","3007627683","3004561553"],"colo":[]},{"id":"3014466106","fei":"3014466106","duns":"854248673","firm":"INTERTEK INDIA PRIVATE LIMITED","registrant":"INTERTEK INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"F Wing, 3rd Floor, Tex Centre, Chandivali Farm Road, Andheri (E), Mumbai, MH 400072, India (IND)","city":"Mumbai","state":null,"pin":"400072","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.1062,"lon":72.89134,"prec":"postcode","geo":"400072, L Ward, Mumbai Zone 5, Mumbai, Mumbai Suburban District, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3015794560","fei":"3015794560","duns":"675486516","firm":"MACSEN DRUGS","registrant":"MACSEN DRUGS","parent":null,"ticker":null,"addr":"F-261, 262, 263 RIICO Industrial Area Gudli, Tehsil Mavli,, Udaipur, Rajasthan 313024, India (IND)","city":"Udaipur","state":"Rajasthan","pin":"313024","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":24.72764,"lon":73.65993,"prec":"postcode","geo":"313024, Badgaon Tehsil, Udaipur, Rajasthan, India","status":2,"alerts":[{"alert":"66-66","list":"red","since":"02/12/2016","notes":"","charges":[{"code":"62 F - - 38","notes":"","product":"Silver Sulfadiazine (Anti-Infective, Topical)","published":"02/12/2016"}],"firm_as_published":"Macsen Laboratories","address_as_published":"Ambamata Ki Ghati , Village Titerdi , Tehsil Girwa, Udaipur, Rajasthan INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"token"}],"letters":[{"date":"2025-03-05T05:00:00Z","posted":"2025-07-29T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/macsen-drugs-698202-03052025","company_as_published":"Macsen Drugs","match":"exact"}],"events":[{"d":"2025-03-05","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/macsen-drugs-698202-03052025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2016-02-12","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""}],"first":"2016-02-12","last":"2025-03-05","sibs":[],"colo":[]},{"id":"3012224511","fei":"3012224511","duns":"862603166","firm":"CLARION COSMETICS","registrant":"Clarion Cosmetics A Division of Nikita Containers Pvt Ltd","parent":null,"ticker":null,"addr":"F-7 Sipcot Industrial Complex, Irungattukkottai, Sriperumbudur, Tamil Nadu 602105, India (IND)","city":"Sriperumbudur","state":"Tamil Nadu","pin":"602105","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":12.96105,"lon":79.95082,"prec":"postcode","geo":"602105, Sriperumbudur, Kanchipuram, Tamil Nadu, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/11/2018","notes":"For industry code 53; only products found to be drug products are subject to DWPE under this listing.","charges":[{"code":"53","notes":"","product":"Cosmetics","published":"06/11/2018"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/11/2018"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"06/11/2018"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"}],"firm_as_published":"JT Cosmetics & Chemicals Pvt Ltd.","address_as_published":"53 Kalol Gidc Estate , Panchmahal, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"}],"letters":[{"date":"2024-04-30T04:00:00Z","posted":"2024-05-07T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-cosmetics-company-limited-677948-04302024","company_as_published":"Global Cosmetics Company Limited","match":"token"}],"events":[{"d":"2024-04-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-cosmetics-company-limited-677948-04302024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2018-06-11","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"For industry code 53; only products found to be drug products are subject to DWPE under this listing."}],"first":"2018-06-11","last":"2024-04-30","sibs":[],"colo":[]},{"id":"3008232264","fei":"3008232264","duns":"677604412","firm":"Inventia Healthcare Limited","registrant":"Inventia Healthcare Limited.","parent":null,"ticker":null,"addr":"F1-F1/1-F75/1, Additional Ambernath MIDC Ambernath (East), Thane, Maharashtra 421506, India (IND)","city":"Thane","state":"Maharashtra","pin":"421506","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021189141","3009887190","3013999816","3018052045","3016575313","3006599894","3006809732","3027577650","3010166801","3032073298","3008374690","3009051788"]},{"id":"F7, SIPCOT Industrial Complex, Gummidipoondi, Gummidipoondi, Tamil Nadu 601201, India (IND)","fei":"","duns":"871583911","firm":"SAI SUPREME CHEMICALS","registrant":"SAI SUPREME CHEMICALS","parent":null,"ticker":null,"addr":"F7, SIPCOT Industrial Complex, Gummidipoondi, Gummidipoondi, Tamil Nadu 601201, India (IND)","city":"Gummidipoondi","state":"Tamil Nadu","pin":"601201","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":13.42741,"lon":80.10821,"prec":"postcode","geo":"601201, Gummidipoondi, Thiruvallur, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009402416","3005035920"]},{"id":"3048513092","fei":"3048513092","duns":"771974793","firm":"KAKSHAL","registrant":"KAKSHAL","parent":null,"ticker":null,"addr":"FIRST FLOOR,LOHCHWAN ROAD,SERVICE STATION,MANDIANA,140701, PATIALA, PUNJAB 140701, India (IND)","city":"PATIALA","state":"Punjab","pin":"140701","ops":["RELABEL"],"expires":"12/31/2026","lat":30.43681,"lon":76.53705,"prec":"postcode","geo":"140701, Rajpura Tahsil, Patiala, Punjab, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3011033544","fei":"3011033544","duns":"650786952","firm":"MSN LABORATORIES PRIVATE LIMITED","registrant":"MSN LABORATORIES PRIVATE LIMITED","parent":"MSN Laboratories (unlisted)","ticker":null,"addr":"FORMULATIONS DIVISION, UNIT-II, SURVEY NOS. 1277& 1319 to 1324, NANDIGAMA (VILLAGE), NANDIGAMA (MANDAL), RANGAREDDY DISTRICT, TELANGANA 509228, India (IND)","city":"RANGAREDDY DISTRICT","state":"Telangana","pin":"509228","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":17.14014,"lon":78.28718,"prec":"postcode","geo":"509228, Kothur mandal, Ranga Reddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3019516576","3005075182","3005254981","3035592613","3008656542","3023132203"],"colo":["3004540906"]},{"id":"3011171511","fei":"3011171511","duns":"650891380","firm":"DR. REDDY'S LABORATORIES LIMITED","registrant":"Dr. Reddy's Laboratories Limited","parent":"Dr. Reddy's Laboratories","ticker":"DRREDDY","addr":"FTO-SEZ - Process-Unit - 02, Survey No. 70, 71 & 73, Devunipalavalasa (V), Ranasthalam Mandal,,, Srikakulam,, Andhra Pradesh 532409, India (IND)","city":"Srikakulam","state":"Andhra Pradesh","pin":"532409","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.15105,"lon":83.65614,"prec":"postcode","geo":"532409, Ranastalam, Srikakulam, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002949085","3014250111","3005336882","3009193040","3012414462","3006549835","3005447965","3005448030","3002806851","3003184497","3002949099","3009483004"],"colo":["3008430469","3013791804","3012390454","3030708811","3004611182"]},{"id":"3009193040","fei":"3009193040","duns":"860037244","firm":"DR. REDDY'S LABORATORIES LIMITED","registrant":"Dr. Reddy's Laboratories Limited","parent":"Dr. Reddy's Laboratories","ticker":"DRREDDY","addr":"FTO-Sez - Process Unit - 01, Survey No 57to59,60,62&72, Sector No 9 to 14 & 17 to 20, Devunipalavalasa Village Ranasthalam(M),, Srikakulam, Andhra Pradesh 532409, India (IND)","city":"Srikakulam","state":"Andhra Pradesh","pin":"532409","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.15105,"lon":83.65614,"prec":"postcode","geo":"532409, Ranastalam, Srikakulam, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002949085","3014250111","3005336882","3011171511","3012414462","3006549835","3005447965","3005448030","3002806851","3003184497","3002949099","3009483004"],"colo":["3008430469","3013791804","3012390454","3030708811","3004611182"]},{"id":"3007308467","fei":"3007308467","duns":"650784148","firm":"First Source Laboratory Solutions Llp","registrant":"First Source Laboratory Solutions Llp","parent":null,"ticker":null,"addr":"First Floor, Plot A1/B, IDA Naccharam Cross Road, Hyderabad, Telangana 500076, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500076","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.43874,"lon":78.56145,"prec":"postcode","geo":"500076, Ward 6 Nacharam, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3048143097","3003504071","3006493505","3011573185","3005851210","3011823550","3008311641","3008768274","3024919921","3019773458"]},{"id":"3026324208","fei":"3026324208","duns":"650517365","firm":"A. G. INDUSTRIES","registrant":"A. G. INDUSTRIES","parent":null,"ticker":null,"addr":"First, C 11, Sector 85 Noida, Janpath Marg, Sector 85, Noida, Gautam Budh Nagar 201305, India (IND)","city":"Noida","state":null,"pin":"201305","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":28.52353,"lon":77.41648,"prec":"postcode","geo":"201305, Noida, Dadri, Gautam Buddha Nagar, Uttar Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3002911411"]},{"id":"3017524864","fei":"3017524864","duns":"861343582","firm":"JANSAT LABS PRIVATE LIMITED","registrant":"JANSAT LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"First,Second And Third, Plot No A-30/2, Tsiic Kukatpally Circle, Kukatpally, Hyderabad, Medchal-Malkajgiri, Telangana 500072, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500072","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.49046,"lon":78.40127,"prec":"postcode","geo":"500072, Ward 115 Balaji Nagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Kukatpally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031662558","3037730318","3030171758","3016445311","3009887324","3027666582","3015443248","3030396086","3038110405"]},{"id":"3033411634","fei":"3033411634","duns":"955408006","firm":"SANRAY LABORATORIES PRIVATE LIMITED","registrant":"SANRAY LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Flat No 48, Sy No 302/3, Ec Extention, Ecil, Kushaiduga, Hyderabad, Telangana 00062, India (IND)","city":"Hyderabad","state":"Telangana","pin":null,"ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.66875,"lon":77.58989,"prec":"tail2","geo":"Hyderabad, Zahirabad mandal, Sangareddy, Telangana, 502220, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3015685305","fei":"3015685305","duns":"675480734","firm":"Alembic Pharmaceuticals Limited","registrant":"Alembic Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Formulation Division III, Plot No. 779P/790P, Village - Karakhadi, Taluka - Padra, Vadodara, Gujarat 391450, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391450","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":22.21881,"lon":72.98271,"prec":"postcode","geo":"391450, Padra Taluka, Vadodara, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2026-07-10T04:00:00Z","posted":"2026-07-21T04:00:00Z","subject":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","company_as_published":"Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.","match":"token"}],"events":[{"d":"2026-07-10","k":"letter","t":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-07-10","last":"2026-07-10","sibs":["3007501748","3003821360","3013826490","3016088083","3004956904","3014866088"],"colo":["3009456513"]},{"id":"3016088083","fei":"3016088083","duns":"675469976","firm":"Alembic Pharmaceuticals Limited","registrant":"Alembic Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Formulation Division IV, Halol Road, Jarod, Taluka Waghodia, Vadodara, Gujarat 391510, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391510","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":22.36446,"lon":73.35992,"prec":"postcode","geo":"391510, Vagodhia Taluka, Vadodara, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2026-07-10T04:00:00Z","posted":"2026-07-21T04:00:00Z","subject":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","company_as_published":"Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.","match":"token"}],"events":[{"d":"2026-07-10","k":"letter","t":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-07-10","last":"2026-07-10","sibs":["3007501748","3003821360","3013826490","3015685305","3004956904","3014866088"],"colo":["3033031378","3013712903"]},{"id":"3019516576","fei":"3019516576","duns":"854405955","firm":"MSN Laboratories Private Limited","registrant":"MSN Laboratories Private Limited,","parent":"MSN Laboratories (unlisted)","ticker":null,"addr":"Formulation Division, Unit -04 Sy. No's (Parts of) : 884, 885 , 929, 930, 932, 933, 935, 937- 941 and 951 Mekaguda (Village), Nandigama (Mandal),, Rangareddy (District), Telangana 509228, India (IND)","city":"Rangareddy (District)","state":"Telangana","pin":"509228","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":17.14014,"lon":78.28718,"prec":"postcode","geo":"509228, Kothur mandal, Ranga Reddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011033544","3005075182","3005254981","3035592613","3008656542","3023132203"],"colo":["3004540906"]},{"id":"3004956904","fei":"3004956904","duns":"650574671","firm":"Alembic Pharmaceuticals Limited","registrant":"Alembic Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol,, PANCHMAHAL, GUJARAT 389350, India (IND)","city":"PANCHMAHAL","state":"Gujarat","pin":"389350","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":22.51554,"lon":73.46023,"prec":"postcode","geo":"389350, Halol Taluka, Panchmahal, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2026-07-10T04:00:00Z","posted":"2026-07-21T04:00:00Z","subject":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","company_as_published":"Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.","match":"token"}],"events":[{"d":"2026-07-10","k":"letter","t":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-07-10","last":"2026-07-10","sibs":["3007501748","3003821360","3013826490","3015685305","3016088083","3014866088"],"colo":["3002809586","3012075440","3014447455","3002957541"]},{"id":"3012414462","fei":"3012414462","duns":"675487682","firm":"DR REDDY'S LABORATORIES LIMITED","registrant":"Dr. Reddy's Laboratories Limited","parent":"Dr. Reddy's Laboratories","ticker":"DRREDDY","addr":"Formulations Technical Operations, FTO-11,Survey No 30,31 & Part of (28,32,33,34,39), APIIC Industrial Park, Pydibhimavaram (V), Ranasthalam (M),, Srikakulam, Andhra Pradesh 532409, India (IND)","city":"Srikakulam","state":"Andhra Pradesh","pin":"532409","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.15105,"lon":83.65614,"prec":"postcode","geo":"532409, Ranastalam, Srikakulam, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002949085","3014250111","3005336882","3011171511","3009193040","3006549835","3005447965","3005448030","3002806851","3003184497","3002949099","3009483004"],"colo":["3008430469","3013791804","3012390454","3030708811","3004611182"]},{"id":"3043512610","fei":"3043512610","duns":"771623773","firm":"FOUNTOMICS LIFESCIENCES PRIVATE LIMITED","registrant":"FOUNTOMICS LIFESCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"G 30/2, Third Floor, General Park, Ameenpur(m), Sultanpur Medak, Patancheru, Telangana 502319, India (IND)","city":"Patancheru","state":"Telangana","pin":"502319","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338","3007800082"]},{"id":"3047574728","fei":"3047574728","duns":"771468124","firm":"GENPEP PHARMACEUTICALS PRIVATE LIMITED","registrant":"GENPEP PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"G-19, MIDC Chakan Phase III, Taluka Khed, Nighoje, Chakan, Pune, Maharashtra 410501, India (IND)","city":"Pune","state":"Maharashtra","pin":"410501","ops":["ANALYSIS","API MANUFACTURE","LABEL"],"expires":"12/31/2026","lat":18.74448,"lon":73.82554,"prec":"postcode","geo":"410501, Khed, Pune, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3009336980","fei":"3009336980","duns":"862174088","firm":"GORAN PHARMA PRIVATE LIMITED","registrant":"GORAN PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"GIDC - I, Bhavnagar Rajkot Road, Dist. Bhavnagar, Sihor, Gujarat, India 364240, India (IND)","city":"Sihor","state":"Gujarat","pin":"364240","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":21.71743,"lon":71.94024,"prec":"postcode","geo":"364240, Sihor Taluka, Bhavnagar, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3020974502","fei":"3020974502","duns":"650454486","firm":"Centre for Cellular and Molecular Platforms","registrant":"Centre for Cellular and Molecular Platforms","parent":null,"ticker":null,"addr":"GKVK Road, Bellary Road, Bangalore, Karnataka 560065, India (IND)","city":"Bangalore","state":"Karnataka","pin":"560065","ops":["ANALYSIS"],"expires":"12/31/2026","lat":13.08531,"lon":77.5778,"prec":"postcode","geo":"560065, Thindlu, Bengaluru North City Corporation, Bengaluru, Yelahanka taluku, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3013284388","fei":"3013284388","duns":"871337488","firm":"Siddharth Carbochem Products Limited","registrant":"Siddharth Carbochem Products Limited","parent":null,"ticker":null,"addr":"GROUND FLOOR, E-3, M.I.D.C.AREA, AJANTA ROAD, NEAR RAYMOND FACTORY, KHURD, Jalgaon, Maharashtra 425003, India (IND)","city":"Jalgaon","state":"Maharashtra","pin":"425003","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":20.93747,"lon":75.608,"prec":"postcode","geo":"425003, Jalgaon, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3044043959"]},{"id":"3003945855","fei":"3003945855","duns":"877013096","firm":"Erythro Pharma Private Limited","registrant":"Erythro Pharma Private Limited","parent":null,"ticker":null,"addr":"Gaddapotharam Syno13, Groundfloor, Mainstreet, Jinnaram Mandal, Sangareddy District, Telangana 502319, India (IND)","city":"Sangareddy District","state":"Telangana","pin":"502319","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043512610","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338","3007800082"]},{"id":"3013353854","fei":"3013353854","duns":"854271049","firm":"STALLION LABORATORIES PRIVATE LIMITED","registrant":"STALLION LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Gallops Industrial Park-II , Plot No.: D-4,5,6,17,18,19, Sarkhej- Bavla Road, Ahmedabad, Gujarat 382110, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382110","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.98725,"lon":72.33585,"prec":"postcode","geo":"382110, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3020233232","3014595023","3017573557"]},{"id":"3007606776","fei":"3007606776","duns":"676415531","firm":"ASG Biochem Private Limited","registrant":"ASG Biochem Private Limited","parent":null,"ticker":null,"addr":"Ganganagar, North 24 Parganas, West Bengal 700132, India (IND)","city":"North 24 Parganas","state":"West Bengal","pin":"700132","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.681,"lon":88.46017,"prec":"postcode","geo":"700132, Kolkata Metropolitan Area, Barrackpur - II, North 24 Parganas, West Bengal, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3007607026","fei":"3007607026","duns":"677383591","firm":"Deccan Nutraceuticals Pvt. Ltd.","registrant":"Deccan Nutraceuticals Pvt. Ltd.","parent":null,"ticker":null,"addr":"Gat No 1065, Golegaon Road, Off Alandi Markal Road, Markal, Tal-Khed, Pune, Maharashtra 412105, India (IND)","city":"Pune","state":"Maharashtra","pin":"412105","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":18.65936,"lon":73.88527,"prec":"postcode","geo":"412105, Haveli Subdistrict, Pune, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3010977634","fei":"3010977634","duns":"915787052","firm":"Lupin Limited","registrant":"Lupin Limited","parent":"Lupin","ticker":"LUPIN","addr":"Gat No 1156, 1157, 1158, 1159 & 1160, Village Ghotawade Taluka - Mulshi, Pune, Maharashtra 412115, India (IND)","city":"Pune","state":"Maharashtra","pin":"412115","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.51698,"lon":73.72829,"prec":"postcode","geo":"412115, Mulshi Subdistrict, Pune, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2021-06-11T04:00:00Z","posted":"2021-06-29T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Office of Pharmaceutical Quality Operations Division I","response":"","closeout":"04/19/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","company_as_published":"Novel Laboratories, Inc. d.b.a LUPIN","match":"token"},{"date":"2022-09-27T04:00:00Z","posted":"2022-11-01T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","company_as_published":"Lupin Limited","match":"exact"}],"events":[{"d":"2022-09-27","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-06-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","x":"Office of Pharmaceutical Quality Operations Division I"}],"first":"2021-06-11","last":"2022-09-27","sibs":["3004995645","3004819820","3002807510","3002807512","3002807511","3009843207","3009831799","3007756473","3015392060","3007549629","3009107538"],"colo":["3029761601"]},{"id":"3029761601","fei":"3029761601","duns":"920507667","firm":"Aragen Biosafety Solutions Private Limited","registrant":"Aragen Biosafety Solutions Private Limited","parent":null,"ticker":null,"addr":"Gat Nos. 367, 373, 375 and 376 Uravade, Mulshi, Pune, Maharashatra 412115, India (IND)","city":"Pune","state":null,"pin":"412115","ops":["ANALYSIS"],"expires":"12/31/2026","lat":18.51698,"lon":73.72829,"prec":"postcode","geo":"412115, Mulshi Subdistrict, Pune, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3010977634"]},{"id":"3006644152","fei":"3006644152","duns":"918608431","firm":"INDOCO REMEDIES LIMITED","registrant":"Indoco Remedies Limited","parent":null,"ticker":null,"addr":"Goa Plant-I, L-14, Verna Industrial Area, Verna, Goa, Goa 403722, India (IND)","city":"Goa","state":"Goa","pin":"403722","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":15.36243,"lon":73.92597,"prec":"postcode","geo":"403722, Salcete, South Goa, Goa, India","status":1,"alerts":[],"letters":[{"date":"2024-12-16T05:00:00Z","posted":"2025-01-07T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indoco-remedies-limited-691594-12162024","company_as_published":"Indoco Remedies Limited","match":"exact"}],"events":[{"d":"2024-12-16","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indoco-remedies-limited-691594-12162024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-12-16","last":"2024-12-16","sibs":["3006784730","3005124189","3006620783","3038105724"],"colo":["3008524952","3004081307","3023677905","3006230648","3004819820","3005719315","3005210225"]},{"id":"3005124189","fei":"3005124189","duns":"915851870","firm":"INDOCO REMEDIES LIMITED","registrant":"Indoco Remedies Limited","parent":null,"ticker":null,"addr":"Goa Plant-II & III, L-32,33,34, Verna Industrial Area, Verna, Goa, Goa 403722, India (IND)","city":"Goa","state":"Goa","pin":"403722","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":15.36243,"lon":73.92597,"prec":"postcode","geo":"403722, Salcete, South Goa, Goa, India","status":1,"alerts":[],"letters":[{"date":"2024-12-16T05:00:00Z","posted":"2025-01-07T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indoco-remedies-limited-691594-12162024","company_as_published":"Indoco Remedies Limited","match":"exact"}],"events":[{"d":"2024-12-16","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indoco-remedies-limited-691594-12162024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-12-16","last":"2024-12-16","sibs":["3006784730","3006644152","3006620783","3038105724"],"colo":["3008524952","3004081307","3023677905","3006230648","3004819820","3005719315","3005210225"]},{"id":"3036725850","fei":"3036725850","duns":"644178193","firm":"Cutyx Research LLP","registrant":"Cutyx Research LLP","parent":null,"ticker":null,"addr":"Gr. Floor, 99, Pushkar Industrial & Logistics Park, Sarkhej Bavla Highway, Changodar, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["RELABEL","REPACK"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3041646841","3043068534","3017085815","3010661577","3007277149","3008957483","3007938603","3010254278","3029456823","3007621329","3008725987","3004011473"]},{"id":"3006098295","fei":"3006098295","duns":"650662658","firm":"NURAY CHEMICALS PRIVATE LIMITED","registrant":"NURAY CHEMICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Ground Floor, Plot No 111, SIDCO Industrial Estate Kakkalur, Tiruvallur, TAMIL NADU 602003, India (IND)","city":"Tiruvallur","state":"Tamil Nadu","pin":"602003","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.12524,"lon":79.91694,"prec":"postcode","geo":"602003, Thiruvallur, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3009864255","fei":"3009864255","duns":"650615953","firm":"RICONPHARMA INDIA PRIVATE LIMITED","registrant":"RICONPHARMA INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Ground, 1st, 2nd Floors At Plot No. 5C, IDA Uppal, Hyderabad, Telangana 500039, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500039","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.40557,"lon":78.56557,"prec":"postcode","geo":"500039, Ward 10 Uppal, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003723117"]},{"id":"3030304532","fei":"3030304532","duns":"871769521","firm":"WIZCURE PHARMAA PRIVATE LIMITED","registrant":"Wizcure Pharmaa Pvt Ltd","parent":null,"ticker":null,"addr":"H 881 Industrial AreaBhiwadi, Alwar, Rajasthan 301019, India (IND)","city":"Alwar","state":"Rajasthan","pin":"301019","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":28.20518,"lon":76.82931,"prec":"postcode","geo":"301019, Tijara Tehsil, Khairthal-Tijara, Rajasthan, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"12/23/2025","notes":"All Drug and Drug Products","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"12/23/2025"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"12/23/2025"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"12/23/2025"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"12/23/2025"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"12/23/2025"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/23/2025"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"12/23/2025"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/23/2025"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/23/2025"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/23/2025"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/23/2025"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/23/2025"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/23/2025"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/23/2025"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/23/2025"}],"firm_as_published":"Wizcure Pharmaa Private Limited","address_as_published":"H-881 Industrial Area, Bhiwadi , Alwar, Rajasthan INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2026-06-24T04:00:00Z","posted":"2026-06-30T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wizcure-pharmaa-private-limited-726378-06242026","company_as_published":"Wizcure Pharmaa Private Limited","match":"exact"}],"events":[{"d":"2026-06-24","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wizcure-pharmaa-private-limited-726378-06242026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2025-12-23","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2025-12-23","last":"2026-06-24","sibs":[],"colo":["3009883410"]},{"id":"3004086192","fei":"3004086192","duns":"650434348","firm":"USV Private Limited","registrant":"USV Private Limited","parent":null,"ticker":null,"addr":"H-13, 16, 16A, 17, 18, 19, 20, 21 & E-22, OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman, Daman & Diu 396210, India (IND)","city":"Dabhel","state":"Daman","pin":"396210","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":20.42558,"lon":72.84559,"prec":"postcode","geo":"396210, Daman, Dadra and Nagar Haveli and Daman and Diu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002977798","3027308441"],"colo":["3006896204","3009681646","3006363714","3006370524","3003647459"]},{"id":"3009578131","fei":"3009578131","duns":"872335722","firm":"IVORY SOAP WORKS LIMITED","registrant":"Ivory Soap Works Ltd","parent":null,"ticker":null,"addr":"H-44. MIDC, Ambad, Nashik, Maharashtra 422010, India (IND)","city":"Nashik","state":"Maharashtra","pin":"422010","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":19.95664,"lon":73.75347,"prec":"postcode","geo":"422010, Nashik Subdistrict, Nashik, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3004544153","fei":"3004544153","duns":"916701498","firm":"SIPRA LABS LIMITED","registrant":"Sipra Labs Limited","parent":null,"ticker":null,"addr":"H. No. 7-2-1813/5/A, Sy. No. 59/6, Sanath Nagar, Adjacent to Post Office, Industrial Estate, Hyderabad, Telangana 500018, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500018","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.45684,"lon":78.43297,"prec":"postcode","geo":"500018, Ward 101 Erragadda, Greater Hyderabad Municipal Corporation Central Zone, Hyderabad, Ameerpet mandal, Hyderabad, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003445931","3009307611"]},{"id":"3043280533","fei":"3043280533","duns":"581742677","firm":"NOVAPEX BIOTECH","registrant":"NOVAPEX BIOTECH","parent":null,"ticker":null,"addr":"H.No.2-81/4/172, Dwarakanagar colony, Chengicherla, Beyond, Eden Market,Boduppal, Secunderabad, Telangana 500092, India (IND)","city":"Secunderabad","state":"Telangana","pin":"500092","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.41338,"lon":78.58507,"prec":"postcode","geo":"500092, Medipally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3003723146","fei":"3003723146","duns":"918610754","firm":"Granules India Limited","registrant":"Granules India Ltd","parent":"Granules India","ticker":"GRANULES","addr":"H.No.6-5 & 6-11, Temple Road, Bonthapally Village, Gummadidala Mandal, Sangareddy, Telangana 502313, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502313","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2025-02-26T05:00:00Z","posted":"2025-03-04T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/granules-india-limited-697115-02262025","company_as_published":"Granules India Limited","match":"exact"}],"events":[{"d":"2025-02-26","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/granules-india-limited-697115-02262025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-02-26","last":"2025-02-26","sibs":["3001319869","3004097901","3006583291","3012884557"],"colo":["3009996280","3014539030","3029798246","3006744199","3032314066","3012234942","3013944676","3007164063","3003510514","3042223406","3003289270","3007931994"]},{"id":"3036572523","fei":"3036572523","duns":"930274660","firm":"Isazi Analytical Services Pvt. Ltd.","registrant":"Isazi Analytical Services Pvt Ltd","parent":null,"ticker":null,"addr":"H13, Gallops Industrial Park, Sarkhej - Bavla Highway, Chacharavadi Vasna, Ahmedabad, Gujarat 382220, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382220","ops":["ANALYSIS"],"expires":"12/31/2026","lat":22.85878,"lon":72.34332,"prec":"postcode","geo":"382220, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008117347","3035187076","3033035639","3004161218","3044181625","3008223599"]},{"id":"3031178556","fei":"3031178556","duns":"643483759","firm":"DRHP Testing Solutions Private Limited","registrant":"DRHP Testing Solutions Private Limited","parent":null,"ticker":null,"addr":"HNO. 4-11-47/SF, 2nd Floor, Information Colony, Hayatnagar, Rangareddy, Telangana 501505, India (IND)","city":"Rangareddy","state":"Telangana","pin":"501505","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.32526,"lon":78.61514,"prec":"postcode","geo":"501505, Hayathnagar mandal, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Ranga Reddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3003892973","fei":"3003892973","duns":"650645877","firm":"Sun Pharmaceutical Industries Limited","registrant":"Sun Pharmaceutical Industries Limited","parent":"Sun Pharmaceutical Industries","ticker":"SUNPHARMA","addr":"Hakeem Abdul Hameed Centenary Hospital, (2nd Floor) Jamia Hamdard (Hamdard University) Hamdard Nagar, New Delhi, Delhi 110062, India (IND)","city":"(2nd Floor) Jamia Hamdard (Hamdard University) Hamdard Nagar","state":"Delhi","pin":"110062","ops":["ANALYSIS"],"expires":"12/31/2026","lat":28.5131,"lon":77.23781,"prec":"postcode","geo":"110062, Delhi, Old Delhi, Delhi, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs.","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs.","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs.","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"Village Ganguwala , Tehsil-Paonta Sahib , Sirmaur, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs.","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"3 Industrial Area , Dewas, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"03/12/2014","notes":"","charges":[{"code":"60","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"}],"firm_as_published":"Sun Pharmaceutical Industries Limited - Karkhadi","address_as_published":"A Plot No 817 , Village Karkhadi , Padra, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"12/07/2022","notes":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","charges":[{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"05/12/2025"},{"code":"55","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/07/2022"},{"code":"56","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Antibiotics (Human/Animal)","published":"12/07/2022"},{"code":"58","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/07/2022"},{"code":"60","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"61","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"62","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"63","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"64","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"65","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"66","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"}],"firm_as_published":"Sun Pharmaceutical Industries Ltd.","address_as_published":"Halol - Baroda Highway , Halol, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-06-08T04:00:00Z","posted":"2022-07-19T13:20:00Z","subject":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","office":"Office of Human and Animal Foods- East Division 3","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","company_as_published":"New Sun Inc.","match":"token"},{"date":"2022-08-17T04:00:00Z","posted":"2022-09-06T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Office of Human and Animal Food Operations – West Division 5","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","company_as_published":"Sun Sen Co., Inc.","match":"token"},{"date":"2023-04-07T04:00:00Z","posted":"2023-08-15T13:20:00Z","subject":"Unapproved New Drugs/Misbranded","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","company_as_published":"STPCA Inc. dba Sun Ten Laboratories","match":"token"},{"date":"2023-05-10T04:00:00Z","posted":"2023-05-30T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations West II","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","company_as_published":"Rhodes Legacy Inc DBA Sun Sprouts","match":"token"},{"date":"2023-10-16T04:00:00Z","posted":"2023-10-16T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","company_as_published":"Sun Pharmaceutical Industries Ltd.","match":"exact"},{"date":"2024-06-18T04:00:00Z","posted":"2024-07-02T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","company_as_published":"Sun Pharmaceutical Industries Limited","match":"exact"},{"date":"2025-03-12T04:00:00Z","posted":"2025-03-18T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","company_as_published":"Waxhead Sun Defense Company","match":"token"}],"events":[{"d":"2025-05-12","k":"charge","t":"66-40 charge 54 — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-03-12","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-06-18","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-10-16","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-05-10","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","x":"Division of Human and Animal Food Operations West II"},{"d":"2023-04-07","k":"letter","t":"Unapproved New Drugs/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","x":"Division of Human and Animal Food Operations West V"},{"d":"2022-12-07","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24"},{"d":"2022-08-17","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","x":"Office of Human and Animal Food Operations – West Division 5"},{"d":"2022-06-08","k":"letter","t":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","x":"Office of Human and Animal Foods- East Division 3"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2014-03-12","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs."},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs"}],"first":"2009-09-10","last":"2025-05-12","sibs":["3003227153","3004520113","3002809586","3003952717","3012032037","3002807979","3010027135","3002871444","3007627683","3004561553"],"colo":[]},{"id":"3002809586","fei":"3002809586","duns":"725959238","firm":"Sun Pharmaceutical Industries Limited","registrant":"Sun Pharmaceutical Industries Limited","parent":"Sun Pharmaceutical Industries","ticker":"SUNPHARMA","addr":"Halol-Baroda Highway, Halol, Gujarat 389350, India (IND)","city":"Halol","state":"Gujarat","pin":"389350","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.51554,"lon":73.46023,"prec":"postcode","geo":"389350, Halol Taluka, Panchmahal, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs.","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs.","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs.","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"Village Ganguwala , Tehsil-Paonta Sahib , Sirmaur, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs.","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"3 Industrial Area , Dewas, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"03/12/2014","notes":"","charges":[{"code":"60","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"}],"firm_as_published":"Sun Pharmaceutical Industries Limited - Karkhadi","address_as_published":"A Plot No 817 , Village Karkhadi , Padra, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"12/07/2022","notes":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","charges":[{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"05/12/2025"},{"code":"55","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/07/2022"},{"code":"56","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Antibiotics (Human/Animal)","published":"12/07/2022"},{"code":"58","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/07/2022"},{"code":"60","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"61","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"62","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"63","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"64","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"65","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"66","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"}],"firm_as_published":"Sun Pharmaceutical Industries Ltd.","address_as_published":"Halol - Baroda Highway , Halol, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-06-08T04:00:00Z","posted":"2022-07-19T13:20:00Z","subject":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","office":"Office of Human and Animal Foods- East Division 3","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","company_as_published":"New Sun Inc.","match":"token"},{"date":"2022-08-17T04:00:00Z","posted":"2022-09-06T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Office of Human and Animal Food Operations – West Division 5","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","company_as_published":"Sun Sen Co., Inc.","match":"token"},{"date":"2023-04-07T04:00:00Z","posted":"2023-08-15T13:20:00Z","subject":"Unapproved New Drugs/Misbranded","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","company_as_published":"STPCA Inc. dba Sun Ten Laboratories","match":"token"},{"date":"2023-05-10T04:00:00Z","posted":"2023-05-30T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations West II","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","company_as_published":"Rhodes Legacy Inc DBA Sun Sprouts","match":"token"},{"date":"2023-10-16T04:00:00Z","posted":"2023-10-16T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","company_as_published":"Sun Pharmaceutical Industries Ltd.","match":"exact"},{"date":"2024-06-18T04:00:00Z","posted":"2024-07-02T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","company_as_published":"Sun Pharmaceutical Industries Limited","match":"exact"},{"date":"2025-03-12T04:00:00Z","posted":"2025-03-18T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","company_as_published":"Waxhead Sun Defense Company","match":"token"}],"events":[{"d":"2025-05-12","k":"charge","t":"66-40 charge 54 — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-03-12","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-06-18","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-10-16","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-05-10","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","x":"Division of Human and Animal Food Operations West II"},{"d":"2023-04-07","k":"letter","t":"Unapproved New Drugs/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","x":"Division of Human and Animal Food Operations West V"},{"d":"2022-12-07","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24"},{"d":"2022-08-17","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","x":"Office of Human and Animal Food Operations – West Division 5"},{"d":"2022-06-08","k":"letter","t":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","x":"Office of Human and Animal Foods- East Division 3"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2014-03-12","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs."},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs"}],"first":"2009-09-10","last":"2025-05-12","sibs":["3003227153","3004520113","3003892973","3003952717","3012032037","3002807979","3010027135","3002871444","3007627683","3004561553"],"colo":["3003821360","3004956904","3012075440","3014447455","3002957541","3014866088"]},{"id":"3013890701","fei":"3013890701","duns":"877221774","firm":"HETERO HEALTHCARE LIMITED","registrant":"HETERO HEALTHCARE LIMITED","parent":"Hetero (unlisted)","ticker":null,"addr":"Hetero Healthcare Ltd, Aiidc Growth Centre, Niz Sila Sinduri Ghopa, Chansari Kamrup, Guwahati, Assam 781101, India (IND)","city":"Guwahati","state":"Assam","pin":"781101","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":26.24998,"lon":91.65075,"prec":"postcode","geo":"781101, North Guwahati (Pt), Kamrup, Assam, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3007543295","fei":"3007543295","duns":"677603030","firm":"Johnson & Johnson Private Limited","registrant":"Janssen Research & Development, L.L.C.","parent":null,"ticker":null,"addr":"Higi House, Opp. Ralli Wolf, L.B.S. Marg, Mulund (W), Mumbai, MH 400080, India (IND)","city":"Mumbai","state":null,"pin":"400080","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.17543,"lon":72.95134,"prec":"postcode","geo":"400080, T Ward, Mumbai Zone 6, Mumbai, Mumbai Suburban District, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2023-08-30T04:00:00Z","posted":"2023-08-30T19:15:00Z","subject":"CGMP/Quality Control/Adulterated/Infant Formula","office":"HUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/reckittmead-johnson-nutrition-654775-08302023","company_as_published":"Reckitt/Mead Johnson Nutrition","match":"token"},{"date":"2025-07-18T04:00:00Z","posted":"2025-09-23T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/janssen-vaccines-corp-johnson-johnson-company-713194-07182025","company_as_published":"Janssen Vaccines Corp., A Johnson & Johnson Company","match":"token"}],"events":[{"d":"2025-07-18","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/janssen-vaccines-corp-johnson-johnson-company-713194-07182025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2023-08-30","k":"letter","t":"CGMP/Quality Control/Adulterated/Infant Formula","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/reckittmead-johnson-nutrition-654775-08302023","x":"HUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB)"}],"first":"2023-08-30","last":"2025-07-18","sibs":[],"colo":["3003445146"]},{"id":"3016859498","fei":"3016859498","duns":"677391975","firm":"ACME FORMULATION PRIVATE LIMITED","registrant":"ACME FORMULATION PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Hormone Block, Village Ghogharwal (Chokiwala), Ropar Road Tehsil Nalagarh, Solan, Himachal Pradesh 174101, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"174101","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":31.06505,"lon":76.69603,"prec":"postcode","geo":"174101, Nalagarh, Solan, Himachal Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2021-07-12T04:00:00Z","posted":"2021-08-10T13:20:00Z","subject":"Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions","office":"Office of Human and Animal Food Operations - East Division 1","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/acme-smoked-fish-corp-613859-07122021","company_as_published":"Acme Smoked Fish Corp.","match":"token"},{"date":"2025-10-10T04:00:00Z","posted":"2025-10-21T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/acme-united-corporation-712324-10102025","company_as_published":"Acme United Corporation","match":"token"}],"events":[{"d":"2025-10-10","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/acme-united-corporation-712324-10102025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2021-07-12","k":"letter","t":"Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/acme-smoked-fish-corp-613859-07122021","x":"Office of Human and Animal Food Operations - East Division 1"}],"first":"2021-07-12","last":"2025-10-10","sibs":[],"colo":["3046619098","3013744962","3012112224","3031080212","3008250236","3014210753","3010868532","3007517881"]},{"id":"3008255419","fei":"3008255419","duns":"650658052","firm":"Mylan Laboratories Limited","registrant":"Viatris Inc.","parent":null,"ticker":null,"addr":"Hosur Steriles Facility, Plot No. 13A, 14, & CP 2, Sipcot Phase II, Krishnagiri Main Road, Hosur, Tamil Nadu 635130, India (IND)","city":"Hosur","state":"Tamil Nadu","pin":"635130","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":12.69608,"lon":77.93034,"prec":"postcode","geo":"635130, Shoolagiri, Krishnagiri, Tamil Nadu, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"12/19/2024","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/19/2024"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"12/19/2024"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/19/2024"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"}],"firm_as_published":"Mylan Laboratories Limited","address_as_published":"(FDF-3) Plot Nos. 11, 12, 13, Indore SEZ , Pharma Zone, Phase II, Sector III , Pithampur, District Dhar, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2024-12-19","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2024-12-19","last":"2024-12-19","sibs":["3005587313","3008316970","3010453141","3007512701","3006355432","3007720135","3007648351"],"colo":[]},{"id":"House No. 5, Ground Floor, First Floor, Second Floor and Third floor, Magnet Corporate Park, Near Thaltej Cross Road, SG Highway,, Ahmedabad, Gujarat 380015, India (IND)","fei":"","duns":"771960631","firm":"Zydus Healthcare Ltd","registrant":"Zydus Healthcare Ltd","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"House No. 5, Ground Floor, First Floor, Second Floor and Third floor, Magnet Corporate Park, Near Thaltej Cross Road, SG Highway,, Ahmedabad, Gujarat 380015, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"380015","ops":["ANALYSIS"],"expires":"12/31/2026","lat":23.02223,"lon":72.52801,"prec":"postcode","geo":"380015, Vejalpur Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009857729","3042700568","3008355986"]},{"id":"3017637440","fei":"3017637440","duns":"856844952","firm":"Suntara Cosmetics Private Limited","registrant":"Suntara Cosmetics Private Limited","parent":null,"ticker":null,"addr":"I-2 & I-4, Indraprasth Industrial and Logistic Park Bharat Gas Street, Vadala Patia, Bareja-Kheda Highway, Kheda, Gujarat 387550, India (IND)","city":"Kheda","state":"Gujarat","pin":"387550","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":22.7444,"lon":72.59518,"prec":"postcode","geo":"387550, Kheda Taluka, Kheda, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/11/2018","notes":"For industry code 53; only products found to be drug products are subject to DWPE under this listing.","charges":[{"code":"53","notes":"","product":"Cosmetics","published":"06/11/2018"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/11/2018"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"06/11/2018"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"}],"firm_as_published":"JT Cosmetics & Chemicals Pvt Ltd.","address_as_published":"53 Kalol Gidc Estate , Panchmahal, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"}],"letters":[{"date":"2024-04-30T04:00:00Z","posted":"2024-05-07T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-cosmetics-company-limited-677948-04302024","company_as_published":"Global Cosmetics Company Limited","match":"token"}],"events":[{"d":"2024-04-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-cosmetics-company-limited-677948-04302024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2018-06-11","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"For industry code 53; only products found to be drug products are subject to DWPE under this listing."}],"first":"2018-06-11","last":"2024-04-30","sibs":[],"colo":[]},{"id":"3018807295","fei":"3018807295","duns":"877566409","firm":"Cephas Life Sciences Private Limited","registrant":"Cephas Life Sciences Private Limited","parent":null,"ticker":null,"addr":"III Floor, Module 313 and 314 Phase I, Ticel Bio Park Limited No 5 CSIR Road, Taramani, Chennai, TAMIL NADU 600113, India (IND)","city":"Chennai","state":"Tamil Nadu","pin":"600113","ops":["ANALYSIS"],"expires":"12/31/2026","lat":12.99292,"lon":80.24367,"prec":"postcode","geo":"600113, Zone 13 Adyar, Chennai Corporation, Chennai, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3007127164"]},{"id":"3012863613","fei":"3012863613","duns":"863655699","firm":"SAB HERBALS AND NUTRACEUTICALS","registrant":"SAB HERBALS AND NUTRACEUTICALS","parent":null,"ticker":null,"addr":"IKGHARA BAJPUR, Udham Singh Nagar,  262401, India (IND)","city":"Udham Singh Nagar","state":null,"pin":"262401","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":29.17137,"lon":79.15468,"prec":"postcode","geo":"262401, Bajpur, Udham Singh Nagar, Uttarakhand, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3005269310","fei":"3005269310","duns":"650833994","firm":"Rxhomeo Private Limited","registrant":"Rxhomeo Inc","parent":null,"ticker":null,"addr":"Indradhanush', 4-1-424 to 426, Bank Street, Abids, Hyderabad, Telangana 500001, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500001","ops":["LABEL","MANUFACTURE","RELABEL"],"expires":"12/31/2026","lat":17.39886,"lon":78.47226,"prec":"postcode","geo":"500001, Ward 78 Gunfoundry, Greater Hyderabad Municipal Corporation Central Zone, Hyderabad, Nampally mandal, Hyderabad, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"05/22/2019","notes":"For 54[][][][]; only drug and drug products (i.e. homeopathic products) are subject to DWPE under this notice.","charges":[{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"05/22/2019"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"05/22/2019"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"05/22/2019"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2019"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2019"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2019"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2019"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2019"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2019"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"05/22/2019"}],"firm_as_published":"Rxhomeo Private Limited","address_as_published":"4-1-424-426 Bank Street , Hyderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2019-05-22","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"For 54[][][][]; only drug and drug products (i.e. homeopathic products) are subject to DWPE under this notice."}],"first":"2019-05-22","last":"2022-05-26","sibs":[],"colo":[]},{"id":"3030526918","fei":"3030526918","duns":"565277263","firm":"BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD.","registrant":"BDR PHARMACEUTICALS INTERNATIONAL PVT LTD","parent":null,"ticker":null,"addr":"Injectable Manufacturing Unit, Ground Floor, General Block At. Vanseti Village, Po. Taj, Taluka Halol, District Panchmahal, Halol, Gujarat 389 350, India (IND)","city":"Halol","state":"Gujarat","pin":null,"ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.54151,"lon":73.43344,"prec":"tail3","geo":"INTEGRA Engineering India Limited, Halol Taluka, Panchmahal, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3031858655","3010166818","3038848101"],"colo":[]},{"id":"3012953979","fei":"3012953979","duns":"737796233","firm":"RUBICON RESEARCH LIMITED","registrant":"Rubicon Research Limited","parent":null,"ticker":null,"addr":"J 4/2, ADDITIONAL MIDC, Satara, Maharashtra 415004, India (IND)","city":"Satara","state":"Maharashtra","pin":"415004","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.65252,"lon":74.03448,"prec":"postcode","geo":"415004, Satara, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3016480976","3006559899","3008252295"],"colo":[]},{"id":"3005866424","fei":"3005866424","duns":"860037404","firm":"SITEC LABS LIMITED","registrant":"SITEC LABS LIMITED","parent":null,"ticker":null,"addr":"Jayashree Plaza, 1st Floor, LBS Marg Bhandup (west), Mumbai, Maharashtra 400078, India (IND)","city":"Mumbai","state":"Maharashtra","pin":"400078","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.1492,"lon":72.93619,"prec":"postcode","geo":"400078, S Ward, Mumbai Zone 6, Mumbai, Mumbai Suburban District, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008763840"],"colo":[]},{"id":"3013999816","fei":"3013999816","duns":"675484557","firm":"ASolution Pharmaceuticals Pvt. Ltd.","registrant":"ASolution Pharmaceuticals Pvt Ltd","parent":null,"ticker":null,"addr":"K-3/8, Additional Ambernath MIDC, Next to MSETCL Power Substation Thakurpada, Thane, Maharashtra State 421506, India (IND)","city":"Thane","state":"Maharashtra","pin":"421506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021189141","3009887190","3008232264","3018052045","3016575313","3006599894","3006809732","3027577650","3010166801","3032073298","3008374690","3009051788"]},{"id":"3004081315","fei":"3004081315","duns":"871411122","firm":"Kopran Research Laboratories Limited","registrant":"Kopran Research Laboratories Limited","parent":null,"ticker":null,"addr":"K-4/4, Additional MIDC, At/Post Birwadi Tal. Mahad, Raigad, Maharashtra 402302, India (IND)","city":"Raigad","state":"Maharashtra","pin":"402302","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":18.10191,"lon":73.50003,"prec":"postcode","geo":"402302, Mahad Taluka, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3002980818","fei":"3002980818","duns":"650449981","firm":"Wanbury Limited","registrant":"Wanbury Limited","parent":null,"ticker":null,"addr":"K.Illindalaparru, Iragavaram Mandal, West Godavari District, Tanuku, Andhra Pradesh 534217, India (IND)","city":"Tanuku","state":"Andhra Pradesh","pin":"534217","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.69203,"lon":81.70703,"prec":"postcode","geo":"534217, Iragavaram, West Godavari, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003227148"],"colo":[]},{"id":"3032234173","fei":"3032234173","duns":"877256314","firm":"KJD Pharma Private Limited","registrant":"KJD Pharma Private Limited","parent":null,"ticker":null,"addr":"KJD Pharma Pvt Ltd, 14B, 3 KIADB, Naubad, Bidar, Bidar, Karnataka 585401, India (IND)","city":"Bidar","state":"Karnataka","pin":"585401","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.91451,"lon":77.51581,"prec":"postcode","geo":"585401, Bidar taluku, Bidar, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["Plot. No :131/A-1,130 C&D, Kolhar Industrial Area,, Bidar, Karnataka 585401, India (IND)"]},{"id":"3006370533","fei":"3006370533","duns":"677605851","firm":"Alkem Laboratories Limited","registrant":"Alkem Laboratories Limited","parent":"Alkem Laboratories","ticker":"ALKEM","addr":"Khasra No 1544, 1553, 1558, 1559 Village Thana, Tehsil Nalagarh, Baddi, Himachal Pradesh 173205, India (IND)","city":"Baddi","state":"Himachal Pradesh","pin":"173205","ops":["ANALYSIS","MANUFACTURE","PACK","REPACK"],"expires":"12/31/2026","lat":30.94458,"lon":76.80677,"prec":"postcode","geo":"173205, Baddi, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008450172","3006851796","3006370524"],"colo":["3013950309","3003897648","3006785414","3031304848","3007187282","3012536712","3018004432","3041778294","3005757050","3005430968","3004738570"]},{"id":"3013950309","fei":"3013950309","duns":"858720927","firm":"ALAINA HEALTHCARE PRIVATE LIMITED","registrant":"ALAINA HEALTHCARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Khasra No. 127-133, Baddi-Barotiwala Road, Baddi, HIMACHAL PRADESH 173205, India (IND)","city":"Baddi","state":"Himachal Pradesh","pin":"173205","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":30.94458,"lon":76.80677,"prec":"postcode","geo":"173205, Baddi, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3006370533","3003897648","3006785414","3031304848","3007187282","3012536712","3018004432","3041778294","3005757050","3005430968","3004738570"]},{"id":"3013744962","fei":"3013744962","duns":"956991966","firm":"PINNACLE LIFE SCIENCE PRIVATE LIMITED","registrant":"PINNACLE LIFE SCIENCE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Khasra No. 1331, 1332 and 1335, Village Manpura, Tehsil Baddi, Solan, Himachal Pradesh 174101, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"174101","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":31.06505,"lon":76.69603,"prec":"postcode","geo":"174101, Nalagarh, Solan, Himachal Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2024-04-17T04:00:00Z","posted":"2024-04-30T13:20:00Z","subject":"Medical Device/Misbranded","office":"Center for Devices and Radiological Health","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-labs-tennessee-llc-dba-pinnacle-biolabs-676367-04172024","company_as_published":"Pinnacle Labs of Tennessee, LLC dba Pinnacle BioLabs","match":"token"},{"date":"2024-10-01T04:00:00Z","posted":"2024-10-22T13:20:00Z","subject":"Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)","office":"Center for Biologics Evaluation and Research (CBER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-transplant-technologies-llc-646783-10012024","company_as_published":"Pinnacle Transplant Technologies, LLC","match":"token"},{"date":"2025-12-12T05:00:00Z","posted":"2025-12-23T05:00:00Z","subject":"Unapproved New Drugs","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025","company_as_published":"Pinnacle Professional Research dba Pinnacle Peptides","match":"token"}],"events":[{"d":"2025-12-12","k":"letter","t":"Unapproved New Drugs","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-professional-research-dba-pinnacle-peptides-719337-12122025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-10-01","k":"letter","t":"Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-transplant-technologies-llc-646783-10012024","x":"Center for Biologics Evaluation and Research (CBER)"},{"d":"2024-04-17","k":"letter","t":"Medical Device/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pinnacle-labs-tennessee-llc-dba-pinnacle-biolabs-676367-04172024","x":"Center for Devices and Radiological Health"}],"first":"2024-04-17","last":"2025-12-12","sibs":[],"colo":["3046619098","3016859498","3012112224","3031080212","3008250236","3014210753","3010868532","3007517881"]},{"id":"3009648228","fei":"3009648228","duns":"862184668","firm":"Dr Sabharwals Wound Care","registrant":"Manish Sabharwal","parent":null,"ticker":null,"addr":"Khasra No. 137, Village Buranwala, Po Barotiwala, Solan, Himachal Pradesh 174103, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"174103","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":30.92027,"lon":76.82333,"prec":"postcode","geo":"174103, Kalka, Panchkula, Haryana, India","status":1,"alerts":[],"letters":[{"date":"2025-08-06T04:00:00Z","posted":"2025-08-12T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","company_as_published":"K & Care Organics","match":"token"}],"events":[{"d":"2025-08-06","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-06","last":"2025-08-06","sibs":[],"colo":["3008932049"]},{"id":"3020826443","fei":"3020826443","duns":"873730752","firm":"PRITAM INTERNATIONAL PRIVATE LIMITED","registrant":"PRITAM INTERNATIONAL PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Khasra No. 138, Raipur Industrial Area, Bhagwanpur, Haridwar, Uttarakhand 247667, India (IND)","city":"Haridwar","state":"Uttarakhand","pin":"247667","ops":["LABEL","MANUFACTURE","PACK","REPACK"],"expires":"12/31/2026","lat":29.86992,"lon":77.88801,"prec":"postcode","geo":"247667, Roorkee, Haridwar, Uttarakhand, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/03/2026","notes":"","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"09/03/2026"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"09/03/2026"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"09/03/2026"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"09/03/2026"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"09/03/2026"},{"code":"55","notes":"","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/03/2026"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"09/03/2026"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"09/03/2026"},{"code":"60","notes":"","product":"Human and Animal Drugs","published":"09/03/2026"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"09/03/2026"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"09/03/2026"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"09/03/2026"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"09/03/2026"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"09/03/2026"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"09/03/2026"}],"firm_as_published":"PRITAM INTERNATIONAL PRIVATE LIMITED","address_as_published":"Khasra No. 138, Raipur Industrial Area , Bhagwanpur , Haridwar, Uttaranchal INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2026-09-03","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""}],"first":"2026-09-03","last":"2026-09-03","sibs":[],"colo":[]},{"id":"3040177693","fei":"3040177693","duns":"930001833","firm":"INNOVA REMEDIES PRIVATE LIMITED","registrant":"INNOVA REMEDIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Khasra No. 25/3, Behind Shree Krishna Concrete Works, Village Champa, Nagpur, Maharashtra 441404, India (IND)","city":"Nagpur","state":"Maharashtra","pin":"441404","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.23069,"lon":79.22635,"prec":"postcode","geo":"441404, Parseoni, Nagpur, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2021-06-10T04:00:00Z","posted":"2021-06-10T16:00:00Z","subject":"Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)","office":"Center for Devices and Radiological Health","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innova-medical-group-inc-614819-06102021","company_as_published":"Innova Medical Group, Inc.","match":"token"}],"events":[{"d":"2021-06-10","k":"letter","t":"Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innova-medical-group-inc-614819-06102021","x":"Center for Devices and Radiological Health"}],"first":"2021-06-10","last":"2021-06-10","sibs":[],"colo":[]},{"id":"3020665163","fei":"3020665163","duns":"873679552","firm":"HORSTER BIOTEK PRIVATE LIMITED","registrant":"HORSTER BIOTEK PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Khasra No.259, Plot No.1 & 2, Village Sukhliya, Sanwer Road Industrial Area, Indore, Madhya Pradesh 452015, India (IND)","city":"Indore","state":"Madhya Pradesh","pin":"452015","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.72239,"lon":75.807,"prec":"postcode","geo":"452015, Indore City, Juni Indore Tahsil, Indore, Madhya Pradesh, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"03/10/2021","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"03/10/2021"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"03/10/2021"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/10/2021"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/10/2021"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/10/2021"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/10/2021"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/10/2021"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/10/2021"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/10/2021"}],"firm_as_published":"Biotek India","address_as_published":"1st Floor , Near Conmant Cross Road; 919/2 Makarpura Road , Vadodara, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"}],"letters":[{"date":"2021-05-13T04:00:00Z","posted":"2021-05-25T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated","office":"Center for Drug Evaluation and Research","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biotek-india-613295-05132021","company_as_published":"Biotek India","match":"token"}],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2021-05-13","k":"letter","t":"CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biotek-india-613295-05132021","x":"Center for Drug Evaluation and Research"},{"d":"2021-03-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2021-03-10","last":"2022-05-26","sibs":[],"colo":[]},{"id":"3012020703","fei":"3012020703","duns":"871409551","firm":"Yash Pharma Laboratories Pvt Ltd","registrant":"Yash Pharma Laboratories Pvt Ltd","parent":null,"ticker":null,"addr":"Khasra Number 19M, Village Raipur, Pargana Bhagwanpur, Dist. Haridwar, Roorkee, Uttarakhand 247661, India (IND)","city":"Roorkee","state":"Uttarakhand","pin":"247661","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":29.97104,"lon":77.79879,"prec":"postcode","geo":"247661, Roorkee, Haridwar, Uttarakhand, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3015077059","Tehsil Bhagwanpur, Khasra No 189/3, 189/4, 190, 190/1, Haridwar, UT 247661, India (IND)","3006895982"]},{"id":"3009150119","fei":"3009150119","duns":"871401927","firm":"RECIPHARM PHARMASERVICES PRIVATE LIMITED","registrant":"RECIPHARM PHARMASERVICES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Khata No. 845/713 and 1108/970/1, 34th KM, Tumkur Road, (NH 4) Teppada Begur, Nelamangala Taluk, Bengaluru, KA 562123, India (IND)","city":"Bengaluru","state":null,"pin":"562123","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":13.11741,"lon":77.38033,"prec":"postcode","geo":"562123, Vishveshwarapura, Mallapura, Nelamangala taluk, Bengaluru North, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043513108","3003821988","3023352430"]},{"id":"3006620783","fei":"3006620783","duns":"675888404","firm":"INDOCO REMEDIES LIMITED","registrant":"Indoco Remedies Limited","parent":null,"ticker":null,"addr":"Kilolab, R-92/93, 1st Floor, T.T.C., M.I.D.C. Thane Belapur Road, Rabale, Navi Mumbai, Maharashtra 400701, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400701","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":19.11985,"lon":73.00488,"prec":"postcode","geo":"400701, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2024-12-16T05:00:00Z","posted":"2025-01-07T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indoco-remedies-limited-691594-12162024","company_as_published":"Indoco Remedies Limited","match":"exact"}],"events":[{"d":"2024-12-16","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indoco-remedies-limited-691594-12162024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-12-16","last":"2024-12-16","sibs":["3006784730","3006644152","3005124189","3038105724"],"colo":["3027513144","3009510975","3003484180","3024731845","3007026867","3005502733","3011560035","3030219467","3013153296"]},{"id":"3008524952","fei":"3008524952","duns":"677603357","firm":"FDC Limited","registrant":"FDC Limited","parent":null,"ticker":null,"addr":"L-121(B), PHASE-III/A VERNA INDUSTRIAL ESTATE, VERNA, SALCETE, GOA 403722, India (IND)","city":"SALCETE","state":"Goa","pin":"403722","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":15.36243,"lon":73.92597,"prec":"postcode","geo":"403722, Salcete, South Goa, Goa, India","status":1,"alerts":[],"letters":[{"date":"2021-02-18T05:00:00Z","posted":"2021-02-19T17:00:00Z","subject":"New Drug/Misbranded","office":"Center for Food Safety and Applied Nutrition (CFSAN)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fdc-nutrition-inc-612264-02182021","company_as_published":"FDC Nutrition Inc.","match":"token"}],"events":[{"d":"2021-02-18","k":"letter","t":"New Drug/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fdc-nutrition-inc-612264-02182021","x":"Center for Food Safety and Applied Nutrition (CFSAN)"}],"first":"2021-02-18","last":"2021-02-18","sibs":["3003204330","3002806958","3004738570"],"colo":["3006644152","3005124189","3004081307","3023677905","3006230648","3004819820","3005719315","3005210225"]},{"id":"3004081307","fei":"3004081307","duns":"650072015","firm":"CIPLA LIMITED","registrant":"CIPLA LIMITED","parent":"Cipla","ticker":"CIPLA","addr":"L-139 to L-146, S-103 to S-105, S-107 to S-112, L-147 to L-147/1/2/3 L-147A, L-138, L-150, S-116, Verna Industrial Estate, Salcette, Goa 403722, India (IND)","city":"Salcette","state":"Goa","pin":"403722","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":15.36243,"lon":73.92597,"prec":"postcode","geo":"403722, Salcete, South Goa, Goa, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"03/14/2017","notes":"","charges":[{"code":"66 S - - 51","notes":"","product":"Tadalafil","published":"03/14/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"03/14/2017"}],"firm_as_published":"Cipla LTD","address_as_published":"Khasra No. 509/1-2 & 520 , Vii-Bhagwanpur , Bhagwanpur, Uttaranchal INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-66","list":"red","since":"10/09/2013","notes":"","charges":[{"code":"60 W - - 16","notes":"","product":"Mebendazole (Anthelmintic)","published":"10/09/2013"}],"firm_as_published":"Cipla Limited","address_as_published":"Patalganga Industrial Area , Plot No A-2, A-33, A-37/2/2, A-42 , Raigad, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"},{"alert":"66-66","list":"red","since":"10/18/2010","notes":"","charges":[{"code":"64 U C S 06","notes":"","product":"Finasteride (Inhibitor (Decarboxylase)), Human - Rx/Single Ingredient, Active Pharm Ingred/Chems for Further Manuf","published":"10/18/2010"}],"firm_as_published":"Cipla, Ltd.","address_as_published":"Plots D-7, D-22, D-27 , M.I.D.C. Industrial Area, Taluka-Daund , Kurkumbh Village, Dist. Pune, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"}],"letters":[{"date":"2023-11-17T05:00:00Z","posted":"2023-11-21T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-660904-11172023","company_as_published":"Cipla Limited","match":"exact"}],"events":[{"d":"2023-11-17","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-660904-11172023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2017-03-14","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2013-10-09","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2010-10-18","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""}],"first":"2010-10-18","last":"2023-11-17","sibs":["3005857289","3002806702","3008581988","3002806710","3002806691"],"colo":["3006644152","3005124189","3008524952","3023677905","3006230648","3004819820","3005719315","3005210225"]},{"id":"3003445146","fei":"3003445146","duns":"737856808","firm":"JNTL CONSUMER HEALTH (INDIA) PRIVATE LIMITED","registrant":"Kenvue Brands LLC","parent":null,"ticker":null,"addr":"Lal Bahadur Shastri Marg, Mulund (West), Mumbai, Maharashtra 400080, India (IND)","city":"Mumbai","state":"Maharashtra","pin":"400080","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.17543,"lon":72.95134,"prec":"postcode","geo":"400080, T Ward, Mumbai Zone 6, Mumbai, Mumbai Suburban District, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3007543295"]},{"id":"3012608389","fei":"3012608389","duns":"854220603","firm":"Syngene International Limited","registrant":"Syngene International Limited","parent":"Syngene International","ticker":"SYNGENE","addr":"MSEZ, Plot No. IP-39, IP-46 & IP-60, IP-25 (Part) & IP-61 (Part) Kalavar Village & Post, Dakshina Kannada, Mangaluru, Karnataka 574142, India (IND)","city":"Mangaluru","state":"Karnataka","pin":"574142","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":12.98069,"lon":74.87137,"prec":"postcode","geo":"574142, Mangaluru taluk, Dakshina Kannada, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003600340","3007907068","3035152598"],"colo":[]},{"id":"3025169808","fei":"3025169808","duns":"931838152","firm":"AIZANT DRUG RESEARCH SOLUTIONS PRIVATE LIMITED","registrant":"AIZANT DRUG RESEARCH SOLUTION PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Maitrivihar Commercial Complex, Block Nos.101-107 & 201 to 206, Ameerpet, Hyderabad, Telangana 500016, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500016","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.43813,"lon":78.45589,"prec":"postcode","geo":"500016, Ward 98 Ameerpet, Greater Hyderabad Municipal Corporation Central Zone, Hyderabad, Ameerpet mandal, Hyderabad, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008243902"],"colo":[]},{"id":"3003897648","fei":"3003897648","duns":"858330880","firm":"Morepen Laboratories Limited","registrant":"Morepen Laboratories Limited","parent":null,"ticker":null,"addr":"Malkumajra, Nalagarh Road, Baddi, Solan, Himachal Pradesh 173205, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"173205","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":30.94458,"lon":76.80677,"prec":"postcode","geo":"173205, Baddi, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006785414","3002807612"],"colo":["3006370533","3013950309","3031304848","3007187282","3012536712","3018004432","3041778294","3005757050","3005430968","3004738570"]},{"id":"3005851210","fei":"3005851210","duns":"650658532","firm":"Aragen Life Sciences Limited","registrant":"Aragen Life Sciences Limited","parent":null,"ticker":null,"addr":"Manufacturing Unit-1, Plot No.28A, IDA, Nacharam Village Uppal Mandal, Medchal-Malkajgiri District,, Hyderabad, Telangana 500076, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500076","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.43874,"lon":78.56145,"prec":"postcode","geo":"500076, Ward 6 Nacharam, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011573185","3014738606"],"colo":["3048143097","3003504071","3006493505","3007308467","3011823550","3008311641","3008768274","3024919921","3019773458"]},{"id":"3014738606","fei":"3014738606","duns":"675477476","firm":"Aragen Life Sciences Limited","registrant":"Aragen Life Sciences Limited","parent":null,"ticker":null,"addr":"Manufacturing Unit-II, Plot No. 94, SEZ, Jawaharlal Nehru Pharma City, Lemarthi (V), Parawada (M), Anakapalli District, Andhra Pradesh 531019, India (IND)","city":"Anakapalli District","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011573185","3005851210"],"colo":["3045048982","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397","3019853340"]},{"id":"3013306721","fei":"3013306721","duns":"675488649","firm":"Novitium Labs Private Limited","registrant":"Novitium Pharma LLC","parent":null,"ticker":null,"addr":"Module 20, SIDCO MultiStoreyed Complex SIDCO IndEst, Thirumazhisai, Chennai, TN 600124, India (IND)","city":"Chennai","state":null,"pin":"600124","ops":["ANALYSIS"],"expires":"12/31/2026","lat":13.06155,"lon":80.03684,"prec":"postcode","geo":"600124, Poonamallee, Thiruvallur, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3014461094"]},{"id":"3014461094","fei":"3014461094","duns":"675476509","firm":"SCITUS PHARMA SERVICES PRIVATE LIMITED","registrant":"SCITUS PHARMA SERVICES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Module 24,25,32-37, SIDCO Multi-storied Complex SIDCO Industrial Estate, Thirumazhisai, CHENNAI,  600124, India (IND)","city":"CHENNAI","state":null,"pin":"600124","ops":["ANALYSIS"],"expires":"12/31/2026","lat":13.06155,"lon":80.03684,"prec":"postcode","geo":"600124, Poonamallee, Thiruvallur, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3013306721"]},{"id":"3006785414","fei":"3006785414","duns":"772653251","firm":"Morepen Laboratories Limited","registrant":"Morepen Laboratories Limited","parent":null,"ticker":null,"addr":"Morepen Village, Malkumajra, Baddi Nalagarh Road Baddi, Baddi, Himachal Pradesh 173205, India (IND)","city":"Baddi","state":"Himachal Pradesh","pin":"173205","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":30.94458,"lon":76.80677,"prec":"postcode","geo":"173205, Baddi, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003897648","3002807612"],"colo":["3006370533","3013950309","3031304848","3007187282","3012536712","3018004432","3041778294","3005757050","3005430968","3004738570"]},{"id":"3046312775","fei":"3046312775","duns":"581742464","firm":"Regenerative Cell Research Institute Private Ltd.","registrant":"Regenerative Cell Research Institute Private Ltd.","parent":null,"ticker":null,"addr":"N 201/1,W 201/2, 1St Floor, Building No.3600, Neovantage Innovation Park Private Limited, Genome Valley, Lalgadi Malakpet Village, Shamirpet Mandal, Medchal, Medchal-Malkajgiri, Telangana 500078, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500078","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.58696,"lon":78.55137,"prec":"postcode","geo":"500078, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3011062091","3025926685","3012071812","3038847754","3012796281","3008377265","3004602077"]},{"id":"3003721861","fei":"3003721861","duns":"650427912","firm":"Calyx Chemicals & Pharmaceuticals Limited","registrant":"Calyx Chemicals & Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"N-102/91, MIDC Tarapur, Boisar, District Palghar, Maharashtra 401506, India (IND)","city":"District Palghar","state":"Maharashtra","pin":"401506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3001174909","3006418686","3006057101","3009118300","3016577628","3016790354","3017545500","3003336449","3013633378","3018369072","3003677831","3002807512"]},{"id":"3012155344","fei":"3012155344","duns":"675479957","firm":"V-Ensure Pharma Technologies Pvt Limited","registrant":"V-Ensure Pharma Technologies Pvt Limited","parent":null,"ticker":null,"addr":"N-32, Additional Patalganga MIDC,Village Badruk Karade Taluk, Raigad, Maharashtra 410206, India (IND)","city":"Raigad","state":"Maharashtra","pin":"410206","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.99503,"lon":73.11401,"prec":"postcode","geo":"410206, Panvel, Panvel Subdistrict, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3009561087","fei":"3009561087","duns":"650638633","firm":"INNOVA PHARMACTIVE PRIVATE LIMITED","registrant":"INNOVA PHARMACTIVE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"NS 13 to 16, Nagpur Industrial Estate Co-operative Society Limited, Nagpur, Maharashtra 440026, India (IND)","city":"Nagpur","state":"Maharashtra","pin":"440026","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.19493,"lon":79.09112,"prec":"postcode","geo":"440026, Nagpur City, Nagpur Urban Taluka, Nagpur, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3002807411","fei":"3002807411","duns":"917335304","firm":"Kothari Phytochemicals International","registrant":"Kothari Phytochemicals International","parent":null,"ticker":null,"addr":"Nagari, P.O. Thanichiyam, Madurai, Tamilnadu 625221, India (IND)","city":"Madurai","state":null,"pin":"625221","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":10.01749,"lon":78.01622,"prec":"postcode","geo":"625221, Vadipatti, Madurai, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3042541221","fei":"3042541221","duns":"772058774","firm":"ONEST LIMITED","registrant":"ONEST LIMITED","parent":null,"ticker":null,"addr":"Nandore, Nos. B-01, B-02, B-03 & B-04, Arham Industrial Park B, Plot No.25, nandore, Boisar, Palghar, Maharashtra 401404, India (IND)","city":"Palghar","state":"Maharashtra","pin":"401404","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":19.69445,"lon":72.78565,"prec":"postcode","geo":"401404, Palghar Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008380269","3007068506","3043682089"]},{"id":"3025926685","fei":"3025926685","duns":"854240874","firm":"Ritsa Pharma Private Limited","registrant":"Ritsa Pharma Private Limited","parent":null,"ticker":null,"addr":"Neovantage Park, Building-1800, Genome Valley, SY No. 101, 101/2, 340, Lalgadi Malakpet, Shamirpet, Medchal Malkajgiri, Hyderabad, Telangana 500078, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500078","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.58696,"lon":78.55137,"prec":"postcode","geo":"500078, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3011062091","3046312775","3012071812","3038847754","3012796281","3008377265","3004602077"]},{"id":"3007481629","fei":"3007481629","duns":"916500143","firm":"Agon Pharma Private Limited","registrant":"Agon Pharma Private Limited","parent":null,"ticker":null,"addr":"New Gat No. 837 & Old Gat No. 142, Milkat No. 1252, Yavat, Taluk Daund, Pune, Maharashtra 412214, India (IND)","city":"Pune","state":"Maharashtra","pin":"412214","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":18.47563,"lon":74.24499,"prec":"postcode","geo":"412214, Daund, Pune, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3035187076","fei":"3035187076","duns":"767611315","firm":"UMENDRA LIFE SCIENCES PRIVATE LIMITED","registrant":"UMENDRA LIFE SCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"New Survey No 211, Village Account No 170 Old Block / Survey No 158, Bavla Taulka Mauje, Amipura Primary School, Amipura,, Ahmedabad, GUJARAT 382220, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382220","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":22.85878,"lon":72.34332,"prec":"postcode","geo":"382220, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"CGMP/OTC Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/umendra-life-sciences-private-limited-721752-06022026","company_as_published":"Umendra Life Sciences Private Limited","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"CGMP/OTC Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/umendra-life-sciences-private-limited-721752-06022026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-06-02","last":"2026-06-02","sibs":[],"colo":["3008117347","3036572523","3033035639","3004161218","3044181625","3008223599"]},{"id":"3022175565","fei":"3022175565","duns":"737936381","firm":"Emcure Pharmaceuticals Limited","registrant":"Emcure Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"New Survey No. 485, (Old Survey No. 160/P-1), Village-Kadu, Taluka-Lakhtar,, Surendranagar, Gujarat 382775, India (IND)","city":"Surendranagar","state":"Gujarat","pin":"382775","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.87341,"lon":71.85033,"prec":"postcode","geo":"382775, Lakhtar Taluka, Surendranagar, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"07/13/2015","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","charges":[{"code":"55","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Pharm Necess & Ctnr For Drug/Bio","published":"07/13/2015"},{"code":"56","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Antibiotics (Human/Animal)","published":"07/13/2015"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"61","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"62","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"63","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"64","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"65","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"66","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"}],"firm_as_published":"Emcure Pharmaceuticals Limited","address_as_published":"Plot No. P-2, I.T.B.T. Park, Phase - II, MIDC, Hinjawadi , Pune, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2015-07-13","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices"}],"first":"2015-07-13","last":"2022-05-26","sibs":["3005782879","3014595023","3006643860"],"colo":[]},{"id":"3014362214","fei":"3014362214","duns":"725656438","firm":"Maiva Pharma Private Limited","registrant":"Maiva Pharma Private Limited","parent":null,"ticker":null,"addr":"No 32, SIPCOT Industrial Complex, Phase I, Hosur, Tamil Nadu 635126, India (IND)","city":"Hosur","state":"Tamil Nadu","pin":"635126","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.75781,"lon":77.81407,"prec":"postcode","geo":"635126, Hosur, Krishnagiri, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004094136"]},{"id":"3004554612","fei":"3004554612","duns":"918513263","firm":"Strides Pharma Science Limited","registrant":"Strides Pharma Science Limited","parent":"Strides Pharma Science","ticker":"STAR","addr":"No 36/7,Suragajakkanahalli, Indlavadi Cross, Anekal Taluk, Bengaluru, Karnataka 562106, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"562106","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.71294,"lon":77.66275,"prec":"postcode","geo":"562106, Agasathimmanahalli, Siddanapalya, Anekal, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005151016","3012448465"],"colo":["3030133758","3032481089"]},{"id":"3005115135","fei":"3005115135","duns":"650521722","firm":"MALLADI DRUGS AND PHARMACEUTICALS LIMITED","registrant":"Malladi Drugs & Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"No 67, SIPCOT Industrial Complex,, Vellore, Tamil Nadu 632403, India (IND)","city":"Vellore","state":"Tamil Nadu","pin":"632403","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":12.95652,"lon":79.30426,"prec":"postcode","geo":"632403, Wallajah, Ranipet, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002780785","3004896422"],"colo":[]},{"id":"3023227362","fei":"3023227362","duns":"860416409","firm":"SYNERGY REMEDIES PRIVATE LIMITED","registrant":"SYNERGY REMEDIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"No 74a And 77a Industrial Park Gajulamandyam, Renigunta Mandal, Tirupati,  517506, India (IND)","city":"Tirupati","state":null,"pin":"517506","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":13.64158,"lon":79.50195,"prec":"tail3","geo":"PHC,Renigunta, Anasam Palle Road, Renigunta Urban, Renigunta, Chittoor, Andhra Pradesh, 517520, India","status":1,"alerts":[],"letters":[{"date":"2022-03-01T05:00:00Z","posted":"2022-03-01T20:00:00Z","subject":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","office":"Center for Tobacco Products","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/synergy-mixing-labs-llc-625235-03012022","company_as_published":"Synergy Mixing Labs, LLC","match":"token"},{"date":"2025-07-16T04:00:00Z","posted":"2025-09-02T04:00:00Z","subject":"Unapproved New Animal Drug Products","office":"Center for Veterinary Medicine","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/synergy-animal-products-inc-712860-07162025","company_as_published":"Synergy Animal Products, Inc.","match":"token"}],"events":[{"d":"2025-07-16","k":"letter","t":"Unapproved New Animal Drug Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/synergy-animal-products-inc-712860-07162025","x":"Center for Veterinary Medicine"},{"d":"2022-03-01","k":"letter","t":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/synergy-mixing-labs-llc-625235-03012022","x":"Center for Tobacco Products"}],"first":"2022-03-01","last":"2025-07-16","sibs":[],"colo":[]},{"id":"3008450172","fei":"3008450172","duns":"862282287","firm":"Alkem Laboratories Limited","registrant":"Alkem Laboratories Limited","parent":"Alkem Laboratories","ticker":"ALKEM","addr":"No-8 Old National Highway At Naugama, Mandva, Ankleshwar, Bharuch, Gujarat 393010, India (IND)","city":"Bharuch","state":"Gujarat","pin":"393010","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":21.67766,"lon":73.01919,"prec":"postcode","geo":"393010, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006370533","3006851796","3006370524"],"colo":[]},{"id":"3005560263","fei":"3005560263","duns":"915837952","firm":"R L Fine Chem","registrant":"R L Fine Chem","parent":null,"ticker":null,"addr":"No. 15, KHB Industrial Area, Bangalore, Karnataka 560064, India (IND)","city":"Bangalore","state":"Karnataka","pin":"560064","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.14017,"lon":77.57225,"prec":"postcode","geo":"560064, Avalahalli, Yelahanka taluku, Bengaluru Urban, Karnataka, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"03/17/2015","notes":"Medical claims on product label","charges":[{"code":"53 E - - 99","notes":"","product":"Other Hair Preparations, Non-coloring), N.E.C.","published":"08/22/2016"},{"code":"53 L - - 99","notes":"","product":"Other Skin Care Preparations, N.E.C.","published":"03/17/2015"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/22/2016"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"03/17/2015"}],"firm_as_published":"ASHWIN FINE CHEMICALS AND PHARMACEUTICALS","address_as_published":"3, SHANTA INDL EST , OFF: W E HIGHWAY , KASHIMIRA, THANE - MAHARAHSTRA INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"05/29/2014","notes":"","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"05/29/2014"}],"firm_as_published":"Fine Processors Private Ltd.","address_as_published":"D - 27 Sector Ii , Noida, Uttar Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-66","list":"red","since":"09/30/2009","notes":"11/2/2000","charges":[{"code":"60 W - S 26","notes":"","product":"Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","published":"03/27/2019"}],"firm_as_published":"Fine Chemicals","address_as_published":"89 Princess Street , Bombay, MS INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"token"}],"letters":[{"date":"2023-04-28T04:00:00Z","posted":"2023-05-16T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations East V","response":"","closeout":"11/17/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/garys-cheesecakes-fine-desserts-654471-04282023","company_as_published":"Gary’s Cheesecakes & Fine Desserts","match":"token"},{"date":"2023-06-20T04:00:00Z","posted":"2023-06-27T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-kecheng-fine-chemicals-co-ltd-659389-06202023","company_as_published":"Chengdu KeCheng Fine Chemicals Co., Ltd.","match":"token"}],"events":[{"d":"2023-06-20","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-kecheng-fine-chemicals-co-ltd-659389-06202023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-04-28","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/garys-cheesecakes-fine-desserts-654471-04282023","x":"Division of Human and Animal Food Operations East V"},{"d":"2019-03-27","k":"charge","t":"66-66 charge 60 W - S 26 — Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2016-08-22","k":"charge","t":"66-41 charge 53 E - - 99 — Other Hair Preparations, Non-coloring), N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2016-08-22","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2015-03-17","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Medical claims on product label"},{"d":"2014-05-29","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":"11/2/2000"}],"first":"2009-09-30","last":"2023-06-20","sibs":["3013140488","3039941881"],"colo":[]},{"id":"3043532297","fei":"3043532297","duns":"854400010","firm":"PREWEL LABS PRIVATE LIMITED","registrant":"PREWEL LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"No. 24, 22nd Main, Marenahalli, J P Nagar 2nd Phase, Bengaluru, Karnataka 560078, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560078","ops":["ANALYSIS"],"expires":"12/31/2026","lat":12.8996,"lon":77.58203,"prec":"postcode","geo":"560078, Jaraganahalli, Bengaluru South City Corporation, Bengaluru, Bangalore South, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3008300442","fei":"3008300442","duns":"676018967","firm":"Anthem Biosciences Limited","registrant":"Anthem Biosciences Limited","parent":"Anthem Biosciences","ticker":"ANTHEMBIO","addr":"No. 49, F1 & F2, Phase I, Canara Bank Road Bommasandra Industrial Area, Bengaluru, Karnataka 560099, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560099","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":12.83934,"lon":77.70554,"prec":"postcode","geo":"560099, Singena Agrahara, Anekal, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3017542362","3013884349"],"colo":["3009310198","3003600340","3043619916","3007078919","3003981475","3006076314","3013637926","3010164491","3035152598"]},{"id":"3041525876","fei":"3041525876","duns":"650945970","firm":"Nuwill Research and Innovations Private Limited","registrant":"Nuwill Research and Innovations Private Limited","parent":null,"ticker":null,"addr":"No. 562/640, 2nd Floor, Janardhan Towers Bilekahalli, Bennerghatta Road, Bengaluru, Karnataka 560076, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560076","ops":["ANALYSIS"],"expires":"12/31/2026","lat":12.88064,"lon":77.60387,"prec":"postcode","geo":"560076, Hulimavu, Bengaluru South City Corporation, Bengaluru, Bangalore South, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005652193","3003813519"]},{"id":"3006897905","fei":"3006897905","duns":"677604984","firm":"Chieron Active Ingredients Private Limited","registrant":"Chieron Active Ingredients Private Limited","parent":null,"ticker":null,"addr":"No. 69, Chandrapadiya Village Vinjamur Mandal, SPSR Nellore, Andhra Pradesh 524228, India (IND)","city":"SPSR Nellore","state":"Andhra Pradesh","pin":"524228","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":14.85683,"lon":79.5715,"prec":"postcode","geo":"524228, Vinjamur, Sri Potti Sriramulu Nellore, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3009028280","fei":"3009028280","duns":"932760985","firm":"ACCENT PHARMA","registrant":"ACCENT PHARMA","parent":null,"ticker":null,"addr":"No. B-159, B-160, B-161, B-162, 22nd Cross Street PIPDIC Industrial Estate, Mettupalayam,, Puducherry, Puducherry 605009, India (IND)","city":"Mettupalayam","state":"Puducherry","pin":"605009","ops":["LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.05494,"lon":79.78237,"prec":"postcode","geo":"605009, Vanur, Viluppuram, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3014319211","fei":"3014319211","duns":"864148801","firm":"Steril-Gene Life Sciences Private Limited","registrant":"Steril-Gene Life Sciences Private Limited","parent":null,"ticker":null,"addr":"No.45, Main Road, Mangalam Village, Villianur Commune, Puducherry,, Puducherry,  605110, India (IND)","city":"Villianur Commune","state":"Puducherry","pin":"605110","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":11.91219,"lon":79.7595,"prec":"postcode","geo":"605110, Villianur Taluk, Puducherry, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3015345916","fei":"3015345916","duns":"861304337","firm":"ALS Testing Services India Private Ltd.","registrant":"ALS Testing Services India Private Ltd.","parent":null,"ticker":null,"addr":"No.65, Bommasandra Jigani Link Road, KIADB Industrial Area, Bangalore, Karnataka 560105, India (IND)","city":"Bangalore","state":"Karnataka","pin":"560105","ops":["ANALYSIS"],"expires":"12/31/2026","lat":12.78642,"lon":77.63458,"prec":"postcode","geo":"560105, Jigani, Anekal, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3038847754"],"colo":["3007512701","3005857289","3003560263","3009882550","3009609358","3004939494","3003768909","3007648351"]},{"id":"3008408466","fei":"3008408466","duns":"650654143","firm":"Vijayasri Organics","registrant":"Vijayasri Organics","parent":null,"ticker":null,"addr":"No:164/A3, Survey No:172/A, S V Co-operative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Sangareddy, Telangana 502325, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502325","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.55317,"lon":78.34216,"prec":"postcode","geo":"502325, Jinnaram mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009451765"],"colo":["3017000602","3041729025","3002806851","3007136165","3008479404","3009609117","3007720135","3005818804","3008932115","3005301950"]},{"id":"3043068534","fei":"3043068534","duns":"766397029","firm":"SYNCBIO RESEARCH PRIVATE LIMITED","registrant":"SYNCBIO RESEARCH PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Office - 1, Maruti Nandan Estate, Changodar, GIDC, Tajpur Road, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["ANALYSIS"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3041646841","3036725850","3017085815","3010661577","3007277149","3008957483","3007938603","3010254278","3029456823","3007621329","3008725987","3004011473"]},{"id":"Office No. 507, Eureka Tower, Mindspace Off Link Road Malad West, Mumbai, Maharashtra 400064, India (IND)","fei":"","duns":"860299632","firm":"NUTRA CARE PRODUCTS PRIVATE LIMITED","registrant":"NUTRA CARE PRODUCTS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Office No. 507, Eureka Tower, Mindspace Off Link Road Malad West, Mumbai, Maharashtra 400064, India (IND)","city":"Mumbai","state":"Maharashtra","pin":"400064","ops":["RELABEL"],"expires":"12/31/2026","lat":19.18875,"lon":72.84009,"prec":"postcode","geo":"400064, P/N Ward, Mumbai Zone 4, Mumbai, Mumbai Suburban District, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2025-08-06T04:00:00Z","posted":"2025-08-12T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","company_as_published":"K & Care Organics","match":"token"}],"events":[{"d":"2025-08-06","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-06","last":"2025-08-06","sibs":[],"colo":[]},{"id":"3010915907","fei":"3010915907","duns":"650732092","firm":"NICO ORGO MARKETING PRIVATE LIMITED","registrant":"Nico Orgo Marketing Pvt Ltd","parent":null,"ticker":null,"addr":"Opp Railway Station, Dakor, Kheda, Gujarat 388225, India (IND)","city":"Kheda","state":"Gujarat","pin":"388225","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.77118,"lon":73.13665,"prec":"postcode","geo":"388225, Thasra Taluka, Kheda, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3017085815","fei":"3017085815","duns":"874094551","firm":"Accuprec Research Labs Pvt. Ltd.","registrant":"Accuprec Research Labs Pvt. Ltd.","parent":null,"ticker":null,"addr":"Opp. Zydus Pharmez, Changodar-Bavla Highway, Near Matoda Patiya, Post Matoda, Taluka-Sanad Ahmedabad, Gujarat 382213, India (IND)","city":"Taluka-Sanad Ahmedabad","state":"Gujarat","pin":"382213","ops":["ANALYSIS"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3041646841","3036725850","3043068534","3010661577","3007277149","3008957483","3007938603","3010254278","3029456823","3007621329","3008725987","3004011473"]},{"id":"3031858655","fei":"3031858655","duns":"737793891","firm":"BDR PHARMACEUTICALS INTERNATIONAL PVT. LTD.","registrant":"BDR PHARMACEUTICALS INTERNATIONAL PVT LTD","parent":null,"ticker":null,"addr":"Oral Solid Dosage Forms Manufacturing Unit. First Floor General Block At. Vanseti Village, Po. Taluka Halol, District Panchmahal, Halol, Gujarat 389 350, India (IND)","city":"Halol","state":"Gujarat","pin":null,"ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.54151,"lon":73.43344,"prec":"tail3","geo":"INTEGRA Engineering India Limited, Halol Taluka, Panchmahal, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3030526918","3010166818","3038848101"],"colo":[]},{"id":"3002807297","fei":"3002807297","duns":"862179827","firm":"Ipca Laboratories Limited","registrant":"Ipca Laboratories Limited","parent":"Ipca Laboratories","ticker":"IPCALAB","addr":"P.O. Sejavta, Ratlam, Madhya Pradesh 457001, India (IND)","city":"Ratlam","state":"Madhya Pradesh","pin":"457001","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":23.32309,"lon":75.0305,"prec":"postcode","geo":"457001, Ratlam, Ratlam Nagar Tahsil, Ratlam, Madhya Pradesh, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"09/30/2009","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","charges":[{"code":"66 V - - 99","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","product":"Miscellaneous Patent Medicines, Etc.","published":"09/30/2009"}],"firm_as_published":"Ipca Laboratories Limited","address_as_published":"P.O. Sejavta , Ratlam, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug."}],"first":"2009-09-30","last":"2009-09-30","sibs":["3007574780","3027770072","3027770075","3005977675","3006057101","3009227929"],"colo":[]},{"id":"3006549835","fei":"3006549835","duns":"650446243","firm":"DR.REDDY'S LABORATORIES LIMITED","registrant":"Dr. Reddy's Laboratories Limited","parent":"Dr. Reddy's Laboratories","ticker":"DRREDDY","addr":"P1 to P9 & Q1 to Q5, Phase - III, VSEZ, Duvvada,, Visakhapatnam, Andhra Pradesh 530 046, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":null,"ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.7036,"lon":83.15138,"prec":"tail3","geo":"Duvvada, Kurmannapalem Road, Duvvada, Kotturu, Gajuwaka, Visakhapatnam, Andhra Pradesh, 530046, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002949085","3014250111","3005336882","3011171511","3009193040","3012414462","3005447965","3005448030","3002806851","3003184497","3002949099","3009483004"],"colo":[]},{"id":"3016903724","fei":"3016903724","duns":"860119343","firm":"FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED","registrant":"FOURRTS INDIA LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"PLANT II, No. 23, Venkatamangalam, Kandigai,, Chennai, Tamil Nadu 600127, India (IND)","city":"Chennai","state":"Tamil Nadu","pin":"600127","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.84213,"lon":80.1486,"prec":"postcode","geo":"600127, Tiruporur, Chengalpattu, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3013200240","fei":"3013200240","duns":"565226827","firm":"Eurofins BioPharma Product Testing India Private Limited","registrant":"Eurofins BioPharma Product Testing India Private Limited","parent":null,"ticker":null,"addr":"PLOT NO 21-22, PHASE II, PEENYA INDUSTRIAL AREA, Bengaluru, Karnataka 560058, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560058","ops":["ANALYSIS"],"expires":"12/31/2026","lat":13.02329,"lon":77.51356,"prec":"postcode","geo":"560058, Parvathi Nagar, Bengaluru West City Corporation, Bengaluru, Bangalore North, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3006949803","3022528084","3013697420"]},{"id":"3010806039","fei":"3010806039","duns":"677381470","firm":"Blossom Pharmaceuticals","registrant":"ALTOVA HEALTHCARE LIMITED","parent":null,"ticker":null,"addr":"PLOT NO 21/22 BARDEZ BLOSSOM PHARMACEUTICALS KARASWADA-TIVIM Karaswada, Tivim, Bardej, GOA, GOA 403526, India (IND)","city":"Bardej","state":"Goa","pin":"403526","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":15.73672,"lon":73.86901,"prec":"tail2","geo":"Manohar International Airport, Mopa AIrport Link Road, Nagzar, Pernem, North Goa, Goa, India","status":1,"alerts":[],"letters":[{"date":"2021-02-18T05:00:00Z","posted":"2021-02-19T17:00:00Z","subject":"New Drug/Misbranded","office":"Center for Food Safety and Applied Nutrition (CFSAN)","response":"","closeout":"07/21/2021","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blossom-nature-llc-612263-02182021","company_as_published":"Blossom Nature, LLC","match":"token"}],"events":[{"d":"2021-02-18","k":"letter","t":"New Drug/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/blossom-nature-llc-612263-02182021","x":"Center for Food Safety and Applied Nutrition (CFSAN)"}],"first":"2021-02-18","last":"2021-02-18","sibs":[],"colo":[]},{"id":"3026584977","fei":"3026584977","duns":"861550907","firm":"INNOVATIVE PHARMA SOLUTIONS PRIVATE LIMITED","registrant":"INNOVATIVE PHARMA SOLUTIONS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"PLOT NO 24,2ND FLOOR, ROAD NO.5 ALEAP I E, PRAGATHI NAGAR, HYDERABAD, TELANGANA 500090, India (IND)","city":"HYDERABAD","state":"Telangana","pin":"500090","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.53062,"lon":78.38101,"prec":"postcode","geo":"500090, Bachupally mandal, Medchal–Malkajgiri, Telangana, India","status":2,"alerts":[{"alert":"66-79","list":"red","since":"10/13/2022","notes":"All Drug and Drug Products DWPE Date; 11/01/2019","charges":[{"code":"55","notes":"All Drug and Drug Products DWPE Date; 11/01/2019","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/28/2021"},{"code":"56","notes":"All Drug and Drug Products DWPE Date; 11/01/2019","product":"Antibiotics (Human/Animal)","published":"10/28/2021"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products DWPE Date; 11/01/2019","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"61","notes":"All Drug and Drug Products DWPE Date; 11/01/2019","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"62","notes":"All Drug and Drug Products DWPE Date; 11/01/2019","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"63","notes":"All Drug and Drug Products DWPE Date; 11/01/2019","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"64","notes":"All Drug and Drug Products DWPE Date; 11/01/2019","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"65","notes":"All Drug and Drug Products DWPE Date; 11/01/2019","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"66","notes":"All Drug and Drug Products DWPE Date; 11/01/2019","product":"Human and Animal Drugs","published":"10/28/2021"}],"firm_as_published":"Unidrug Innovative Pharma Technologies Limited","address_as_published":"Plot No 84 , Sector E; Sanwer Road , Indore, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","match":"token"}],"letters":[{"date":"2024-02-22T05:00:00Z","posted":"2024-03-05T14:20:00Z","subject":"Finished Pharmaceuticals/Unapproved New Drug/Misbranded","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innovative-formulations-llc-dba-insane-labz-672952-02222024","company_as_published":"Innovative Formulations, LLC dba Insane Labz","match":"token"}],"events":[{"d":"2024-02-22","k":"letter","t":"Finished Pharmaceuticals/Unapproved New Drug/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/innovative-formulations-llc-dba-insane-labz-672952-02222024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2022-10-13","k":"alert","t":"Listed on import alert 66-79","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products DWPE Date; 11/01/2019"},{"d":"2022-05-26","k":"charge","t":"66-79 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":""},{"d":"2021-10-28","k":"charge","t":"66-79 charge 55 — Pharm Necess & Ctnr For Drug/Bio","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products DWPE Date; 11/01/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 56 — Antibiotics (Human/Animal)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products DWPE Date; 11/01/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 60 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products DWPE Date; 11/01/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 61 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products DWPE Date; 11/01/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 62 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products DWPE Date; 11/01/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 63 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products DWPE Date; 11/01/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 64 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products DWPE Date; 11/01/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 65 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products DWPE Date; 11/01/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 66 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products DWPE Date; 11/01/2019"}],"first":"2021-10-28","last":"2024-02-22","sibs":[],"colo":["3014250111","3013593602","3013758337","3008569405","3013580504","3027524740","3017981159","3002949099","3009483004","3003971663","3004021229","3004446312"]},{"id":"3031304848","fei":"3031304848","duns":"738530875","firm":"ALLIANCE FORMULATIONS","registrant":"ALLIANCE FORMULATIONS","parent":null,"ticker":null,"addr":"PLOT NO 30B -31- 32 ALLIANCE FORMULATIONS JHARMAJRI EPIP PHASE-I, Solan, HIMACHAL PRADESH 173205, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"173205","ops":["LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":30.94458,"lon":76.80677,"prec":"postcode","geo":"173205, Baddi, Solan, Himachal Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2023-07-13T04:00:00Z","posted":"2023-07-13T19:00:00Z","subject":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","office":"Center for Tobacco Products","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/national-tobacco-alliance-inc-dba-kc-smoke-vape-658241-07132023","company_as_published":"The National Tobacco Alliance, Inc. d/b/a KC Smoke & Vape","match":"token"},{"date":"2023-09-11T04:00:00Z","posted":"2023-09-12T13:00:00Z","subject":"Unapproved New Drugs/Misbranded","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/walgreens-boots-alliance-inc-663404-09112023","company_as_published":"Walgreens Boots Alliance, Inc.","match":"token"}],"events":[{"d":"2023-09-11","k":"letter","t":"Unapproved New Drugs/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/walgreens-boots-alliance-inc-663404-09112023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-07-13","k":"letter","t":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/national-tobacco-alliance-inc-dba-kc-smoke-vape-658241-07132023","x":"Center for Tobacco Products"}],"first":"2023-07-13","last":"2023-09-11","sibs":[],"colo":["3006370533","3013950309","3003897648","3006785414","3007187282","3012536712","3018004432","3041778294","3005757050","3005430968","3004738570"]},{"id":"PLOT NO 4C,MN SC & TECH BIOTECH PARK GENOME VALLEY, TURKAPALLY, SHAMIRPET RANGAREDDY, Hyderabad, Telangana 500101, India (IND)","fei":"","duns":"738304795","firm":"VELZEN PHARMA PRIVATE LIMITED","registrant":"VELZEN PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"PLOT NO 4C,MN SC & TECH BIOTECH PARK GENOME VALLEY, TURKAPALLY, SHAMIRPET RANGAREDDY, Hyderabad, Telangana 500101, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500101","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.65514,"lon":78.60618,"prec":"postcode","geo":"500101, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038528882","3006587427","3017754175","3039644403","3039411568","3006527015","3009522832","3012704791","3030495702","3009883135","3011960448"]},{"id":"3038149173","fei":"3038149173","duns":"873672011","firm":"HORSTER LIFE SCIENCE PVT LTD","registrant":"HORSTER LIFE SCIENCE PVT LTD","parent":null,"ticker":null,"addr":"PLOT NO 905/12/A, GIDC ESTATE, PANOLI, ANKLESHWAR, BHARUCH,GUJ, BHARUCH, GUJARAT 394116, India (IND)","city":"BHARUCH","state":"Gujarat","pin":"394116","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.53479,"lon":72.95568,"prec":"postcode","geo":"394116, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3030554615","3003952717","3003053502","3015776899","3013151303","3009627283","3004196193"]},{"id":"3011103533","fei":"3011103533","duns":"650816494","firm":"FIRST TIME US PHARMACEUTICALS (INDIA) PRIVATE LIMITED","registrant":"FIRST TIME US PHARMACEUTICALS (INDIA) PRIVATE LIMITED","parent":null,"ticker":null,"addr":"PLOT NO C-112, MIDC PAWANE, TTC INDUSTRIAL AREA, NAVI MUMBAI, MAHARASHTRA 400705, India (IND)","city":"NAVI MUMBAI","state":"Maharashtra","pin":"400705","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.06727,"lon":73.00917,"prec":"postcode","geo":"400705, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"08/28/2012","notes":"Country; India","charges":[{"code":"63 H - - 22","notes":"","product":"Senna (Cathartic)","published":"08/28/2012"},{"code":"63 H - - 99","notes":"","product":"Cathartic N.E.C.","published":"08/28/2012"},{"code":"66 C - - 99","notes":"","product":"Stool Softener N.E.C.","published":"08/28/2012"}],"firm_as_published":"Time Laboratories","address_as_published":"I Parekh Road , Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"08/19/2012","notes":"India","charges":[{"code":"63 H - - 22","notes":"","product":"Senna (Cathartic)","published":"08/19/2012"},{"code":"63 H - - 99","notes":"","product":"Cathartic N.E.C.","published":"08/19/2012"},{"code":"66 C - - 99","notes":"","product":"Stool Softener N.E.C.","published":"08/19/2012"}],"firm_as_published":"Time Laboratories","address_as_published":"201, Mahavir Ind.Estate, Chandansar rd. , Virar ( East ) , Thane, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[],"events":[{"d":"2012-08-28","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Country; India"},{"d":"2012-08-19","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"India"}],"first":"2012-08-19","last":"2012-08-28","sibs":[],"colo":["3020879673","C 404, TTC Industrial Area MIDC, Pawane, Navi Mumbai,  400705, India (IND)","3010585824","3006441076"]},{"id":"3018052045","fei":"3018052045","duns":"861497280","firm":"Akshar Gamma Steriles LLP","registrant":"Akshar Gamma Steriles LLP","parent":null,"ticker":null,"addr":"PLOT NO N-13, NEAR WATSON PHARMA CO, ADDL MIDC ANAND NAGAR, AMBERNATH EAST, Thane, Maharashtra 421506, India (IND)","city":"Thane","state":"Maharashtra","pin":"421506","ops":["STERILIZE"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021189141","3009887190","3008232264","3013999816","3016575313","3006599894","3006809732","3027577650","3010166801","3032073298","3008374690","3009051788"]},{"id":"3043800366","fei":"3043800366","duns":"771541447","firm":"PANDJ CRETECHEM PRIVATE LIMITED","registrant":"PANDJ CRETECHEM PRIVATE LIMITED","parent":null,"ticker":null,"addr":"PLOT NO Z 17 and Z 18, DAHEJ SEZ PART 1, 4a, DAHEJ,, Bharuch, Gujarat 392130, India (IND)","city":"Bharuch","state":"Gujarat","pin":"392130","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.71286,"lon":72.61625,"prec":"postcode","geo":"392130, Vagra Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3040332349","3005404478","3018972378","3012664809","3010027135","3014919100","3010228235","3007514214","3005737619","3030599291"]},{"id":"3006896204","fei":"3006896204","duns":"677602480","firm":"MEDLEY PHARMACEUTICALS LIMITED","registrant":"MEDLEY PHARMACEUTICALS LIMITED","parent":null,"ticker":null,"addr":"PLOT NO. 18 AND 19, ZARI CAUSEWAY ROAD, KACHIGAM, DAMAN, DAMAN AND DIU 396210, India (IND)","city":"KACHIGAM","state":"Daman","pin":"396210","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":20.42558,"lon":72.84559,"prec":"postcode","geo":"396210, Daman, Dadra and Nagar Haveli and Daman and Diu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004086192","3009681646","3006363714","3006370524","3003647459"]},{"id":"3010331979","fei":"3010331979","duns":"650900223","firm":"ESKAY IODINE PVT. LTD.","registrant":"ESKAY IODINE PVT. LTD.","parent":null,"ticker":null,"addr":"PLOT NO. 907/2, JHAGADIA GIDC ESTATE,, BHARUCH, GUJARAT 393110, India (IND)","city":"BHARUCH","state":"Gujarat","pin":"393110","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.6831,"lon":73.17284,"prec":"postcode","geo":"393110, Jhagadiya Taluka, Bharuch, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2022-03-25T04:00:00Z","posted":"2022-03-28T14:00:00Z","subject":"Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/iodine-products-inc-628296-03252022","company_as_published":"Iodine Products Inc","match":"token"}],"events":[{"d":"2022-03-25","k":"letter","t":"Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/iodine-products-inc-628296-03252022","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2022-03-25","last":"2022-03-25","sibs":[],"colo":["3019101447","3006216494"]},{"id":"3020983424","fei":"3020983424","duns":"565243514","firm":"SHIVALIK RASAYAN LIMITED","registrant":"SHIVALIK RASAYAN LIMITED","parent":null,"ticker":null,"addr":"PLOT NO. D-2/CH/41/A, DAHEJ- II, INDUSTRIAL ESTATE V- VADDALA T-VAGRA, BHARUCH, GJ (GUJARAT) 392140, India (IND)","city":"BHARUCH","state":"Gujarat","pin":"392140","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.85613,"lon":72.80491,"prec":"postcode","geo":"392140, Vagra Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038199887"]},{"id":"3030509366","fei":"3030509366","duns":"929877680","firm":"ALMON HEALTHCARE PRIVATE LIMITED","registrant":"ALMON HEALTHCARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"PLOT NO.4, SANKALP INDUSTRIAL ESTATE, BEHIND KERALA GIDC, BAVALA, AHMEDABAD-382240, GUJARAT, AHMEDABAD, GUJARAT 382240, India (IND)","city":"AHMEDABAD","state":"Gujarat","pin":"382240","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.73027,"lon":72.2636,"prec":"postcode","geo":"382240, Bavla Taluka, Ahmedabad, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/09/2026","notes":"All Drug and Drug Products (including excipients)","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"06/09/2026"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"06/09/2026"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"06/09/2026"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"06/09/2026"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"06/09/2026"},{"code":"55","notes":"All Drug and Drug Products (including excipients)","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/09/2026"},{"code":"56","notes":"All Drug and Drug Products (including excipients)","product":"Antibiotics (Human/Animal)","published":"06/09/2026"},{"code":"58","notes":"All Drug and Drug Products (including excipients)","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"06/09/2026"},{"code":"60","notes":"All Drug and Drug Products (including excipients)","product":"Human and Animal Drugs","published":"06/09/2026"},{"code":"61","notes":"All Drug and Drug Products (including excipients)","product":"Human and Animal Drugs","published":"06/09/2026"},{"code":"62","notes":"All Drug and Drug Products (including excipients)","product":"Human and Animal Drugs","published":"06/09/2026"},{"code":"63","notes":"All Drug and Drug Products (including excipients)","product":"Human and Animal Drugs","published":"06/09/2026"},{"code":"64","notes":"All Drug and Drug Products (including excipients)","product":"Human and Animal Drugs","published":"06/09/2026"},{"code":"65","notes":"All Drug and Drug Products (including excipients)","product":"Human and Animal Drugs","published":"06/09/2026"},{"code":"66","notes":"All Drug and Drug Products (including excipients)","product":"Human and Animal Drugs","published":"06/09/2026"}],"firm_as_published":"Almon Healthcare Private Limited","address_as_published":"Sk Industrial Estate Plot No 4 , Behind Kerala Gidc , Ahmedabad, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2026-07-13T04:00:00Z","posted":"2026-07-21T04:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/almon-healthcare-private-limited-729291-07132026","company_as_published":"Almon Healthcare Private Limited","match":"exact"}],"events":[{"d":"2026-07-13","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/almon-healthcare-private-limited-729291-07132026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2026-06-09","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products (including excipients)"}],"first":"2026-06-09","last":"2026-07-13","sibs":[],"colo":[]},{"id":"3031960635","fei":"3031960635","duns":"756100404","firm":"CIRO PHARMA PRIVATE LIMITED","registrant":"CIRO PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"PLOT NO.: 28, BIO-TECH PARK, PHASE-III, KARKAPATLA VILLAGE, MARKOOK MANDAL, SIDDIPET DISTRICT, TELANGANA 502281, India (IND)","city":"SIDDIPET DISTRICT","state":"Telangana","pin":"502281","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.81912,"lon":78.7342,"prec":"postcode","geo":"502281, Gajwel mandal, Siddipet, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3014404150","Plot No.- 09, Biotech Park, Phase-III, Sy No.-321, Karkapatla (V), Markook (M),, Siddipet, Telangana 502281, India (IND)","3032184895","3027345324","3027380201","3014483338"]},{"id":"3005447965","fei":"3005447965","duns":"650443471","firm":"DR. REDDY'S LABORATORIES LIMITED","registrant":"Dr. Reddy's Laboratories Limited","parent":"Dr. Reddy's Laboratories","ticker":"DRREDDY","addr":"Peddadevulapally, Tripuraram Mandal, Nalgonda, Telangana 508 207, India (IND)","city":"Nalgonda","state":"Telangana","pin":null,"ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":16.82508,"lon":79.47125,"prec":"tail3","geo":"Tripuraram mandal, Nalgonda, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002949085","3014250111","3005336882","3011171511","3009193040","3012414462","3006549835","3005448030","3002806851","3003184497","3002949099","3009483004"],"colo":[]},{"id":"3007187282","fei":"3007187282","duns":"857979552","firm":"PANACEA BIOTEC PHARMA LIMITED","registrant":"PANACEA BIOTEC PHARMA LIMITED","parent":null,"ticker":null,"addr":"Pharma Block, Malpur, Baddi, Solan, Himachal Pradesh 173205, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"173205","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":30.94458,"lon":76.80677,"prec":"postcode","geo":"173205, Baddi, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3006370533","3013950309","3003897648","3006785414","3031304848","3012536712","3018004432","3041778294","3005757050","3005430968","3004738570"]},{"id":"3004540906","fei":"3004540906","duns":"918588174","firm":"NATCO PHARMA LIMITED","registrant":"NATCO PHARMA LIMITED","parent":"Natco Pharma","ticker":"NATCOPHARM","addr":"Pharma Division, Kothur, Rangareddy, Telangana 509228, India (IND)","city":"Rangareddy","state":"Telangana","pin":"509228","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.14014,"lon":78.28718,"prec":"postcode","geo":"509228, Kothur mandal, Ranga Reddy, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2024-04-08T04:00:00Z","posted":"2024-04-16T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"09/29/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natco-pharma-limited-672564-04082024","company_as_published":"Natco Pharma Limited","match":"exact"}],"events":[{"d":"2024-04-08","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natco-pharma-limited-672564-04082024","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2024-04-08","last":"2024-04-08","sibs":["3009870595","3004065860","3015380536"],"colo":["3011033544","3019516576"]},{"id":"3017348002","fei":"3017348002","duns":"867547120","firm":"East African India Overseas","registrant":"East African India Overseas","parent":null,"ticker":null,"addr":"Pharmacity, Plot No. 8, Selaqui, Dehradun, Uttarakhand 248011, India (IND)","city":"Dehradun","state":"Uttarakhand","pin":"248011","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":30.36521,"lon":77.85851,"prec":"postcode","geo":"248011, Vikasnagar, Dehradun, Uttarakhand, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005890633","3008127341"]},{"id":"3021329253","fei":"3021329253","duns":"565277249","firm":"Eurofins Advinus BioPharma Services India Private Limited","registrant":"Eurofins Advinus BioPharma Services India Private Limited","parent":null,"ticker":null,"addr":"Plot #17 F, Bidadi Industrial Area, 2nd Phase, Sector-1, Bidadi, Ramanagara-Karnataka, Bengaluru,  562109, India (IND)","city":"Bidadi","state":"Karnataka","pin":"562109","ops":["API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":12.78215,"lon":77.40738,"prec":"postcode","geo":"562109, Ramanagara taluk, Bengaluru South, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3022528084"],"colo":[]},{"id":"3012071812","fei":"3012071812","duns":"650864775","firm":"AIRIS PHARMA PRIVATE LIMITED","registrant":"AIRIS PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot - 64 & 65, Survey Number 342 ALEAP Industrial Estate Gajularamaram Village Quthbullapur Mandal, Hyderabad, Telangana 500078, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500078","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.58696,"lon":78.55137,"prec":"postcode","geo":"500078, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2023-12-08T05:00:00Z","posted":"2024-01-23T14:20:00Z","subject":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","office":"Center for Tobacco Products","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shenzhen-airis-electronic-co-ltd-673296-12082023","company_as_published":"Shenzhen Airis Electronic Co. Ltd.","match":"token"}],"events":[{"d":"2023-12-08","k":"letter","t":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shenzhen-airis-electronic-co-ltd-673296-12082023","x":"Center for Tobacco Products"}],"first":"2023-12-08","last":"2023-12-08","sibs":[],"colo":["3011062091","3046312775","3025926685","3038847754","3012796281","3008377265","3004602077"]},{"id":"3043513089","fei":"3043513089","duns":"955412830","firm":"BRICHEM SCIENCES PRIVATE LIMITED","registrant":"BRICHEM SCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot 140 Gidc, Kalol, Gandhinagar, Gujarat 382721, India (IND)","city":"Gandhinagar","state":"Gujarat","pin":"382721","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":23.22926,"lon":72.50863,"prec":"postcode","geo":"382721, Kalol Taluka, Gandhinagar, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005029956","3007623760"]},{"id":"3010079586","fei":"3010079586","duns":"871273203","firm":"ABHILASHA PHARMA PVT. LTD.","registrant":"ABHILASHA PHARMA PVT. LTD.","parent":null,"ticker":null,"addr":"Plot 1408,1409,GIDC, Ankleshwar, Dist. Bharuch, Gujarat 393002, India (IND)","city":"Dist. Bharuch","state":"Gujarat","pin":"393002","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003722314","3003696998","3014078015","3003650383","3006851796","3030461518","3004086396","3006509185","3002806711","3008314161","3004006229","3012032037"]},{"id":"3018005839","fei":"3018005839","duns":"854248562","firm":"AURORE LIFE SCIENCES PRIVATE LIMITED","registrant":"Aurore Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Plot 180/2 & 3, Khazipally (V), Jinnaram (M), Sangareddy, Telangana 502319, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502319","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043512610","3003945855","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338","3007800082"]},{"id":"3006851796","fei":"3006851796","duns":"862811773","firm":"Alkem Laboratories Limited","registrant":"Alkem Laboratories Limited","parent":"Alkem Laboratories","ticker":"ALKEM","addr":"Plot 288/A, 289-290, GIDC Industrial Estate, Ankleshwar,, Bharuch, Gujarat 393002, India (IND)","city":"Bharuch","state":"Gujarat","pin":"393002","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006370533","3008450172","3006370524"],"colo":["3003722314","3003696998","3014078015","3003650383","3010079586","3030461518","3004086396","3006509185","3002806711","3008314161","3004006229","3012032037"]},{"id":"3004810446","fei":"3004810446","duns":"862234820","firm":"Amoli Organics (A Division of Umedica Laboratories Pvt.Ltd)","registrant":"Amoli Organics (A Division of Umedica Laboratories Pvt. Ltd.)","parent":null,"ticker":null,"addr":"Plot 322/4, 40 Shed Area, G.I.D.C, Vapi, District, GIDC VAPI, Valsad, GUJARAT 396195, India (IND)","city":"Valsad","state":"Gujarat","pin":"396195","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":20.36447,"lon":72.9263,"prec":"postcode","geo":"396195, Vapi Taluka, Valsad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3007836955"],"colo":["3004414652","3006688078","3009765202","3007850324","3008460260","3034419392"]},{"id":"3008957541","fei":"3008957541","duns":"650830669","firm":"Kumar Organic Products Limited","registrant":"Kumar Organic Products Limited","parent":null,"ticker":null,"addr":"Plot 94P, 103 & 104, Pharma Sez, HN Pura Road, KIADB Industrial Area, Hassan, Karnataka 573201, India (IND)","city":"Hassan","state":"Karnataka","pin":"573201","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.00989,"lon":76.10336,"prec":"postcode","geo":"573201, Hasana taluk, Hassan, Karnataka, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"08/01/2012","notes":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).India","charges":[{"code":"53 E - - 01","notes":"","product":"Hair Conditioners (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 07","notes":"","product":"Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 99","notes":"","product":"Other Hair Preparations, Non-coloring), N.E.C.","published":"08/01/2012"},{"code":"62 C - - 41","notes":"","product":"Minoxidil (Anti-Hypertensive)","published":"08/01/2012"},{"code":"62 C - - 99","notes":"","product":"Anti-Hypertensive N.E.C.","published":"08/01/2012"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/01/2012"}],"firm_as_published":"Kumar Organic Products Limited","address_as_published":"Plot 94P, 103 & 104, Pharma Sez, HN Pura Road, KIADB Industrial Area , Hassan, Karnataka INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"08/01/2012","notes":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India","charges":[{"code":"53 E - - 01","notes":"","product":"Hair Conditioners (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 07","notes":"","product":"Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 99","notes":"","product":"Other Hair Preparations, Non-coloring), N.E.C.","published":"08/01/2012"},{"code":"62 C - - 41","notes":"","product":"Minoxidil (Anti-Hypertensive)","published":"08/01/2012"},{"code":"62 C - - 99","notes":"","product":"Anti-Hypertensive N.E.C.","published":"08/01/2012"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/01/2012"}],"firm_as_published":"Kumar Organic Products Ltd.","address_as_published":"Plot No. 60&65, Road No.3, Jigani Industrial Area, Jigani, , Anekal Taluk, Bengaluru, Karnataka INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"08/01/2012","notes":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India","charges":[{"code":"53 E - - 01","notes":"","product":"Hair Conditioners (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 07","notes":"","product":"Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 99","notes":"","product":"Other Hair Preparations, Non-coloring), N.E.C.","published":"08/01/2012"},{"code":"62 C - - 41","notes":"","product":"Minoxidil (Anti-Hypertensive)","published":"08/01/2012"},{"code":"62 C - - 99","notes":"","product":"Anti-Hypertensive N.E.C.","published":"08/01/2012"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/01/2012"}],"firm_as_published":"Kumar Organic Products Ltd.","address_as_published":"Anekai Taluk , S No 49; Bannerghatta Road , Bengaluru, Karnataka INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2012-08-01","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).India"},{"d":"2012-08-01","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India"},{"d":"2012-08-01","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India"}],"first":"2012-08-01","last":"2012-08-01","sibs":["3009167769","3003768909"],"colo":[]},{"id":"3023677905","fei":"3023677905","duns":"677604129","firm":"MARKSANS PHARMA LIMITED","registrant":"MARKSANS PHARMA LIMITED","parent":null,"ticker":null,"addr":"Plot A-1, Phase 1- A, Verna Industrial Estate, Verna, Goa 403722, India (IND)","city":"Verna","state":"Goa","pin":"403722","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":15.36243,"lon":73.92597,"prec":"postcode","geo":"403722, Salcete, South Goa, Goa, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006230648"],"colo":["3006644152","3005124189","3008524952","3004081307","3004819820","3005719315","3005210225"]},{"id":"3002806702","fei":"3002806702","duns":"917066446","firm":"CIPLA LIMITED","registrant":"CIPLA LIMITED","parent":"Cipla","ticker":"CIPLA","addr":"Plot D-7, D-22, D-27 MIDC Industrial Area, Kurkumbh Village, Taluka-Daund, Pune, Maharashtra 413802, India (IND)","city":"Pune","state":"Maharashtra","pin":"413802","ops":["ANALYSIS","API MANUFACTURE","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.35405,"lon":74.55832,"prec":"postcode","geo":"413802, Daund, Pune, Maharashtra, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"03/14/2017","notes":"","charges":[{"code":"66 S - - 51","notes":"","product":"Tadalafil","published":"03/14/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"03/14/2017"}],"firm_as_published":"Cipla LTD","address_as_published":"Khasra No. 509/1-2 & 520 , Vii-Bhagwanpur , Bhagwanpur, Uttaranchal INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-66","list":"red","since":"10/09/2013","notes":"","charges":[{"code":"60 W - - 16","notes":"","product":"Mebendazole (Anthelmintic)","published":"10/09/2013"}],"firm_as_published":"Cipla Limited","address_as_published":"Patalganga Industrial Area , Plot No A-2, A-33, A-37/2/2, A-42 , Raigad, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"},{"alert":"66-66","list":"red","since":"10/18/2010","notes":"","charges":[{"code":"64 U C S 06","notes":"","product":"Finasteride (Inhibitor (Decarboxylase)), Human - Rx/Single Ingredient, Active Pharm Ingred/Chems for Further Manuf","published":"10/18/2010"}],"firm_as_published":"Cipla, Ltd.","address_as_published":"Plots D-7, D-22, D-27 , M.I.D.C. Industrial Area, Taluka-Daund , Kurkumbh Village, Dist. Pune, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"}],"letters":[{"date":"2023-11-17T05:00:00Z","posted":"2023-11-21T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-660904-11172023","company_as_published":"Cipla Limited","match":"exact"}],"events":[{"d":"2023-11-17","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-660904-11172023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2017-03-14","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2013-10-09","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2010-10-18","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""}],"first":"2010-10-18","last":"2023-11-17","sibs":["3005857289","3004081307","3008581988","3002806710","3002806691"],"colo":["3037146694","3005782879"]},{"id":"3016575313","fei":"3016575313","duns":"650410850","firm":"ATUL BIOSCIENCE LIMITED","registrant":"ATUL BIOSCIENCE LIMITED","parent":null,"ticker":null,"addr":"Plot N-37, Additional Industrial Area, MIDC, Anand Nagar, MMR Zone-II, Ambernath (East), Maharashtra 421506, India (IND)","city":"Ambernath (East)","state":"Maharashtra","pin":"421506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021189141","3009887190","3008232264","3013999816","3018052045","3006599894","3006809732","3027577650","3010166801","3032073298","3008374690","3009051788"]},{"id":"3012160303","fei":"3012160303","duns":"877850539","firm":"Vasudha Pharma Chem Limited","registrant":"Vasudha Pharma Chem Limited","parent":null,"ticker":null,"addr":"Plot No - 24, 24A & 24B APSEZ, Denotified Area, Rambili, Anakapalli, Andhra Pradesh 531011, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002093078","3009822397"],"colo":["3026032363","3023346708","3011538548","3015709928","3013629262","3014255847","3020444708","3030613318","3026297382","3013580138","3021487911","3016965485"]},{"id":"3019101447","fei":"3019101447","duns":"854377501","firm":"FARMSON BASIC DRUGS PRIVATE LIMITED","registrant":"FARMSON BASIC DRUGS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No - 748/1, GIDC Industrial Estate, Jhagadia,, Bharuch,  393110, India (IND)","city":"Bharuch","state":null,"pin":"393110","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.6831,"lon":73.17284,"prec":"postcode","geo":"393110, Jhagadiya Taluka, Bharuch, Gujarat, India","status":2,"alerts":[{"alert":"66-79","list":"red","since":"10/13/2022","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","charges":[{"code":"55","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/28/2021"},{"code":"56","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Antibiotics (Human/Animal)","published":"10/28/2021"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"61","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"62","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"63","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"64","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"65","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"66","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"}],"firm_as_published":"Basic Pharma Life Science Private Ltd.","address_as_published":"Plot No.146/B GIDC Estate , Opp. New Fire Station , Ankleshwar, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","match":"token"}],"letters":[],"events":[{"d":"2022-10-13","k":"alert","t":"Listed on import alert 66-79","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2022-05-26","k":"charge","t":"66-79 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":""},{"d":"2021-10-28","k":"charge","t":"66-79 charge 55 — Pharm Necess & Ctnr For Drug/Bio","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 56 — Antibiotics (Human/Animal)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 60 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 61 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 62 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 63 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 64 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 65 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 66 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"}],"first":"2021-10-28","last":"2022-10-13","sibs":["3013841460","3017116839"],"colo":["3010331979","3006216494"]},{"id":"3010957801","fei":"3010957801","duns":"915600808","firm":"Acharya Chemicals","registrant":"Acharya Chemicals","parent":null,"ticker":null,"addr":"Plot No - W-40,W-41 and W-42 MIDC , Morivali Village, Ambernath (West), Thane, Maharashtra 421501, India (IND)","city":"Thane","state":"Maharashtra","pin":"421501","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":19.20622,"lon":73.18433,"prec":"postcode","geo":"421501, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003973520"]},{"id":"3005000147","fei":"3005000147","duns":"877267365","firm":"THEMIS MEDICARE LIMITED dba ARTEMIS BIOTECH","registrant":"THEMIS MEDICARE LIMITED dba ARTEMIS BIOTECH","parent":null,"ticker":null,"addr":"Plot No 1 And 5, Industrial Development Area, Jeedimetla, Hyderabad, TG 500055, India (IND)","city":"Hyderabad","state":null,"pin":"500055","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003937580","3037699325","3003447972","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869","3018694293"]},{"id":"3005694111","fei":"3005694111","duns":"925627080","firm":"Megafine Pharma (P) Limited","registrant":"Megafine Pharma (P) Limited","parent":null,"ticker":null,"addr":"Plot No 1 to 5, 31-35 & 48-51, 26 & K/201 Lakhmapur, Tal. Dindori, Nashik, Maharashtra 422202, India (IND)","city":"Nashik","state":"Maharashtra","pin":"422202","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":20.44579,"lon":75.04352,"prec":"postcode","geo":"422202, Chalisgaon, Jalgaon, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006688078"],"colo":[]},{"id":"3005448030","fei":"3005448030","duns":"650443679","firm":"DR. REDDY'S LABORATORIES LIMITED","registrant":"Dr. Reddy's Laboratories Limited","parent":"Dr. Reddy's Laboratories","ticker":"DRREDDY","addr":"Plot No 1, 75A ,75B, 105, 110, 111 & 112, Sri Venkateswara Co-operative Industrial Estate, Bollaram, Jinnaram (Mandal), Sangareddy, Telangana 502 325, India (IND)","city":"Sangareddy","state":"Telangana","pin":null,"ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.60014,"lon":78.33566,"prec":"tail3","geo":"Jinnaram mandal, Sangareddy, Telangana, 502325, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002949085","3014250111","3005336882","3011171511","3009193040","3012414462","3006549835","3005447965","3002806851","3003184497","3002949099","3009483004"],"colo":[]},{"id":"3038847754","fei":"3038847754","duns":"766381082","firm":"ALS TESTING SERVICES INDIA PRIVATE LIMITED","registrant":"ALS TESTING SERVICES INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 1, Synergy Square, Genome Valley, Secunderabad,, Medchal-Malkajgiri, Telangana 500078, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500078","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.58696,"lon":78.55137,"prec":"postcode","geo":"500078, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3015345916"],"colo":["3011062091","3046312775","3025926685","3012071812","3012796281","3008377265","3004602077"]},{"id":"3012796281","fei":"3012796281","duns":"869684734","firm":"Aspen Biopharma Labs Pvt Ltd","registrant":"Aspen Biopharma Labs Pvt Ltd","parent":null,"ticker":null,"addr":"Plot No 10, Biotech Park Phase-II, Lalgadi Malakpet Village,Turkapally, Shameerpet Mandal, Medchal Malkajgiri, Telangana 500078, India (IND)","city":"Medchal Malkajgiri","state":"Telangana","pin":"500078","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.58696,"lon":78.55137,"prec":"postcode","geo":"500078, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"01/15/2025","notes":"All Drug and Drug Products","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"01/15/2025"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"01/15/2025"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"01/15/2025"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"01/15/2025"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"01/15/2025"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"01/15/2025"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"01/15/2025"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"01/15/2025"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/15/2025"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/15/2025"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/15/2025"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/15/2025"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/15/2025"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/15/2025"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"01/15/2025"}],"firm_as_published":"Aspen Biopharma Labs Pvt., Ltd.","address_as_published":"Plot No 10, Biotech Park Phase-II , Lalgadi Malakpet Village,Turkapally, Shameerpet Mandal , Medchal Malkajgiri, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2025-03-05T05:00:00Z","posted":"2025-03-25T04:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aspen-biopharma-labs-private-limited-698665-03052025","company_as_published":"Aspen Biopharma Labs Private Limited","match":"exact"}],"events":[{"d":"2025-03-05","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aspen-biopharma-labs-private-limited-698665-03052025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2025-01-15","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2025-01-15","last":"2025-03-05","sibs":[],"colo":["3011062091","3046312775","3025926685","3012071812","3038847754","3008377265","3004602077"]},{"id":"3008380269","fei":"3008380269","duns":"675630493","firm":"Bliss GVS Pharma Limited","registrant":"Bliss GVS Pharma Limited","parent":null,"ticker":null,"addr":"Plot No 11, Survey No 38, Gut No 312 Dewan Udyog Nagar, Aliyali Village, Palghar, Maharashtra 401404, India (IND)","city":"Palghar","state":"Maharashtra","pin":"401404","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.69445,"lon":72.78565,"prec":"postcode","geo":"401404, Palghar Subdistrict, Palghar, Maharashtra, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"09/14/2021","notes":"The product appears to be an unapproved new drug as the product�s labeling includes claims such as (not an all-inclusive list): �Indications . . . FUNBACT-A� provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision��.","charges":[{"code":"53 L - - 03","notes":"","product":"Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)","published":"09/14/2021"},{"code":"56 D - - 41","notes":"","product":"Neomycin Sulfate (Aminoglycosides)","published":"09/14/2021"},{"code":"56 G - - 99","notes":"","product":"Antifungal N.E.C.","published":"09/14/2021"},{"code":"61 H - - 99","notes":"","product":"Anti-Bacterial, N.E.C.","published":"09/14/2021"},{"code":"61 W - - 04","notes":"","product":"Clotrimazole (Anti-Fungal) (Not Antibiotic)","published":"09/14/2021"},{"code":"64 L - - 06","notes":"","product":"Betamethasone Dipropionate (Glucocorticoid)","published":"09/14/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"09/14/2021"}],"firm_as_published":"Bliss GVS Pharma Limited","address_as_published":"Plot No 11, Survey No 38, , Gut No. 312, Dewan Udyog Nagar; Aliyali Village , Palghar, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2021-09-14","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"The product appears to be an unapproved new drug as the product�s labeling includes claims such as (not an all-inclusive list): �Indications . . . FUNBACT-A� provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision��."}],"first":"2021-09-14","last":"2021-09-14","sibs":["3007068506"],"colo":["3042541221","3043682089"]},{"id":"3008430469","fei":"3008430469","duns":"725026384","firm":"Andhra Organics Limited","registrant":"Andhra Organics Limited","parent":null,"ticker":null,"addr":"Plot No 110A, I.D.A., Pydibhimavaram (V), Ranasthalam (M), Srikakulam District, Andhra Pradesh 532409, India (IND)","city":"Srikakulam District","state":"Andhra Pradesh","pin":"532409","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":18.15105,"lon":83.65614,"prec":"postcode","geo":"532409, Ranastalam, Srikakulam, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3002949085","3005336882","3011171511","3009193040","3012414462","3013791804","3012390454","3030708811","3004611182"]},{"id":"3044681913","fei":"3044681913","duns":"854147569","firm":"LARSON PHARMA PRIVATE LIMITED","registrant":"LARSON PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 120 to 122, Growth Centre, Raichur, Karnataka 584102, India (IND)","city":"Raichur","state":"Karnataka","pin":"584102","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.2259,"lon":77.39571,"prec":"postcode","geo":"584102, Rayachuru taluku, Raichur, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3039378398","fei":"3039378398","duns":"955413085","firm":"SALICYLATES & CHEMICALS PRIVATE LIMITED","registrant":"SALICYLATES CHEMICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 133 To 142, Survey 239/part, Phase-ii Industrial Park, Pashamylaram,patancheru Mandal, Sangareddy, Telangana 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003504071"],"colo":["3029943792","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167","3005075182"]},{"id":"3009609358","fei":"3009609358","duns":"650611390","firm":"MICROTROL STERILISATION SERVICES PRIVATE LIMITED","registrant":"Microtrol Sterilisation Services Pvt. Ltd.","parent":null,"ticker":null,"addr":"Plot No 14 Bommasandra Jigani Link Road, KIADB Industrial Area, Bangalore, KA 560105, India (IND)","city":"Bangalore","state":null,"pin":"560105","ops":["STERILIZE"],"expires":"12/31/2026","lat":12.78642,"lon":77.63458,"prec":"postcode","geo":"560105, Jigani, Anekal, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3007512701","3005857289","3003560263","3009882550","3015345916","3004939494","3003768909","3007648351"]},{"id":"3026032363","fei":"3026032363","duns":"931856732","firm":"KREATIVE ACTIVES PRIVATE LIMITED","registrant":"KREATIVE ACTIVES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 15B6, Apsez, Denotified Area, Atchutapuram, Visakhapatnam, Andhra Pradesh 531011, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3012160303","3023346708","3011538548","3015709928","3013629262","3014255847","3020444708","3030613318","3026297382","3013580138","3021487911","3016965485"]},{"id":"3010661577","fei":"3010661577","duns":"650762060","firm":"Amneal Pharmaceuticals Private Limited","registrant":"Amneal Pharmaceuticals of New York, LLC","parent":null,"ticker":null,"addr":"Plot No 16 & 17, PHARMEZ Special Economic Zone Sarkhej-Bavla N.H. No. 8A, Vil.: Matoda, Tal.: Sanand, Ahmedabad, GJ 382213, India (IND)","city":"Ahmedabad","state":null,"pin":"382213","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2025-08-27T04:00:00Z","posted":"2025-09-02T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","company_as_published":"Amneal Pharmaceuticals, LLC","match":"exact"}],"events":[{"d":"2025-08-27","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-27","last":"2025-08-27","sibs":["3030461061","3010254278","3029456823","3017573557","3018907202","3008223599"],"colo":["3041646841","3036725850","3043068534","3017085815","3007277149","3008957483","3007938603","3007621329","3008725987","3004011473","3008394466","3007869619"]},{"id":"3004495158","fei":"3004495158","duns":"867064609","firm":"Micro Labs Limited","registrant":"Micro Labs Limited","parent":null,"ticker":null,"addr":"Plot No 16 & 24, Veerasandra Industrial Area Electronic City Phase 2, Bengaluru, Karnataka 560100, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560100","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.84601,"lon":77.66127,"prec":"postcode","geo":"560100, Bangalore South, Bengaluru Urban, Karnataka, India","status":1,"alerts":[],"letters":[{"date":"2024-09-10T04:00:00Z","posted":"2024-11-08T19:00:00Z","subject":"CGMP/QSR/Medical Devices/Adulterated","office":"Center for Devices and Radiological Health","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-x-ltd-692084-09102024","company_as_published":"Micro-X Ltd.","match":"token"},{"date":"2024-12-03T05:00:00Z","posted":"2024-12-17T14:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-orgo-chem-686458-12032024","company_as_published":"Micro Orgo Chem","match":"token"}],"events":[{"d":"2024-12-03","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-orgo-chem-686458-12032024","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-09-10","k":"letter","t":"CGMP/QSR/Medical Devices/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-x-ltd-692084-09102024","x":"Center for Devices and Radiological Health"}],"first":"2024-09-10","last":"2024-12-03","sibs":["3009310198","3004939494","3017157902","3005210225"],"colo":["1000172912","3015283245","3007907068"]},{"id":"3027770075","fei":"3027770075","duns":"932518653","firm":"Ipca Laboratories Limited","registrant":"Ipca Laboratories Limited","parent":"Ipca Laboratories","ticker":"IPCALAB","addr":"Plot No 16 - 22, Industrial Area No 01, A B Road, Dewas, Madhya Pradesh 455001, India (IND)","city":"Dewas","state":"Madhya Pradesh","pin":"455001","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.95531,"lon":76.0728,"prec":"postcode","geo":"455001, Dewas, Dewas Nagar Tahsil, Dewas, Madhya Pradesh, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"09/30/2009","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","charges":[{"code":"66 V - - 99","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","product":"Miscellaneous Patent Medicines, Etc.","published":"09/30/2009"}],"firm_as_published":"Ipca Laboratories Limited","address_as_published":"P.O. Sejavta , Ratlam, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug."}],"first":"2009-09-30","last":"2009-09-30","sibs":["3007574780","3027770072","3002807297","3005977675","3006057101","3009227929"],"colo":[]},{"id":"3009681646","fei":"3009681646","duns":"858971751","firm":"OLIVE HEALTHCARE","registrant":"Olive Healthcare","parent":null,"ticker":null,"addr":"Plot No 163/2, Mahatma Gandhi Nagar Dabhel Village, Nani Daman, Unit II, Daman,  396210, India (IND)","city":"Mahatma Gandhi Nagar Dabhel Village","state":"Daman","pin":"396210","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":20.42558,"lon":72.84559,"prec":"postcode","geo":"396210, Daman, Dadra and Nagar Haveli and Daman and Diu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004086192","3006896204","3006363714","3006370524","3003647459"]},{"id":"3002806958","fei":"3002806958","duns":"650441301","firm":"FDC Limited","registrant":"FDC Limited","parent":null,"ticker":null,"addr":"Plot No 19&20/2,MIDC Industrial Area,Village Dhatav, Roha, District: Raigad, Roha, Maharashtra 402 116, India (IND)","city":"Roha","state":"Maharashtra","pin":null,"ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":18.43429,"lon":73.11813,"prec":"tail3","geo":"Roha, Sub District Hospital, NH548A, Roha, Roha Taluka, Raigad, Maharashtra, 402109, India","status":1,"alerts":[],"letters":[{"date":"2021-02-18T05:00:00Z","posted":"2021-02-19T17:00:00Z","subject":"New Drug/Misbranded","office":"Center for Food Safety and Applied Nutrition (CFSAN)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fdc-nutrition-inc-612264-02182021","company_as_published":"FDC Nutrition Inc.","match":"token"}],"events":[{"d":"2021-02-18","k":"letter","t":"New Drug/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fdc-nutrition-inc-612264-02182021","x":"Center for Food Safety and Applied Nutrition (CFSAN)"}],"first":"2021-02-18","last":"2021-02-18","sibs":["3003204330","3008524952","3004738570"],"colo":[]},{"id":"3023346708","fei":"3023346708","duns":"929613216","firm":"SSV PHARMA PRIVATE LIMITED","registrant":"SSV PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 1A, Pudi, Achutapuram, Visakhapatnam,  531011, India (IND)","city":"Visakhapatnam","state":null,"pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3012160303","3026032363","3011538548","3015709928","3013629262","3014255847","3020444708","3030613318","3026297382","3013580138","3021487911","3016965485"]},{"id":"3010165135","fei":"3010165135","duns":"650668507","firm":"Avesta Pharma Private Limited","registrant":"Avesta Pharma Private Limited","parent":null,"ticker":null,"addr":"Plot No 2, Gut No. 189/1, 189/2, 191/2, 191/6, 194, 165/3, 166, 167, 168, 169 Post Office-Alonde, Taluka Vikramgad, Palghar, Maharashtra 421303, India (IND)","city":"Palghar","state":"Maharashtra","pin":"421303","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.66089,"lon":73.14004,"prec":"postcode","geo":"421303, Wada Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3011823550","fei":"3011823550","duns":"872216409","firm":"Perfomics Analytical Labs LLP","registrant":"Perfomics Analytical Labs LLP","parent":null,"ticker":null,"addr":"Plot No 20, Road No12, Tech Park Nacharam, Hyderabad, Telangana 500076, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500076","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.43874,"lon":78.56145,"prec":"postcode","geo":"500076, Ward 6 Nacharam, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3048143097","3003504071","3006493505","3011573185","3007308467","3005851210","3008311641","3008768274","3024919921","3019773458"]},{"id":"3030460504","fei":"3030460504","duns":"855533679","firm":"VEERHEALTH CARE LIMITED","registrant":"VEERHEALTH CARE LIMITED","parent":null,"ticker":null,"addr":"Plot No 224 Block No 846, Vibrant Business Park Opp UPL N H 8, Vapi Valsad, GJ 396191, India (IND)","city":"Vapi Valsad","state":null,"pin":"396191","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":20.3801,"lon":72.93509,"prec":"postcode","geo":"396191, Vapi Taluka, Valsad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2025-08-06T04:00:00Z","posted":"2025-08-12T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","company_as_published":"K & Care Organics","match":"token"}],"events":[{"d":"2025-08-06","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-06","last":"2025-08-06","sibs":[],"colo":["3011893554"]},{"id":"3010836438","fei":"3010836438","duns":"955413797","firm":"SHODHANA LABORATORIES PRIVATE LIMITED","registrant":"SHODHANA LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 24, 25 & 26, Phase-I, IDA Jeedimetla, Quthbullapur Mandal,, Hyderabad,  500055, India (IND)","city":"Hyderabad","state":null,"pin":"500055","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3029445647"],"colo":["3003937580","3037699325","3003447972","3005000147","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869","3018694293"]},{"id":"3003952717","fei":"3003952717","duns":"918591058","firm":"Sun Pharmaceutical Industries Limited","registrant":"Sun Pharmaceutical Industries Limited","parent":"Sun Pharmaceutical Industries","ticker":"SUNPHARMA","addr":"Plot No 24/2, 25, Phase IV, GIDC, Panoli, Bharuch, Gujarat 394116, India (IND)","city":"Bharuch","state":"Gujarat","pin":"394116","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":21.53479,"lon":72.95568,"prec":"postcode","geo":"394116, Ankleshwar Taluka, Bharuch, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs.","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs.","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs.","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"Village Ganguwala , Tehsil-Paonta Sahib , Sirmaur, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs.","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"3 Industrial Area , Dewas, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"03/12/2014","notes":"","charges":[{"code":"60","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"}],"firm_as_published":"Sun Pharmaceutical Industries Limited - Karkhadi","address_as_published":"A Plot No 817 , Village Karkhadi , Padra, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"12/07/2022","notes":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","charges":[{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"05/12/2025"},{"code":"55","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/07/2022"},{"code":"56","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Antibiotics (Human/Animal)","published":"12/07/2022"},{"code":"58","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/07/2022"},{"code":"60","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"61","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"62","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"63","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"64","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"65","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"66","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"}],"firm_as_published":"Sun Pharmaceutical Industries Ltd.","address_as_published":"Halol - Baroda Highway , Halol, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-06-08T04:00:00Z","posted":"2022-07-19T13:20:00Z","subject":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","office":"Office of Human and Animal Foods- East Division 3","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","company_as_published":"New Sun Inc.","match":"token"},{"date":"2022-08-17T04:00:00Z","posted":"2022-09-06T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Office of Human and Animal Food Operations – West Division 5","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","company_as_published":"Sun Sen Co., Inc.","match":"token"},{"date":"2023-04-07T04:00:00Z","posted":"2023-08-15T13:20:00Z","subject":"Unapproved New Drugs/Misbranded","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","company_as_published":"STPCA Inc. dba Sun Ten Laboratories","match":"token"},{"date":"2023-05-10T04:00:00Z","posted":"2023-05-30T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations West II","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","company_as_published":"Rhodes Legacy Inc DBA Sun Sprouts","match":"token"},{"date":"2023-10-16T04:00:00Z","posted":"2023-10-16T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","company_as_published":"Sun Pharmaceutical Industries Ltd.","match":"exact"},{"date":"2024-06-18T04:00:00Z","posted":"2024-07-02T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","company_as_published":"Sun Pharmaceutical Industries Limited","match":"exact"},{"date":"2025-03-12T04:00:00Z","posted":"2025-03-18T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","company_as_published":"Waxhead Sun Defense Company","match":"token"}],"events":[{"d":"2025-05-12","k":"charge","t":"66-40 charge 54 — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-03-12","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-06-18","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-10-16","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-05-10","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","x":"Division of Human and Animal Food Operations West II"},{"d":"2023-04-07","k":"letter","t":"Unapproved New Drugs/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","x":"Division of Human and Animal Food Operations West V"},{"d":"2022-12-07","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24"},{"d":"2022-08-17","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","x":"Office of Human and Animal Food Operations – West Division 5"},{"d":"2022-06-08","k":"letter","t":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","x":"Office of Human and Animal Foods- East Division 3"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2014-03-12","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs."},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs"}],"first":"2009-09-10","last":"2025-05-12","sibs":["3003227153","3004520113","3003892973","3002809586","3012032037","3002807979","3010027135","3002871444","3007627683","3004561553"],"colo":["3030554615","3038149173","3003053502","3015776899","3013151303","3009627283","3004196193"]},{"id":"3006363714","fei":"3006363714","duns":"918608365","firm":"Macleods Pharmaceuticals Limited","registrant":"Macleods Pharmaceuticals Limited","parent":"Macleods (unlisted)","ticker":null,"addr":"Plot No 25-27, Survey No 366 Premier Industrial Estate Kachigam, Daman, Daman 396210, India (IND)","city":"Survey No 366 Premier Industrial Estate Kachigam","state":"Daman","pin":"396210","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":20.42558,"lon":72.84559,"prec":"postcode","geo":"396210, Daman, Dadra and Nagar Haveli and Daman and Diu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3018011011","3006607469","3018972378","3007517881"],"colo":["3004086192","3006896204","3009681646","3006370524","3003647459"]},{"id":"3008306018","fei":"3008306018","duns":"675488312","firm":"TRIMAX BIO SCIENCES PRIVATE LIMITED","registrant":"TRIMAX BIO SCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 27,Raichur Growth Centre, Wadloor Road, Chiksugur, Raichur, Karnataka 584134, India (IND)","city":"Raichur","state":"Karnataka","pin":"584134","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.28522,"lon":77.31796,"prec":"postcode","geo":"584134, Rayachuru taluku, Raichur, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3042698816","3007197995"]},{"id":"3030461518","fei":"3030461518","duns":"644916432","firm":"Muby Chem Private Limited","registrant":"Muby Chem Private Limited","parent":null,"ticker":null,"addr":"Plot No 2900/46, 47, 162, 163, 164, 165, 166, 167, GIDC Ankleshwar, Ankleshwar, District: Bharuch, Gujarat 393002, India (IND)","city":"District: Bharuch","state":"Gujarat","pin":"393002","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003722314","3003696998","3014078015","3003650383","3010079586","3006851796","3004086396","3006509185","3002806711","3008314161","3004006229","3012032037"]},{"id":"3038475692","fei":"3038475692","duns":"856827863","firm":"FORMEL LABS PRIVATE LIMITED","registrant":"FORMEL LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 306,307,308,309, Sy No 438,444,445,446,447, Kadechur, Badiyal Industrial area, Yadgir, Karnataka 585221, India (IND)","city":"Yadgir","state":"Karnataka","pin":"585221","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.57388,"lon":77.25266,"prec":"postcode","geo":"585221, Yadagiri taluku, Yadgir, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031204878","3030355960","3043148873","3038159483"]},{"id":"3004086396","fei":"3004086396","duns":"918593737","firm":"Zentiva Private Limited","registrant":"Zentiva, k.s.","parent":null,"ticker":null,"addr":"Plot No 3501 to 3515, 6301 to 6313 & 16 Meter Road/c, GIDC Estate, ANKLESHWAR, Gujarat 393002, India (IND)","city":"ANKLESHWAR","state":"Gujarat","pin":"393002","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003722314","3003696998","3014078015","3003650383","3010079586","3006851796","3030461518","3006509185","3002806711","3008314161","3004006229","3012032037"]},{"id":"3014404150","fei":"3014404150","duns":"860479899","firm":"ANAXLABORATORIES PRIVATE LIMITED","registrant":"ANAXLABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 36/A, Biotech Park Phase - III Karkapatla Village, Markook Mandal,, Siddipet, Telangana 502281, India (IND)","city":"Siddipet","state":"Telangana","pin":"502281","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.81912,"lon":78.7342,"prec":"postcode","geo":"502281, Gajwel mandal, Siddipet, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031960635","Plot No.- 09, Biotech Park, Phase-III, Sy No.-321, Karkapatla (V), Markook (M),, Siddipet, Telangana 502281, India (IND)","3032184895","3027345324","3027380201","3014483338"]},{"id":"3017001542","fei":"3017001542","duns":"738671840","firm":"KLM LABORATORIES PRIVATE LIMITED","registrant":"KLM LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 381, Horizon Industrial Park, Near Bamangam, Tal- Karjan, Vadodara, Gujarat 391243, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391243","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.13388,"lon":73.18071,"prec":"postcode","geo":"391243, Vadodara Rural Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3032592163"],"colo":["3018899465"]},{"id":"3007277149","fei":"3007277149","duns":"677378034","firm":"Intas Pharmaceuticals Limited","registrant":"Intas Pharmaceuticals Limited","parent":"Intas (unlisted)","ticker":null,"addr":"Plot No 423/P/A, Sarkhej-Bavla Highway, Moraiya, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/01/2023","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"11/15/2024"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"11/15/2024"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"11/15/2024"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"11/15/2024"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"11/15/2024"},{"code":"55","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/01/2023"},{"code":"56","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Antibiotics (Human/Animal)","published":"06/01/2023"},{"code":"58","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"06/01/2023"},{"code":"60","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"61","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"62","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"63","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"64","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"65","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"66","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"}],"firm_as_published":"Intas Pharmaceuticals Limited","address_as_published":"Pharmez Plot No 5-14 , Near Village Matoda; Sarkhej-Bavla Highway No 8-A , Sanand, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"11/14/2023","notes":"These products are excluded from DWPE: Azacitidine Injection 62I[][]99 Clonazepam Tablet 61M[][]06 Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"04/09/2024"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"04/09/2024"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"04/09/2024"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"04/09/2024"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"04/09/2024"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"11/14/2023"},{"code":"56","notes":"All Drug and Drug Products;","product":"Antibiotics (Human/Animal)","published":"11/14/2023"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"11/14/2023"},{"code":"60","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"61","notes":"All Drug and Drug Products; These products are excluded from DWPE: Clonazepam Tablet 61M[][]06","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"62","notes":"All Drug and Drug Products; These products are excluded from DWPE: Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95 Azacitidine Injection 62I[][]99","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"63","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"64","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/14/2023"}],"firm_as_published":"Intas Pharmaceuticals Limited","address_as_published":"Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi , Sarkhej-Bavla Highway, Taluka-Sanand, Matoda , Ahmedabad, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2023-07-28T04:00:00Z","posted":"2023-08-01T14:31:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"},{"date":"2023-11-21T05:00:00Z","posted":"2023-11-28T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"},{"date":"2026-03-30T04:00:00Z","posted":"2026-04-28T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"}],"events":[{"d":"2026-03-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2023-11-21","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-11-14","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE: Azacitidine Injection 62I[][]99 Clonazepam Tablet 61M[][]06 Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95"},{"d":"2023-07-28","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-06-01","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32"}],"first":"2023-06-01","last":"2026-03-30","sibs":["3003722314","3005890633","3003157498","3004011473","3011743992"],"colo":["3041646841","3036725850","3043068534","3017085815","3010661577","3008957483","3007938603","3010254278","3029456823","3007621329","3008725987","3008394466"]},{"id":"3006587427","fei":"3006587427","duns":"675597260","firm":"Vimta Labs Limited","registrant":"Vimta Labs Limited","parent":null,"ticker":null,"addr":"Plot No 5, Life Sciences Facility, Neovantage Science & Technology Park Private Limited, Shamirpet, Genome Valley, Turkapally, Medchal Malkajgiri, Hyderabad, Telangana 500101, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500101","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.65514,"lon":78.60618,"prec":"postcode","geo":"500101, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038528882","PLOT NO 4C,MN SC & TECH BIOTECH PARK GENOME VALLEY, TURKAPALLY, SHAMIRPET RANGAREDDY, Hyderabad, Telangana 500101, India (IND)","3017754175","3039644403","3039411568","3006527015","3009522832","3012704791","3030495702","3009883135","3011960448"]},{"id":"3015893531","fei":"3015893531","duns":"675488598","firm":"Wang Pharmaceuticals & Chemicals","registrant":"Wang Pharmaceuticals Chemicals","parent":null,"ticker":null,"addr":"Plot No 52, Phase 2, Sector 14, IMT Bawal, Rewari, Haryana 123501, India (IND)","city":"Rewari","state":"Haryana","pin":"123501","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":28.0877,"lon":76.57142,"prec":"postcode","geo":"123501, Bawal, Rewari, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3009528099","fei":"3009528099","duns":"675928980","firm":"MAKSON HEALTH CARE PRIVATE LIMITED","registrant":"MAKSON HEALTH CARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 6 -A Sector D Akvn Industrial Area Mandideep, Raisen, MP 462046, India (IND)","city":"Raisen","state":null,"pin":"462046","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":23.11984,"lon":77.50068,"prec":"postcode","geo":"462046, Samarda Kaliyasot, Kolar Tahsil, Bhopal, Madhya Pradesh, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"05/29/2014","notes":"","charges":[{"code":"60 L - - 99","notes":"","product":"Analgesic, N.E.C.","published":"09/25/2015"},{"code":"62 G - - 99","notes":"","product":"Anti-Inflammatory N.E.C.","published":"05/29/2014"},{"code":"62 G - - 99","notes":"","product":"Anti-Inflammatory N.E.C.","published":"09/25/2015"},{"code":"62 M - - 01","notes":"","product":"Camphor (Anti-Pruritic)","published":"09/25/2015"},{"code":"62 M - - 08","notes":"","product":"Menthol (Anti-Pruritic)","published":"09/05/2024"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"09/25/2015"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"09/05/2024"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"05/29/2014"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"09/25/2015"}],"firm_as_published":"Makson Health Care Private Ltd.","address_as_published":"182 - 183 Gummadidala Mandal , Survey , Annaram, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[{"date":"2025-08-06T04:00:00Z","posted":"2025-08-12T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","company_as_published":"K & Care Organics","match":"token"}],"events":[{"d":"2025-08-06","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-09-05","k":"charge","t":"66-41 charge 62 M - - 08 — Menthol (Anti-Pruritic)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-09-05","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2015-09-25","k":"charge","t":"66-41 charge 60 L - - 99 — Analgesic, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2015-09-25","k":"charge","t":"66-41 charge 62 G - - 99 — Anti-Inflammatory N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2015-09-25","k":"charge","t":"66-41 charge 62 M - - 01 — Camphor (Anti-Pruritic)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2015-09-25","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2015-09-25","k":"charge","t":"66-41 charge 66 Y - - 99 — Exhibits - Other Drug Related Items N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""}],"first":"2014-05-29","last":"2025-08-06","sibs":["3006744199"],"colo":["3002807511","3007756473"]},{"id":"3008311641","fei":"3008311641","duns":"650484871","firm":"GPT Pharmaceuticals Private Limited","registrant":"GPT Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"Plot No 6/3 Road No 11 I.D.A Nacharam, Hyderabad, Telangana 500076, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500076","ops":["API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":17.43874,"lon":78.56145,"prec":"postcode","geo":"500076, Ward 6 Nacharam, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3048143097","3003504071","3006493505","3011573185","3007308467","3005851210","3011823550","3008768274","3024919921","3019773458"]},{"id":"3004058439","fei":"3004058439","duns":"917996324","firm":"GREEN WAVES PRIVATE LIMITED","registrant":"GREEN WAVES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 60, Baula, Po-Bali, Cuttack, Odisha 754029, India (IND)","city":"Cuttack","state":"Odisha","pin":"754029","ops":["API MANUFACTURE","LABEL"],"expires":"12/31/2026","lat":20.52478,"lon":85.61941,"prec":"postcode","geo":"754029, Athagad, Cuttack, Odisha, India","status":1,"alerts":[],"letters":[{"date":"2022-12-16T05:00:00Z","posted":"2022-12-27T14:20:00Z","subject":"Drug Product/Adulterated","office":"Division of Pharmaceutical Quality Operations IV","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-pharmaceuticals-inc-635162-12162022","company_as_published":"Green Pharmaceuticals Inc.","match":"token"},{"date":"2023-08-23T04:00:00Z","posted":"2023-09-05T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-pharmaceutical-co-ltd-663544-08232023","company_as_published":"Green Pharmaceutical Co. Ltd.","match":"token"}],"events":[{"d":"2023-08-23","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-pharmaceutical-co-ltd-663544-08232023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2022-12-16","k":"letter","t":"Drug Product/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/green-pharmaceuticals-inc-635162-12162022","x":"Division of Pharmaceutical Quality Operations IV"}],"first":"2022-12-16","last":"2023-08-23","sibs":[],"colo":[]},{"id":"3017146711","fei":"3017146711","duns":"861720679","firm":"HORIZON BIOLABS PRIVATE LIMITED","registrant":"HORIZON BIOLABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 61/1,Sy No 374, CIE, Gandhi Nagar Expansion,Balanagar Quthbullapur Mandal, Medchal-Malkajgiri District,, Hyderabad, Telangana 500037, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500037","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.47821,"lon":78.44338,"prec":"postcode","geo":"500037, Ward 120 Balanagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Balanagar mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3016067081","3012278124","3014798074","3031055543","3009883190","3013495798","3014683316","3015069609"]},{"id":"3042250439","fei":"3042250439","duns":"771521144","firm":"SVK LABORATORIES PRIVATE LIMITED","registrant":"SVK LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 7 Part And Plot No 8 5 Part, Industrial Park Attivaram, Attivaram, Ozili, Nellore, ANDHRA PRADESH 524001, India (IND)","city":"Nellore","state":"Andhra Pradesh","pin":"524001","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":14.45169,"lon":79.98455,"prec":"postcode","geo":"524001, Nellore, Sri Potti Sriramulu Nellore, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3007721548","fei":"3007721548","duns":"677111277","firm":"SOFTECH PHARMA PRIVATE LIMITED","registrant":"SOFTECH PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 708 / 6, Behind Somnath Temple,, Daman, Gujarat 396215, India (IND)","city":"Daman","state":"Gujarat","pin":"396215","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":20.40097,"lon":72.88586,"prec":"postcode","geo":"396215, Vapi Taluka, Valsad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3017642539","fei":"3017642539","duns":"930225721","firm":"Vasu Healthcare Pvt. Ltd.","registrant":"VASU HEALTHCARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 720, Gidc, Gidc Manjusar, Manjusar Savli, Vadodara, Gujarat 391775, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391775","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.44087,"lon":73.20032,"prec":"postcode","geo":"391775, Savli Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038882417","3027308441"]},{"id":"3021138307","fei":"3021138307","duns":"868237565","firm":"Vannsh Life Sciences Private Limited","registrant":"Vannsh Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Plot No 73, J N P C, Thanam (V), Parawada (M), Visakhapatnam,  531021, India (IND)","city":"Visakhapatnam","state":null,"pin":"531021","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163","3038912601"]},{"id":"3012363567","fei":"3012363567","duns":"650879310","firm":"NEUHEIT PHARMA TECHNOLOGIES PRIVATE LIMITED","registrant":"NEUHEIT PHARMA TECHNOLOGIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No 9, Block-A, ALEAP Industrial Estate, Nandigama Village, Patancheru Mandal, Hyderabad, Sangareddy, Telangana 502319, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502319","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043512610","3003945855","3018005839","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338","3007800082"]},{"id":"3021375472","fei":"3021375472","duns":"877779333","firm":"AURUM PHARMA LAB LLP","registrant":"AURUM PHARMA LAB LLP","parent":null,"ticker":null,"addr":"Plot No 98 , Sy No 186/2, Navodaya Industrial Area, Phase V, IDA Cherlapally,, Hyderabad, Telangana 500051, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500051","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.66875,"lon":77.58989,"prec":"tail2","geo":"Hyderabad, Zahirabad mandal, Sangareddy, Telangana, 502220, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005485158"]},{"id":"3008772334","fei":"3008772334","duns":"677605764","firm":"Smilax Laboratories Limited","registrant":"Smilax Laboratories Limited","parent":null,"ticker":null,"addr":"Plot No :70, Jawaharlal Nehru Pharma City, E-Bonangi Village, Parawada (M), Visakhapatnam, Andhra Pradesh 531019, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006251127"],"colo":["3045048982","3014738606","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397","3019853340"]},{"id":"Plot No A-6/2, MIDC Industrial Area, MIDC Nanded, Nanded, Maharashtra 431603, India (IND)","fei":"","duns":"929976917","firm":"Godavari Drugs Limited","registrant":"Aarna USA INC","parent":null,"ticker":null,"addr":"Plot No A-6/2, MIDC Industrial Area, MIDC Nanded, Nanded, Maharashtra 431603, India (IND)","city":"Nanded","state":"Maharashtra","pin":"431603","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.12565,"lon":77.32895,"prec":"postcode","geo":"431603, Nanded, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3006121542","fei":"3006121542","duns":"565243443","firm":"QbD Research and Development Lab Pvt. Ltd.","registrant":"QbD Research and Development Lab Pvt. Ltd.","parent":null,"ticker":null,"addr":"Plot No A75, Galaxy Aromas and Co., Nehru Nagar, Road No. 21, Thane, Maharashtra 400604, India (IND)","city":"Thane","state":"Maharashtra","pin":"400604","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.19187,"lon":72.95459,"prec":"postcode","geo":"400604, Thane, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3006559899"]},{"id":"3003484180","fei":"3003484180","duns":"650786127","firm":"SGS India Private Limited","registrant":"SGS North America Inc.","parent":null,"ticker":null,"addr":"Plot No A772/773, MIDC, TTC Industrial Area, Koparkhairane, Navi Mumbai, Maharashtra 400701, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400701","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.11985,"lon":73.00488,"prec":"postcode","geo":"400701, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3027513144","3009510975","3006620783","3024731845","3007026867","3005502733","3011560035","3030219467","3013153296"]},{"id":"3038105724","fei":"3038105724","duns":"855531249","firm":"INDOCO REMEDIES LIMITED","registrant":"Indoco Remedies Limited","parent":null,"ticker":null,"addr":"Plot No B-19, MIDC, Waluj, Aurangabad Taluka: Gangapur, District: Aurangabad (Chhatrapati Sambhajinagar), Maharashtra 431136, India (IND)","city":"District: Aurangabad (Chhatrapati Sambhajinagar)","state":"Maharashtra","pin":"431136","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.83683,"lon":75.25441,"prec":"postcode","geo":"431136, Chhatrapati Sambhajinagar, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2024-12-16T05:00:00Z","posted":"2025-01-07T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indoco-remedies-limited-691594-12162024","company_as_published":"Indoco Remedies Limited","match":"exact"}],"events":[{"d":"2024-12-16","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/indoco-remedies-limited-691594-12162024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-12-16","last":"2024-12-16","sibs":["3006784730","3006644152","3005124189","3006620783"],"colo":["3008316970","3003204330","3007542588","3008580576","3009227929","3003983454"]},{"id":"3030840962","fei":"3030840962","duns":"872347304","firm":"K.P. Manish Global Ingredients Private Limited","registrant":"K.P. Manish Global Ingredients Private Limited","parent":null,"ticker":null,"addr":"Plot No B-2, SIPCOT Industrial Complex Kudikadu, Cuddalore,  607005, India (IND)","city":"Cuddalore","state":null,"pin":"607005","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":11.74269,"lon":79.75031,"prec":"tail2","geo":"Cuddalore, Tamil Nadu, 607002, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003585876"]},{"id":"3005669319","fei":"3005669319","duns":"725076298","firm":"Encube Ethicals Limited","registrant":"Encube Ethicals Limited","parent":null,"ticker":null,"addr":"Plot No C-1 Madkaim Industrial Estate, Ponda,  403404, India (IND)","city":"Ponda","state":null,"pin":"403404","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":15.41683,"lon":73.97618,"prec":"postcode","geo":"403404, Ponda, South Goa, Goa, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3037647985","3030695079","3007532627"],"colo":[]},{"id":"3040332349","fei":"3040332349","duns":"771715001","firm":"MENDAS PHARMA PRIVATE LIMITED","registrant":"MENDAS PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No D-2-Ch-18, D-2-Ch-19, D-2-Ch-20, Dahej Ii, Dahej Industrial Estate, Vagra, Bharuch, GUJARAT 392130, India (IND)","city":"Bharuch","state":"Gujarat","pin":"392130","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.71286,"lon":72.61625,"prec":"postcode","geo":"392130, Vagra Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043800366","3005404478","3018972378","3012664809","3010027135","3014919100","3010228235","3007514214","3005737619","3030599291"]},{"id":"3015167570","fei":"3015167570","duns":"650727915","firm":"SANIKA CHEMICALS PRIVATE LIMITED","registrant":"Mr. Rajan Gopinath Thakur","parent":null,"ticker":null,"addr":"Plot No E28, Midc Road Khaire, Mahad Midc , Raigad, Raigad, Maharashtra 402309, India (IND)","city":"Raigad","state":"Maharashtra","pin":"402309","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":18.23582,"lon":73.44552,"prec":"tail3","geo":"Raigad, Lingana to Raigad, Vagheri, Chatri Nizampur, Vagheri, Mahad Taluka, Raigad, Maharashtra, 402305, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3041888751","1000283831","3031325873"]},{"id":"3008177314","fei":"3008177314","duns":"862282969","firm":"Deepak Fertilisers And Petrochemicals Corporation Limited","registrant":"Deepak Fertilisers And Petrochemical Corporation Limited","parent":null,"ticker":null,"addr":"Plot No K-1, K-7 & K-8 MIDC Industrial Area, Taloja, Raigad, MAHARASHTRA 410208, India (IND)","city":"Raigad","state":"Maharashtra","pin":"410208","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.06884,"lon":73.11504,"prec":"postcode","geo":"410208, Panvel, Panvel Subdistrict, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3014207480","3009934288","3044141181","3005048741","3004947391","3027545288","3004455093","3015986431","3025922195","3003908605"]},{"id":"3008252295","fei":"3008252295","duns":"677604197","firm":"Rubicon Research Limited","registrant":"Rubicon Research Limited","parent":null,"ticker":null,"addr":"Plot No K-30/4 & K30/5, MIDC, Additional Ambernath Area,, Thane, Maharashtra 421 506, India (IND)","city":"Thane","state":"Maharashtra","pin":null,"ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.18522,"lon":73.20311,"prec":"tail3","geo":"Additional Industrial Area, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3016480976","3006559899","3012953979"],"colo":[]},{"id":"3006230648","fei":"3006230648","duns":"925822975","firm":"MARKSANS PHARMA LIMITED","registrant":"MARKSANS PHARMA LIMITED","parent":null,"ticker":null,"addr":"Plot No L-82 & L-83, Verna Industrial Estate,, Verna, Goa 403722, India (IND)","city":"Verna","state":"Goa","pin":"403722","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":15.36243,"lon":73.92597,"prec":"postcode","geo":"403722, Salcete, South Goa, Goa, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3023677905"],"colo":["3006644152","3005124189","3008524952","3004081307","3004819820","3005719315","3005210225"]},{"id":"3018011011","fei":"3018011011","duns":"854247775","firm":"Macleods Pharmaceuticals Limited","registrant":"Macleods Pharmaceuticals Limited","parent":"Macleods (unlisted)","ticker":null,"addr":"Plot No M-50 to M-54-A Indore, Special Economic Zone,Phase II, Pithampur., Dhar, Madhya Pradesh 454774, India (IND)","city":"Dhar","state":"Madhya Pradesh","pin":"454774","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.59103,"lon":75.65274,"prec":"postcode","geo":"454774, Bhondiya, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006363714","3006607469","3018972378","3007517881"],"colo":["3030695079","3009298759","3006086845"]},{"id":"3038882417","fei":"3038882417","duns":"860175910","firm":"BILLS BIOTECH PRIVATE LIMITED","registrant":"BILLS BIOTECH PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No P/01 biotech park Phase 1 Manjusar G I D C, Savli Industrial Estate, Vadodara, Gujarat 391775, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391775","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.44087,"lon":73.20032,"prec":"postcode","geo":"391775, Savli Taluka, Vadodara, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2025-09-11T04:00:00Z","posted":"2025-09-11T04:00:00Z","subject":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","office":"Center for Tobacco Products","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wild-bills-tobacco-alpena-llc-712517-09112025","company_as_published":"Wild Bill's Tobacco of Alpena LLC","match":"token"}],"events":[{"d":"2025-09-11","k":"letter","t":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wild-bills-tobacco-alpena-llc-712517-09112025","x":"Center for Tobacco Products"}],"first":"2025-09-11","last":"2025-09-11","sibs":[],"colo":["3017642539","3027308441"]},{"id":"3004672766","fei":"3004672766","duns":"677318665","firm":"Glenmark Pharmaceuticals Limited","registrant":"Glenmark Pharmaceuticals Inc., USA","parent":"Glenmark Pharmaceuticals","ticker":"GLENMARK","addr":"Plot No S-7, Colvale Industrial Estate, Colvale-Bardez,, Goa, GA 403513, India (IND)","city":"Colvale-Bardez","state":"Goa","pin":"403513","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":15.65439,"lon":73.8443,"prec":"postcode","geo":"403513, Bardez, North Goa, Goa, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"10/25/2022","notes":"All Drug Products;","charges":[{"code":"55","notes":"All Drug Products;","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/25/2022"},{"code":"56","notes":"All Drug Products;","product":"Antibiotics (Human/Animal)","published":"10/25/2022"},{"code":"58","notes":"All Drug Products;","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"10/25/2022"},{"code":"60","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"61","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"62","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"63","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"64","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"65","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"66","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"}],"firm_as_published":"Glenmark Pharmaceuticals Limited","address_as_published":"Village Kishanpura, Baddi Nalagarh Road , Baddi , Solan, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-11-22T05:00:00Z","posted":"2022-12-06T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-637314-11222022","company_as_published":"Glenmark Pharmaceuticals Limited","match":"exact"},{"date":"2025-07-11T04:00:00Z","posted":"2025-07-22T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-708270-07112025","company_as_published":"Glenmark Pharmaceuticals Limited","match":"exact"}],"events":[{"d":"2025-07-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-708270-07112025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2022-11-22","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-637314-11222022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2022-10-25","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products;"}],"first":"2022-10-25","last":"2025-07-11","sibs":["3008565058","3009915929","3005757050"],"colo":[]},{"id":"3037325465","fei":"3037325465","duns":"876766479","firm":"ADITA BIO SYS PRIVATE LIMITED","registrant":"ADITA BIO SYS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No Spl-26, Kssidc, Antharasanahalli, Tumakuru, Karnataka 572106, India (IND)","city":"Tumakuru","state":"Karnataka","pin":"572106","ops":["ANALYSIS"],"expires":"12/31/2026","lat":13.41345,"lon":77.14312,"prec":"postcode","geo":"572106, Tumkur taluk, Tumakuru, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3009934288","fei":"3009934288","duns":"872325463","firm":"Jindal Drugs Private Limited","registrant":"Jindal Drugs Private Limited","parent":null,"ticker":null,"addr":"Plot No T-22, M I D C Industrial Area, Taloja, Navi Mumbai, Maharastra 410208, India (IND)","city":"Navi Mumbai","state":null,"pin":"410208","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.06884,"lon":73.11504,"prec":"postcode","geo":"410208, Panvel, Panvel Subdistrict, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3014207480","3008177314","3044141181","3005048741","3004947391","3027545288","3004455093","3015986431","3025922195","3003908605"]},{"id":"3002806851","fei":"3002806851","duns":"915718626","firm":"DR. REDDY'S LABORATORIES LIMITED","registrant":"Dr. Reddy's Laboratories Limited","parent":"Dr. Reddy's Laboratories","ticker":"DRREDDY","addr":"Plot No's. 137,138,145 &146, Sri Venkateswara Co-Operative Industrial Estate, Bollaram Village, Jinnaram Mandal, Sangareddy, Telangana 502325, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502325","ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.55317,"lon":78.34216,"prec":"postcode","geo":"502325, Jinnaram mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002949085","3014250111","3005336882","3011171511","3009193040","3012414462","3006549835","3005447965","3005448030","3003184497","3002949099","3009483004"],"colo":["3017000602","3041729025","3008408466","3007136165","3008479404","3009609117","3007720135","3005818804","3008932115","3005301950"]},{"id":"3006509185","fei":"3006509185","duns":"650476943","firm":"Apex Healthcare Limited","registrant":"Apex Healthcare Limited","parent":null,"ticker":null,"addr":"Plot No- 4710, 4711, 4707- A/8, 4707-A/9, Gidc Industrial Estate, Ankleshwar, Dist. - Bharuch, Ankleshwar, Gujarat 393002, India (IND)","city":"Ankleshwar","state":"Gujarat","pin":"393002","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2023-08-23T04:00:00Z","posted":"2023-08-23T15:00:00Z","subject":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","office":"Center for Tobacco Products","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apex-vape-inc-665306-08232023","company_as_published":"Apex Vape, Inc","match":"token"}],"events":[{"d":"2023-08-23","k":"letter","t":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apex-vape-inc-665306-08232023","x":"Center for Tobacco Products"}],"first":"2023-08-23","last":"2023-08-23","sibs":[],"colo":["3003722314","3003696998","3014078015","3003650383","3010079586","3006851796","3030461518","3004086396","3002806711","3008314161","3004006229","3012032037"]},{"id":"3016445311","fei":"3016445311","duns":"861446182","firm":"ENERGON LABS PRIVATE LIMITED","registrant":"ENERGON LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No-10B, D.No. 5-36/1/10B, Tsiic, Prashanthi Nagar, Kukatpally(V & M), Medchal Malkajgiri, Hyderabad, Telangana 500072, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500072","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.49046,"lon":78.40127,"prec":"postcode","geo":"500072, Ward 115 Balaji Nagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Kukatpally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031662558","3037730318","3030171758","3017524864","3009887324","3027666582","3015443248","3030396086","3038110405"]},{"id":"3043173447","fei":"3043173447","duns":"874117508","firm":"EFDEE PHARMA PRIVATE LIMITED","registrant":"EFDEE PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. - 351 - 352, Gidc Estate, Waghodia, Vadodara, Gujarat Gujarat, India (IND)","city":"Vadodara","state":"Gujarat","pin":null,"ops":["MANUFACTURE"],"expires":"12/31/2026","lat":22.30433,"lon":73.40168,"prec":"tail3","geo":"Waghodia, Vagodhia Taluka, Vadodara, Gujarat, 391760, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3011452148","fei":"3011452148","duns":"650870293","firm":"Jeevan Scientific Technology Limited","registrant":"Jeevan Scientific Technology Limited","parent":null,"ticker":null,"addr":"Plot No. 1 & 2, Sai Krupa Enclave, Manikonda Jagir, Near Lanco Hills, Golconda Post, Hyderabad, Telangana 500008, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500008","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.3707,"lon":78.35552,"prec":"postcode","geo":"500008, Gandipet mandal, Ranga Reddy, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2024-07-09T04:00:00Z","posted":"2024-07-23T13:20:00Z","subject":"New Drugs/Dietary Supplements/Food Labeling/Misbranded","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/formulation-technology-inc-672905-07092024","company_as_published":"Formulation Technology, Inc.","match":"token"}],"events":[{"d":"2024-07-09","k":"letter","t":"New Drugs/Dietary Supplements/Food Labeling/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/formulation-technology-inc-672905-07092024","x":"Division of Human and Animal Food Operations West V"}],"first":"2024-07-09","last":"2024-07-09","sibs":["3012278124"],"colo":[]},{"id":"3008957483","fei":"3008957483","duns":"650461283","firm":"Zydus Lifesciences Limited","registrant":"Zydus Lifesciences Limited","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Plot No. 1 B, PHARMEZ Special Economic Zone, Sarkhej Bavla N.H.No. 8A, Matoda, Tal.: Sanand, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2024-08-29T04:00:00Z","posted":"2024-09-10T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"12/16/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","company_as_published":"Zydus Lifesciences Limited","match":"exact"},{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","company_as_published":"Zydus Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-29","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-29","last":"2026-06-02","sibs":["3003696998","3006595385","3007938603","3007621329","3006809732","3006026405","3002806475","3012977526","3002984011","3013712903","3005430968"],"colo":["3041646841","3036725850","3043068534","3017085815","3010661577","3007277149","3010254278","3029456823","3008725987","3004011473","3008394466","3007869619"]},{"id":"3015216749","fei":"3015216749","duns":"675482180","firm":"GAMMA AGRO-MEDICAL PROCESSINGS PRIVATE LIMITED","registrant":"GAMMA AGROMEDICAL PROCESSINGS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 1, Road No-4, Export Promotion Ind. Park, Pashamylaram, Medak,, Telangana,  502307, India (IND)","city":"Medak","state":"Telangana","pin":"502307","ops":["STERILIZE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2025-07-09T04:00:00Z","posted":"2025-07-22T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medical-chemical-corporation-706007-07092025","company_as_published":"Medical Chemical Corporation","match":"token"},{"date":"2026-04-09T04:00:00Z","posted":"2026-04-14T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medical-products-laboratories-inc-721916-04092026","company_as_published":"Medical Products Laboratories, Inc.","match":"token"}],"events":[{"d":"2026-04-09","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medical-products-laboratories-inc-721916-04092026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2025-07-09","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medical-chemical-corporation-706007-07092025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-07-09","last":"2026-04-09","sibs":[],"colo":["3029943792","3039378398","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167","3005075182"]},{"id":"3007938603","fei":"3007938603","duns":"863362789","firm":"Zydus Lifesciences Limited","registrant":"Zydus Lifesciences Limited","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Plot No. 1-A/1&2 PHARMEZ, (Special Economic Zone) Matoda, Sarkhej Bavla N.H. No. 8A, Tal-Sanand, Dist-Ahmedabad, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2024-08-29T04:00:00Z","posted":"2024-09-10T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"12/16/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","company_as_published":"Zydus Lifesciences Limited","match":"exact"},{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","company_as_published":"Zydus Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-29","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-29","last":"2026-06-02","sibs":["3003696998","3006595385","3008957483","3007621329","3006809732","3006026405","3002806475","3012977526","3002984011","3013712903","3005430968"],"colo":["3041646841","3036725850","3043068534","3017085815","3010661577","3007277149","3010254278","3029456823","3008725987","3004011473","3008394466","3007869619"]},{"id":"3005497507","fei":"3005497507","duns":"915389741","firm":"Unichem Laboratories Limited","registrant":"Unichem Laboratories Limited, India","parent":null,"ticker":null,"addr":"Plot No. 10 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa 403511, India (IND)","city":"Bardez","state":"Goa","pin":"403511","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":15.53041,"lon":73.79171,"prec":"postcode","geo":"403511, Bardez, North Goa, Goa, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004082076","3006456888","3004373180","3013585679"],"colo":[]},{"id":"3005151016","fei":"3005151016","duns":"860477684","firm":"Strides Pharma Science Limited","registrant":"Strides Pharma Science Limited","parent":"Strides Pharma Science","ticker":"STAR","addr":"Plot No. 101 to 108 & 153, SIDCO Pharmaceutical Complex, Alathur, Chengalpattu, Tamil Nadu 603110, India (IND)","city":"Chengalpattu","state":"Tamil Nadu","pin":"603110","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.71867,"lon":80.09467,"prec":"postcode","geo":"603110, Chengalpattu, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004554612","3012448465"],"colo":["3005216842","3011361515","3005782924","3003597293","3020342635","3003747558","3009042530"]},{"id":"3017037090","fei":"3017037090","duns":"651018702","firm":"LAURUS LABS LIMITED","registrant":"LAURUS LABS LIMITED","parent":"Laurus Labs","ticker":"LAURUSLABS","addr":"Plot No. 102 & 103, Visakha Pharmacity Limited SEZ, Parawada, Anakapalli, Andhra Pradesh 531 019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":null,"ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.62973,"lon":83.08979,"prec":"tail3","geo":"Primary Health Centre, Parawada, Opp: Police Station, Paravada, Visakhapatnam, Andhra Pradesh, 531021, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3007083664","3011538548","3014255847","3006527015"],"colo":[]},{"id":"3011747378","fei":"3011747378","duns":"650916617","firm":"Alivira Animal Health Limited","registrant":"Alivira Animal Health Limited","parent":null,"ticker":null,"addr":"Plot No. 104 to 109 and Part of 112 and 113, Visakha Pharmacity-SEZ, JNPC, Parawada Mandal, Anakapalli District, Visakhapatnam, Andhra Pradesh 531019, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3045048982","3014738606","3008772334","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397","3019853340"]},{"id":"3005782924","fei":"3005782924","duns":"916410202","firm":"Anjan Drug Private Limited","registrant":"Anjan Drug Private Limited","parent":null,"ticker":null,"addr":"Plot No. 109, 110, 115 & 116, SIDCO Pharmaceutical Industrial Estate, Thirupporur Taluk, Chengalpattu District, Alathur, Tamil Nadu 603110, India (IND)","city":"Alathur","state":"Tamil Nadu","pin":"603110","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":12.71867,"lon":80.09467,"prec":"postcode","geo":"603110, Chengalpattu, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009402416"],"colo":["3005216842","3011361515","3005151016","3003597293","3020342635","3003747558","3009042530"]},{"id":"3023873700","fei":"3023873700","duns":"854518809","firm":"AVASYA LABS PRIVATE LIMITED","registrant":"AVASYA LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 11, 47 & 48, Ground Floor, Subhash Chandrabose Nagar, New Hafeezpet, Hyderabad, Telangana 500049, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500049","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.4989,"lon":78.35701,"prec":"postcode","geo":"500049, Ward 108 Miyapur, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Serilingampalle mandal, Ranga Reddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3030695079","fei":"3030695079","duns":"645080178","firm":"Encube Ethicals Limited","registrant":"Encube Ethicals Limited","parent":null,"ticker":null,"addr":"Plot No. 113, Smart Industrial Park (SIP), Pithampur,, Indore, Madhya Pradesh 454774, India (IND)","city":"Indore","state":"Madhya Pradesh","pin":"454774","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.59103,"lon":75.65274,"prec":"postcode","geo":"454774, Bhondiya, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3037647985","3005669319","3007532627"],"colo":["3018011011","3009298759","3006086845"]},{"id":"3012112224","fei":"3012112224","duns":"650921799","firm":"ACME GENERICS PRIVATE LIMITED","registrant":"ACME GENERICS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 115, HPSIDC Industrial Area Davni, P.O. Gurumajra, Tehsil Nalagarh, Solan, Himachal Pradesh 174101, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"174101","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":31.06505,"lon":76.69603,"prec":"postcode","geo":"174101, Nalagarh, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3046619098","3016859498","3013744962","3031080212","3008250236","3014210753","3010868532","3007517881"]},{"id":"3008316085","fei":"3008316085","duns":"860037912","firm":"Pfizer Healthcare India Private Limited","registrant":"Hospira, Inc.","parent":null,"ticker":null,"addr":"Plot No. 116, 117, 118, 119, 111 (Part) and 123 (Part), Jawaharlal Nehru Pharma City (SEZ), Parawada Mandal, Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3045048982","3014738606","3008772334","3011747378","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397","3019853340"]},{"id":"3003184497","fei":"3003184497","duns":"918607722","firm":"DR. REDDY'S LABORATORIES LIMITED","registrant":"Dr. Reddy's Laboratories Limited","parent":"Dr. Reddy's Laboratories","ticker":"DRREDDY","addr":"Plot No. 116, Sri Venkateswara Co-Operative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Sangareddy, Telangana 502 325, India (IND)","city":"Sangareddy","state":"Telangana","pin":null,"ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.60014,"lon":78.33566,"prec":"tail3","geo":"Jinnaram mandal, Sangareddy, Telangana, 502325, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002949085","3014250111","3005336882","3011171511","3009193040","3012414462","3006549835","3005447965","3005448030","3002806851","3002949099","3009483004"],"colo":[]},{"id":"3030907257","fei":"3030907257","duns":"772066647","firm":"LOZEN PHARMA PRIVATE LIMITED","registrant":"LOZEN PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 12-17, Kotur-Belur Industrial Area, Dharwad,  580011, India (IND)","city":"Dharwad","state":null,"pin":"580011","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":15.51877,"lon":74.92146,"prec":"postcode","geo":"580011, Dharawada taluku, Dharwad, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3016504267"],"colo":["3022989727"]},{"id":"3009887324","fei":"3009887324","duns":"650548972","firm":"DKR LABS ANALYTICAL SERVICES","registrant":"DKR LABS ANALYTICAL SERVICES","parent":null,"ticker":null,"addr":"Plot No. 121, IDA, Prashanthi Nagar, Kukatpally, Hyderabad, Telangana 500072, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500072","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.49046,"lon":78.40127,"prec":"postcode","geo":"500072, Ward 115 Balaji Nagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Kukatpally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031662558","3037730318","3030171758","3017524864","3016445311","3027666582","3015443248","3030396086","3038110405"]},{"id":"3013593602","fei":"3013593602","duns":"650784031","firm":"Invitron Advanced Analytics Private Limited","registrant":"Invitron Advanced Analytics Private Limited","parent":null,"ticker":null,"addr":"Plot No. 126 & 105, Survey No. 342, ALEAP Industrial Estate Near Pragathi Nagar Road, Gajularamaram, Hyderabad, Telangana 500090, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500090","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.53062,"lon":78.38101,"prec":"postcode","geo":"500090, Bachupally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3014250111","3026584977","3013758337","3008569405","3013580504","3027524740","3017981159","3002949099","3009483004","3003971663","3004021229","3004446312"]},{"id":"3019975128","fei":"3019975128","duns":"854154097","firm":"Auriga Research Private Limited","registrant":"Auriga Research Private Limited","parent":null,"ticker":null,"addr":"Plot No. 136, 6th Cross, 2nd Stage, Yeshwanthpur Industrial Suburb, Bengaluru, Karnataka 560022, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560022","ops":["ANALYSIS"],"expires":"12/31/2026","lat":13.0255,"lon":77.54584,"prec":"postcode","geo":"560022, Goraguntepalya, Bengaluru West City Corporation, Bengaluru, Bangalore North, Bengaluru Urban, Karnataka, India","status":1,"alerts":[],"letters":[{"date":"2026-08-12T04:00:00Z","posted":"2026-08-18T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/auriga-research-pvt-ltd-730694-08122026","company_as_published":"Auriga Research Pvt. Ltd.","match":"exact"}],"events":[{"d":"2026-08-12","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/auriga-research-pvt-ltd-730694-08122026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-08-12","last":"2026-08-12","sibs":["3018256823"],"colo":[]},{"id":"3044141181","fei":"3044141181","duns":"772077106","firm":"GANDHAR LIFESCIENCES PRIVATE LIMITED","registrant":"GANDHAR LIFESCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 136, Second Floor, Taloja MIDC Main Road, Taloja, Panvel, Maharashtra 410208, India (IND)","city":"Panvel","state":"Maharashtra","pin":"410208","ops":["MANUFACTURE","RELABEL"],"expires":"12/31/2026","lat":19.06884,"lon":73.11504,"prec":"postcode","geo":"410208, Panvel, Panvel Subdistrict, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3014207480","3008177314","3009934288","3005048741","3004947391","3027545288","3004455093","3015986431","3025922195","3003908605"]},{"id":"3018256823","fei":"3018256823","duns":"854098887","firm":"Auriga Research Private Limited","registrant":"Auriga Research Private Limited","parent":null,"ticker":null,"addr":"Plot No. 136, Sector 5, IMT Manesar, Gurugram, Haryana 122052, India (IND)","city":"Gurugram","state":"Haryana","pin":"122052","ops":["ANALYSIS"],"expires":"12/31/2026","lat":28.36402,"lon":76.92564,"prec":"postcode","geo":"122052, Manesar, Gurugram, Haryana, India","status":1,"alerts":[],"letters":[{"date":"2026-08-12T04:00:00Z","posted":"2026-08-18T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/auriga-research-pvt-ltd-730694-08122026","company_as_published":"Auriga Research Pvt. Ltd.","match":"exact"}],"events":[{"d":"2026-08-12","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/auriga-research-pvt-ltd-730694-08122026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-08-12","last":"2026-08-12","sibs":["3019975128"],"colo":[]},{"id":"3027037264","fei":"3027037264","duns":"581636886","firm":"Sai Life Sciences Limited","registrant":"Sai Life Sciences Limited","parent":"Sai Life Sciences","ticker":"SAILIFE","addr":"Plot No. 136-A, 136-B and 137, Kolhar Industrial Area, Bidar, Karnataka 585403, India (IND)","city":"Bidar","state":"Karnataka","pin":"585403","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.89564,"lon":77.51307,"prec":"postcode","geo":"585403, Bidar taluku, Bidar, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006398900","3004602077","3005301950"],"colo":[]},{"id":"3040483155","fei":"3040483155","duns":"957315881","firm":"Vizag Care Ingredients Private Limited","registrant":"Symrise, Inc.","parent":null,"ticker":null,"addr":"Plot No. 13b & 13a, J.n. Pharmacity Jawaharlalnehru, Andhra Pradesh, Paravada Visakhapatnam 531019, India (IND)","city":"J.n. Pharmacity Jawaharlalnehru","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2025-08-06T04:00:00Z","posted":"2025-08-12T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","company_as_published":"K & Care Organics","match":"token"}],"events":[{"d":"2025-08-06","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-06","last":"2025-08-06","sibs":[],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397","3019853340"]},{"id":"3014026060","fei":"3014026060","duns":"650513877","firm":"Alivus Life Sciences Limited","registrant":"Glenmark Pharmaceuticals Inc., USA","parent":"Glenmark Pharmaceuticals","ticker":"GLENMARK","addr":"Plot No. 141-143, 160-165, 170-172, Chandramouli Sahakari Audyogik Vasahat Maryadit, Pune-Hyderabad Highway,, Mohol, Solapur, Maharashtra 413213, India (IND)","city":"Solapur","state":"Maharashtra","pin":"413213","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.79475,"lon":75.63202,"prec":"postcode","geo":"413213, Mohol, Solapur, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004006229","3007514214"],"colo":[]},{"id":"3013913573","fei":"3013913573","duns":"860416555","firm":"Mankind Pharma Limited","registrant":"Mankind Pharma Limited","parent":"Mankind Pharma","ticker":"MANKIND","addr":"Plot No. 145, Sector - 7, IMT Manesar, Gurugram, Haryana 122050, India (IND)","city":"Gurugram","state":"Haryana","pin":"122050","ops":["ANALYSIS"],"expires":"12/31/2026","lat":28.36565,"lon":76.93138,"prec":"postcode","geo":"122050, Manesar, Gurugram, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3014150265","3009083745"],"colo":[]},{"id":"3014641319","fei":"3014641319","duns":"878239960","firm":"LDD Bioscience Private Limited","registrant":"LDD Bioscience Private Limited","parent":null,"ticker":null,"addr":"Plot No. 146, Sector 5 IMT Manesar, Gurugram, Haryana 122051, India (IND)","city":"Gurugram","state":"Haryana","pin":"122051","ops":["API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":28.36246,"lon":76.92567,"prec":"postcode","geo":"122051, Manesar, Gurugram, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3010254278","fei":"3010254278","duns":"860156658","firm":"Amneal Pharmaceuticals Private Limited","registrant":"Amneal Pharmaceuticals of New York, LLC","parent":null,"ticker":null,"addr":"Plot No. 15, PHARMEZ Special Economic Zone Sarkhej-Bavla N.H. No. 8A, Vil.: Matoda, Tal. Sanand, Ahmedabad, GJ 382213, India (IND)","city":"Ahmedabad","state":null,"pin":"382213","ops":["ANALYSIS","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2025-08-27T04:00:00Z","posted":"2025-09-02T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","company_as_published":"Amneal Pharmaceuticals, LLC","match":"exact"}],"events":[{"d":"2025-08-27","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-27","last":"2025-08-27","sibs":["3030461061","3010661577","3029456823","3017573557","3018907202","3008223599"],"colo":["3041646841","3036725850","3043068534","3017085815","3007277149","3008957483","3007938603","3007621329","3008725987","3004011473","3008394466","3007869619"]},{"id":"3029456823","fei":"3029456823","duns":"959962800","firm":"Amneal Pharmaceuticals Private Limited","registrant":"Amneal Pharmaceuticals of New York, LLC","parent":null,"ticker":null,"addr":"Plot No. 15,16,17 PHARMEZ Special Economic Zone Sarkhej-Bavla N.H. No. 8A, Vil.: Matoda, Tal. Sanand, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2025-08-27T04:00:00Z","posted":"2025-09-02T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","company_as_published":"Amneal Pharmaceuticals, LLC","match":"exact"}],"events":[{"d":"2025-08-27","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-27","last":"2025-08-27","sibs":["3030461061","3010661577","3010254278","3017573557","3018907202","3008223599"],"colo":["3041646841","3036725850","3043068534","3017085815","3007277149","3008957483","3007938603","3007621329","3008725987","3004011473","3008394466","3007869619"]},{"id":"3004819820","fei":"3004819820","duns":"677600414","firm":"LUPIN LIMITED","registrant":"LUPIN LIMITED","parent":"Lupin","ticker":"LUPIN","addr":"Plot No. 15-B, Phase 1-A, Verna Industrial Area, Verna, Salcette, Goa 403722, India (IND)","city":"Salcette","state":"Goa","pin":"403722","ops":["MANUFACTURE","PACK"],"expires":"12/31/2026","lat":15.36243,"lon":73.92597,"prec":"postcode","geo":"403722, Salcete, South Goa, Goa, India","status":1,"alerts":[],"letters":[{"date":"2021-06-11T04:00:00Z","posted":"2021-06-29T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Office of Pharmaceutical Quality Operations Division I","response":"","closeout":"04/19/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","company_as_published":"Novel Laboratories, Inc. d.b.a LUPIN","match":"token"},{"date":"2022-09-27T04:00:00Z","posted":"2022-11-01T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","company_as_published":"Lupin Limited","match":"exact"}],"events":[{"d":"2022-09-27","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-06-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","x":"Office of Pharmaceutical Quality Operations Division I"}],"first":"2021-06-11","last":"2022-09-27","sibs":["3004995645","3010977634","3002807510","3002807512","3002807511","3009843207","3009831799","3007756473","3015392060","3007549629","3009107538"],"colo":["3006644152","3005124189","3008524952","3004081307","3023677905","3006230648","3005719315","3005210225"]},{"id":"3007136165","fei":"3007136165","duns":"677520290","firm":"APICORE PHARMACEUTICALS PRIVATE LIMITED","registrant":"APICORE PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 154/A/6, Survey number 172/A, S V Co-operative Industrial Estate, IDA Bollaram, Bollaram Village, Jinnaram Mandal, Sangareddy., Hyderabad, Telangana 502325, India (IND)","city":"Hyderabad","state":"Telangana","pin":"502325","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.55317,"lon":78.34216,"prec":"postcode","geo":"502325, Jinnaram mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006767695","3012575874"],"colo":["3017000602","3041729025","3008408466","3002806851","3008479404","3009609117","3007720135","3005818804","3008932115","3005301950"]},{"id":"3003597293","fei":"3003597293","duns":"650475218","firm":"Par Active Technologies Private Limited","registrant":"Par Health USA, LLC","parent":null,"ticker":null,"addr":"Plot No. 16,17,31 & 32 Sidco Pharmaceutical Complex Alathur, Chengalpattu District, Chennai, TAMIL NADU 603110, India (IND)","city":"Chennai","state":"Tamil Nadu","pin":"603110","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":12.71867,"lon":80.09467,"prec":"postcode","geo":"603110, Chengalpattu, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005216842","3011361515","3005151016","3005782924","3020342635","3003747558","3009042530"]},{"id":"3034735246","fei":"3034735246","duns":"929597063","firm":"WARREN REMEDIES PRIVATE LIMITED","registrant":"Indoco Remedies Limited","parent":null,"ticker":null,"addr":"Plot No. 17, AURIC Shendra, Sector No. 13, Shendra M.I.D.C., Chhatrapati Sambhajinagar, Maharashtra 431154, India (IND)","city":"Chhatrapati Sambhajinagar","state":"Maharashtra","pin":"431154","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":19.87726,"lon":75.33902,"prec":"tail2","geo":"Chhatrapati Sambhajinagar, Maharashtra, 431002, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004101736","3015838038","3009915929","3041504075","3009278506"]},{"id":"3005048741","fei":"3005048741","duns":"862464427","firm":"SRIKEM LABORATORIES PRIVATE LIMITED","registrant":"SRIKEM LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 17/22, 17/23, 17/24 & 17/13, MIDC, Taloja, Tal. Panvel, Raigad, Navi Mumbai, Maharashtra 410208, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"410208","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.06884,"lon":73.11504,"prec":"postcode","geo":"410208, Panvel, Panvel Subdistrict, Raigad, Maharashtra, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"07/06/2016","notes":"All Drugs and Drug Products; Problem: (GMP) Good Manufacturing Practices","charges":[{"code":"55","notes":"All Drugs and Drug Products; Problem: (GMP) Good Manufacturing Practices","product":"Pharm Necess & Ctnr For Drug/Bio","published":"07/06/2016"},{"code":"56","notes":"All Drugs and Drug Products; Problem: (GMP) Good Manufacturing Practices","product":"Antibiotics (Human/Animal)","published":"07/06/2016"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drugs and Drug Products; Problem: (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/06/2016"},{"code":"61","notes":"All Drugs and Drug Products; Problem: (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/06/2016"},{"code":"62","notes":"All Drugs and Drug Products; Problem: (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/06/2016"},{"code":"63","notes":"All Drugs and Drug Products; Problem: (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/06/2016"},{"code":"64","notes":"All Drugs and Drug Products; Problem: (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/06/2016"},{"code":"65","notes":"All Drugs and Drug Products; Problem: (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/06/2016"},{"code":"66","notes":"All Drugs and Drug Products; Problem: (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/06/2016"}],"firm_as_published":"Srikem Laboratories Private Ltd.","address_as_published":"Plot No. 17/22, 17/23, 17/24 & 17/13, MIDC, Taloja, Tal. Panvel, Raigad , Navi Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2016-07-06","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs and Drug Products; Problem: (GMP) Good Manufacturing Practices"}],"first":"2016-07-06","last":"2022-05-26","sibs":[],"colo":["3014207480","3008177314","3009934288","3044141181","3004947391","3027545288","3004455093","3015986431","3025922195","3003908605"]},{"id":"3030493098","fei":"3030493098","duns":"854126098","firm":"Kekule Life Sciences Limited","registrant":"Kekule Life Sciences Limited","parent":null,"ticker":null,"addr":"Plot No. 171 and 181, IDA, Kondapalli, NTR District, Andhra Pradesh 521228, India (IND)","city":"NTR District","state":"Andhra Pradesh","pin":"521228","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.62148,"lon":80.53822,"prec":"postcode","geo":"521228, Ibrahimpatnam, NTR, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3016905331","3007025492"]},{"id":"3007083664","fei":"3007083664","duns":"650751774","firm":"LAURUS LABS LIMITED","registrant":"LAURUS LABS LIMITED","parent":"Laurus Labs","ticker":"LAURUSLABS","addr":"Plot No. 18, Jawaharlal Nehru Pharma City, Parawada, Anakapalli, Andhra Pradesh 531021, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531021","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3017037090","3011538548","3014255847","3006527015"],"colo":["3021138307","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163","3038912601"]},{"id":"3003144728","fei":"3003144728","duns":"650351666","firm":"Jubilant Biosys Limited","registrant":"Jubilant Biosys Limited","parent":null,"ticker":null,"addr":"Plot No. 18,56,57 &58, KIADB Industrial Area, Nanjangud, Mysuru, Karnataka 571302, India (IND)","city":"Mysuru","state":"Karnataka","pin":"571302","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":12.18005,"lon":76.74186,"prec":"postcode","geo":"571302, Nanjanagudu taluk, Mysuru District, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3037408540","fei":"3037408540","duns":"864218277","firm":"LAKSH FINE CHEM PRIVATE LIMITED","registrant":"LAKSH FINE CHEM PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 1801/02, 1801/03, 1801/04, Phase IV, GIDC, Vithhal Udyog Nagar, Anand, Gujarat, 388121 India, Anand, Gujarat 388121, India (IND)","city":"Anand","state":"Gujarat","pin":"388121","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.52968,"lon":72.92574,"prec":"postcode","geo":"388121, Anand Rural Taluka, Anand, Gujarat, India","status":2,"alerts":[{"alert":"66-66","list":"red","since":"09/30/2009","notes":"11/2/2000","charges":[{"code":"60 W - S 26","notes":"","product":"Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","published":"03/27/2019"}],"firm_as_published":"Fine Chemicals","address_as_published":"89 Princess Street , Bombay, MS INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"token"}],"letters":[],"events":[{"d":"2019-03-27","k":"charge","t":"66-66 charge 60 W - S 26 — Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":"11/2/2000"}],"first":"2009-09-30","last":"2019-03-27","sibs":[],"colo":[]},{"id":"3011538548","fei":"3011538548","duns":"650885309","firm":"LAURUS LABS LIMITED","registrant":"LAURUS LABS LIMITED","parent":"Laurus Labs","ticker":"LAURUSLABS","addr":"Plot No. 19, 20 & 21, Western Sector APSEZ Gurajapalem Village, Rambilli Mandal, Anakapalli, Andhra Pradesh 531011, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531011","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3017037090","3007083664","3014255847","3006527015"],"colo":["3012160303","3026032363","3023346708","3015709928","3013629262","3020444708","3030613318","3026297382","3013580138","3021487911","3016965485","3016661377"]},{"id":"3006456888","fei":"3006456888","duns":"650434371","firm":"Unichem Laboratories Limited","registrant":"Unichem Laboratories Limited, India","parent":null,"ticker":null,"addr":"Plot No. 197, Sector-1, Pithampur, Dhar, Madhya Pradesh 454775, India (IND)","city":"Dhar","state":"Madhya Pradesh","pin":"454775","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004082076","3005497507","3004373180","3013585679"],"colo":["3010453141","3007574780","3016480976","3008565058","3005259207","3008581988","3005594847","3038913994","3016268582","3014281041","3008861587","3043782814"]},{"id":"3007621329","fei":"3007621329","duns":"650348852","firm":"Zydus Lifesciences Limited","registrant":"Zydus Lifesciences Limited","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Plot No. 1A, PHARMEZ Special Economic Zone, Sarkhej - Bavla N. H. No. 8A, Matoda, Tal : Sanand, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2024-08-29T04:00:00Z","posted":"2024-09-10T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"12/16/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","company_as_published":"Zydus Lifesciences Limited","match":"exact"},{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","company_as_published":"Zydus Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-29","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-29","last":"2026-06-02","sibs":["3003696998","3006595385","3008957483","3007938603","3006809732","3006026405","3002806475","3012977526","3002984011","3013712903","3005430968"],"colo":["3041646841","3036725850","3043068534","3017085815","3010661577","3007277149","3010254278","3029456823","3008725987","3004011473","3008394466","3007869619"]},{"id":"3005466325","fei":"3005466325","duns":"675828590","firm":"Apotex Pharmachem India Pvt. Ltd.","registrant":"Apotex Pharmachem India Pvt. Ltd.","parent":null,"ticker":null,"addr":"Plot No. 1a, Bommasandra Industrial Area, 4th Phase, Bommasandra Industrial Estate (Post Office), Bangalore, Karnataka 560 099, India (IND)","city":"Bangalore","state":"Karnataka","pin":null,"ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":12.81493,"lon":77.69136,"prec":"tail3","geo":"Bommasandra Post Office, Hosur Road, Bommasandra, Kittaganahalli, Anekal, Bengaluru Urban, Karnataka, 560099, India","status":1,"alerts":[],"letters":[{"date":"2025-10-31T04:00:00Z","posted":"2025-11-04T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apotex-inc-714137-10312025","company_as_published":"Apotex Inc.","match":"token"}],"events":[{"d":"2025-10-31","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apotex-inc-714137-10312025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-10-31","last":"2025-10-31","sibs":[],"colo":[]},{"id":"3017864048","fei":"3017864048","duns":"872295061","firm":"Maithili Life Sciences Private Limited","registrant":"Maithili Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Plot No. 2, APIIC Industrial Estate, Gajulamandyam Village Renigunta Mandal, Tirupati, Tirupati, Andhra Pradesh 517520, India (IND)","city":"Tirupati","state":"Andhra Pradesh","pin":"517520","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.64654,"lon":79.49995,"prec":"postcode","geo":"517520, Renigunta, Tirupati, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004896422","3020873746"]},{"id":"3008565058","fei":"3008565058","duns":"862603186","firm":"Glenmark Pharmaceuticals Limited","registrant":"Glenmark Pharmaceuticals Inc., USA","parent":"Glenmark Pharmaceuticals","ticker":"GLENMARK","addr":"Plot No. 2, Phase-2, Pharma Zone SEZ Pithampur, Dhar, Madhya Pradesh 454775, India (IND)","city":"Dhar","state":"Madhya Pradesh","pin":"454775","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"10/25/2022","notes":"All Drug Products;","charges":[{"code":"55","notes":"All Drug Products;","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/25/2022"},{"code":"56","notes":"All Drug Products;","product":"Antibiotics (Human/Animal)","published":"10/25/2022"},{"code":"58","notes":"All Drug Products;","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"10/25/2022"},{"code":"60","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"61","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"62","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"63","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"64","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"65","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"66","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"}],"firm_as_published":"Glenmark Pharmaceuticals Limited","address_as_published":"Village Kishanpura, Baddi Nalagarh Road , Baddi , Solan, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-11-22T05:00:00Z","posted":"2022-12-06T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-637314-11222022","company_as_published":"Glenmark Pharmaceuticals Limited","match":"exact"},{"date":"2025-07-11T04:00:00Z","posted":"2025-07-22T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-708270-07112025","company_as_published":"Glenmark Pharmaceuticals Limited","match":"exact"}],"events":[{"d":"2025-07-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-708270-07112025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2022-11-22","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-637314-11222022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2022-10-25","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products;"}],"first":"2022-10-25","last":"2025-07-11","sibs":["3004672766","3009915929","3005757050"],"colo":["3010453141","3007574780","3016480976","3006456888","3005259207","3008581988","3005594847","3038913994","3016268582","3014281041","3008861587","3043782814"]},{"id":"3008725987","fei":"3008725987","duns":"644976418","firm":"Senador Laboratories Private Limited","registrant":"Xiromed LLC","parent":null,"ticker":null,"addr":"Plot No. 20 & 21, Pharmez, Sarkhej Balvla National Highway No. 8-A, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3041646841","3036725850","3043068534","3017085815","3010661577","3007277149","3008957483","3007938603","3010254278","3029456823","3007621329","3004011473"]},{"id":"3030133758","fei":"3030133758","duns":"957053589","firm":"CDYMAX (INDIA) PHARMA PRIVATE LIMITED","registrant":"Cdymax (India) Pharma Private Limited","parent":null,"ticker":null,"addr":"Plot No. 20 and 169, Sy. No. 132, 243 And 244, Rajapura Village Bommasandra Jigani Link Road, Industrial Area, Anekal, Bengalurur 562106, India (IND)","city":"Anekal","state":null,"pin":"562106","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":12.71294,"lon":77.66275,"prec":"postcode","geo":"562106, Agasathimmanahalli, Siddanapalya, Anekal, Bengaluru Urban, Karnataka, India","status":1,"alerts":[],"letters":[{"date":"2025-11-13T05:00:00Z","posted":"2025-11-18T05:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cdymax-india-pharma-private-limited-715022-11132025","company_as_published":"Cdymax India Pharma Private Limited","match":"exact"}],"events":[{"d":"2025-11-13","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cdymax-india-pharma-private-limited-715022-11132025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-11-13","last":"2025-11-13","sibs":["3009882550"],"colo":["3004554612","3032481089"]},{"id":"3008127341","fei":"3008127341","duns":"677604490","firm":"Sidmak Laboratories (India) Private Limited","registrant":"Sidmak Laboratories (India) Private Limited","parent":null,"ticker":null,"addr":"Plot No. 20, Pharma City, Selaqui Industrial Area, Vikas Nagar, Dehradun - 248011, Uttarakhand, India, Dehradun, Uttarakhand 248011, India (IND)","city":"Dehradun","state":"Uttarakhand","pin":"248011","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":30.36521,"lon":77.85851,"prec":"postcode","geo":"248011, Vikasnagar, Dehradun, Uttarakhand, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005890633","3017348002"]},{"id":"3007026935","fei":"3007026935","duns":"650485241","firm":"Eskay Speciality Chemicals","registrant":"Eskay Speciality Chemicals","parent":null,"ticker":null,"addr":"Plot No. 207B & 208, Surat Special Economic Zone, Road No. 4, GIDC, Surat, Gujarat 394230, India (IND)","city":"Surat","state":"Gujarat","pin":"394230","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.08626,"lon":72.86963,"prec":"postcode","geo":"394230, Chorasi Taluka, Surat, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3006254924","3010703501","3008953049"]},{"id":"3004956855","fei":"3004956855","duns":"916728337","firm":"Biocon Limited","registrant":"Biocon Limited","parent":"Biocon","ticker":"BIOCON","addr":"Plot No. 213-215 and 216/B, Phase II IDA, Pashamylaram, Sangareddy, Telangana 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["1000172912","3006400591","3010164491"],"colo":["3029943792","3039378398","3015216749","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167","3005075182"]},{"id":"3003053502","fei":"3003053502","duns":"650434645","firm":"Unique Pharmaceutical Laboratories","registrant":"Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)","parent":"JB Chemicals & Pharmaceuticals","ticker":"JBCHEPHARM","addr":"Plot No. 215-219, G.I.D.C Industrial Area, Bharuch,  394116, India (IND)","city":"Bharuch","state":null,"pin":"394116","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":21.53479,"lon":72.95568,"prec":"postcode","geo":"394116, Ankleshwar Taluka, Bharuch, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/28/2013","notes":"All drugs and drug products","charges":[{"code":"50","notes":"","product":"Color Additiv Food/Drug/Cosmetic","published":"06/28/2013"},{"code":"55","notes":"All drugs and drug products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/28/2013"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"06/28/2013"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"61","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"62","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"63","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"64","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"65","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"66","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"}],"firm_as_published":"Unique Chemicals","address_as_published":"Shiv Mahape Gansoli , Thane Belapur Road , Navi Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-41","list":"red","since":"03/10/2017","notes":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.","charges":[{"code":"21 D - - 13","notes":"","product":"Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates","published":"03/10/2017"},{"code":"21 K - - 14","notes":"","product":"Plum, Juice, Pit Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"21 V - - 34","notes":"","product":"Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars","published":"03/10/2017"},{"code":"22 D - - 05","notes":"","product":"Bitter Melon, Juice, Vine Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"54 K - - 08","notes":"","product":"Aloe (Herbal and Botanical (not teas) II (continued))","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"395 Food Park , Rai Industrial Estate , Sonepat, Haryana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"08/25/2017","notes":"Disease claims made on product labeling.","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"08/25/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/25/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"1 Plot No 21 , Road No , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"03/10/2017","notes":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.","charges":[{"code":"21 D - - 13","notes":"","product":"Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates","published":"03/10/2017"},{"code":"21 K - - 14","notes":"","product":"Plum, Juice, Pit Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"21 V - - 34","notes":"","product":"Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars","published":"03/10/2017"},{"code":"22 D - - 05","notes":"","product":"Bitter Melon, Juice, Vine Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"54 K - - 08","notes":"","product":"Aloe (Herbal and Botanical (not teas) II (continued))","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"B- 63,2 nd Floor, Prashat Vihar. , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2017-08-25","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Disease claims made on product labeling."},{"d":"2017-03-10","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper."},{"d":"2017-03-10","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper."},{"d":"2013-06-28","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All drugs and drug products"}],"first":"2013-06-28","last":"2022-05-26","sibs":["3013151303"],"colo":["3030554615","3038149173","3003952717","3015776899","3009627283","3004196193"]},{"id":"3029929541","fei":"3029929541","duns":"675482641","firm":"Zenfold Sustainable Technologies Private Limited","registrant":"Zenfold Sustainable Technologies Private Limited","parent":null,"ticker":null,"addr":"Plot No. 218 and 219, IDA, Phase-II, Pashamylaram, Sangareddy District, Sangareddy, Telangana 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3029943792","3039378398","3015216749","3004956855","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167","3005075182"]},{"id":"3007850324","fei":"3007850324","duns":"650790228","firm":"AARTI PHARMALABS LIMITED (custom synthesis Division)","registrant":"AARTI PHARMALABS LIMITED","parent":null,"ticker":null,"addr":"Plot No. 22-C/1 & 22-C/2, 1st Phase, G.I.D.C., Vapi, Valsad, Gujarat 396195, India (IND)","city":"Valsad","state":"Gujarat","pin":"396195","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":20.36447,"lon":72.9263,"prec":"postcode","geo":"396195, Vapi Taluka, Valsad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004414652","3006688078","3009765202","3004810446","3008460260","3034419392"]},{"id":"3006607469","fei":"3006607469","duns":"650376184","firm":"Macleods Pharmaceuticals Limited","registrant":"Macleods Pharmaceuticals Limited","parent":"Macleods (unlisted)","ticker":null,"addr":"Plot No. 2209, GIDC Industrial Estate Sarigam, Umbergeon, Valsad, Gujarat 396155, India (IND)","city":"Valsad","state":"Gujarat","pin":"396155","ops":["ANALYSIS","API MANUFACTURE","LABEL","MANUFACTURE","PACK","PARTICLE SIZE REDUCTION"],"expires":"12/31/2026","lat":20.26813,"lon":72.8594,"prec":"postcode","geo":"396155, Umbergaon Taluka, Valsad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006363714","3018011011","3018972378","3007517881"],"colo":[]},{"id":"3008460260","fei":"3008460260","duns":"920635096","firm":"UMEDICA LABORATORIES PRIVATE LIMITED","registrant":"UMEDICA LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 221 and 221/1, GIDC, IInd Phase,, Vapi, Gujarat 396195, India (IND)","city":"Vapi","state":"Gujarat","pin":"396195","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":20.36447,"lon":72.9263,"prec":"postcode","geo":"396195, Vapi Taluka, Valsad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004414652","3006688078","3009765202","3004810446","3007850324","3034419392"]},{"id":"3010770804","fei":"3010770804","duns":"650605491","firm":"Synthokem Labs Private Limited","registrant":"Synthokem Labs Private Limited","parent":null,"ticker":null,"addr":"Plot No. 222 to 224 & 235 to 237 Phase-II IDA Pashamylaram, Patancheru (Mandal), Sangareddy, Telangana 502319, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502319","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043512610","3003945855","3018005839","3012363567","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338","3007800082"]},{"id":"3008465427","fei":"3008465427","duns":"864393104","firm":"Pharmaffiliates Private Limited","registrant":"Pharmaffiliates Private Limited","parent":null,"ticker":null,"addr":"Plot No. 225, Industrial Area Phase-II, Panchkula, Haryana 134113, India (IND)","city":"Panchkula","state":"Haryana","pin":"134113","ops":["ANALYSIS"],"expires":"12/31/2026","lat":30.68484,"lon":76.84167,"prec":"postcode","geo":"134113, Sector 15, Panchkula, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031580787"]},{"id":"3030824559","fei":"3030824559","duns":"644774086","firm":"Symbio Generrics India Private Limited","registrant":"Symbio Generrics India Private Ltd","parent":null,"ticker":null,"addr":"Plot No. 22H, Survey No.: 34P & 35P, APSEZ Lalam koduru village, Rambilli Mandal,, Anakapalli, Andhra Pradesh 531 011, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":null,"ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.67153,"lon":82.77476,"prec":"tail2","geo":"Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3001329340","fei":"3001329340","duns":"915837935","firm":"Valens Molecules Private Limited","registrant":"Valens Molecules Private Limited","parent":null,"ticker":null,"addr":"Plot No. 23, Phase I Industrial Development Area Jeedimetla, Hyderabad, Telangana 500055, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500055","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3013629262","3003802255"],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869","3018694293"]},{"id":"3015709928","fei":"3015709928","duns":"675473353","firm":"Innovare Labs Private Limited","registrant":"Innovare Labs Private Limited","parent":null,"ticker":null,"addr":"Plot No. 23A & 23B, Lalam Koduru (V), APSEZ, Denotified Area, Atchutapuram, Rambilli Mandal, Visakhapatnam, Andhra Pradesh 531011, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3012160303","3026032363","3023346708","3011538548","3013629262","3014255847","3020444708","3030613318","3026297382","3013580138","3021487911","3016965485"]},{"id":"3006192929","fei":"3006192929","duns":"918441911","firm":"SHIVA ANALYTICALS (INDIA) PRIVATE LIMITED","registrant":"SHIVA ANALYTICALS (INDIA) PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 24 D (P) & 34D, KIADB Industrial Area, Hoskote,, Bengaluru, Karnataka 562114, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"562114","ops":["ANALYSIS"],"expires":"12/31/2026","lat":13.08252,"lon":77.84501,"prec":"postcode","geo":"562114, Hosakote taluk, Bengaluru North, Karnataka, India","status":1,"alerts":[],"letters":[{"date":"2025-07-23T04:00:00Z","posted":"2025-07-29T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shiva-analyticals-private-limited-707857-07232025","company_as_published":"Shiva Analyticals Private Limited","match":"token"}],"events":[{"d":"2025-07-23","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shiva-analyticals-private-limited-707857-07232025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-07-23","last":"2025-07-23","sibs":[],"colo":[]},{"id":"3013885060","fei":"3013885060","duns":"675469002","firm":"Vanamali Organics Private Limited","registrant":"Vanamali Organics Private Limited","parent":null,"ticker":null,"addr":"Plot No. 24A & 24B, TSIIC, Survey No. 480, IDA Mankhal, Maheswaram Mandal, Ranga Reddy District, Hyderabad, Telangana 501 359, India (IND)","city":"Hyderabad","state":"Telangana","pin":null,"ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.41284,"lon":78.45681,"prec":"tail3","geo":"Zilla Praja Parishad Ranga Reddy District, Anand Nagar Entrance Road, Chintal Basti, Ward 91 Khairatabad, Greater Hyderabad Municipal Corporation Central Zone, Hyderabad, Khairatabad mandal, Hyderabad, Telangana, 500004, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3013629262","fei":"3013629262","duns":"675476129","firm":"Valens Molecules Private Limited","registrant":"Valens Molecules Private Limited","parent":null,"ticker":null,"addr":"Plot No. 24C, APIIC-SEZ De-Notified Area, Atchutapuram, Viskhapatnam, Andhra Pradesh 531011, India (IND)","city":"Viskhapatnam","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3001329340","3003802255"],"colo":["3012160303","3026032363","3023346708","3011538548","3015709928","3014255847","3020444708","3030613318","3026297382","3013580138","3021487911","3016965485"]},{"id":"3014255847","fei":"3014255847","duns":"675474102","firm":"LAURUS LABS LIMITED","registrant":"LAURUS LABS LIMITED","parent":"Laurus Labs","ticker":"LAURUSLABS","addr":"Plot No. 25, 25A to 25K, APSEZ De-Notified Area, Lalamkoduru Village, Rambilli Mandal, Anakapalli, Andhra Pradesh 531011, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531011","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3017037090","3007083664","3011538548","3006527015"],"colo":["3012160303","3026032363","3023346708","3015709928","3013629262","3020444708","3030613318","3026297382","3013580138","3021487911","3016965485","3016661377"]},{"id":"3030560746","fei":"3030560746","duns":"877193590","firm":"KRS PHARMACEUTICALS PRIVATE LIMITED","registrant":"KRS PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 26, Sy No. 2 and 5, Jawaharlal Nehru Pharma City, Thanan Village, Parawada, Anakapalli, Andra Pradesh 531019, India (IND)","city":"Anakapalli","state":null,"pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3014527724","3015955297","3019200343","3008250894","3009822397","3019853340"]},{"id":"3005011516","fei":"3005011516","duns":"918431821","firm":"Adani Pharmachem Pvt Ltd","registrant":"Adani Pharmachem Pvt Ltd","parent":null,"ticker":null,"addr":"Plot No. 2729 to 2731, Road - I-1 G.I.D.C., Village Metoda, Taluka Lodhika, Rajkot, Gujarat 360021, India (IND)","city":"Rajkot","state":"Gujarat","pin":"360021","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.24459,"lon":70.67764,"prec":"postcode","geo":"360021, Lodhika Taluka, Rajkot, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3020444708","fei":"3020444708","duns":"644903909","firm":"GMFC LABS PRIVATE LIMITED","registrant":"GMFC LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 27B And 27B-15, APSEZ-De-Notified Area, Atchutapuram, ANDHRA PRADESH, ANAKAPALLI, Andhra Pradesh 531011, India (IND)","city":"Atchutapuram","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3012160303","3026032363","3023346708","3011538548","3015709928","3013629262","3014255847","3030613318","3026297382","3013580138","3021487911","3016965485"]},{"id":"3014406503","fei":"3014406503","duns":"871802852","firm":"STYRAX PHARMA PRIVATE LIMITED","registrant":"STYRAX PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 27B, J N Pharma City, Parawada, Anakapalli, Andhra Pradesh 531021, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531021","ops":["API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021138307","3007083664","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163","3038912601"]},{"id":"3030613318","fei":"3030613318","duns":"876819222","firm":"VASISTA PHARMA CHEM PRIVATE LIMITED","registrant":"MAHAS CHEMICALS SERVICES","parent":null,"ticker":null,"addr":"Plot No. 27B1, 27B2, 27B13 & 27B14, De-Notified Area, APSEZ APIIC, Atchutapuram, Visakhapatnam, Andhra Pradesh 531011, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3012160303","3026032363","3023346708","3011538548","3015709928","3013629262","3014255847","3020444708","3026297382","3013580138","3021487911","3016965485"]},{"id":"3032481089","fei":"3032481089","duns":"957801598","firm":"Aragen Biologics Private Limited","registrant":"Aragen Biologics Private Limited","parent":null,"ticker":null,"addr":"Plot No. 284/A, BLR-3, Bommasandra Jigani Link Road, Jigani, Bengaluru, Karnataka 562106, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"562106","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":12.71294,"lon":77.66275,"prec":"postcode","geo":"562106, Agasathimmanahalli, Siddanapalya, Anekal, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004554612","3030133758"]},{"id":"3022837118","fei":"3022837118","duns":"738673104","firm":"Hetero Labs Limited","registrant":"Hetero Labs Limited","parent":"Hetero (unlisted)","ticker":null,"addr":"Plot No. 28P1 to 36P1 and 37 to 54, Vemagal Industrial Area, Hobli Vemagal Kolar, Karnataka 563102, India (IND)","city":"Hobli Vemagal Kolar","state":"Karnataka","pin":"563102","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":13.1809,"lon":78.09148,"prec":"postcode","geo":"563102, Kolar taluk, Kolar, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005406526","3011002833","3009093782","3008307735","3008294355","3004378446"],"colo":[]},{"id":"3005074449","fei":"3005074449","duns":"918536145","firm":"Maneesh Pharmaceuticals Limited","registrant":"Maneesh Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Plot No. 29-33, Ancillary Industrial Plots,Waman Patil Marg Deonar, Mumbai, MH 400043, India (IND)","city":"Mumbai","state":null,"pin":"400043","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.06331,"lon":72.92099,"prec":"postcode","geo":"400043, M/E Ward, Mumbai Zone 5, Mumbai, Mumbai Suburban District, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3031204878","fei":"3031204878","duns":"955479157","firm":"Vidgas Science & Technologies Private Limited","registrant":"Vidgas Science & Technologies Private Limited","parent":null,"ticker":null,"addr":"Plot No. 290, Sy No. 551,552,553 And 559 Kadechur and Badiyal industrial area, Hobli Saidapur Taluk, Yadgir, Karnataka 585221, India (IND)","city":"Yadgir","state":"Karnataka","pin":"585221","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":16.57388,"lon":77.25266,"prec":"postcode","geo":"585221, Yadagiri taluku, Yadgir, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038475692","3030355960","3043148873","3038159483"]},{"id":"3002806711","fei":"3002806711","duns":"916130698","firm":"Cadila Pharmaceuticals Limited","registrant":"Cadila Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Plot No. 294, GIDC Industrial Estate, Ankleshwar, Gujarat 393002, India (IND)","city":"Ankleshwar","state":"Gujarat","pin":"393002","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3007684569","3014078015"],"colo":["3003722314","3003696998","3003650383","3010079586","3006851796","3030461518","3004086396","3006509185","3008314161","3004006229","3012032037","3004390840"]},{"id":"3017754175","fei":"3017754175","duns":"876766737","firm":"Chemo India Formulations Pvt Ltd","registrant":"Chemo India Formulations Pvt Ltd","parent":null,"ticker":null,"addr":"Plot No. 2B & 2C, Biotech Park – Phase II,, Lalgadi Malakpet, Hyderabad 500101, India (IND)","city":"Lalgadi Malakpet","state":null,"pin":"500101","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":17.65514,"lon":78.60618,"prec":"postcode","geo":"500101, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038528882","PLOT NO 4C,MN SC & TECH BIOTECH PARK GENOME VALLEY, TURKAPALLY, SHAMIRPET RANGAREDDY, Hyderabad, Telangana 500101, India (IND)","3006587427","3039644403","3039411568","3006527015","3009522832","3012704791","3030495702","3009883135","3011960448"]},{"id":"3004947391","fei":"3004947391","duns":"916063956","firm":"CHEMSPEC CHEMICALS PRIVATE LIMITED","registrant":"CHEMSPEC CHEMICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 3-C, MIDC Taloja, Taluka- Panvel, Navi Mumbai, Raigad, MH 410208, India (IND)","city":"Raigad","state":null,"pin":"410208","ops":["API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":19.06884,"lon":73.11504,"prec":"postcode","geo":"410208, Panvel, Panvel Subdistrict, Raigad, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2025-12-23T05:00:00Z","posted":"2026-01-13T05:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chemspec-chemicals-private-limited-718403-12232025","company_as_published":"Chemspec Chemicals Private Limited","match":"exact"}],"events":[{"d":"2025-12-23","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chemspec-chemicals-private-limited-718403-12232025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-12-23","last":"2025-12-23","sibs":[],"colo":["3014207480","3008177314","3009934288","3044141181","3005048741","3027545288","3004455093","3015986431","3025922195","3003908605"]},{"id":"3014798074","fei":"3014798074","duns":"873683702","firm":"ADEPT PHARMA AND BIOSCIENCE EXCELLENCE PRIVATE LIMITED","registrant":"ADEPT PHARMA AND BIOSCIENCE EXCELLENCE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 30 & 31, Survey No: 196, 197, 198 Rajiv Gandhi Nagar, Moosapet (V), GHMC Kukatpally Circle, Balanagar (M), Hyderabad, Telangana 500037, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500037","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.47821,"lon":78.44338,"prec":"postcode","geo":"500037, Ward 120 Balanagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Balanagar mandal, Medchal–Malkajgiri, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2023-01-24T05:00:00Z","posted":"2023-01-31T14:20:00Z","subject":"CGMP/Dietary Supplement/Misbranded","office":"Division of Human and Animal Food Operations East IV","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/adept-life-science-llc-635400-01242023","company_as_published":"Adept Life Science, LLC","match":"token"}],"events":[{"d":"2023-01-24","k":"letter","t":"CGMP/Dietary Supplement/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/adept-life-science-llc-635400-01242023","x":"Division of Human and Animal Food Operations East IV"}],"first":"2023-01-24","last":"2023-01-24","sibs":[],"colo":["3016067081","3012278124","3017146711","3031055543","3009883190","3013495798","3014683316","3015069609"]},{"id":"3000280991","fei":"3000280991","duns":"862603148","firm":"Gland Chemicals Private Limited","registrant":"Gland Chemicals Private Limited","parent":null,"ticker":null,"addr":"Plot No. 30 A & B, 2nd Phase, KIADB Industrial Area, Kolar District, Malur, Karnataka 563130, India (IND)","city":"Malur","state":"Karnataka","pin":"563130","ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":13.03854,"lon":77.97355,"prec":"postcode","geo":"563130, Maluru taluk, Kolar, Karnataka, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"08/01/2018","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"08/01/2018"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"08/01/2018"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"}],"firm_as_published":"Gland Chemicals Private Limited","address_as_published":"& B - 11 Plot No B - 3 , Sipcot Industrial Park; & B - 6 To B - 18 , Chennai, Tamil Nadu INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2018-08-01","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2018-08-01","last":"2022-05-26","sibs":["3008386908","3003983454"],"colo":[]},{"id":"3015776899","fei":"3015776899","duns":"675472519","firm":"Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)","registrant":"Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)","parent":"JB Chemicals & Pharmaceuticals","ticker":"JBCHEPHARM","addr":"Plot No. 304-308, G.I.D.C. Industrial Area Panoli, Bharuch, GUJARAT 394116, India (IND)","city":"Bharuch","state":"Gujarat","pin":"394116","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":21.53479,"lon":72.95568,"prec":"postcode","geo":"394116, Ankleshwar Taluka, Bharuch, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/28/2013","notes":"All drugs and drug products","charges":[{"code":"50","notes":"","product":"Color Additiv Food/Drug/Cosmetic","published":"06/28/2013"},{"code":"55","notes":"All drugs and drug products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/28/2013"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"06/28/2013"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"61","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"62","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"63","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"64","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"65","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"66","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"}],"firm_as_published":"Unique Chemicals","address_as_published":"Shiv Mahape Gansoli , Thane Belapur Road , Navi Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-41","list":"red","since":"03/10/2017","notes":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.","charges":[{"code":"21 D - - 13","notes":"","product":"Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates","published":"03/10/2017"},{"code":"21 K - - 14","notes":"","product":"Plum, Juice, Pit Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"21 V - - 34","notes":"","product":"Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars","published":"03/10/2017"},{"code":"22 D - - 05","notes":"","product":"Bitter Melon, Juice, Vine Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"54 K - - 08","notes":"","product":"Aloe (Herbal and Botanical (not teas) II (continued))","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"395 Food Park , Rai Industrial Estate , Sonepat, Haryana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"08/25/2017","notes":"Disease claims made on product labeling.","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"08/25/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/25/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"1 Plot No 21 , Road No , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"03/10/2017","notes":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.","charges":[{"code":"21 D - - 13","notes":"","product":"Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates","published":"03/10/2017"},{"code":"21 K - - 14","notes":"","product":"Plum, Juice, Pit Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"21 V - - 34","notes":"","product":"Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars","published":"03/10/2017"},{"code":"22 D - - 05","notes":"","product":"Bitter Melon, Juice, Vine Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"54 K - - 08","notes":"","product":"Aloe (Herbal and Botanical (not teas) II (continued))","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"B- 63,2 nd Floor, Prashat Vihar. , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2017-08-25","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Disease claims made on product labeling."},{"d":"2017-03-10","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper."},{"d":"2017-03-10","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper."},{"d":"2013-06-28","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All drugs and drug products"}],"first":"2013-06-28","last":"2022-05-26","sibs":["3003647459"],"colo":["3030554615","3038149173","3003952717","3003053502","3013151303","3009627283","3004196193"]},{"id":"3007907068","fei":"3007907068","duns":"918278532","firm":"Syngene International Limited","registrant":"Syngene International Limited","parent":"Syngene International","ticker":"SYNGENE","addr":"Plot No. 31, Clinical Development, Tower 1, Semicon Park, Bengaluru, Karnataka 560100, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560100","ops":["ANALYSIS"],"expires":"12/31/2026","lat":12.84601,"lon":77.66127,"prec":"postcode","geo":"560100, Bangalore South, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003600340","3012608389","3035152598"],"colo":["1000172912","3015283245","3004495158"]},{"id":"3008314161","fei":"3008314161","duns":"650477925","firm":"RPG Life Sciences Limited","registrant":"RPG Life Sciences Limited","parent":null,"ticker":null,"addr":"Plot No. 3102/A, GIDC Industrial Estate, Ankleshwar, Bharuch, Gujarat 393002, India (IND)","city":"Bharuch","state":"Gujarat","pin":"393002","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/11/2013","notes":"","charges":[{"code":"50","notes":"","product":"Color Additiv Food/Drug/Cosmetic","published":"06/11/2013"},{"code":"55","notes":"","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/11/2013"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"06/11/2013"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"","product":"Human and Animal Drugs","published":"06/11/2013"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"06/11/2013"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"06/11/2013"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"06/11/2013"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"06/11/2013"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"06/11/2013"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"06/11/2013"}],"firm_as_published":"RPG Life Sciences Limited","address_as_published":"Plot No. 3102/A, GIDC Industrial Estate , Ankleshwar, Bharuch, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"06/10/2013","notes":"","charges":[{"code":"50","notes":"","product":"Color Additiv Food/Drug/Cosmetic","published":"06/10/2013"},{"code":"55","notes":"","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/10/2013"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"06/10/2013"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"","product":"Human and Animal Drugs","published":"06/10/2013"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"06/10/2013"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"06/10/2013"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"06/10/2013"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"06/10/2013"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"06/10/2013"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"06/10/2013"}],"firm_as_published":"RPG Life Sciences Limited","address_as_published":"25, M.I.D.C. Land, Thane , Thane-Belapur Road , Navi Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2013-06-11","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2013-06-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""}],"first":"2013-06-10","last":"2022-05-26","sibs":[],"colo":["3003722314","3003696998","3014078015","3003650383","3010079586","3006851796","3030461518","3004086396","3006509185","3002806711","3004006229","3012032037"]},{"id":"3004006229","fei":"3004006229","duns":"650283737","firm":"Alivus Life Sciences Limited","registrant":"Glenmark Pharmaceuticals Inc., USA","parent":"Glenmark Pharmaceuticals","ticker":"GLENMARK","addr":"Plot No. 3109, GIDC Industrial Estate, District Bharuch, Ankleshwar, Gujarat 393002, India (IND)","city":"Ankleshwar","state":"Gujarat","pin":"393002","ops":["ANALYSIS","API MANUFACTURE","LABEL"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3014026060","3007514214"],"colo":["3003722314","3003696998","3014078015","3003650383","3010079586","3006851796","3030461518","3004086396","3006509185","3002806711","3008314161","3012032037"]},{"id":"3014527724","fei":"3014527724","duns":"675477097","firm":"SRIKAR LABORATORIES PRIVATE LIMITED","registrant":"SRIKAR LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 32 A, J. N. Pharma city, Parawada Mandal, Visakhapatnam, Andhra Pradesh 531019, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3015955297","3019200343","3008250894","3009822397","3019853340"]},{"id":"3004881451","fei":"3004881451","duns":"915793457","firm":"MEDISPRAY LABORATORIES PRIVATE LIMITED","registrant":"Medispray Laboratories Private Limited.","parent":null,"ticker":null,"addr":"Plot No. 346,347 and 348, Kundaim Industrial Estate, Kundaim, Ponda, Goa 403115, India (IND)","city":"Ponda","state":"Goa","pin":"403115","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":15.44648,"lon":73.97056,"prec":"postcode","geo":"403115, Ponda, South Goa, Goa, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3010703501","fei":"3010703501","duns":"915414132","firm":"Globela Pharma Pvt. Ltd.","registrant":"Globela Pharma Pvt. Ltd.","parent":null,"ticker":null,"addr":"Plot No. 357-358, Road No.3, GIDC, Sachin, Surat, Gujarat 394230, India (IND)","city":"Surat","state":"Gujarat","pin":"394230","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":21.08626,"lon":72.86963,"prec":"postcode","geo":"394230, Chorasi Taluka, Surat, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3006254924","3007026935","3008953049"]},{"id":"3012536712","fei":"3012536712","duns":"862227528","firm":"N.G. ELECTRO PRODUCTS PRIVATE LIMITED","registrant":"NG Electro Products Pvt Ltd","parent":null,"ticker":null,"addr":"Plot No. 36, HIMUDA Industrial Area Phase-4 Bhatoli Kalan, Baddi, Himachal Pradesh 173205, India (IND)","city":"Baddi","state":"Himachal Pradesh","pin":"173205","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":30.94458,"lon":76.80677,"prec":"postcode","geo":"173205, Baddi, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3006370533","3013950309","3003897648","3006785414","3031304848","3007187282","3018004432","3041778294","3005757050","3005430968","3004738570"]},{"id":"3002093078","fei":"3002093078","duns":"725431626","firm":"Vasudha Pharma Chem Limited","registrant":"Vasudha Pharma Chem Limited","parent":null,"ticker":null,"addr":"Plot No. 37/A, 38, 39 A & B Phase I, I.D.A, Jeedimetla, Hyderabad, TELANGANA 500055, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500055","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012160303","3009822397"],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3003649250","3006590829","3002806664","3006251127","3001319869","3018694293"]},{"id":"3003649250","fei":"3003649250","duns":"650331564","firm":"Virchow Laboratories Limited","registrant":"Virchow Laboratories Limited","parent":null,"ticker":null,"addr":"Plot No. 4 to 10, S.V.Co-op. Industrial Estate, IDA Jeedimetla Hyderabad, Telangana 500055, India (IND)","city":"IDA Jeedimetla Hyderabad","state":"Telangana","pin":"500055","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3006590829","3002806664","3006251127","3001319869","3018694293"]},{"id":"3013151303","fei":"3013151303","duns":"864354608","firm":"Unique Pharmaceutical Laboratories","registrant":"Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)","parent":"JB Chemicals & Pharmaceuticals","ticker":"JBCHEPHARM","addr":"Plot No. 4, Phase IV, G.I.D.C Industrial Estate, Bharuch, GJ 394116, India (IND)","city":"Bharuch","state":null,"pin":"394116","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":21.53479,"lon":72.95568,"prec":"postcode","geo":"394116, Ankleshwar Taluka, Bharuch, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/28/2013","notes":"All drugs and drug products","charges":[{"code":"50","notes":"","product":"Color Additiv Food/Drug/Cosmetic","published":"06/28/2013"},{"code":"55","notes":"All drugs and drug products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/28/2013"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"06/28/2013"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"61","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"62","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"63","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"64","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"65","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"66","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"}],"firm_as_published":"Unique Chemicals","address_as_published":"Shiv Mahape Gansoli , Thane Belapur Road , Navi Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-41","list":"red","since":"03/10/2017","notes":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.","charges":[{"code":"21 D - - 13","notes":"","product":"Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates","published":"03/10/2017"},{"code":"21 K - - 14","notes":"","product":"Plum, Juice, Pit Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"21 V - - 34","notes":"","product":"Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars","published":"03/10/2017"},{"code":"22 D - - 05","notes":"","product":"Bitter Melon, Juice, Vine Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"54 K - - 08","notes":"","product":"Aloe (Herbal and Botanical (not teas) II (continued))","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"395 Food Park , Rai Industrial Estate , Sonepat, Haryana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"08/25/2017","notes":"Disease claims made on product labeling.","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"08/25/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/25/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"1 Plot No 21 , Road No , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"03/10/2017","notes":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.","charges":[{"code":"21 D - - 13","notes":"","product":"Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates","published":"03/10/2017"},{"code":"21 K - - 14","notes":"","product":"Plum, Juice, Pit Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"21 V - - 34","notes":"","product":"Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars","published":"03/10/2017"},{"code":"22 D - - 05","notes":"","product":"Bitter Melon, Juice, Vine Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"54 K - - 08","notes":"","product":"Aloe (Herbal and Botanical (not teas) II (continued))","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"B- 63,2 nd Floor, Prashat Vihar. , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2017-08-25","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Disease claims made on product labeling."},{"d":"2017-03-10","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper."},{"d":"2017-03-10","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper."},{"d":"2013-06-28","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All drugs and drug products"}],"first":"2013-06-28","last":"2022-05-26","sibs":["3003053502"],"colo":["3030554615","3038149173","3003952717","3015776899","3009627283","3004196193"]},{"id":"3039644403","fei":"3039644403","duns":"771676449","firm":"VTIDES LIFESCIENCES PRIVATE LIMITED","registrant":"VTIDES LIFESCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 4, Survey Nos. 101 and 101/2 & 340, MD 7073, Shamirpet Mandal, Bharat Biotech Registered Office, Genome Valley, Turkapally, Medchal-Malkajgiri, Telangana 500101, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500101","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.65514,"lon":78.60618,"prec":"postcode","geo":"500101, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038528882","PLOT NO 4C,MN SC & TECH BIOTECH PARK GENOME VALLEY, TURKAPALLY, SHAMIRPET RANGAREDDY, Hyderabad, Telangana 500101, India (IND)","3006587427","3017754175","3039411568","3006527015","3009522832","3012704791","3030495702","3009883135","3011960448"]},{"id":"3008377265","fei":"3008377265","duns":"871410645","firm":"BE BIOSOL PRIVATE LIMITED","registrant":"BE BIOSOL PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 4, Sy No. 542/P, Biotech Park, Phase II, Kolthur Village, Shamirpet Mandal, Medchal-Malkajgiri, Telangana 500078, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500078","ops":["ANALYSIS","API MANUFACTURE","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.58696,"lon":78.55137,"prec":"postcode","geo":"500078, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009522832"],"colo":["3011062091","3046312775","3025926685","3012071812","3038847754","3012796281","3004602077"]},{"id":"3004939494","fei":"3004939494","duns":"677604546","firm":"Micro Labs Limited","registrant":"Micro Labs Limited","parent":null,"ticker":null,"addr":"Plot No. 43-45, KIADB, Jigani - Bommasandra Link Road, Anekal Taluk, Bengaluru, Karnataka 560105, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560105","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":12.78642,"lon":77.63458,"prec":"postcode","geo":"560105, Jigani, Anekal, Bengaluru Urban, Karnataka, India","status":1,"alerts":[],"letters":[{"date":"2024-09-10T04:00:00Z","posted":"2024-11-08T19:00:00Z","subject":"CGMP/QSR/Medical Devices/Adulterated","office":"Center for Devices and Radiological Health","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-x-ltd-692084-09102024","company_as_published":"Micro-X Ltd.","match":"token"},{"date":"2024-12-03T05:00:00Z","posted":"2024-12-17T14:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-orgo-chem-686458-12032024","company_as_published":"Micro Orgo Chem","match":"token"}],"events":[{"d":"2024-12-03","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-orgo-chem-686458-12032024","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-09-10","k":"letter","t":"CGMP/QSR/Medical Devices/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-x-ltd-692084-09102024","x":"Center for Devices and Radiological Health"}],"first":"2024-09-10","last":"2024-12-03","sibs":["3009310198","3004495158","3017157902","3005210225"],"colo":["3007512701","3005857289","3003560263","3009882550","3015345916","3009609358","3003768909","3007648351"]},{"id":"3008953049","fei":"3008953049","duns":"915819330","firm":"ACUTAAS CHEMICALS LIMITED","registrant":"ACUTAAS CHEMICALS LIMITED","parent":null,"ticker":null,"addr":"Plot No. 440/4, 5, 6, 8206-B, 478, 479, 494 & 495, Road No. 82/A & 82/C, G.I.D.C., Sachin Taluka Ch, Surat, Gujarat 394230, India (IND)","city":"Surat","state":"Gujarat","pin":"394230","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.08626,"lon":72.86963,"prec":"postcode","geo":"394230, Chorasi Taluka, Surat, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3031813491"],"colo":["3006254924","3007026935","3010703501"]},{"id":"3003157498","fei":"3003157498","duns":"725927649","firm":"Intas Pharmaceuticals Limited","registrant":"Intas Pharmaceuticals Limited","parent":"Intas (unlisted)","ticker":null,"addr":"Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi , Sarkhej-Bavla Highway , Taluka -Sanand, Matoda, Ahmedabad, Gujarat 382210, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382210","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.96445,"lon":72.4238,"prec":"postcode","geo":"382210, Sanand Taluka, Ahmedabad, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/01/2023","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"11/15/2024"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"11/15/2024"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"11/15/2024"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"11/15/2024"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"11/15/2024"},{"code":"55","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/01/2023"},{"code":"56","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Antibiotics (Human/Animal)","published":"06/01/2023"},{"code":"58","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"06/01/2023"},{"code":"60","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"61","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"62","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"63","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"64","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"65","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"66","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"}],"firm_as_published":"Intas Pharmaceuticals Limited","address_as_published":"Pharmez Plot No 5-14 , Near Village Matoda; Sarkhej-Bavla Highway No 8-A , Sanand, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"11/14/2023","notes":"These products are excluded from DWPE: Azacitidine Injection 62I[][]99 Clonazepam Tablet 61M[][]06 Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"04/09/2024"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"04/09/2024"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"04/09/2024"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"04/09/2024"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"04/09/2024"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"11/14/2023"},{"code":"56","notes":"All Drug and Drug Products;","product":"Antibiotics (Human/Animal)","published":"11/14/2023"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"11/14/2023"},{"code":"60","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"61","notes":"All Drug and Drug Products; These products are excluded from DWPE: Clonazepam Tablet 61M[][]06","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"62","notes":"All Drug and Drug Products; These products are excluded from DWPE: Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95 Azacitidine Injection 62I[][]99","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"63","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"64","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/14/2023"}],"firm_as_published":"Intas Pharmaceuticals Limited","address_as_published":"Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi , Sarkhej-Bavla Highway, Taluka-Sanand, Matoda , Ahmedabad, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2023-07-28T04:00:00Z","posted":"2023-08-01T14:31:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"},{"date":"2023-11-21T05:00:00Z","posted":"2023-11-28T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"},{"date":"2026-03-30T04:00:00Z","posted":"2026-04-28T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"}],"events":[{"d":"2026-03-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2023-11-21","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-11-14","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE: Azacitidine Injection 62I[][]99 Clonazepam Tablet 61M[][]06 Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95"},{"d":"2023-07-28","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-06-01","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32"}],"first":"2023-06-01","last":"2026-03-30","sibs":["3003722314","3005890633","3007277149","3004011473","3011743992"],"colo":["3016710326","3006595385","3006026405","3023491920","3002984011"]},{"id":"3014463103","fei":"3014463103","duns":"675478488","firm":"INSTAPILL PRIVATE LIMITED","registrant":"INSTAPILL PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 46, 45, 44, 43, 98-101, 1st Phase KIADB Industrial Area, Harohalli Taluk, Bengaluru South District, Bengaluru, Karnataka 562112, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"562112","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.68682,"lon":77.50493,"prec":"postcode","geo":"562112, Harohalli taluk, Bengaluru South, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3036230268","3017542362","3035948306","3013884349"]},{"id":"3012032037","fei":"3012032037","duns":"915854723","firm":"Sun Pharmaceutical Industries Limited","registrant":"Sun Pharmaceutical Industries Limited","parent":"Sun Pharmaceutical Industries","ticker":"SUNPHARMA","addr":"Plot No. 4708, GIDC Industrial Estate, Ankleshwar, Gujarat 393002, India (IND)","city":"Ankleshwar","state":"Gujarat","pin":"393002","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs.","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs.","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs.","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"Village Ganguwala , Tehsil-Paonta Sahib , Sirmaur, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs.","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"3 Industrial Area , Dewas, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"03/12/2014","notes":"","charges":[{"code":"60","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"}],"firm_as_published":"Sun Pharmaceutical Industries Limited - Karkhadi","address_as_published":"A Plot No 817 , Village Karkhadi , Padra, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"12/07/2022","notes":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","charges":[{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"05/12/2025"},{"code":"55","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/07/2022"},{"code":"56","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Antibiotics (Human/Animal)","published":"12/07/2022"},{"code":"58","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/07/2022"},{"code":"60","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"61","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"62","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"63","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"64","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"65","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"66","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"}],"firm_as_published":"Sun Pharmaceutical Industries Ltd.","address_as_published":"Halol - Baroda Highway , Halol, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-06-08T04:00:00Z","posted":"2022-07-19T13:20:00Z","subject":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","office":"Office of Human and Animal Foods- East Division 3","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","company_as_published":"New Sun Inc.","match":"token"},{"date":"2022-08-17T04:00:00Z","posted":"2022-09-06T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Office of Human and Animal Food Operations – West Division 5","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","company_as_published":"Sun Sen Co., Inc.","match":"token"},{"date":"2023-04-07T04:00:00Z","posted":"2023-08-15T13:20:00Z","subject":"Unapproved New Drugs/Misbranded","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","company_as_published":"STPCA Inc. dba Sun Ten Laboratories","match":"token"},{"date":"2023-05-10T04:00:00Z","posted":"2023-05-30T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations West II","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","company_as_published":"Rhodes Legacy Inc DBA Sun Sprouts","match":"token"},{"date":"2023-10-16T04:00:00Z","posted":"2023-10-16T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","company_as_published":"Sun Pharmaceutical Industries Ltd.","match":"exact"},{"date":"2024-06-18T04:00:00Z","posted":"2024-07-02T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","company_as_published":"Sun Pharmaceutical Industries Limited","match":"exact"},{"date":"2025-03-12T04:00:00Z","posted":"2025-03-18T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","company_as_published":"Waxhead Sun Defense Company","match":"token"}],"events":[{"d":"2025-05-12","k":"charge","t":"66-40 charge 54 — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-03-12","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-06-18","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-10-16","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-05-10","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","x":"Division of Human and Animal Food Operations West II"},{"d":"2023-04-07","k":"letter","t":"Unapproved New Drugs/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","x":"Division of Human and Animal Food Operations West V"},{"d":"2022-12-07","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24"},{"d":"2022-08-17","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","x":"Office of Human and Animal Food Operations – West Division 5"},{"d":"2022-06-08","k":"letter","t":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","x":"Office of Human and Animal Foods- East Division 3"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2014-03-12","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs."},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs"}],"first":"2009-09-10","last":"2025-05-12","sibs":["3003227153","3004520113","3003892973","3002809586","3003952717","3002807979","3010027135","3002871444","3007627683","3004561553"],"colo":["3003722314","3003696998","3014078015","3003650383","3010079586","3006851796","3030461518","3004086396","3006509185","3002806711","3008314161","3004006229"]},{"id":"3027305199","fei":"3027305199","duns":"643566449","firm":"Alder Biochem Private Limited","registrant":"Alder Biochem Private Limited","parent":null,"ticker":null,"addr":"Plot No. 4A, Sara Industrial Estate, Selaqui, Dehradun, Uttarakhand 248197, India (IND)","city":"Dehradun","state":"Uttarakhand","pin":"248197","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":30.37952,"lon":77.8445,"prec":"postcode","geo":"248197, Vikasnagar, Dehradun, Uttarakhand, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3026297382","fei":"3026297382","duns":"930261025","firm":"Ceyone Life Sciences Private Limited","registrant":"Ceyone Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Plot No. 4M, 4M1 & 4L, APSEZ, De-Notified Area, Atchutapuram, Lalamkoduru (V), Rambilli (M), Anakapalli, Andhra Pradesh 531011, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3012160303","3026032363","3023346708","3011538548","3015709928","3013629262","3014255847","3020444708","3030613318","3013580138","3021487911","3016965485"]},{"id":"3004011473","fei":"3004011473","duns":"915837971","firm":"Intas Pharmaceuticals Limited","registrant":"Intas Pharmaceuticals Limited","parent":"Intas (unlisted)","ticker":null,"addr":"Plot No. 5 to 14, Pharmez, Near Village Matoda, Sarkhej-Bavla Highway, No. 8-A, Taluka Sanand, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/01/2023","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"11/15/2024"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"11/15/2024"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"11/15/2024"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"11/15/2024"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"11/15/2024"},{"code":"55","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/01/2023"},{"code":"56","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Antibiotics (Human/Animal)","published":"06/01/2023"},{"code":"58","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"06/01/2023"},{"code":"60","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"61","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"62","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"63","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"64","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"65","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"66","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"}],"firm_as_published":"Intas Pharmaceuticals Limited","address_as_published":"Pharmez Plot No 5-14 , Near Village Matoda; Sarkhej-Bavla Highway No 8-A , Sanand, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"11/14/2023","notes":"These products are excluded from DWPE: Azacitidine Injection 62I[][]99 Clonazepam Tablet 61M[][]06 Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"04/09/2024"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"04/09/2024"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"04/09/2024"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"04/09/2024"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"04/09/2024"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"11/14/2023"},{"code":"56","notes":"All Drug and Drug Products;","product":"Antibiotics (Human/Animal)","published":"11/14/2023"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"11/14/2023"},{"code":"60","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"61","notes":"All Drug and Drug Products; These products are excluded from DWPE: Clonazepam Tablet 61M[][]06","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"62","notes":"All Drug and Drug Products; These products are excluded from DWPE: Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95 Azacitidine Injection 62I[][]99","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"63","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"64","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/14/2023"}],"firm_as_published":"Intas Pharmaceuticals Limited","address_as_published":"Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi , Sarkhej-Bavla Highway, Taluka-Sanand, Matoda , Ahmedabad, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2023-07-28T04:00:00Z","posted":"2023-08-01T14:31:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"},{"date":"2023-11-21T05:00:00Z","posted":"2023-11-28T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"},{"date":"2026-03-30T04:00:00Z","posted":"2026-04-28T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"}],"events":[{"d":"2026-03-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2023-11-21","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-11-14","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE: Azacitidine Injection 62I[][]99 Clonazepam Tablet 61M[][]06 Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95"},{"d":"2023-07-28","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-06-01","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32"}],"first":"2023-06-01","last":"2026-03-30","sibs":["3003722314","3005890633","3007277149","3003157498","3011743992"],"colo":["3041646841","3036725850","3043068534","3017085815","3010661577","3008957483","3007938603","3010254278","3029456823","3007621329","3008725987","3008394466"]},{"id":"3026587575","fei":"3026587575","duns":"932580580","firm":"SNJ Labs Pvt. Ltd.","registrant":"SNJ Labs Pvt. Ltd.","parent":null,"ticker":null,"addr":"Plot No. 5 to 16, Survey No. 137 Ta. Kotda Sangani, Dist. Rajkot, Padavala, Gujarat 360024, India (IND)","city":"Padavala","state":"Gujarat","pin":"360024","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.16483,"lon":70.79569,"prec":"postcode","geo":"360024, Kotda Sangani Taluka, Rajkot, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3033182608"]},{"id":"3009298759","fei":"3009298759","duns":"677604336","firm":"Symbiotec Pharmalab Limited","registrant":"Symbiotec Pharmalab Limited","parent":null,"ticker":null,"addr":"Plot No. 5, 6, 7 & 8, Pharma Zone, Phase II, Indore Special Economic Zone, Pithampur, Dhar, Madhya Pradesh 454774, India (IND)","city":"Dhar","state":"Madhya Pradesh","pin":"454774","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.59103,"lon":75.65274,"prec":"postcode","geo":"454774, Bhondiya, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005122933"],"colo":["3018011011","3030695079","3006086845"]},{"id":"3039411568","fei":"3039411568","duns":"738678449","firm":"Difgen pharmaceuticals Pvt Ltd.","registrant":"DifGen Pharmaceuticals LLC","parent":null,"ticker":null,"addr":"Plot No. 5, Neovantage Science and technology park, Genome Valley, Shamirpet, Medchal-Malkajgir, Hyderabad, Telangana 500101, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500101","ops":["ANALYSIS","STERILIZE"],"expires":"12/31/2026","lat":17.65514,"lon":78.60618,"prec":"postcode","geo":"500101, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3038110405"],"colo":["3038528882","PLOT NO 4C,MN SC & TECH BIOTECH PARK GENOME VALLEY, TURKAPALLY, SHAMIRPET RANGAREDDY, Hyderabad, Telangana 500101, India (IND)","3006587427","3017754175","3039644403","3006527015","3009522832","3012704791","3030495702","3009883135","3011960448"]},{"id":"3048757914","fei":"3048757914","duns":"771676668","firm":"3XPER INNOVENTURE LIMITED","registrant":"3XPER INNOVENTURE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 53 Part, 54 and 55, Palachur Village, Pellakur Mandal, Naidupeta, Tirupati, Andhra Pradesh 524421, India (IND)","city":"Tirupati","state":"Andhra Pradesh","pin":"524421","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.62776,"lon":79.43528,"prec":"tail3","geo":"Srinivasa Flyover, Tirupathi Urban, Tataiah Gunta, Tirupati, Tirupati (Urban), Tirupati, Andhra Pradesh, 517500, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3011895410"]},{"id":"3027308441","fei":"3027308441","duns":"930147721","firm":"USV Private Limited","registrant":"USV Private Limited","parent":null,"ticker":null,"addr":"Plot No. 538 to 540, 597 to 618, 619 to 625, GIDC Industrial Area - Savli, Taluka – Savli, Manjusar, Vadodara, Gujarat 391775, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391775","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.44087,"lon":73.20032,"prec":"postcode","geo":"391775, Savli Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002977798","3004086192"],"colo":["3017642539","3038882417"]},{"id":"3030355960","fei":"3030355960","duns":"643563664","firm":"SURAJ LABORATORIES PRIVATE LIMITED","registrant":"SURAJ LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 540/3P1, 540/4 & 540/5, KIADB Kadechur Badiyal Industrial Area Kadechur Village, Yadgir, KARNATAKA 585221, India (IND)","city":"Yadgir","state":"Karnataka","pin":"585221","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.57388,"lon":77.25266,"prec":"postcode","geo":"585221, Yadagiri taluku, Yadgir, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038475692","3031204878","3043148873","3038159483"]},{"id":"3042698816","fei":"3042698816","duns":"859994462","firm":"Vibrant Pharmachem Private Limited","registrant":"Vibrant Pharmachem Private Limited","parent":null,"ticker":null,"addr":"Plot No. 57, 58, 69 & 70, Raichur Growth Centre, Raichur, Karnataka 584134, India (IND)","city":"Raichur","state":"Karnataka","pin":"584134","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.28522,"lon":77.31796,"prec":"postcode","geo":"584134, Rayachuru taluku, Raichur, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008306018","3007197995"]},{"id":"3008494993","fei":"3008494993","duns":"650051147","firm":"Synbiotics Limited","registrant":"Synbiotics Limited","parent":null,"ticker":null,"addr":"Plot No. 570, 571 & 576/A, Maitry Marg, ECP Canal Road, Luna Village, Taluka Padra, Vadodara, Gujarat 391440, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391440","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.24672,"lon":73.08544,"prec":"postcode","geo":"391440, Padra Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005183272","3009167769","3009119873","3005906909","3009219197","3006767695","3007836955","3008405956","3002806475","3010166818","3038848101"]},{"id":"3004390840","fei":"3004390840","duns":"650084754","firm":"ION EXCHANGE INDIA LIMITED","registrant":"ION EXCHANGE INDIA LIMITED","parent":null,"ticker":null,"addr":"Plot No. 5811-12-13, G.I.D.C. Estate, Ankleshwar, Dist., Bharuch, Gujarat 393002, India (IND)","city":"Bharuch","state":"Gujarat","pin":"393002","ops":["ANALYSIS","API MANUFACTURE","LABEL"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003722314","3003696998","3014078015","3003650383","3010079586","3006851796","3030461518","3004086396","3006509185","3002806711","3008314161","3004006229"]},{"id":"3017157902","fei":"3017157902","duns":"675486308","firm":"MICRO LABS LIMITED","registrant":"Micro Labs Limited","parent":null,"ticker":null,"addr":"Plot No. 58C/12, Kudulu Village, Near Hosur Road, Singasandra, Bengaluru, Karnataka 560068, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560068","ops":["ANALYSIS"],"expires":"12/31/2026","lat":12.89422,"lon":77.64235,"prec":"postcode","geo":"560068, Hosapalya, Bengaluru South City Corporation, Bengaluru, Bangalore South, Bengaluru Urban, Karnataka, India","status":1,"alerts":[],"letters":[{"date":"2024-09-10T04:00:00Z","posted":"2024-11-08T19:00:00Z","subject":"CGMP/QSR/Medical Devices/Adulterated","office":"Center for Devices and Radiological Health","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-x-ltd-692084-09102024","company_as_published":"Micro-X Ltd.","match":"token"},{"date":"2024-12-03T05:00:00Z","posted":"2024-12-17T14:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-orgo-chem-686458-12032024","company_as_published":"Micro Orgo Chem","match":"token"}],"events":[{"d":"2024-12-03","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-orgo-chem-686458-12032024","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-09-10","k":"letter","t":"CGMP/QSR/Medical Devices/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-x-ltd-692084-09102024","x":"Center for Devices and Radiological Health"}],"first":"2024-09-10","last":"2024-12-03","sibs":["3009310198","3004495158","3004939494","3005210225"],"colo":[]},{"id":"3027666582","fei":"3027666582","duns":"876818291","firm":"DAEWOONG PHARMACEUTICAL (INDIA) PRIVATE LIMITED","registrant":"DAEWOONG PHARMACEUTICAL INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 5A, APIIC, Prashanth Nagar KUKATPALLY, Hyderabad, Telangana 500072, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500072","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.49046,"lon":78.40127,"prec":"postcode","geo":"500072, Ward 115 Balaji Nagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Kukatpally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031662558","3037730318","3030171758","3017524864","3016445311","3009887324","3015443248","3030396086","3038110405"]},{"id":"3003768909","fei":"3003768909","duns":"918155912","firm":"Kumar Organic Products Limited","registrant":"Kumar Organic Products Limited","parent":null,"ticker":null,"addr":"Plot No. 60&65, Road No.3, Jigani Industrial Area, Jigani, Anekal Taluk, Bangalore, Karnataka 560105, India (IND)","city":"Bangalore","state":"Karnataka","pin":"560105","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":12.78642,"lon":77.63458,"prec":"postcode","geo":"560105, Jigani, Anekal, Bengaluru Urban, Karnataka, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"08/01/2012","notes":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).India","charges":[{"code":"53 E - - 01","notes":"","product":"Hair Conditioners (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 07","notes":"","product":"Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 99","notes":"","product":"Other Hair Preparations, Non-coloring), N.E.C.","published":"08/01/2012"},{"code":"62 C - - 41","notes":"","product":"Minoxidil (Anti-Hypertensive)","published":"08/01/2012"},{"code":"62 C - - 99","notes":"","product":"Anti-Hypertensive N.E.C.","published":"08/01/2012"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/01/2012"}],"firm_as_published":"Kumar Organic Products Limited","address_as_published":"Plot 94P, 103 & 104, Pharma Sez, HN Pura Road, KIADB Industrial Area , Hassan, Karnataka INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"08/01/2012","notes":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India","charges":[{"code":"53 E - - 01","notes":"","product":"Hair Conditioners (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 07","notes":"","product":"Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 99","notes":"","product":"Other Hair Preparations, Non-coloring), N.E.C.","published":"08/01/2012"},{"code":"62 C - - 41","notes":"","product":"Minoxidil (Anti-Hypertensive)","published":"08/01/2012"},{"code":"62 C - - 99","notes":"","product":"Anti-Hypertensive N.E.C.","published":"08/01/2012"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/01/2012"}],"firm_as_published":"Kumar Organic Products Ltd.","address_as_published":"Plot No. 60&65, Road No.3, Jigani Industrial Area, Jigani, , Anekal Taluk, Bengaluru, Karnataka INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"08/01/2012","notes":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India","charges":[{"code":"53 E - - 01","notes":"","product":"Hair Conditioners (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 07","notes":"","product":"Tonics, Dressings, and other Hair Grooming Aids (Hair Preparations, Non-coloring)","published":"08/01/2012"},{"code":"53 E - - 99","notes":"","product":"Other Hair Preparations, Non-coloring), N.E.C.","published":"08/01/2012"},{"code":"62 C - - 41","notes":"","product":"Minoxidil (Anti-Hypertensive)","published":"08/01/2012"},{"code":"62 C - - 99","notes":"","product":"Anti-Hypertensive N.E.C.","published":"08/01/2012"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/01/2012"}],"firm_as_published":"Kumar Organic Products Ltd.","address_as_published":"Anekai Taluk , S No 49; Bannerghatta Road , Bengaluru, Karnataka INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2012-08-01","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil).India"},{"d":"2012-08-01","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India"},{"d":"2012-08-01","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"NOTE; Aminexil is also known as (2;4-diaminopyrimidine 3-oxide; 2;4-DPO; diaminopyrimidine oxide; DPO; Dercose; and Kopexil);India"}],"first":"2012-08-01","last":"2012-08-01","sibs":["3009167769","3008957541"],"colo":["3007512701","3005857289","3003560263","3009882550","3015345916","3009609358","3004939494","3007648351"]},{"id":"3035948306","fei":"3035948306","duns":"766427365","firm":"DESANO PHARMACEUTICALS PRIVATE LIMITED","registrant":"DESANO PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 600-612, 3rd Phase, Harohalli KIADB Industrial Area, Bannikuppe Village, Kanakapura Taluk, Ramanagara District, Bengaluru, Karnataka 562112, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"562112","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":12.68682,"lon":77.50493,"prec":"postcode","geo":"562112, Harohalli taluk, Bengaluru South, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3036230268","3017542362","3014463103","3013884349"]},{"id":"3015955297","fei":"3015955297","duns":"860414151","firm":"ENANTI LABS PRIVATE LIMITED","registrant":"ENANTI LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 60D, J. N. Pharmacity parawada Mandal, Visakhapatnam, Andhra Pradesh 531019, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3019200343","3008250894","3009822397","3019853340"]},{"id":"3019200343","fei":"3019200343","duns":"854220450","firm":"Valary Lab Private Limited","registrant":"Valary Lab Private Limited","parent":null,"ticker":null,"addr":"Plot No. 61, J.N. Pharma City, Thanam (V), Parawada (Mandal), Anakapalli District, Andhra Pradesh 531019, India (IND)","city":"Anakapalli District","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3008250894","3009822397","3019853340"]},{"id":"3034419392","fei":"3034419392","duns":"756074460","firm":"BHAGERIA INDUSTRIES LIMITED","registrant":"BHAGERIA JAJODIA PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 6102/10, IV Phase, G.I.D.C. Valsad, VAPI, GUJARAT 396195, India (IND)","city":"VAPI","state":"Gujarat","pin":"396195","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":20.36447,"lon":72.9263,"prec":"postcode","geo":"396195, Vapi Taluka, Valsad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004414652","3006688078","3009765202","3004810446","3007850324","3008460260"]},{"id":"3009627283","fei":"3009627283","duns":"918602111","firm":"Hikal Limited","registrant":"Hikal Limited","parent":null,"ticker":null,"addr":"Plot No. 629/630-B, GIDC Estate, Panoli, Bharuch, Gujarat 394116, India (IND)","city":"Bharuch","state":"Gujarat","pin":"394116","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.53479,"lon":72.95568,"prec":"postcode","geo":"394116, Ankleshwar Taluka, Bharuch, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2025-08-20T04:00:00Z","posted":"2025-09-09T04:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hikal-limited-709370-08202025","company_as_published":"Hikal Limited","match":"exact"}],"events":[{"d":"2025-08-20","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hikal-limited-709370-08202025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-20","last":"2025-08-20","sibs":["3003560263"],"colo":["3030554615","3038149173","3003952717","3003053502","3015776899","3013151303","3004196193"]},{"id":"3011960469","fei":"3011960469","duns":"863363535","firm":"VENKAR CHEMICALS PRIVATE LIMITED","registrant":"VENKAR CHEMICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 64 to 67, Phase-II, Chemical zone, IDA-Pashamylaram,, Sangareddy, Hyderabad, Telangana 502319, India (IND)","city":"Hyderabad","state":"Telangana","pin":"502319","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003445931"],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338","3007800082"]},{"id":"3006590829","fei":"3006590829","duns":"650367605","firm":"NAKODA CHEMICALS LIMITED","registrant":"NAKODA CHEMICALS LIMITED","parent":null,"ticker":null,"addr":"Plot No. 64/A and 65/B, Phase-I IDA, Jeedimetla, Hyderabad, Telangana 500055, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500055","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3002806664","3006251127","3001319869","3018694293"]},{"id":"3005977675","fei":"3005977675","duns":"918917303","firm":"Ipca Laboratories Limited","registrant":"Ipca Laboratories Limited","parent":"Ipca Laboratories","ticker":"IPCALAB","addr":"Plot No. 65, 99 and 126, Danudyog Industrial Estate, Piparia, Silvassa, U.T. of Dadra and Nagar Haveli and Daman and Diu 396230, India (IND)","city":"Silvassa","state":"Daman","pin":"396230","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":20.24604,"lon":73.03104,"prec":"postcode","geo":"396230, Nagar Haveli, Dadra and Nagar Haveli, Dadra and Nagar Haveli and Daman and Diu, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"09/30/2009","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","charges":[{"code":"66 V - - 99","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","product":"Miscellaneous Patent Medicines, Etc.","published":"09/30/2009"}],"firm_as_published":"Ipca Laboratories Limited","address_as_published":"P.O. Sejavta , Ratlam, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug."}],"first":"2009-09-30","last":"2009-09-30","sibs":["3007574780","3027770072","3002807297","3027770075","3006057101","3009227929"],"colo":["3010758031","3005205440"]},{"id":"3043148873","fei":"3043148873","duns":"771490446","firm":"Fleming Laboratories Limited","registrant":"Fleming Laboratories Limited","parent":null,"ticker":null,"addr":"Plot No. 67, 68, 69, 70, 71, 76, 77, 78, 79, 80, Kadechur Industrial Area, Yadgir, Karnataka 585221, India (IND)","city":"Yadgir","state":"Karnataka","pin":"585221","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.57388,"lon":77.25266,"prec":"postcode","geo":"585221, Yadagiri taluku, Yadgir, Karnataka, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"10/20/2017","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/20/2017"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"10/20/2017"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"}],"firm_as_published":"Fleming Laboratories Limited","address_as_published":"Survey No 270; Nawabpet Village , Shivampet Mandal , Medak district, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"04/11/2011","notes":"All Drug Products","charges":[{"code":"55","notes":"All Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/20/2019"},{"code":"56","notes":"All Drug Products","product":"Antibiotics (Human/Animal)","published":"04/11/2011"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"61","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"62","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"63","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"64","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"65","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"66","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"}],"firm_as_published":"Fleming Laboratories Limited","address_as_published":"Plot No , 48 Temple Rock Enclave; Tarbund Road , Secunderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2019-12-20","k":"charge","t":"66-40 charge 55 — Pharm Necess & Ctnr For Drug/Bio","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 60 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 61 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 62 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 63 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 64 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 65 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 66 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2017-10-20","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"},{"d":"2011-04-11","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"}],"first":"2011-04-11","last":"2022-05-26","sibs":["3007931994","3018566556"],"colo":["3038475692","3031204878","3030355960","3038159483"]},{"id":"3005259207","fei":"3005259207","duns":"862202793","firm":"Piramal Pharma Limited","registrant":"Piramal Pharma Limited","parent":"Piramal Pharma","ticker":"PPLPHARMA","addr":"Plot No. 67-70, Sector II, District Dhar, Pithampur, Madhya Pradesh 454775, India (IND)","city":"Pithampur","state":"Madhya Pradesh","pin":"454775","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"10/27/2009","notes":"","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"10/27/2009"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"10/29/2009"}],"firm_as_published":"Piramal Enterprises Ltd","address_as_published":"1 Nirlon Complex , Western Express Highway , Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[],"events":[{"d":"2009-10-29","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2009-10-27","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""}],"first":"2009-10-27","last":"2009-10-29","sibs":["3008763768","3008394466","3003803288"],"colo":["3010453141","3007574780","3016480976","3006456888","3008565058","3008581988","3005594847","3038913994","3016268582","3014281041","3008861587","3043782814"]},{"id":"3008250894","fei":"3008250894","duns":"650490191","firm":"RAKS Pharma Pvt. Limited","registrant":"RAKS Pharma Pvt. Limited","parent":null,"ticker":null,"addr":"Plot No. 68, Jawaharlal Nehru Pharma City, Parawada (M), Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005737619"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3009822397","3019853340"]},{"id":"3029445647","fei":"3029445647","duns":"642473543","firm":"SHODHANA LABORATORIES PRIVATE LIMITED","registrant":"SHODHANA LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 69, J.N.Pharma City, Road No.8, Parawada, Visakhapatnam, Visakhapatnam 531021, India (IND)","city":"Visakhapatnam","state":null,"pin":"531021","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3010836438"],"colo":["3021138307","3007083664","3014406503","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163","3038912601"]},{"id":"3013914542","fei":"3013914542","duns":"675474672","firm":"OPTIMUS PHARMA PRIVATE LIMITED","registrant":"OPTIMUS PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 73/B & 73/B/2, EPIP, Pashamylaram (V), Patancheru (M), Sangareddy, Telangana, 502307 India, Hyderabad, TELANGANA 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["ANALYSIS","LABEL","MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167","3005075182"]},{"id":"3009656696","fei":"3009656696","duns":"675826655","firm":"Prudence Pharma Chem","registrant":"PRUDENCE PHARMA CHEM","parent":null,"ticker":null,"addr":"Plot No. 7407, Behind Lyka Labs, GIDC Estate, Ankleshwar, Gujarat 393002, India (IND)","city":"Ankleshwar","state":"Gujarat","pin":"393002","ops":["ANALYSIS"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003722314","3003696998","3014078015","3003650383","3010079586","3006851796","3030461518","3004086396","3006509185","3002806711","3008314161","3004006229"]},{"id":"3011524794","fei":"3011524794","duns":"650882322","firm":"LAURUS SYNTHESIS PRIVATE LIMITED","registrant":"LAURUS SYNTHESIS PRIVATE LIMITED","parent":"Laurus Labs","ticker":"LAURUSLABS","addr":"Plot No. 74B, Jawaharlal Nehru Pharma City, Parawada, Anakapalli, Andhra Pradesh 531021, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531021","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3030127492"],"colo":["3021138307","3007083664","3014406503","3029445647","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163","3038912601"]},{"id":"3003973520","fei":"3003973520","duns":"915838629","firm":"Centaur Pharmaceuticals Private Limited","registrant":"Centaur Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"Plot No. 75,76,76/1 & 74 Chikhloli, MIDC, Ambernath (West),Thane, Maharashtra 421501, India (IND)","city":"Thane","state":"Maharashtra","pin":"421501","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":19.20622,"lon":73.18433,"prec":"postcode","geo":"421501, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2023-06-05T04:00:00Z","posted":"2023-07-18T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"07/21/2026","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centaur-pharmaceuticals-private-ltd-651080-06052023","company_as_published":"Centaur Pharmaceuticals Private Ltd.","match":"exact"},{"date":"2023-07-25T04:00:00Z","posted":"2023-08-01T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centaur-pharmaceuticals-private-ltd-655231-07252023","company_as_published":"Centaur Pharmaceuticals Private Ltd.","match":"exact"}],"events":[{"d":"2023-07-25","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centaur-pharmaceuticals-private-ltd-655231-07252023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-06-05","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centaur-pharmaceuticals-private-ltd-651080-06052023","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2023-06-05","last":"2023-07-25","sibs":["3013630102","3008861619"],"colo":["3010957801"]},{"id":"3006216494","fei":"3006216494","duns":"677604366","firm":"Gulbrandsen Technologies India Private Limited","registrant":"Gulbrandsen Technologies India Private Limited","parent":null,"ticker":null,"addr":"Plot No. 761/A Jhagadia GIDC, Jhagadia, Dist. Bharuch, Gujarat 393110, India (IND)","city":"Dist. Bharuch","state":"Gujarat","pin":"393110","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.6831,"lon":73.17284,"prec":"postcode","geo":"393110, Jhagadiya Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3010331979","3019101447"]},{"id":"3009822397","fei":"3009822397","duns":"915838120","firm":"Vasudha pharma chem limited","registrant":"Vasudha Pharma Chem Limited","parent":null,"ticker":null,"addr":"Plot No. 79 Jawaharlal Nehru Pharma city, Thanam (V), Parawada (M),, Ankapalli (D), Andhra Pradesh 531019, India (IND)","city":"Ankapalli (D)","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012160303","3002093078"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3019853340"]},{"id":"3004944629","fei":"3004944629","duns":"916438583","firm":"Sandoz Private Limited","registrant":"Sandoz Private Limited","parent":null,"ticker":null,"addr":"Plot No. 8-A/2 and 8-B, TTC Industrial Area Kalwe Block, Village Dighe, Navi Mumbai, Maharashtra 400708, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400708","ops":["ANALYSIS","MANUFACTURE","PACK","REPACK"],"expires":"12/31/2026","lat":19.16979,"lon":73.00462,"prec":"postcode","geo":"400708, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3027620173"],"colo":["3005658262","3009890383","3014425346"]},{"id":"3014425346","fei":"3014425346","duns":"675482528","firm":"Par Formulations Private Limited","registrant":"Par Health USA, LLC","parent":null,"ticker":null,"addr":"Plot No. 8-A1/2 Kalwa Block, TTC Industrial Area Thane- Belapur Road, MIDC Digha-Airoli, Navi Mumbai, Maharashtra 400708, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400708","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.16979,"lon":73.00462,"prec":"postcode","geo":"400708, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2026-04-15T04:00:00Z","posted":"2026-04-21T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/par-health-usa-llc-endo-usa-inc-722121-04152026","company_as_published":"Par Health USA, LLC & Endo USA, Inc.","match":"token"}],"events":[{"d":"2026-04-15","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/par-health-usa-llc-endo-usa-inc-722121-04152026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-04-15","last":"2026-04-15","sibs":["3007027193","3016268582"],"colo":["3005658262","3009890383","3004944629","3027620173"]},{"id":"3041230546","fei":"3041230546","duns":"771413125","firm":"OZONE LIFESCIENCE","registrant":"OZONE LIFESCIENCE","parent":null,"ticker":null,"addr":"Plot No. 8006/2, GIDC Estate, Ankleshwar, Ankleshwar, Gujarat 393002, India (IND)","city":"Ankleshwar","state":"Gujarat","pin":"393002","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003722314","3003696998","3014078015","3003650383","3010079586","3006851796","3030461518","3004086396","3006509185","3002806711","3008314161","3004006229"]},{"id":"3015447224","fei":"3015447224","duns":"861588041","firm":"SR Generics Private Limited","registrant":"SR Generics Private Limited","parent":null,"ticker":null,"addr":"Plot No. 80C, Road No -20,Jawaharlal Nehru Pharma City, Parawada, Anakapalli, Andhra pradesh 531021, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531021","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163","3038912601"]},{"id":"3019853340","fei":"3019853340","duns":"873680863","firm":"MAHI DRUGS PRIVATE LIMITED","registrant":"MAHI DRUGS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 82, J.N. Pharma City, Parawada,, Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2022-08-15T04:00:00Z","posted":"2022-09-13T13:20:00Z","subject":"Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions","office":"Center for Food Safety and Applied Nutrition (CFSAN)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mahi-frozen-foods-637152-08152022","company_as_published":"Mahi Frozen Foods","match":"token"}],"events":[{"d":"2022-08-15","k":"letter","t":"Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mahi-frozen-foods-637152-08152022","x":"Center for Food Safety and Applied Nutrition (CFSAN)"}],"first":"2022-08-15","last":"2022-08-15","sibs":[],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3005485158","fei":"3005485158","duns":"924839850","firm":"ZENARA PHARMA PRIVATE LIMITED","registrant":"Manik Reddy Pullagurla","parent":null,"ticker":null,"addr":"Plot No. 83/B, 84, 87 to 96, Phase III, IDA Cherlapally, Hyderabad, Telangana 500051, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500051","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.66875,"lon":77.58989,"prec":"tail2","geo":"Hyderabad, Zahirabad mandal, Sangareddy, Telangana, 502220, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021375472"]},{"id":"3004483648","fei":"3004483648","duns":"918316485","firm":"RESONANCE LABORATORIES PRIVATE LIMITED","registrant":"RESONANCE LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 8C & 9A, KIADB Industrial Area, Bashettihalli, Doddaballapur, Bengaluru, KA 561203, India (IND)","city":"Bengaluru","state":null,"pin":"561203","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.33957,"lon":77.49855,"prec":"postcode","geo":"561203, Doddaballapura taluk, Bengaluru North, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3017501030"]},{"id":"3010758031","fei":"3010758031","duns":"650309284","firm":"KusuMa PharMa","registrant":"KusuMa PharMa","parent":null,"ticker":null,"addr":"Plot No. 9 & 10, Survey No. 61/2, Masat Village, Silvassa, Dadra Nagar Haveli 396230, India (IND)","city":"Silvassa","state":"Dadra","pin":"396230","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":20.24604,"lon":73.03104,"prec":"postcode","geo":"396230, Nagar Haveli, Dadra and Nagar Haveli, Dadra and Nagar Haveli and Daman and Diu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005977675","3005205440"]},{"id":"3008581988","fei":"3008581988","duns":"918596409","firm":"CIPLA LIMITED","registrant":"CIPLA LIMITED","parent":"Cipla","ticker":"CIPLA","addr":"Plot No. 9 &10 Indore Special Economic Zone, Phase II - Pithampur, District Dhar, Indore, Madhya Pradesh 454775, India (IND)","city":"Indore","state":"Madhya Pradesh","pin":"454775","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"03/14/2017","notes":"","charges":[{"code":"66 S - - 51","notes":"","product":"Tadalafil","published":"03/14/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"03/14/2017"}],"firm_as_published":"Cipla LTD","address_as_published":"Khasra No. 509/1-2 & 520 , Vii-Bhagwanpur , Bhagwanpur, Uttaranchal INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-66","list":"red","since":"10/09/2013","notes":"","charges":[{"code":"60 W - - 16","notes":"","product":"Mebendazole (Anthelmintic)","published":"10/09/2013"}],"firm_as_published":"Cipla Limited","address_as_published":"Patalganga Industrial Area , Plot No A-2, A-33, A-37/2/2, A-42 , Raigad, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"},{"alert":"66-66","list":"red","since":"10/18/2010","notes":"","charges":[{"code":"64 U C S 06","notes":"","product":"Finasteride (Inhibitor (Decarboxylase)), Human - Rx/Single Ingredient, Active Pharm Ingred/Chems for Further Manuf","published":"10/18/2010"}],"firm_as_published":"Cipla, Ltd.","address_as_published":"Plots D-7, D-22, D-27 , M.I.D.C. Industrial Area, Taluka-Daund , Kurkumbh Village, Dist. Pune, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"}],"letters":[{"date":"2023-11-17T05:00:00Z","posted":"2023-11-21T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-660904-11172023","company_as_published":"Cipla Limited","match":"exact"}],"events":[{"d":"2023-11-17","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-660904-11172023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2017-03-14","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2013-10-09","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2010-10-18","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""}],"first":"2010-10-18","last":"2023-11-17","sibs":["3005857289","3004081307","3002806702","3002806710","3002806691"],"colo":["3010453141","3007574780","3016480976","3006456888","3008565058","3005259207","3005594847","3038913994","3016268582","3014281041","3008861587","3043782814"]},{"id":"3009451765","fei":"3009451765","duns":"677604682","firm":"Vijayasri Organics Private Limited","registrant":"Vijayasri Organics Private Limited","parent":null,"ticker":null,"addr":"Plot No. 9, Jawaharlal Nehru Pharma City Parawada, Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008408466"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3002806664","fei":"3002806664","duns":"918607727","firm":"Laxai Life Sciences Private Limited","registrant":"Laxai Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Plot No. 9/A, Phase-III, Jeedimetla, Quthubullapur,, Medchal-Malkajgiri District, Telangana 500055, India (IND)","city":"Medchal-Malkajgiri District","state":"Telangana","pin":"500055","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3006251127","3001319869","3018694293"]},{"id":"3018004432","fei":"3018004432","duns":"860350860","firm":"FORTSCHRITT HEALTHCARE LIMITED","registrant":"FORTSCHRITT HEALTHCARE LIMITED","parent":null,"ticker":null,"addr":"Plot No. 91/2, DIC Industrial Area Baddi, Solan, HP 173205, India (IND)","city":"Solan","state":null,"pin":"173205","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":30.94458,"lon":76.80677,"prec":"postcode","geo":"173205, Baddi, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3006370533","3013950309","3003897648","3006785414","3031304848","3007187282","3012536712","3041778294","3005757050","3005430968","3004738570"]},{"id":"3022125340","fei":"3022125340","duns":"565270798","firm":"Biocon Biosphere Limited","registrant":"Biocon Limited","parent":"Biocon","ticker":"BIOCON","addr":"Plot No. 95, Visakha Pharmacity, SEZ, Jawaharlal Nehru Pharma City, Paravada (M), Anakapalli, Andhra Pradesh 531021, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531021","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3043619916"],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3013656125","3008570863","3010823443","3012575874","3027357163","3038912601"]},{"id":"3005594847","fei":"3005594847","duns":"650323801","firm":"Medilux Laboratories Private Limited","registrant":"Medilux Laboratories PVT Ltd","parent":null,"ticker":null,"addr":"Plot No. 98-99, Sector -1, Industrial Area, Pithampur, Dist. Dhar, Pithampur, Madhya Pradesh 454775, India (IND)","city":"Pithampur","state":"Madhya Pradesh","pin":"454775","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3010453141","3007574780","3016480976","3006456888","3008565058","3005259207","3008581988","3038913994","3016268582","3014281041","3008861587","3043782814"]},{"id":"3004373180","fei":"3004373180","duns":"918598095","firm":"Unichem Laboratories Limited","registrant":"Unichem Laboratories Limited, India","parent":null,"ticker":null,"addr":"Plot No. 99, MIDC Area, Roha, Raigad, Maharashtra 402116, India (IND)","city":"Raigad","state":"Maharashtra","pin":"402116","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":18.43661,"lon":73.15174,"prec":"postcode","geo":"402116, Roha Taluka, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004082076","3005497507","3006456888","3013585679"],"colo":[]},{"id":"3008768274","fei":"3008768274","duns":"677637710","firm":"COHANCE LIFESCIENCES LIMITED","registrant":"COHANCE LIFESCIENCES LIMITED","parent":null,"ticker":null,"addr":"Plot No. A-19/C, A-23A, & A-23B, Road No. 18, IDA Nacharam, Uppal Mandal, Medchal-Malkajgiri, Telangana 500076, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500076","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.43874,"lon":78.56145,"prec":"postcode","geo":"500076, Ward 6 Nacharam, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2026-01-30T05:00:00Z","posted":"2026-02-03T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cohance-lifesciences-limited-718812-01302026","company_as_published":"Cohance Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-01-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cohance-lifesciences-limited-718812-01302026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-01-30","last":"2026-01-30","sibs":["3003650383","3006493505","1000623515","3005554260","3019037664"],"colo":["3048143097","3003504071","3011573185","3007308467","3005851210","3011823550","3008311641","3024919921","3019773458"]},{"id":"3005343793","fei":"3005343793","duns":"677604388","firm":"Teva API India Private Ltd.","registrant":"Teva API India Private Ltd.","parent":null,"ticker":null,"addr":"Plot No. A-2, A-2/1, A-2/2 UPSIDC Industrial Area, Bijnor Road, Gajraula, Amroha (Uttar Prades 244235, India (IND)","city":"Gajraula","state":null,"pin":"244235","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":28.86696,"lon":78.22328,"prec":"postcode","geo":"244235, Dhanaura, Amroha, Uttar Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3002806710","fei":"3002806710","duns":"916940208","firm":"CIPLA LIMITED","registrant":"CIPLA LIMITED","parent":"Cipla","ticker":"CIPLA","addr":"Plot No. A-2, A-33, A-42 and A-37/2/2, Patalganga Industrial Area, Raigad, Maharashtra 410220, India (IND)","city":"Raigad","state":"Maharashtra","pin":"410220","ops":["ANALYSIS","API MANUFACTURE","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.86792,"lon":73.16278,"prec":"postcode","geo":"410220, Panvel Subdistrict, Raigad, Maharashtra, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"03/14/2017","notes":"","charges":[{"code":"66 S - - 51","notes":"","product":"Tadalafil","published":"03/14/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"03/14/2017"}],"firm_as_published":"Cipla LTD","address_as_published":"Khasra No. 509/1-2 & 520 , Vii-Bhagwanpur , Bhagwanpur, Uttaranchal INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-66","list":"red","since":"10/09/2013","notes":"","charges":[{"code":"60 W - - 16","notes":"","product":"Mebendazole (Anthelmintic)","published":"10/09/2013"}],"firm_as_published":"Cipla Limited","address_as_published":"Patalganga Industrial Area , Plot No A-2, A-33, A-37/2/2, A-42 , Raigad, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"},{"alert":"66-66","list":"red","since":"10/18/2010","notes":"","charges":[{"code":"64 U C S 06","notes":"","product":"Finasteride (Inhibitor (Decarboxylase)), Human - Rx/Single Ingredient, Active Pharm Ingred/Chems for Further Manuf","published":"10/18/2010"}],"firm_as_published":"Cipla, Ltd.","address_as_published":"Plots D-7, D-22, D-27 , M.I.D.C. Industrial Area, Taluka-Daund , Kurkumbh Village, Dist. Pune, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"}],"letters":[{"date":"2023-11-17T05:00:00Z","posted":"2023-11-21T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-660904-11172023","company_as_published":"Cipla Limited","match":"exact"}],"events":[{"d":"2023-11-17","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-660904-11172023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2017-03-14","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2013-10-09","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2010-10-18","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""}],"first":"2010-10-18","last":"2023-11-17","sibs":["3005857289","3004081307","3002806702","3008581988","3002806691"],"colo":["3003227148","3006784730","3010437486"]},{"id":"3002807979","fei":"3002807979","duns":"650456002","firm":"Sun Pharmaceutical Industries Limited","registrant":"Sun Pharmaceutical Industries Limited","parent":"Sun Pharmaceutical Industries","ticker":"SUNPHARMA","addr":"Plot No. A-41, Industrial Area Phase-VIII A, S.A.S. Nagar, Mohali, Punjab 160071, India (IND)","city":"Mohali","state":"Punjab","pin":"160071","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":30.70302,"lon":76.70231,"prec":"postcode","geo":"160071, S.A.S. Nagar (Mohali) Tahsil, Sahibzada Ajit Singh Nagar, Punjab, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs.","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs.","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs.","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"Village Ganguwala , Tehsil-Paonta Sahib , Sirmaur, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs.","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"3 Industrial Area , Dewas, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"03/12/2014","notes":"","charges":[{"code":"60","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"}],"firm_as_published":"Sun Pharmaceutical Industries Limited - Karkhadi","address_as_published":"A Plot No 817 , Village Karkhadi , Padra, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"12/07/2022","notes":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","charges":[{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"05/12/2025"},{"code":"55","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/07/2022"},{"code":"56","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Antibiotics (Human/Animal)","published":"12/07/2022"},{"code":"58","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/07/2022"},{"code":"60","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"61","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"62","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"63","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"64","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"65","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"66","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"}],"firm_as_published":"Sun Pharmaceutical Industries Ltd.","address_as_published":"Halol - Baroda Highway , Halol, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-06-08T04:00:00Z","posted":"2022-07-19T13:20:00Z","subject":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","office":"Office of Human and Animal Foods- East Division 3","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","company_as_published":"New Sun Inc.","match":"token"},{"date":"2022-08-17T04:00:00Z","posted":"2022-09-06T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Office of Human and Animal Food Operations – West Division 5","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","company_as_published":"Sun Sen Co., Inc.","match":"token"},{"date":"2023-04-07T04:00:00Z","posted":"2023-08-15T13:20:00Z","subject":"Unapproved New Drugs/Misbranded","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","company_as_published":"STPCA Inc. dba Sun Ten Laboratories","match":"token"},{"date":"2023-05-10T04:00:00Z","posted":"2023-05-30T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations West II","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","company_as_published":"Rhodes Legacy Inc DBA Sun Sprouts","match":"token"},{"date":"2023-10-16T04:00:00Z","posted":"2023-10-16T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","company_as_published":"Sun Pharmaceutical Industries Ltd.","match":"exact"},{"date":"2024-06-18T04:00:00Z","posted":"2024-07-02T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","company_as_published":"Sun Pharmaceutical Industries Limited","match":"exact"},{"date":"2025-03-12T04:00:00Z","posted":"2025-03-18T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","company_as_published":"Waxhead Sun Defense Company","match":"token"}],"events":[{"d":"2025-05-12","k":"charge","t":"66-40 charge 54 — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-03-12","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-06-18","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-10-16","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-05-10","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","x":"Division of Human and Animal Food Operations West II"},{"d":"2023-04-07","k":"letter","t":"Unapproved New Drugs/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","x":"Division of Human and Animal Food Operations West V"},{"d":"2022-12-07","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24"},{"d":"2022-08-17","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","x":"Office of Human and Animal Food Operations – West Division 5"},{"d":"2022-06-08","k":"letter","t":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","x":"Office of Human and Animal Foods- East Division 3"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2014-03-12","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs."},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs"}],"first":"2009-09-10","last":"2025-05-12","sibs":["3003227153","3004520113","3003892973","3002809586","3003952717","3012032037","3010027135","3002871444","3007627683","3004561553"],"colo":[]},{"id":"3021389808","fei":"3021389808","duns":"854377573","firm":"Teyro Labs Private Limited","registrant":"Teyro Labs Private Limited","parent":null,"ticker":null,"addr":"Plot No. A-9/1, SIPCOT Industrial Growth Centre Oragadam, Kanchipuram District, Tamil Nadu 601301, India (IND)","city":"Kanchipuram District","state":"Tamil Nadu","pin":"601301","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.87958,"lon":80.01653,"prec":"postcode","geo":"601301, Sriperumbudur, Kanchipuram, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3011571416"]},{"id":"3005719315","fei":"3005719315","duns":"677605709","firm":"Watson Pharma Private Limited","registrant":"Watson Pharma Private Limited","parent":null,"ticker":null,"addr":"Plot No. A3-A-6, Phase 1A Verna Industrial Estate, Verna, Salcette, Goa 403722, India (IND)","city":"Salcette","state":"Goa","pin":"403722","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":15.36243,"lon":73.92597,"prec":"postcode","geo":"403722, Salcete, South Goa, Goa, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3006644152","3005124189","3008524952","3004081307","3023677905","3006230648","3004819820","3005210225"]},{"id":"3038913994","fei":"3038913994","duns":"770788555","firm":"Felix Generics Private Limited","registrant":"Felix Pharmaceuticals PVT Limited","parent":null,"ticker":null,"addr":"Plot No. A8 & A9, Special Economic Zone, Phase II, Pithampur, Dhar 454775, Madhya Pradesh, India, Dhar, Madhya Pradesh 454775, India (IND)","city":"Dhar","state":"Madhya Pradesh","pin":"454775","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3015612053","3014281041"],"colo":["3010453141","3007574780","3016480976","3006456888","3008565058","3005259207","3008581988","3005594847","3016268582","3008861587","3043782814","3010165392"]},{"id":"3008327597","fei":"3008327597","duns":"677604181","firm":"INGA PHARMACEUTICALS","registrant":"INGA PHARMACEUTICALS","parent":null,"ticker":null,"addr":"Plot No. B-1 (pt.), Phase II, Zone-A MEPZ-Special Economic Zone, NH-45, Tambaram, Chennai, Tamil Nadu 600045, India (IND)","city":"Chennai","state":"Tamil Nadu","pin":"600045","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":12.92891,"lon":80.11441,"prec":"postcode","geo":"600045, Tambaram, Chengalpattu, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003602532"]},{"id":"3031055543","fei":"3031055543","duns":"959968364","firm":"Analys Lab Private Limited","registrant":"Analys Lab Private Limited","parent":null,"ticker":null,"addr":"Plot No. B-10, Technocrat Industrial Estate Phase-II, Balanagar Village & Mandal, Medchal Malkajgiri Dist, Hyderabad, Telangana 500037, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500037","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.47821,"lon":78.44338,"prec":"postcode","geo":"500037, Ward 120 Balanagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Balanagar mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3013495798","3013495819"],"colo":["3016067081","3012278124","3017146711","3014798074","3009883190","3014683316","3015069609"]},{"id":"3007542588","fei":"3007542588","duns":"862273427","firm":"MIDAS CARE PHARMACEUTICALS PRIVATE LIMITED","registrant":"MIDAS CARE PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. B-16, MIDC, Waluj, Aurangabad, Maharashtra 431136, India (IND)","city":"Aurangabad","state":"Maharashtra","pin":"431136","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.83683,"lon":75.25441,"prec":"postcode","geo":"431136, Chhatrapati Sambhajinagar, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2025-08-06T04:00:00Z","posted":"2025-08-12T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","company_as_published":"K & Care Organics","match":"token"}],"events":[{"d":"2025-08-06","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-06","last":"2025-08-06","sibs":[],"colo":["3008316970","3003204330","3038105724","3008580576","3009227929","3003983454"]},{"id":"3009915929","fei":"3009915929","duns":"650565703","firm":"Glenmark Pharmaceuticals Limited","registrant":"Glenmark Pharmaceuticals Inc., USA","parent":"Glenmark Pharmaceuticals","ticker":"GLENMARK","addr":"Plot No. B-25, MIDC, Shendra, Chhatrapati Sambhajinagar (previously known as Aurangabad), Maharashtra 431154, India (IND)","city":"Chhatrapati Sambhajinagar (previously known as Aurangabad)","state":"Maharashtra","pin":"431154","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.56703,"lon":76.41646,"prec":"state","geo":"Maharashtra, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"10/25/2022","notes":"All Drug Products;","charges":[{"code":"55","notes":"All Drug Products;","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/25/2022"},{"code":"56","notes":"All Drug Products;","product":"Antibiotics (Human/Animal)","published":"10/25/2022"},{"code":"58","notes":"All Drug Products;","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"10/25/2022"},{"code":"60","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"61","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"62","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"63","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"64","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"65","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"66","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"}],"firm_as_published":"Glenmark Pharmaceuticals Limited","address_as_published":"Village Kishanpura, Baddi Nalagarh Road , Baddi , Solan, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-11-22T05:00:00Z","posted":"2022-12-06T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-637314-11222022","company_as_published":"Glenmark Pharmaceuticals Limited","match":"exact"},{"date":"2025-07-11T04:00:00Z","posted":"2025-07-22T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-708270-07112025","company_as_published":"Glenmark Pharmaceuticals Limited","match":"exact"}],"events":[{"d":"2025-07-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-708270-07112025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2022-11-22","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-637314-11222022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2022-10-25","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products;"}],"first":"2022-10-25","last":"2025-07-11","sibs":["3004672766","3008565058","3005757050"],"colo":["3004101736","3015838038","3034735246","3041504075","3009278506"]},{"id":"3008386908","fei":"3008386908","duns":"914234285","firm":"GLAND CHEMICALS PRIVATE LIMITED","registrant":"Gland Chemicals Private Limited","parent":null,"ticker":null,"addr":"Plot No. B-3, B-4,B-5 (Part) & B-6 (Part) & B-11 to B-18, SIPCOT Industrial Park, Irungattukottai, Sriperumbudur, Kanchipuram, Tamil Nadu 602117, India (IND)","city":"Kanchipuram","state":"Tamil Nadu","pin":"602117","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":12.97084,"lon":79.97635,"prec":"postcode","geo":"602117, Sriperumbudur, Kanchipuram, Tamil Nadu, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"08/01/2018","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"08/01/2018"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"08/01/2018"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"}],"firm_as_published":"Gland Chemicals Private Limited","address_as_published":"& B - 11 Plot No B - 3 , Sipcot Industrial Park; & B - 6 To B - 18 , Chennai, Tamil Nadu INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2018-08-01","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2018-08-01","last":"2022-05-26","sibs":["3000280991","3003983454"],"colo":["3027393896","3004540907"]},{"id":"3041504075","fei":"3041504075","duns":"645026130","firm":"HARMAN FINOCHEM LIMITED","registrant":"HARMAN FINOCHEM LIMITED","parent":null,"ticker":null,"addr":"Plot No. B-6, MIDC Industrial Area, Shendra, Chhatrapati Sambhajinagar, Maharashtra 431154, India (IND)","city":"Chhatrapati Sambhajinagar","state":"Maharashtra","pin":"431154","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":19.87228,"lon":75.47133,"prec":"tail3","geo":"Shendra, Chhatrapati Sambhajinagar, Maharashtra, 431201, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004101736","3015838038","3003130103"],"colo":["3034735246","3009915929","3009278506"]},{"id":"3027337476","fei":"3027337476","duns":"932595653","firm":"THURS ORGANICS PRIVATE LIMITED","registrant":"THURS ORGANICS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. B-89, Thurs Organic Private Limited Midc Lote Parshuram, Lote, Ratnagiri, MAHARASHTRA 415722, India (IND)","city":"Ratnagiri","state":"Maharashtra","pin":"415722","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.57724,"lon":73.52335,"prec":"postcode","geo":"415722, Khed Taluka, Ratnagiri, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3007497376"]},{"id":"3003602532","fei":"3003602532","duns":"916667939","firm":"PharmaZell (India) Private Limited","registrant":"Pharmazell (India) Private Limited","parent":null,"ticker":null,"addr":"Plot No. B5 & B6, Chennai, Tamilnadu 600045, India (IND)","city":"Chennai","state":null,"pin":"600045","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":12.92891,"lon":80.11441,"prec":"postcode","geo":"600045, Tambaram, Chengalpattu, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008248967"],"colo":["3008327597"]},{"id":"3031325873","fei":"3031325873","duns":"756019382","firm":"Privi Specialty Chemicals LTD.","registrant":"Privi Specialty Chemicals LTD.","parent":null,"ticker":null,"addr":"Plot No. C-10 & C-11/1, M.I.D.C, Raigad., Mahad, Maharashtra 402309, India (IND)","city":"Mahad","state":"Maharashtra","pin":"402309","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":18.23582,"lon":73.44552,"prec":"tail3","geo":"Raigad, Raigad Fort Trail, Hirkaniwadi, Mahad Taluka, Raigad, Maharashtra, 402305, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3041888751","1000283831","3015167570"]},{"id":"3002808114","fei":"3002808114","duns":"677602249","firm":"Arch Pharmalabs Limited","registrant":"Arch Pharmalabs Limited","parent":null,"ticker":null,"addr":"Plot No. C-21/22 & F40, M.I.D.C., Phase II, Manpada Road, Sagaon, Dombivli (E), Thane, Maharashtra 421 204, India (IND)","city":"Thane","state":"Maharashtra","pin":null,"ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.21118,"lon":73.09113,"prec":"tail3","geo":"Dombivli East, Dombivli, Kalyan-Dombivli, Kalyan Subdistrict, Thane, Maharashtra, 421201, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3007556480"],"colo":[]},{"id":"3027545288","fei":"3027545288","duns":"957792980","firm":"RAVI BIOLIFE PRIVATE LIMITED","registrant":"RAVI BIOLIFE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. C-21/9, M I D C Industrial Area, Taloja, Padghe, Raigad, Maharashtra 410208, India (IND)","city":"Raigad","state":"Maharashtra","pin":"410208","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.06884,"lon":73.11504,"prec":"postcode","geo":"410208, Panvel, Panvel Subdistrict, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3014207480","3008177314","3009934288","3044141181","3005048741","3004947391","3004455093","3015986431","3025922195","3003908605"]},{"id":"3014150265","fei":"3014150265","duns":"675473030","firm":"Mankind Pharma Limited","registrant":"Mankind Pharma Limited","parent":"Mankind Pharma","ticker":"MANKIND","addr":"Plot No. C-23, 23(A), C-24 & C-25, RIICO Industrial Area, Sotanala, Kotputli-Behror, Rajasthan 301701, India (IND)","city":"Kotputli-Behror","state":"Rajasthan","pin":"301701","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":27.88871,"lon":76.28325,"prec":"postcode","geo":"301701, Behror Tehsil, Kotputli-Behror, Rajasthan, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3013913573","3009083745"],"colo":[]},{"id":"3038199887","fei":"3038199887","duns":"772679169","firm":"BEC Chemicals Private Limited","registrant":"BEC Chemicals Private Limited","parent":null,"ticker":null,"addr":"Plot No. C7, GIDC Saykha, Taluk Vagra, Bharuch,  392140, India (IND)","city":"Bharuch","state":null,"pin":"392140","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.85613,"lon":72.80491,"prec":"postcode","geo":"392140, Vagra Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3020983424"]},{"id":"3005404478","fei":"3005404478","duns":"863882638","firm":"Meghmani LLP","registrant":"Meghmani LLP","parent":null,"ticker":null,"addr":"Plot No. CH-3, GIDC Estate, Dahej, Taluka Vagra, Bharuch, Gujarat 392130, India (IND)","city":"Bharuch","state":"Gujarat","pin":"392130","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":21.71286,"lon":72.61625,"prec":"postcode","geo":"392130, Vagra Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3030599291"],"colo":["3043800366","3040332349","3018972378","3012664809","3010027135","3014919100","3010228235","3007514214","3005737619"]},{"id":"3007005296","fei":"3007005296","duns":"650459014","firm":"AARTI PHARMALABS LIMITED","registrant":"AARTI PHARMALABS LIMITED","parent":null,"ticker":null,"addr":"Plot No. D - 53, 55, 56, 57, 59 & 60, M.I.D.C. Phase-II, Kalyan-Shil Road, Dombivli (East), Thane, Maharashtra 421204, India (IND)","city":"Thane","state":"Maharashtra","pin":"421204","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.1703,"lon":73.09164,"prec":"postcode","geo":"421204, Dombivali, Kalyan Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005256484"],"colo":["3037647985","3004985767"]},{"id":"3005782879","fei":"3005782879","duns":"677602452","firm":"EMCURE PHARMACEUTICALS LIMITED","registrant":"Emcure Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Plot No. D-24 & D-24/1, M.I.D.C. Kurkumbh, Taluka-Daund, Pune, Maharashtra 413802, India (IND)","city":"Pune","state":"Maharashtra","pin":"413802","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":18.35405,"lon":74.55832,"prec":"postcode","geo":"413802, Daund, Pune, Maharashtra, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"07/13/2015","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","charges":[{"code":"55","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Pharm Necess & Ctnr For Drug/Bio","published":"07/13/2015"},{"code":"56","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Antibiotics (Human/Animal)","published":"07/13/2015"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"61","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"62","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"63","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"64","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"65","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"66","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"}],"firm_as_published":"Emcure Pharmaceuticals Limited","address_as_published":"Plot No. P-2, I.T.B.T. Park, Phase - II, MIDC, Hinjawadi , Pune, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2015-07-13","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices"}],"first":"2015-07-13","last":"2022-05-26","sibs":["3022175565","3014595023","3006643860"],"colo":["3037146694","3002806702"]},{"id":"3018972378","fei":"3018972378","duns":"854247786","firm":"Macleods Pharmaceuticals Limited","registrant":"Macleods Pharmaceuticals Limited","parent":"Macleods (unlisted)","ticker":null,"addr":"Plot No. D-3/ 27 Dahej Road, Sambheti Village, Dahej, Bharuch, Gujarat 392130, India (IND)","city":"Bharuch","state":"Gujarat","pin":"392130","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":21.71286,"lon":72.61625,"prec":"postcode","geo":"392130, Vagra Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006363714","3018011011","3006607469","3007517881"],"colo":["3043800366","3040332349","3005404478","3012664809","3010027135","3014919100","3010228235","3007514214","3005737619","3030599291"]},{"id":"3006527015","fei":"3006527015","duns":"676413153","firm":"LAURUS LABS LIMITED","registrant":"LAURUS LABS LIMITED","parent":"Laurus Labs","ticker":"LAURUSLABS","addr":"Plot No. DS-1 & 2, IKP Knowledge Park, Genome Valley, Turkapally Village, Shamirpet Mandal, Medchal-Malkajgiri, Telangana 500101, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500101","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.65514,"lon":78.60618,"prec":"postcode","geo":"500101, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3017037090","3007083664","3011538548","3014255847"],"colo":["3038528882","PLOT NO 4C,MN SC & TECH BIOTECH PARK GENOME VALLEY, TURKAPALLY, SHAMIRPET RANGAREDDY, Hyderabad, Telangana 500101, India (IND)","3006587427","3017754175","3039644403","3039411568","3009522832","3012704791","3030495702","3009883135","3011960448"]},{"id":"3006418686","fei":"3006418686","duns":"650453124","firm":"AARTI DRUGS LTD","registrant":"AARTI DRUGS LTD","parent":null,"ticker":null,"addr":"Plot No. E - 22 MIDC, Tarapur, Tal Palghar, Dist. THANE, MAHARASHTRA 401506, India (IND)","city":"Dist. THANE","state":"Maharashtra","pin":"401506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"03/23/2015","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","charges":[{"code":"55","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Pharm Necess & Ctnr For Drug/Bio","published":"03/23/2015"},{"code":"56","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Antibiotics (Human/Animal)","published":"03/23/2015"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"},{"code":"61","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"},{"code":"62","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"},{"code":"63","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"},{"code":"64","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"},{"code":"65","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"},{"code":"66","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"}],"firm_as_published":"Aarti Drugs Ltd","address_as_published":"Midc Plot No E21 , Tarapur, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2015-03-23","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices"}],"first":"2015-03-23","last":"2022-05-26","sibs":["3011893554"],"colo":["3001174909","3003721861","3006057101","3009118300","3016577628","3016790354","3017545500","3003336449","3013633378","3018369072","3003677831","3002807512"]},{"id":"3009278506","fei":"3009278506","duns":"864496135","firm":"Wockhardt Limited","registrant":"WOCKHARDT LIMITED","parent":"Wockhardt","ticker":"WOCKPHARMA","addr":"Plot No. E-1/1, M.I.D.C. Area, Shendra, Aurangabad, Maharashtra 431154, India (IND)","city":"Aurangabad","state":"Maharashtra","pin":"431154","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":19.87184,"lon":75.47087,"prec":"tail3","geo":"Kiran Navgire, Jalna Road, Chhatrapati Sambhajinagar, Maharashtra, 431201, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"05/22/2013","notes":"All Drugs and drug products;","charges":[{"code":"55","notes":"All Drugs and drug products;","product":"Pharm Necess & Ctnr For Drug/Bio","published":"05/22/2013"},{"code":"56","notes":"All Drugs and drug products;","product":"Antibiotics (Human/Animal)","published":"05/22/2013"},{"code":"58","notes":"All Drugs and drug products;","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drugs and drug products;","product":"Human and Animal Drugs","published":"05/22/2013"},{"code":"61","notes":"All Drugs and drug products;","product":"Human and Animal Drugs","published":"05/22/2013"},{"code":"62","notes":"All Drugs and drug products","product":"Human and Animal Drugs","published":"05/22/2013"},{"code":"63","notes":"All Drugs and drug products;","product":"Human and Animal Drugs","published":"05/22/2013"},{"code":"64","notes":"All Drugs and drug products","product":"Human and Animal Drugs","published":"05/22/2013"},{"code":"65","notes":"All Drugs and drug products","product":"Human and Animal Drugs","published":"05/22/2013"},{"code":"66","notes":"All Drugs and drug products;","product":"Human and Animal Drugs","published":"05/22/2013"}],"firm_as_published":"Wockhardt Limited","address_as_published":"H - 14/2 Midc Area , Waluj , Aurangabad, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"11/26/2013","notes":"All Drug and Drug Products","charges":[{"code":"50","notes":"","product":"Color Additiv Food/Drug/Cosmetic","published":"09/28/2016"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"11/26/2013"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"09/28/2016"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2013"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2013"},{"code":"62","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/26/2013"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2013"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2013"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2013"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/26/2013"}],"firm_as_published":"Wockhardt Limited","address_as_published":"L-1, MIDC Area, Jalgaon Road 43 , Chikalthana , Aurangabad, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"08/05/2016","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"08/05/2016"},{"code":"56","notes":"All Drug and Drug Products;","product":"Antibiotics (Human/Animal)","published":"08/05/2016"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/05/2016"}],"firm_as_published":"Wockhardt, Ltd.","address_as_published":"Sf-12 Shrinathji Arcade Plot 138 , Bulk Drug Division; Karmatur Road , Ankleshwar, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs and drug products;"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2016-09-28","k":"charge","t":"66-40 charge 50 — Color Additiv Food/Drug/Cosmetic","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2016-09-28","k":"charge","t":"66-40 charge 56 — Antibiotics (Human/Animal)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2016-08-05","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"},{"d":"2013-11-26","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"},{"d":"2013-05-22","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs and drug products;"}],"first":"2013-05-22","last":"2022-05-26","sibs":["3007523885"],"colo":["3004101736","3015838038","3034735246","3009915929","3041504075"]},{"id":"3044043959","fei":"3044043959","duns":"877799284","firm":"RMC Performance Chemicals Private Limited","registrant":"RMC Performance Chemicals Private Limited","parent":null,"ticker":null,"addr":"Plot No. E-3/Part, MIDC Area, Jalgaon, Audyogik Vasahat Jalgaon, Jalgaon, Maharashtra 425003, India (IND)","city":"Jalgaon","state":"Maharashtra","pin":"425003","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":20.93747,"lon":75.608,"prec":"postcode","geo":"425003, Jalgaon, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3013284388"]},{"id":"3006057101","fei":"3006057101","duns":"918580838","firm":"Ipca Laboratories Limited","registrant":"Ipca Laboratories Limited","parent":"Ipca Laboratories","ticker":"IPCALAB","addr":"Plot No. E-41, E-129 And E-128/2, MIDC Tarapur Boisar, Palghar, Maharashtra 401506, India (IND)","city":"Palghar","state":"Maharashtra","pin":"401506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"09/30/2009","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","charges":[{"code":"66 V - - 99","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","product":"Miscellaneous Patent Medicines, Etc.","published":"09/30/2009"}],"firm_as_published":"Ipca Laboratories Limited","address_as_published":"P.O. Sejavta , Ratlam, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug."}],"first":"2009-09-30","last":"2009-09-30","sibs":["3007574780","3027770072","3002807297","3027770075","3005977675","3009227929"],"colo":["3001174909","3003721861","3006418686","3009118300","3016577628","3016790354","3017545500","3003336449","3013633378","3018369072","3003677831","3002807512"]},{"id":"3003130103","fei":"3003130103","duns":"915099662","firm":"HARMAN FINOCHEM LIMITED","registrant":"HARMAN FINOCHEM LIMITED","parent":null,"ticker":null,"addr":"Plot No. E-7, E-8, E-9 & E-53 M.I.D.C. Industrial Area, Chikalthana, Chhatrapati Sambhajinagar, Maharashtra 431006, India (IND)","city":"Chhatrapati Sambhajinagar","state":"Maharashtra","pin":"431006","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.87506,"lon":75.37945,"prec":"postcode","geo":"431006, Chhatrapati Sambhajinagar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004101736","3015838038","3041504075"],"colo":["3007523885"]},{"id":"3003925108","fei":"3003925108","duns":"676245969","firm":"AMOL PHARMACEUTICALS PRIVATE LIMITED","registrant":"AMOL PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. E1-362-363-364, Sitapura Industrial Area Sanganer, Jaipur, Rajasthan 302022, India (IND)","city":"Jaipur","state":"Rajasthan","pin":"302022","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":26.7736,"lon":75.83811,"prec":"postcode","geo":"302022, Sanganer Tehsil, Jaipur, Rajasthan, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004462816"]},{"id":"3008580576","fei":"3008580576","duns":"677602796","firm":"Curia India Private Limited","registrant":"Curia India Private Limited","parent":null,"ticker":null,"addr":"Plot No. G-1/1, 1/2, Near MIDC Water Tank MIDC Area, Waluj, Aurangabad, Maharashtra 431136, India (IND)","city":"Aurangabad","state":"Maharashtra","pin":"431136","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":19.83683,"lon":75.25441,"prec":"postcode","geo":"431136, Chhatrapati Sambhajinagar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008316970","3003204330","3038105724","3007542588","3009227929","3003983454"]},{"id":"3027393896","fei":"3027393896","duns":"931839496","firm":"Esjay Pharma Private Limited","registrant":"Esjay Pharma Private Limited","parent":null,"ticker":null,"addr":"Plot No. G28 & 29, 12th Main Road, SIPCOT Industrial Park, Sriperumbudur Taluka, Irungattukottai, Kancheepuram, TN 602117, India (IND)","city":"Kancheepuram","state":null,"pin":"602117","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.97084,"lon":79.97635,"prec":"postcode","geo":"602117, Sriperumbudur, Kanchipuram, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008386908","3004540907"]},{"id":"3008763840","fei":"3008763840","duns":"650517571","firm":"SITEC LABS LIMITED","registrant":"SITEC LABS LIMITED","parent":null,"ticker":null,"addr":"Plot No. Gen 40 and PAP-A-417, TTC Industrial Area, MIDC, Behind Millennium Business Park, Near NELCO Bus Stop, Mahape, Navi Mumbai, Maharashtra 400710, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400710","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.10848,"lon":73.02077,"prec":"postcode","geo":"400710, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005866424"],"colo":["3009565091","3010408344","3027402875"]},{"id":"3009227929","fei":"3009227929","duns":"677603004","firm":"IPCA LABORATORIES LIMITED","registrant":"Ipca Laboratories Limited","parent":"Ipca Laboratories","ticker":"IPCALAB","addr":"Plot No. H-4, MIDC, Waluj, Chhatrapati Sambhajinagar, Maharashtra 431136, India (IND)","city":"Chhatrapati Sambhajinagar","state":"Maharashtra","pin":"431136","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.83683,"lon":75.25441,"prec":"postcode","geo":"431136, Chhatrapati Sambhajinagar, Maharashtra, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"09/30/2009","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","charges":[{"code":"66 V - - 99","notes":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug.","product":"Miscellaneous Patent Medicines, Etc.","published":"09/30/2009"}],"firm_as_published":"Ipca Laboratories Limited","address_as_published":"P.O. Sejavta , Ratlam, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"8/22/2008. Piccan Teething Remedy. The combination of paracetamol (acetaminophen) and diphenhydramine has not been evaluated under the OTC Drug Review for use in relieving children's teething pain and associated troubles. The labeling contains structure/function claims; such as using the product to relieve childrens teething pains; making this product a drug under 201(g)(1) of the FFDCA. Further; we are not aware that this drug is generally accepted as safe and effective for its labeled uses. Consequently; this drug appears to be a new drug."}],"first":"2009-09-30","last":"2009-09-30","sibs":["3007574780","3027770072","3002807297","3027770075","3005977675","3006057101"],"colo":["3008316970","3003204330","3038105724","3007542588","3008580576","3003983454"]},{"id":"3013140488","fei":"3013140488","duns":"871410164","firm":"R.L.Fine Chem Private Limited","registrant":"R.L.Fine Chem Private Limited","parent":null,"ticker":null,"addr":"Plot No. IP-27-29, KIADB Industrial Area, 1st Phase, Kudumalakunte Village, Chikkabalapur District, Gowribidanoor, Bengaluru, Karnataka 561208, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"561208","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.62658,"lon":77.5264,"prec":"postcode","geo":"561208, Gauribidanuru taluk, Chikkaballapura, Karnataka, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"03/17/2015","notes":"Medical claims on product label","charges":[{"code":"53 E - - 99","notes":"","product":"Other Hair Preparations, Non-coloring), N.E.C.","published":"08/22/2016"},{"code":"53 L - - 99","notes":"","product":"Other Skin Care Preparations, N.E.C.","published":"03/17/2015"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/22/2016"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"03/17/2015"}],"firm_as_published":"ASHWIN FINE CHEMICALS AND PHARMACEUTICALS","address_as_published":"3, SHANTA INDL EST , OFF: W E HIGHWAY , KASHIMIRA, THANE - MAHARAHSTRA INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"05/29/2014","notes":"","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"05/29/2014"}],"firm_as_published":"Fine Processors Private Ltd.","address_as_published":"D - 27 Sector Ii , Noida, Uttar Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-66","list":"red","since":"09/30/2009","notes":"11/2/2000","charges":[{"code":"60 W - S 26","notes":"","product":"Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","published":"03/27/2019"}],"firm_as_published":"Fine Chemicals","address_as_published":"89 Princess Street , Bombay, MS INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"token"}],"letters":[{"date":"2023-04-28T04:00:00Z","posted":"2023-05-16T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations East V","response":"","closeout":"11/17/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/garys-cheesecakes-fine-desserts-654471-04282023","company_as_published":"Gary’s Cheesecakes & Fine Desserts","match":"token"},{"date":"2023-06-20T04:00:00Z","posted":"2023-06-27T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-kecheng-fine-chemicals-co-ltd-659389-06202023","company_as_published":"Chengdu KeCheng Fine Chemicals Co., Ltd.","match":"token"}],"events":[{"d":"2023-06-20","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-kecheng-fine-chemicals-co-ltd-659389-06202023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-04-28","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/garys-cheesecakes-fine-desserts-654471-04282023","x":"Division of Human and Animal Food Operations East V"},{"d":"2019-03-27","k":"charge","t":"66-66 charge 60 W - S 26 — Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2016-08-22","k":"charge","t":"66-41 charge 53 E - - 99 — Other Hair Preparations, Non-coloring), N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2016-08-22","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2015-03-17","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Medical claims on product label"},{"d":"2014-05-29","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":"11/2/2000"}],"first":"2009-09-30","last":"2023-06-20","sibs":["3005560263","3039941881"],"colo":[]},{"id":"3009118300","fei":"3009118300","duns":"957318738","firm":"Melody Healthcare Pvt. Ltd.","registrant":"Melody Healthcare Pvt Ltd","parent":null,"ticker":null,"addr":"Plot No. J-61, Midc, Tarapur Industrial Area Tarapur, Palghar, Maharashtra 401506, India (IND)","city":"Palghar","state":"Maharashtra","pin":"401506","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3001174909","3003721861","3006418686","3006057101","3016577628","3016790354","3017545500","3003336449","3013633378","3018369072","3003677831","3002807512"]},{"id":"3016577628","fei":"3016577628","duns":"867064606","firm":"SHAKTI LIFESCIENCE PRIVATE LIMITED","registrant":"SHAKTI LIFESCIENCE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. K2, Salwad, Navapur Road, Tarapur M.I.D.C Boisar, Palghar, MH 401506, India (IND)","city":"Palghar","state":null,"pin":"401506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3001174909","3003721861","3006418686","3006057101","3009118300","3016790354","3017545500","3003336449","3013633378","3018369072","3003677831","3002807512"]},{"id":"3004455093","fei":"3004455093","duns":"675472749","firm":"Sharon Bio-Medicine Limited","registrant":"Sharon BioMedicine Limited","parent":null,"ticker":null,"addr":"Plot No. L-6, MIDC, Taloja,, Raigad, Maharashtra 410208, India (IND)","city":"Raigad","state":"Maharashtra","pin":"410208","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.06884,"lon":73.11504,"prec":"postcode","geo":"410208, Panvel, Panvel Subdistrict, Raigad, Maharashtra, India","status":2,"alerts":[{"alert":"66-76","list":"red","since":"07/13/2016","notes":"All Drug & Drug Products","charges":[{"code":"55","notes":"All Drug & Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"07/13/2016"},{"code":"56","notes":"All Drug & Drug Products","product":"Antibiotics (Human/Animal)","published":"07/13/2016"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug & Drug Products","product":"Human and Animal Drugs","published":"07/13/2016"},{"code":"61","notes":"All Drug & Drug Products","product":"Human and Animal Drugs","published":"07/13/2016"},{"code":"62","notes":"All Drug & Drug Products","product":"Human and Animal Drugs","published":"07/13/2016"},{"code":"63","notes":"All Drug & Drug Products","product":"Human and Animal Drugs","published":"07/13/2016"},{"code":"64","notes":"All Drug & Drug Products","product":"Human and Animal Drugs","published":"07/13/2016"},{"code":"65","notes":"All Drug & Drug Products","product":"Human and Animal Drugs","published":"07/13/2016"},{"code":"66","notes":"All Drug & Drug Products","product":"Human and Animal Drugs","published":"07/13/2016"}],"firm_as_published":"Sharon Bio-Medicine Limited","address_as_published":"Khasra No 1027/28/30/37, Selaqui Industrial Area , Central Hope Town , Dehradun, Uttarakhand INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_1155.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-76 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1155.html","x":""},{"d":"2016-07-13","k":"alert","t":"Listed on import alert 66-76","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1155.html","x":"All Drug & Drug Products"}],"first":"2016-07-13","last":"2022-05-26","sibs":[],"colo":["3014207480","3008177314","3009934288","3044141181","3005048741","3004947391","3027545288","3015986431","3025922195","3003908605"]},{"id":"3006086845","fei":"3006086845","duns":"871401908","firm":"THINQ Pharma-CRO Limited","registrant":"THINQ Pharma-CRO Limited","parent":null,"ticker":null,"addr":"Plot No. M 40 & 42, Sector 3, Dhar, Pithampur, Madhya Pradesh 454774, India (IND)","city":"Pithampur","state":"Madhya Pradesh","pin":"454774","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.59103,"lon":75.65274,"prec":"postcode","geo":"454774, Bhondiya, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3018011011","3030695079","3009298759"]},{"id":"3016268582","fei":"3016268582","duns":"877850053","firm":"Par Formulations Private Limited","registrant":"Par Health USA, LLC","parent":null,"ticker":null,"addr":"Plot No. M 82 & M 83, Industrial Area, Dhar, Madhya Pradesh 454775, India (IND)","city":"Dhar","state":"Madhya Pradesh","pin":"454775","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2026-04-15T04:00:00Z","posted":"2026-04-21T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/par-health-usa-llc-endo-usa-inc-722121-04152026","company_as_published":"Par Health USA, LLC & Endo USA, Inc.","match":"token"}],"events":[{"d":"2026-04-15","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/par-health-usa-llc-endo-usa-inc-722121-04152026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-04-15","last":"2026-04-15","sibs":["3007027193","3014425346"],"colo":["3010453141","3007574780","3016480976","3006456888","3008565058","3005259207","3008581988","3005594847","3038913994","3014281041","3008861587","3043782814"]},{"id":"3014281041","fei":"3014281041","duns":"675481843","firm":"Felix Generics Private Limited","registrant":"Felix Pharmaceuticals PVT Limited","parent":null,"ticker":null,"addr":"Plot No. M-24,25,26 & 27, Special Economic Zone Phase II, Pithampur, Dhar, Madhya Pradesh 454775, India (IND)","city":"Dhar","state":"Madhya Pradesh","pin":"454775","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3015612053","3038913994"],"colo":["3010453141","3007574780","3016480976","3006456888","3008565058","3005259207","3008581988","3005594847","3016268582","3008861587","3043782814","3010165392"]},{"id":"3006599894","fei":"3006599894","duns":"864354789","firm":"ENALTEC LABS PRIVATE LIMITED","registrant":"Enaltec Labs Private Limited","parent":null,"ticker":null,"addr":"Plot No. N -61, Additional Ambernath MIDC, Anand Nagar, Ambernath East, Thane, Maharashtra 421506, India (IND)","city":"Thane","state":"Maharashtra","pin":"421506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021189141","3009887190","3008232264","3013999816","3018052045","3016575313","3006809732","3027577650","3010166801","3032073298","3008374690","3009051788"]},{"id":"3016790354","fei":"3016790354","duns":"771974247","firm":"Emil Pharmaceuticals Industries Private Ltd.","registrant":"EMIL PHARMACEUTICAL INDUSTRIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. N- 12, Emil Pharmaceuticals Industries Private Limited, Salwade, Midc Tarapur, Kolwade, Dist. Palghar, Maharashtra 401506, India (IND)","city":"Dist. Palghar","state":"Maharashtra","pin":"401506","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3001174909","3003721861","3006418686","3006057101","3009118300","3016577628","3017545500","3003336449","3013633378","3018369072","3003677831","3002807512"]},{"id":"3017545500","fei":"3017545500","duns":"675627643","firm":"CIRON DRUGS AND PHARMACEUTICALS PVT LTD","registrant":"CIRON DRUGS AND PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. N-119/1 and N-119/2, MIDC, Tarapur, Maharashtra 401506, India (IND)","city":"Tarapur","state":"Maharashtra","pin":"401506","ops":["ANALYSIS","LABEL","MANUFACTURE"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3001174909","3003721861","3006418686","3006057101","3009118300","3016577628","3016790354","3003336449","3013633378","3018369072","3003677831","3002807512"]},{"id":"3006809732","fei":"3006809732","duns":"643554130","firm":"Zydus Lifesciences Limited","registrant":"Zydus Lifesciences Limited","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Plot No. N-15, MIDC, Additional Ambernath Anandnagar, Ambernath East, Thane, Maharashtra 421506, India (IND)","city":"Thane","state":"Maharashtra","pin":"421506","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2024-08-29T04:00:00Z","posted":"2024-09-10T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"12/16/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","company_as_published":"Zydus Lifesciences Limited","match":"exact"},{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","company_as_published":"Zydus Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-29","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-29","last":"2026-06-02","sibs":["3003696998","3006595385","3008957483","3007938603","3007621329","3006026405","3002806475","3012977526","3002984011","3013712903","3005430968"],"colo":["3021189141","3009887190","3008232264","3013999816","3018052045","3016575313","3006599894","3027577650","3010166801","3032073298","3008374690","3009051788"]},{"id":"3003336449","fei":"3003336449","duns":"756062764","firm":"Bajaj Healthcare Ltd","registrant":"Baja Healthcare Ltd","parent":null,"ticker":null,"addr":"Plot No. N-178, Tarapur Industrial Area, MIDC Boisar 401506 Palghar, Boisar, Maharashtra 401506, India (IND)","city":"Boisar","state":"Maharashtra","pin":"401506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008087189"],"colo":["3001174909","3003721861","3006418686","3006057101","3009118300","3016577628","3016790354","3017545500","3013633378","3018369072","3003677831","3002807512"]},{"id":"3027577650","fei":"3027577650","duns":"863750278","firm":"CUREWORTH DRUGS & INTERMEDIATES PRIVATE LIMITED","registrant":"CUREWORTH DRUGS & INTERMEDIATES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. N-49, Additional MIDC Zone, Thane, Maharashtra 421506, India (IND)","city":"Thane","state":"Maharashtra","pin":"421506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021189141","3009887190","3008232264","3013999816","3018052045","3016575313","3006599894","3006809732","3010166801","3032073298","3008374690","3009051788"]},{"id":"3010166801","fei":"3010166801","duns":"650630457","firm":"Bioxera Pharma Private Limited","registrant":"Bioxera Pharma Private Limited","parent":null,"ticker":null,"addr":"Plot No. N-57, Additional Ambernath MIDC, Anand Nagar, Ambernath East, Dist. Thane, Ambernath, Maharashtra 421506, India (IND)","city":"Ambernath","state":"Maharashtra","pin":"421506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021189141","3009887190","3008232264","3013999816","3018052045","3016575313","3006599894","3006809732","3027577650","3032073298","3008374690","3009051788"]},{"id":"3032073298","fei":"3032073298","duns":"930037491","firm":"Supriya Lifescience Limited","registrant":"Supriya Lifescience Limited","parent":null,"ticker":null,"addr":"Plot No. N-60, MIDC, Additional Ambernath Industrial Area Ambernath, Thane, Maharashtra 421506, India (IND)","city":"Thane","state":"Maharashtra","pin":"421506","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003882508","3007497376"],"colo":["3021189141","3009887190","3008232264","3013999816","3018052045","3016575313","3006599894","3006809732","3027577650","3010166801","3008374690","3009051788"]},{"id":"3008374690","fei":"3008374690","duns":"650465441","firm":"Solara Active Pharma Sciences Limited","registrant":"SOLARA ACTIVE PHARMA SCIENCES LIMITED","parent":null,"ticker":null,"addr":"Plot No. N39/ N39-1, Anand nagar MIDC, Additional Ambernath, Ambernath (East), Mumbai, Maharashtra 421506, India (IND)","city":"Mumbai","state":"Maharashtra","pin":"421506","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003585876","3016965485","3008252997","3002808058","3011856449"],"colo":["3021189141","3009887190","3008232264","3013999816","3018052045","3016575313","3006599894","3006809732","3027577650","3010166801","3032073298","3009051788"]},{"id":"3020233232","fei":"3020233232","duns":"854248583","firm":"Finecure Pharmaceuticals LTD.","registrant":"Finecure Pharmaceuticals LTD","parent":null,"ticker":null,"addr":"Plot No. PF-5 & 6, Sanand Industrial Estate-II, Ahmedabad, Gujarat 382110, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382110","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":22.98725,"lon":72.33585,"prec":"postcode","geo":"382110, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3013353854","3014595023","3017573557"]},{"id":"3024731845","fei":"3024731845","duns":"955446947","firm":"VASA COSMETICS PRIVATE LIMITED","registrant":"VASA COSMETICS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. R-19, Ttc Industrial Area Midc, Rabale, Navi Mumbai,  400701, India (IND)","city":"Navi Mumbai","state":null,"pin":"400701","ops":["LABEL","MANUFACTURE"],"expires":"12/31/2026","lat":19.11985,"lon":73.00488,"prec":"postcode","geo":"400701, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/11/2018","notes":"For industry code 53; only products found to be drug products are subject to DWPE under this listing.","charges":[{"code":"53","notes":"","product":"Cosmetics","published":"06/11/2018"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/11/2018"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"06/11/2018"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"}],"firm_as_published":"JT Cosmetics & Chemicals Pvt Ltd.","address_as_published":"53 Kalol Gidc Estate , Panchmahal, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"}],"letters":[{"date":"2024-04-30T04:00:00Z","posted":"2024-05-07T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-cosmetics-company-limited-677948-04302024","company_as_published":"Global Cosmetics Company Limited","match":"token"}],"events":[{"d":"2024-04-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-cosmetics-company-limited-677948-04302024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2018-06-11","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"For industry code 53; only products found to be drug products are subject to DWPE under this listing."}],"first":"2018-06-11","last":"2024-04-30","sibs":[],"colo":["3027513144","3009510975","3006620783","3003484180","3007026867","3005502733","3011560035","3030219467","3013153296"]},{"id":"3007026867","fei":"3007026867","duns":"859710950","firm":"FUSION SCIENTIFIC LABORATORIES PRIVATE LIMITED","registrant":"FUSION SCIENTIFIC LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. R-656, MIDC, TTC Industrial Area, Rabale,, Navi Mumbai, Maharashtra 400701, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400701","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.11985,"lon":73.00488,"prec":"postcode","geo":"400701, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3027513144","3009510975","3006620783","3003484180","3024731845","3005502733","3011560035","3030219467","3013153296"]},{"id":"3005502733","fei":"3005502733","duns":"650479012","firm":"RioCare India Private Limited","registrant":"Riocare India Private Limited","parent":null,"ticker":null,"addr":"Plot No. R-940, TTC Industrial Area MIDC Rabale District Thane, Navi Mumbai, Maharashtra 400701, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400701","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.11985,"lon":73.00488,"prec":"postcode","geo":"400701, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3027513144","3009510975","3006620783","3003484180","3024731845","3007026867","3011560035","3030219467","3013153296"]},{"id":"3028790835","fei":"3028790835","duns":"854281351","firm":"STHREE CHEMICALS PRIVATE LIMITED","registrant":"STHREE CHEMICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. S-117 to S120, SIPCOT Industrial Complex, Phase-111, Sipcot Mugundaryapuram, Ranipet, Tamilnadu 632405, India (IND)","city":"Ranipet","state":null,"pin":"632405","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":12.91862,"lon":79.40819,"prec":"tail2","geo":"Ranipet, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3005210225","fei":"3005210225","duns":"915793658","firm":"Micro Labs Limited","registrant":"Micro Labs Limited","parent":null,"ticker":null,"addr":"Plot No. S-155 to S-159 & N1, Phase III & Phase IV, Verna Industrial Estate, Verna, Goa 403722, India (IND)","city":"Verna","state":"Goa","pin":"403722","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":15.36243,"lon":73.92597,"prec":"postcode","geo":"403722, Salcete, South Goa, Goa, India","status":1,"alerts":[],"letters":[{"date":"2024-09-10T04:00:00Z","posted":"2024-11-08T19:00:00Z","subject":"CGMP/QSR/Medical Devices/Adulterated","office":"Center for Devices and Radiological Health","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-x-ltd-692084-09102024","company_as_published":"Micro-X Ltd.","match":"token"},{"date":"2024-12-03T05:00:00Z","posted":"2024-12-17T14:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-orgo-chem-686458-12032024","company_as_published":"Micro Orgo Chem","match":"token"}],"events":[{"d":"2024-12-03","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-orgo-chem-686458-12032024","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-09-10","k":"letter","t":"CGMP/QSR/Medical Devices/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/micro-x-ltd-692084-09102024","x":"Center for Devices and Radiological Health"}],"first":"2024-09-10","last":"2024-12-03","sibs":["3009310198","3004495158","3004939494","3017157902"],"colo":["3006644152","3005124189","3008524952","3004081307","3023677905","3006230648","3004819820","3005719315"]},{"id":"3005903939","fei":"3005903939","duns":"860037948","firm":"Amneal Oncology Private Limited","registrant":"Amneal Pharmaceuticals of New York, LLC","parent":null,"ticker":null,"addr":"Plot No. S-3, S-4, S-5A, TSIIC-SEZ Village-Polepally Mandal-Jadcherla MAHABOOBNAGAR, Mahaboobnagar, TG 509301, India (IND)","city":"Mahaboobnagar","state":null,"pin":"509301","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":16.76333,"lon":78.1484,"prec":"postcode","geo":"509301, Jadcherla mandal, Mahabubnagar, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009876430","3008307735","3008294355"]},{"id":"3014595023","fei":"3014595023","duns":"675467924","firm":"Emcure Pharmaceuticals Limited","registrant":"Emcure Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Plot No. SM-14, 15 & 16/1, GIDC, Sanand - II, Charal, Tal - Sanand, Ahmedabad, Gujarat 382110, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382110","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.98725,"lon":72.33585,"prec":"postcode","geo":"382110, Sanand Taluka, Ahmedabad, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"07/13/2015","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","charges":[{"code":"55","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Pharm Necess & Ctnr For Drug/Bio","published":"07/13/2015"},{"code":"56","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Antibiotics (Human/Animal)","published":"07/13/2015"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"61","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"62","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"63","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"64","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"65","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"66","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"}],"firm_as_published":"Emcure Pharmaceuticals Limited","address_as_published":"Plot No. P-2, I.T.B.T. Park, Phase - II, MIDC, Hinjawadi , Pune, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2015-07-13","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices"}],"first":"2015-07-13","last":"2022-05-26","sibs":["3022175565","3005782879","3006643860"],"colo":["3013353854","3020233232","3017573557"]},{"id":"3015986431","fei":"3015986431","duns":"725188184","firm":"Gandhar Oil Refinery (india) limited","registrant":"Gandhar Oil Refinery india limited","parent":null,"ticker":null,"addr":"Plot No. T-10 www.gandharoil.com M.I.D.C Taloja Main Road, Raigad, Maharashtra 410208, India (IND)","city":"Raigad","state":"Maharashtra","pin":"410208","ops":["MANUFACTURE","RELABEL"],"expires":"12/31/2026","lat":19.06884,"lon":73.11504,"prec":"postcode","geo":"410208, Panvel, Panvel Subdistrict, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3014207480","3008177314","3009934288","3044141181","3005048741","3004947391","3027545288","3004455093","3025922195","3003908605"]},{"id":"3013585679","fei":"3013585679","duns":"871412278","firm":"Unichem Laboratories Limited","registrant":"Unichem Laboratories Limited, India","parent":null,"ticker":null,"addr":"Plot No. T-47, Five Star MIDC, Kagal - Hatkanangale, Kolhapur, Maharashtra 416236, India (IND)","city":"Kolhapur","state":"Maharashtra","pin":"416236","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":16.70284,"lon":74.24053,"prec":"tail2","geo":"Kolhapur, Karvir, Kolhapur, Maharashtra, 416003, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004082076","3005497507","3006456888","3004373180"],"colo":[]},{"id":"3031811219","fei":"3031811219","duns":"771705099","firm":"DEFT CHEMICALS PRIVATE LIMITED","registrant":"DEFT CHEMICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. U 16, U17, U21, U22, Industrial Area, Malanpur, Bhind, Madhya Pradesh 477116, India (IND)","city":"Bhind","state":"Madhya Pradesh","pin":"477116","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":26.4248,"lon":78.44186,"prec":"postcode","geo":"477116, Gohad, Gohad Tahsil, Bhind, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3018490749","fei":"3018490749","duns":"854129956","firm":"Lee Pharma Limited","registrant":"Lee Pharma Limited","parent":null,"ticker":null,"addr":"Plot No. V, Phase-II, VSEZ, Duvvada, Sabbavaram (M), Visakhapatnam, Andhra Pradesh 530049, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"530049","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.7523,"lon":83.17805,"prec":"tail3","geo":"Sabbavaram – Sheelanagar Port Connectivity Corridor, Ahmed Nagar, Cheemalapalle (R), Jerripotulapalem, Pendurthi, Visakhapatnam, Andhra Pradesh, 530047, India","status":1,"alerts":[],"letters":[{"date":"2023-08-28T04:00:00Z","posted":"2024-03-05T14:20:00Z","subject":"Food Labeling/Misbranded","office":"Division of Human and Animal Food Operations East VI","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gilster-mary-lee-corporation-658271-08282023","company_as_published":"Gilster-Mary Lee Corporation","match":"token"}],"events":[{"d":"2023-08-28","k":"letter","t":"Food Labeling/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gilster-mary-lee-corporation-658271-08282023","x":"Division of Human and Animal Food Operations East VI"}],"first":"2023-08-28","last":"2023-08-28","sibs":["3009103626","3030599910"],"colo":["3009056604"]},{"id":"3010031450","fei":"3010031450","duns":"650637817","firm":"ANANT PHARMACEUTICALS PRIVATE LIMITED","registrant":"ANANT PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No. W / 57 A, Additional MIDC, Anand Nagar Ambernath East, Thane, Maharashtra 421507, India (IND)","city":"Thane","state":"Maharashtra","pin":"421507","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.36536,"lon":73.36854,"prec":"tail2","geo":"Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3012664809","fei":"3012664809","duns":"862199968","firm":"Ajanta Pharma Limited","registrant":"Ajanta Pharma Limited","parent":"Ajanta Pharma","ticker":"AJANTPHARM","addr":"Plot No. Z-103 /A Dahej SEZ - Part II, Bharuch, Gujarat 392130, India (IND)","city":"Bharuch","state":"Gujarat","pin":"392130","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":21.71286,"lon":72.61625,"prec":"postcode","geo":"392130, Vagra Taluka, Bharuch, Gujarat, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"12/17/2010","notes":"India","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"12/17/2010"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"12/17/2010"},{"code":"64 H - - 99","notes":"","product":"Expectorant N.E.C.","published":"12/17/2010"}],"firm_as_published":"Ajanta Medicals PVT.LTD.","address_as_published":"71 , Ponda, Goa INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"09/30/2009","notes":"Kamagra 100mg oral tablet; 4/4/2003","charges":[{"code":"65 P D - 02","notes":"Kamagra 100mg oral tablet; 4/4/2003","product":"Sildenafil Citrate (Regulator), Human - Rx/Combination Ingredient","published":"09/13/2019"}],"firm_as_published":"Ajanta Pharma Limited","address_as_published":"318 Linking Road , Mumbai, INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"01/20/2017","notes":"Product contains Sildenafil Citrate","charges":[{"code":"65 P - - 02","notes":"","product":"Sildenafil Citrate (Regulator)","published":"01/20/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"01/20/2017"}],"firm_as_published":"Ajanta Pharma Ltd.","address_as_published":"B-4/5/6 Midc Industrial Area , District - Aurangabad , Paithan, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2019-09-13","k":"charge","t":"66-41 charge 65 P D - 02 — Sildenafil Citrate (Regulator), Human - Rx/Combination Ingredient","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Kamagra 100mg oral tablet; 4/4/2003"},{"d":"2017-01-20","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Product contains Sildenafil Citrate"},{"d":"2010-12-17","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"India"},{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Kamagra 100mg oral tablet; 4/4/2003"}],"first":"2009-09-30","last":"2019-09-13","sibs":["3006785788"],"colo":["3043800366","3040332349","3005404478","3018972378","3010027135","3014919100","3010228235","3007514214","3005737619","3030599291"]},{"id":"3010027135","fei":"3010027135","duns":"860038081","firm":"Sun Pharmaceutical Industries Limited","registrant":"Sun Pharmaceutical Industries Limited","parent":"Sun Pharmaceutical Industries","ticker":"SUNPHARMA","addr":"Plot No. Z-15, Dahej SEZ-I Industrial Area, Tal. Vagra, Bharuch, Gujarat 392130, India (IND)","city":"Bharuch","state":"Gujarat","pin":"392130","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":21.71286,"lon":72.61625,"prec":"postcode","geo":"392130, Vagra Taluka, Bharuch, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs.","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs.","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs.","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"Village Ganguwala , Tehsil-Paonta Sahib , Sirmaur, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs.","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"3 Industrial Area , Dewas, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"03/12/2014","notes":"","charges":[{"code":"60","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"}],"firm_as_published":"Sun Pharmaceutical Industries Limited - Karkhadi","address_as_published":"A Plot No 817 , Village Karkhadi , Padra, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"12/07/2022","notes":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","charges":[{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"05/12/2025"},{"code":"55","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/07/2022"},{"code":"56","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Antibiotics (Human/Animal)","published":"12/07/2022"},{"code":"58","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/07/2022"},{"code":"60","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"61","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"62","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"63","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"64","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"65","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"66","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"}],"firm_as_published":"Sun Pharmaceutical Industries Ltd.","address_as_published":"Halol - Baroda Highway , Halol, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-06-08T04:00:00Z","posted":"2022-07-19T13:20:00Z","subject":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","office":"Office of Human and Animal Foods- East Division 3","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","company_as_published":"New Sun Inc.","match":"token"},{"date":"2022-08-17T04:00:00Z","posted":"2022-09-06T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Office of Human and Animal Food Operations – West Division 5","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","company_as_published":"Sun Sen Co., Inc.","match":"token"},{"date":"2023-04-07T04:00:00Z","posted":"2023-08-15T13:20:00Z","subject":"Unapproved New Drugs/Misbranded","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","company_as_published":"STPCA Inc. dba Sun Ten Laboratories","match":"token"},{"date":"2023-05-10T04:00:00Z","posted":"2023-05-30T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations West II","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","company_as_published":"Rhodes Legacy Inc DBA Sun Sprouts","match":"token"},{"date":"2023-10-16T04:00:00Z","posted":"2023-10-16T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","company_as_published":"Sun Pharmaceutical Industries Ltd.","match":"exact"},{"date":"2024-06-18T04:00:00Z","posted":"2024-07-02T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","company_as_published":"Sun Pharmaceutical Industries Limited","match":"exact"},{"date":"2025-03-12T04:00:00Z","posted":"2025-03-18T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","company_as_published":"Waxhead Sun Defense Company","match":"token"}],"events":[{"d":"2025-05-12","k":"charge","t":"66-40 charge 54 — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-03-12","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-06-18","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-10-16","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-05-10","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","x":"Division of Human and Animal Food Operations West II"},{"d":"2023-04-07","k":"letter","t":"Unapproved New Drugs/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","x":"Division of Human and Animal Food Operations West V"},{"d":"2022-12-07","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24"},{"d":"2022-08-17","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","x":"Office of Human and Animal Food Operations – West Division 5"},{"d":"2022-06-08","k":"letter","t":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","x":"Office of Human and Animal Foods- East Division 3"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2014-03-12","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs."},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs"}],"first":"2009-09-10","last":"2025-05-12","sibs":["3003227153","3004520113","3003892973","3002809586","3003952717","3012032037","3002807979","3002871444","3007627683","3004561553"],"colo":["3043800366","3040332349","3005404478","3018972378","3012664809","3014919100","3010228235","3007514214","3005737619","3030599291"]},{"id":"3014919100","fei":"3014919100","duns":"675478845","firm":"Milan Laboratories (India) Pvt. Ltd","registrant":"Milan Laboratories (India) Private Limited","parent":null,"ticker":null,"addr":"Plot No. Z-96/A, Dahej SEZ Phase II, Dahej, Gujarat 392130, India (IND)","city":"Dahej","state":"Gujarat","pin":"392130","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":21.71286,"lon":72.61625,"prec":"postcode","geo":"392130, Vagra Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043800366","3040332349","3005404478","3018972378","3012664809","3010027135","3010228235","3007514214","3005737619","3030599291"]},{"id":"3010228235","fei":"3010228235","duns":"864147745","firm":"Torrent Pharmaceuticals Limited","registrant":"Torrent Pharma, Inc.","parent":"Torrent Pharmaceuticals","ticker":"TORNTPHARM","addr":"Plot No. Z/104 to 106, Dahej SEZ Part-II, Taluka Vagra, Dist. Bharuch, Bharuch, Gujarat 392130, India (IND)","city":"Bharuch","state":"Gujarat","pin":"392130","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":21.71286,"lon":72.61625,"prec":"postcode","geo":"392130, Vagra Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005029956","3008861587","3006763261","3012740315"],"colo":["3043800366","3040332349","3005404478","3018972378","3012664809","3010027135","3014919100","3007514214","3005737619","3030599291"]},{"id":"Plot No.- 09, Biotech Park, Phase-III, Sy No.-321, Karkapatla (V), Markook (M),, Siddipet, Telangana 502281, India (IND)","fei":"","duns":"771974237","firm":"DN Life Sciences India Private Limited","registrant":"DN Life Sciences India Private Limited","parent":null,"ticker":null,"addr":"Plot No.- 09, Biotech Park, Phase-III, Sy No.-321, Karkapatla (V), Markook (M),, Siddipet, Telangana 502281, India (IND)","city":"Siddipet","state":"Telangana","pin":"502281","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.81912,"lon":78.7342,"prec":"postcode","geo":"502281, Gajwel mandal, Siddipet, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031960635","3014404150","3032184895","3027345324","3027380201","3014483338"]},{"id":"3036652634","fei":"3036652634","duns":"766401623","firm":"Novamed Laboratories Private Limited","registrant":"Novamed Laboratories Private Limited","parent":null,"ticker":null,"addr":"Plot No.- o3, Sector-16, HSIIDC Industrial Estate, Bahadurgarh, Haryana 124507, India (IND)","city":"Bahadurgarh","state":"Haryana","pin":"124507","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":28.68627,"lon":76.92413,"prec":"postcode","geo":"124507, Bahadurgarh, Jhajjar, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3006076314","fei":"3006076314","duns":"862584104","firm":"Apotex Research Private Limited","registrant":"Apotex Inc.","parent":null,"ticker":null,"addr":"Plot No.1 And 2, Bommasandra Industrial Area, 4th Phase, Jigani Link Road, Bengaluru, Karnataka 560099, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560099","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":12.83934,"lon":77.70554,"prec":"postcode","geo":"560099, Singena Agrahara, Anekal, Bengaluru Urban, Karnataka, India","status":1,"alerts":[],"letters":[{"date":"2025-10-31T04:00:00Z","posted":"2025-11-04T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apotex-inc-714137-10312025","company_as_published":"Apotex Inc.","match":"token"}],"events":[{"d":"2025-10-31","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apotex-inc-714137-10312025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-10-31","last":"2025-10-31","sibs":["3007078919"],"colo":["3009310198","3003600340","3043619916","3003981475","3008300442","3013637926","3010164491","3035152598"]},{"id":"3013987923","fei":"3013987923","duns":"920393555","firm":"SATYADEEPTHA PHARMACEUTICALS LIMITED","registrant":"SATYADEEPTHA PHARMACEUTICALS LIMITED","parent":null,"ticker":null,"addr":"Plot No.101A, 101B, 101P1 & 100P4,Industrial Development Area, Humnabad, Bidar, Karnataka 585330, India (IND)","city":"Bidar","state":"Karnataka","pin":"585330","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.74714,"lon":77.10934,"prec":"postcode","geo":"585330, Humanabadh, Chittaguppa taluku, Bidar, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3017299509","3014002712"]},{"id":"3013580138","fei":"3013580138","duns":"873673290","firm":"ESCIENTIA ADVANCED SCIENCES PRIVATE LIMITED","registrant":"ESCIENTIA ADVANCED SCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.11, 11A, 12 and 12A, APSEZ, Atchutapuram, Anakapalli, Andhra Pradesh 531011, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3012160303","3026032363","3023346708","3011538548","3015709928","3013629262","3014255847","3020444708","3030613318","3026297382","3021487911","3016965485"]},{"id":"3003802255","fei":"3003802255","duns":"675596129","firm":"Valens Molecules Private Limited","registrant":"Valens Molecules Private Limited","parent":null,"ticker":null,"addr":"Plot No.11, Road No. 2, Industrial Estate Medchal Malkajgiri Dist., Medchal, Telangana 501401, India (IND)","city":"Medchal","state":"Telangana","pin":"501401","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62984,"lon":78.48653,"prec":"postcode","geo":"501401, Medchal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3001329340","3013629262"],"colo":["3038105776","3004443761","3014529730","3022190657"]},{"id":"3008405956","fei":"3008405956","duns":"650468064","firm":"APOTHECON PHARMACEUTICALS PRIVATE LIMITED","registrant":"APOTHECON PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.1134 to 1137,1138 A&B, 1143 A&B,1144 A&B, Padra-Jambusar Highway, At & Post:-Dabhasa, Taluka Padra,, Vadodara, GJ 391440, India (IND)","city":"Vadodara","state":null,"pin":"391440","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.24672,"lon":73.08544,"prec":"postcode","geo":"391440, Padra Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005183272","3009167769","3009119873","3005906909","3009219197","3006767695","3007836955","3008494993","3002806475","3010166818","3038848101"]},{"id":"3008248967","fei":"3008248967","duns":"878839106","firm":"Pharmazell (India) Private Limited","registrant":"Pharmazell (India) Private Limited","parent":null,"ticker":null,"addr":"Plot No.115, Visakha Pharmacity Limited. SEZ, Parawada, Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003602532"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3006251127","fei":"3006251127","duns":"650294866","firm":"Smilax Laboratories Limited","registrant":"Smilax Laboratories Limited","parent":null,"ticker":null,"addr":"Plot No.12/A, Phase III, IDA, Jeedimetla, Hyderabad, Telangana 500055, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500055","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008772334"],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3001319869","3018694293"]},{"id":"3013758337","fei":"3013758337","duns":"675466037","firm":"Etico Lifesciences Private Limited","registrant":"Etico Lifesciences Private Limited","parent":null,"ticker":null,"addr":"Plot No.121 & 122, ALEAP Industrial Estate Pragathi Nagar, Kukatpally, Hyderabad, Telangana 500090, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500090","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.53062,"lon":78.38101,"prec":"postcode","geo":"500090, Bachupally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3014250111","3026584977","3013593602","3008569405","3013580504","3027524740","3017981159","3002949099","3009483004","3003971663","3004021229","3004446312"]},{"id":"3012806860","fei":"3012806860","duns":"871290025","firm":"Ajinomoto Bio-Pharma Services India Private Limited","registrant":"Ajinomoto OmniChem N.V.","parent":null,"ticker":null,"addr":"Plot No.121 (Part) & 122, Visakha Pharmacity Limited SEZ, Parawada, Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3013127166","fei":"3013127166","duns":"651038106","firm":"LUPIN MANUFACTURING SOLUTIONS LIMITED","registrant":"LUPIN MANUFACTURING SOLUTIONS LIMITED","parent":"Lupin","ticker":"LUPIN","addr":"Plot No.130, Road No. 11, J.N. Pharma City, Parawada (M), Anakapalli District, Andhra Pradesh 531019, India (IND)","city":"Anakapalli District","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005906909"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3013841460","fei":"3013841460","duns":"867058089","firm":"FARMSON BASIC DRUGS PRIVATE LIMITED","registrant":"FARMSON BASIC DRUGS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.14, GIDC Industrial Estate, Nandesari, Vadodara, Gujarat 391340, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391340","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.4178,"lon":73.09492,"prec":"tail3","geo":"Nandesari, NH48, Vadodara, Vadodara Rural Taluka, Vadodara, Gujarat, 390001, India","status":2,"alerts":[{"alert":"66-79","list":"red","since":"10/13/2022","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","charges":[{"code":"55","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/28/2021"},{"code":"56","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Antibiotics (Human/Animal)","published":"10/28/2021"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"61","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"62","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"63","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"64","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"65","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"66","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"}],"firm_as_published":"Basic Pharma Life Science Private Ltd.","address_as_published":"Plot No.146/B GIDC Estate , Opp. New Fire Station , Ankleshwar, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","match":"token"}],"letters":[],"events":[{"d":"2022-10-13","k":"alert","t":"Listed on import alert 66-79","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2022-05-26","k":"charge","t":"66-79 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":""},{"d":"2021-10-28","k":"charge","t":"66-79 charge 55 — Pharm Necess & Ctnr For Drug/Bio","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 56 — Antibiotics (Human/Animal)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 60 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 61 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 62 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 63 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 64 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 65 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 66 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"}],"first":"2021-10-28","last":"2022-10-13","sibs":["3019101447","3017116839"],"colo":[]},{"id":"3001319869","fei":"3001319869","duns":"918457644","firm":"Granules India Limited","registrant":"Granules India Ltd","parent":"Granules India","ticker":"GRANULES","addr":"Plot No.15 A/1, Phase-III, IDA, Jeedimetla, Quthbullapur Mandal, Medchal-Malkajgiri District, Telangana 500055, India (IND)","city":"Medchal-Malkajgiri District","state":"Telangana","pin":"500055","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2025-02-26T05:00:00Z","posted":"2025-03-04T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/granules-india-limited-697115-02262025","company_as_published":"Granules India Limited","match":"exact"}],"events":[{"d":"2025-02-26","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/granules-india-limited-697115-02262025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-02-26","last":"2025-02-26","sibs":["3003723146","3004097901","3006583291","3012884557"],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3018694293"]},{"id":"3008479404","fei":"3008479404","duns":"858162416","firm":"Rampex Labs Pvt Ltd.","registrant":"Rampex Labs Pvt. Ltd.","parent":null,"ticker":null,"addr":"Plot No.151, S.V. Co-Operative Industrial Estate, Village Road, IDA Bollaram, Sangareddy, Telangana 502325, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502325","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.55317,"lon":78.34216,"prec":"postcode","geo":"502325, Jinnaram mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3010633689"],"colo":["3017000602","3041729025","3008408466","3002806851","3007136165","3009609117","3007720135","3005818804","3008932115","3005301950"]},{"id":"3038159483","fei":"3038159483","duns":"772648600","firm":"SVR Drugs and Intermediates","registrant":"SVR Drugs and Intermediates","parent":null,"ticker":null,"addr":"Plot No.165 &166, Sy No.461 & 462 Kadechur Badiyal Industrial Area, Kadechur, Saidapur, Yadgir, Karnataka 585221, India (IND)","city":"Yadgir","state":"Karnataka","pin":"585221","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":16.57388,"lon":77.25266,"prec":"postcode","geo":"585221, Yadagiri taluku, Yadgir, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038475692","3031204878","3030355960","3043148873"]},{"id":"3039941881","fei":"3039941881","duns":"854126514","firm":"R.L.FINE CHEM PRIVATE LIMITED","registrant":"R.L.FINE CHEM PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.165–182, APIIC Growth Centre, Thumakunta, Sri Sathya Sai District, Hindupur, Andhra Pradesh 515211, India (IND)","city":"Hindupur","state":"Andhra Pradesh","pin":"515211","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.73514,"lon":77.47749,"prec":"postcode","geo":"515211, Hindupur, Sri Sathya Sai, Andhra Pradesh, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"03/17/2015","notes":"Medical claims on product label","charges":[{"code":"53 E - - 99","notes":"","product":"Other Hair Preparations, Non-coloring), N.E.C.","published":"08/22/2016"},{"code":"53 L - - 99","notes":"","product":"Other Skin Care Preparations, N.E.C.","published":"03/17/2015"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/22/2016"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"03/17/2015"}],"firm_as_published":"ASHWIN FINE CHEMICALS AND PHARMACEUTICALS","address_as_published":"3, SHANTA INDL EST , OFF: W E HIGHWAY , KASHIMIRA, THANE - MAHARAHSTRA INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"05/29/2014","notes":"","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"05/29/2014"}],"firm_as_published":"Fine Processors Private Ltd.","address_as_published":"D - 27 Sector Ii , Noida, Uttar Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-66","list":"red","since":"09/30/2009","notes":"11/2/2000","charges":[{"code":"60 W - S 26","notes":"","product":"Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","published":"03/27/2019"}],"firm_as_published":"Fine Chemicals","address_as_published":"89 Princess Street , Bombay, MS INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"token"}],"letters":[{"date":"2023-04-28T04:00:00Z","posted":"2023-05-16T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations East V","response":"","closeout":"11/17/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/garys-cheesecakes-fine-desserts-654471-04282023","company_as_published":"Gary’s Cheesecakes & Fine Desserts","match":"token"},{"date":"2023-06-20T04:00:00Z","posted":"2023-06-27T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-kecheng-fine-chemicals-co-ltd-659389-06202023","company_as_published":"Chengdu KeCheng Fine Chemicals Co., Ltd.","match":"token"}],"events":[{"d":"2023-06-20","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/chengdu-kecheng-fine-chemicals-co-ltd-659389-06202023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-04-28","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/garys-cheesecakes-fine-desserts-654471-04282023","x":"Division of Human and Animal Food Operations East V"},{"d":"2019-03-27","k":"charge","t":"66-66 charge 60 W - S 26 — Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2016-08-22","k":"charge","t":"66-41 charge 53 E - - 99 — Other Hair Preparations, Non-coloring), N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2016-08-22","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2015-03-17","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Medical claims on product label"},{"d":"2014-05-29","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":"11/2/2000"}],"first":"2009-09-30","last":"2023-06-20","sibs":["3005560263","3013140488"],"colo":["3019853324"]},{"id":"3024919921","fei":"3024919921","duns":"878236174","firm":"CHEMTEX LABS INDIA PRIVATE LIMITED","registrant":"CHEMTEX LABS INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.17&22, 2nd Floor, TSllC Tech Park Road No.12, IDA Nacharam, Hyderabad, Telangana 500076, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500076","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.43874,"lon":78.56145,"prec":"postcode","geo":"500076, Ward 6 Nacharam, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3048143097","3003504071","3006493505","3011573185","3007308467","3005851210","3011823550","3008311641","3008768274","3019773458"]},{"id":"3009609117","fei":"3009609117","duns":"864151252","firm":"HY-GRO CHEMICALS PHARMTEK PRIVATE LIMITED","registrant":"HY-GRO CHEMICALS PHARMTEK PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.174, Progressive , Industrial Society Bollaram, Narsapur Tq., Medak, TS 502325, India (IND)","city":"Medak","state":null,"pin":"502325","ops":["API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":17.55317,"lon":78.34216,"prec":"postcode","geo":"502325, Jinnaram mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3017000602","3041729025","3008408466","3002806851","3007136165","3008479404","3007720135","3005818804","3008932115","3005301950"]},{"id":"3008394466","fei":"3008394466","duns":"677604091","firm":"Piramal Pharma Limited","registrant":"Piramal Pharma Limited","parent":"Piramal Pharma","ticker":"PPLPHARMA","addr":"Plot No.19 PHARMEZ, Village Matoda Sarkhej-Bawla NH. No.8A, Taluka Sanand, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["ANALYSIS"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"10/27/2009","notes":"","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"10/27/2009"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"10/29/2009"}],"firm_as_published":"Piramal Enterprises Ltd","address_as_published":"1 Nirlon Complex , Western Express Highway , Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[],"events":[{"d":"2009-10-29","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2009-10-27","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""}],"first":"2009-10-27","last":"2009-10-29","sibs":["3008763768","3005259207","3003803288"],"colo":["3041646841","3036725850","3043068534","3017085815","3010661577","3007277149","3008957483","3007938603","3010254278","3029456823","3007621329","3008725987"]},{"id":"3011893554","fei":"3011893554","duns":"756088355","firm":"AARTI DRUGS LIMITED","registrant":"AARTI DRUGS LIMITED","parent":null,"ticker":null,"addr":"Plot No.211&213, Road No.2, Gidc, Sarigam, Valsad, GUJARAT 396191, India (IND)","city":"Valsad","state":"Gujarat","pin":"396191","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":20.3801,"lon":72.93509,"prec":"postcode","geo":"396191, Vapi Taluka, Valsad, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"03/23/2015","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","charges":[{"code":"55","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Pharm Necess & Ctnr For Drug/Bio","published":"03/23/2015"},{"code":"56","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Antibiotics (Human/Animal)","published":"03/23/2015"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"},{"code":"61","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"},{"code":"62","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"},{"code":"63","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"},{"code":"64","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"},{"code":"65","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"},{"code":"66","notes":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices","product":"Human and Animal Drugs","published":"03/23/2015"}],"firm_as_published":"Aarti Drugs Ltd","address_as_published":"Midc Plot No E21 , Tarapur, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2015-03-23","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products; Problem: (GMP)Good Manufacturing Practices"}],"first":"2015-03-23","last":"2022-05-26","sibs":["3006418686"],"colo":["3030460504"]},{"id":"3047392863","fei":"3047392863","duns":"581654579","firm":"ARENE LIFE SCIENCES PRIVATE LIMITED","registrant":"Arene Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Plot No.24 B/1, sangareddy, IDA Phase 1,Patancheru, sangareddy, Patancheru, Hyderabad, Sangareddy, Telangana 502319, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502319","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3033870708","3013438177"],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3020983417","3009103626","3008154209","3015218020","3009261338","3007800082"]},{"id":"3013656125","fei":"3013656125","duns":"675482435","firm":"Sionc Pharmaceuticals Private Limited","registrant":"Sionc Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"Plot No.25 & 25A, Road No. 1, JN Pharma city, Parawada,, Visakhapatnam, Andhra Pradesh 531021, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531021","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008570863"],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3010823443","3012575874","3027357163","3038912601","3006763261"]},{"id":"3006026405","fei":"3006026405","duns":"650650802","firm":"Zydus Lifesciences Limited","registrant":"Zydus Lifesciences Limited","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Plot No.254-255, Sarkhej-Bavla National Highway No. 8A Changodar, Tal-Sanand, Ahmedabad, Gujarat 382210, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382210","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.96445,"lon":72.4238,"prec":"postcode","geo":"382210, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2024-08-29T04:00:00Z","posted":"2024-09-10T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"12/16/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","company_as_published":"Zydus Lifesciences Limited","match":"exact"},{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","company_as_published":"Zydus Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-29","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-29","last":"2026-06-02","sibs":["3003696998","3006595385","3008957483","3007938603","3007621329","3006809732","3002806475","3012977526","3002984011","3013712903","3005430968"],"colo":["3016710326","3003157498","3023491920"]},{"id":"3013884349","fei":"3013884349","duns":"675476445","firm":"Anthem Biosciences Limited","registrant":"Anthem Biosciences Limited","parent":"Anthem Biosciences","ticker":"ANTHEMBIO","addr":"Plot No.276-P & 277-P, SY. No. 20, Bannikuppe Road Harohalli Industrial Area, Phase-II, Harohalli Taluk, Bengaluru, Bengaluru South District, Karnataka 562112, India (IND)","city":"Bengaluru South District","state":"Karnataka","pin":"562112","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":12.68682,"lon":77.50493,"prec":"postcode","geo":"562112, Harohalli taluk, Bengaluru South, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3017542362","3008300442"],"colo":["3036230268","3014463103","3035948306"]},{"id":"3021487911","fei":"3021487911","duns":"565271800","firm":"SYNAPTICS LABS PRIVATE LIMITED","registrant":"SYNAPTICS LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.28-B, Industrial Park, Atchutapuram, APIIC Lalamkoduru (V), Rambilli (M), Anakapalli, Andhra Pradesh 531011, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531011","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3012160303","3026032363","3023346708","3011538548","3015709928","3013629262","3014255847","3020444708","3030613318","3026297382","3013580138","3016965485"]},{"id":"3019853324","fei":"3019853324","duns":"861469409","firm":"FLOWCHEM PHARMA PRIVATE LIMITED","registrant":"FLOWCHEM PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.2B-2 & 2C, Gollapuram Industrial Park, Hindupur Taluk, Sri Sathyasai District, Andhra Pradesh 515211, India (IND)","city":"Sri Sathyasai District","state":"Andhra Pradesh","pin":"515211","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.73514,"lon":77.47749,"prec":"postcode","geo":"515211, Hindupur, Sri Sathya Sai, Andhra Pradesh, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"01/22/2026","notes":"All Drugs and Drug Products","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"01/22/2026"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"01/22/2026"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"01/22/2026"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"01/22/2026"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"01/22/2026"},{"code":"55","notes":"All Drugs and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"01/22/2026"},{"code":"55","notes":"","product":"Pharm Necess & Ctnr For Drug/Bio","published":"01/22/2026"},{"code":"56","notes":"All Drugs and Drug Products","product":"Antibiotics (Human/Animal)","published":"01/22/2026"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"01/22/2026"},{"code":"58","notes":"All Drugs and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"01/22/2026"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"01/22/2026"},{"code":"60","notes":"All Drugs and Drug Products","product":"Human and Animal Drugs","published":"01/22/2026"},{"code":"60","notes":"","product":"Human and Animal Drugs","published":"01/22/2026"},{"code":"61","notes":"All Drugs and Drug Products","product":"Human and Animal Drugs","published":"01/22/2026"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"01/22/2026"},{"code":"62","notes":"All Drugs and Drug Products","product":"Human and Animal Drugs","published":"01/22/2026"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"01/22/2026"},{"code":"63","notes":"All Drugs and Drug Products","product":"Human and Animal Drugs","published":"01/22/2026"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"01/22/2026"},{"code":"64","notes":"All Drugs and Drug Products","product":"Human and Animal Drugs","published":"01/22/2026"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"01/22/2026"},{"code":"65","notes":"All Drugs and Drug Products","product":"Human and Animal Drugs","published":"01/22/2026"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"01/22/2026"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"01/22/2026"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"01/22/2026"}],"firm_as_published":"Flowchem Pharma Private Limited","address_as_published":"8(P) Plot No 2b - 2 - 2c , Survey No 7(P) &; Gollapuram Industrial Park , Hindupur, Andhra Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2026-03-11T04:00:00Z","posted":"2026-03-17T04:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flowchem-pharma-private-limited-720719-03112026","company_as_published":"Flowchem Pharma Private Limited","match":"exact"}],"events":[{"d":"2026-03-11","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/flowchem-pharma-private-limited-720719-03112026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2026-01-22","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs and Drug Products"}],"first":"2026-01-22","last":"2026-03-11","sibs":[],"colo":["3039941881"]},{"id":"3009883190","fei":"3009883190","duns":"677056355","firm":"LUCID LABORATORIES PRIVATE LIMITED","registrant":"LUCID LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.3 IDA, Balanagar, Hyderabad, Telangana 500037, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500037","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.47821,"lon":78.44338,"prec":"postcode","geo":"500037, Ward 120 Balanagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Balanagar mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3016067081","3012278124","3017146711","3014798074","3031055543","3013495798","3014683316","3015069609"]},{"id":"3007869619","fei":"3007869619","duns":"676190889","firm":"Zydus Hospira Oncology Private Limited","registrant":"Hospira, Inc.","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Plot No.3, Pharmez, Special Economic Zone, Sarkhej Bavla Highway, Village Matoda, Taluka Sanand, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3041646841","3036725850","3043068534","3017085815","3010661577","3007277149","3008957483","3007938603","3010254278","3029456823","3007621329","3008725987"]},{"id":"3007197995","fei":"3007197995","duns":"915076164","firm":"SHILPA PHARMA LIFESCIENCES LIMITED","registrant":"SHILPA PHARMA LIFESCIENCES LIMITED","parent":null,"ticker":null,"addr":"Plot No.33,33A & 40 to 47, Raichur Industrial Growth Centre, Chicksugur, Raichur, Karnataka 584134, India (IND)","city":"Raichur","state":"Karnataka","pin":"584134","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":16.28522,"lon":77.31796,"prec":"postcode","geo":"584134, Rayachuru taluku, Raichur, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3025560903"],"colo":["3008306018","3042698816"]},{"id":"3008570863","fei":"3008570863","duns":"864354620","firm":"SIONC PHARMACEUTICALS PRIVATE LIMITED","registrant":"SIONC PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.34A, Road No. 1, JN Pharma city, Parawada, Visakhapatnam, Andhra Pradesh 531021, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531021","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3013656125"],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3010823443","3012575874","3027357163","3038912601","3006763261"]},{"id":"3020342635","fei":"3020342635","duns":"871613680","firm":"AMRUTANJAN HEALTH CARE LIMITED","registrant":"AMRUTANJAN HEALTH CARE LIMITED","parent":null,"ticker":null,"addr":"Plot No.37,38, 39, SIDCO Pharmaceutical Complex, Thiruporur Taluk, Alathur Village, Chengalpattu, Tamil Nadu 603110, India (IND)","city":"Chengalpattu","state":"Tamil Nadu","pin":"603110","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":12.71867,"lon":80.09467,"prec":"postcode","geo":"603110, Chengalpattu, Tamil Nadu, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"12/18/2013","notes":"","charges":[{"code":"53 L - - 99","notes":"","product":"Other Skin Care Preparations, N.E.C.","published":"05/29/2014"},{"code":"55 P - - 93","notes":"","product":"Eucalyptus Oil (Pharmaceutic Necessity - Flavor)","published":"05/29/2014"},{"code":"60 L - - 99","notes":"","product":"Analgesic, N.E.C.","published":"05/29/2014"},{"code":"60 L - - 99","notes":"","product":"Analgesic, N.E.C.","published":"05/29/2014"},{"code":"60 V - - 99","notes":"","product":"Anterior Pituitary Suppressor N.E.C.","published":"05/29/2014"},{"code":"62 G - - 99","notes":"","product":"Anti-Inflammatory N.E.C.","published":"05/29/2014"},{"code":"62 G - - 99","notes":"","product":"Anti-Inflammatory N.E.C.","published":"05/29/2014"},{"code":"62 G - - 99","notes":"","product":"Anti-Inflammatory N.E.C.","published":"05/29/2014"},{"code":"66 L - - 99","notes":"","product":"Thyromimetic N.E.C.","published":"12/18/2013"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"12/18/2013"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"05/29/2014"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"05/29/2014"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"05/29/2014"}],"firm_as_published":"Amrutanjan Health Care Ltd","address_as_published":"Luz Church Rd , Chennai, INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"12/19/2013","notes":"","charges":[{"code":"53 L - - 99","notes":"","product":"Other Skin Care Preparations, N.E.C.","published":"05/29/2014"},{"code":"55 P - - 93","notes":"","product":"Eucalyptus Oil (Pharmaceutic Necessity - Flavor)","published":"05/29/2014"},{"code":"60 L - - 99","notes":"","product":"Analgesic, N.E.C.","published":"05/29/2014"},{"code":"60 L - - 99","notes":"","product":"Analgesic, N.E.C.","published":"05/29/2014"},{"code":"60 V - - 99","notes":"","product":"Anterior Pituitary Suppressor N.E.C.","published":"05/29/2014"},{"code":"62 G - - 99","notes":"","product":"Anti-Inflammatory N.E.C.","published":"05/29/2014"},{"code":"62 G - - 99","notes":"","product":"Anti-Inflammatory N.E.C.","published":"05/29/2014"},{"code":"62 G - - 99","notes":"","product":"Anti-Inflammatory N.E.C.","published":"05/29/2014"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"12/19/2013"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"05/29/2014"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"05/29/2014"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"05/29/2014"}],"firm_as_published":"Amrutanjan Health Care Ltd","address_as_published":"Plot No 14 , Industrial Developement , Hyderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"05/29/2014","notes":"","charges":[{"code":"53 L - - 99","notes":"","product":"Other Skin Care Preparations, N.E.C.","published":"05/29/2014"},{"code":"55 P - - 93","notes":"","product":"Eucalyptus Oil (Pharmaceutic Necessity - Flavor)","published":"05/29/2014"},{"code":"60 L - - 99","notes":"","product":"Analgesic, N.E.C.","published":"05/29/2014"},{"code":"60 L - - 99","notes":"","product":"Analgesic, N.E.C.","published":"05/29/2014"},{"code":"60 V - - 99","notes":"","product":"Anterior Pituitary Suppressor N.E.C.","published":"05/29/2014"},{"code":"62 G - - 99","notes":"","product":"Anti-Inflammatory N.E.C.","published":"05/29/2014"},{"code":"62 G - - 99","notes":"","product":"Anti-Inflammatory N.E.C.","published":"05/29/2014"},{"code":"62 G - - 99","notes":"","product":"Anti-Inflammatory N.E.C.","published":"05/29/2014"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"05/29/2014"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"05/29/2014"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"05/29/2014"}],"firm_as_published":"Amrutanjan Limited","address_as_published":"4245 Luz Church Road , Mylopore, TN INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[{"date":"2025-08-06T04:00:00Z","posted":"2025-08-12T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","company_as_published":"K & Care Organics","match":"token"}],"events":[{"d":"2025-08-06","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2014-05-29","k":"charge","t":"66-41 charge 53 L - - 99 — Other Skin Care Preparations, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 55 P - - 93 — Eucalyptus Oil (Pharmaceutic Necessity - Flavor)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 60 L - - 99 — Analgesic, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 60 L - - 99 — Analgesic, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 60 V - - 99 — Anterior Pituitary Suppressor N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 62 G - - 99 — Anti-Inflammatory N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 62 G - - 99 — Anti-Inflammatory N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 62 G - - 99 — Anti-Inflammatory N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 66 Y - - 99 — Exhibits - Other Drug Related Items N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 66 Y - - 99 — Exhibits - Other Drug Related Items N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 53 L - - 99 — Other Skin Care Preparations, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 55 P - - 93 — Eucalyptus Oil (Pharmaceutic Necessity - Flavor)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 60 L - - 99 — Analgesic, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 60 L - - 99 — Analgesic, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 60 V - - 99 — Anterior Pituitary Suppressor N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 62 G - - 99 — Anti-Inflammatory N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 62 G - - 99 — Anti-Inflammatory N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 62 G - - 99 — Anti-Inflammatory N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 66 Y - - 99 — Exhibits - Other Drug Related Items N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"charge","t":"66-41 charge 66 Y - - 99 — Exhibits - Other Drug Related Items N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2013-12-19","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2013-12-18","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""}],"first":"2013-12-18","last":"2025-08-06","sibs":[],"colo":["3005216842","3011361515","3005151016","3005782924","3003597293","3003747558","3009042530"]},{"id":"3026674643","fei":"3026674643","duns":"955481128","firm":"SPAR Pharma LLP","registrant":"SPAR Pharma LLP","parent":null,"ticker":null,"addr":"Plot No.3A, Jawaharlal Nehru Pharma City Parawada, Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3033182608","fei":"3033182608","duns":"650702538","firm":"ENDOC LIFECARE PRIVATE LIMITED","registrant":"ENDOC LIFECARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.4 to 7, Survey No.53, Behind Saurashtra Paper Board Shapar Veraval, Shapar Tal.Kotada Sangani, Rajkot, Gujarat 360024, India (IND)","city":"Rajkot","state":"Gujarat","pin":"360024","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.16483,"lon":70.79569,"prec":"postcode","geo":"360024, Kotda Sangani Taluka, Rajkot, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3026587575"]},{"id":"3008569405","fei":"3008569405","duns":"650690048","firm":"TEENA BIO LABS PRIVATE LIMITED","registrant":"TEENA BIO LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.41, S.V.Co-Operative Industrial Estate,Bachupally (V&M),Medchal-Malkajgiri District, Hyderabad, Telangana 500090, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500090","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.53062,"lon":78.38101,"prec":"postcode","geo":"500090, Bachupally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3031580787"],"colo":["3014250111","3026584977","3013593602","3013758337","3013580504","3027524740","3017981159","3002949099","3009483004","3003971663","3004021229","3004446312"]},{"id":"3017087685","fei":"3017087685","duns":"860477473","firm":"APISTER LIFESCIENCES PRIVATE LIMITED","registrant":"APISTER LIFESCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.41/1. G.I.D.C. Estate, Kalol, Gandhinagar, Gujarat 382725, India (IND)","city":"Gandhinagar","state":"Gujarat","pin":"382725","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":23.22113,"lon":72.5043,"prec":"postcode","geo":"382725, Kalol Taluka, Gandhinagar, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3013495798","fei":"3013495798","duns":"650984565","firm":"Analys Lab Private Limited","registrant":"Analys Lab Private Limited","parent":null,"ticker":null,"addr":"Plot No.47, 4th Floor, IDA, Balanagar Medchal Malkajgiri, Medchal Malkajgiri, Telangana 500037, India (IND)","city":"Medchal Malkajgiri","state":"Telangana","pin":"500037","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.47821,"lon":78.44338,"prec":"postcode","geo":"500037, Ward 120 Balanagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Balanagar mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3031055543","3013495819"],"colo":["3016067081","3012278124","3017146711","3014798074","3009883190","3014683316","3015069609"]},{"id":"3004196193","fei":"3004196193","duns":"650434652","firm":"Unique Chemicals (A Division of J.B. Chemicals & Pharmaceuticals Ltd.)","registrant":"Unique Chemicals (A Division of JB Chemicals Pharmaceuticals Ltd)","parent":"JB Chemicals & Pharmaceuticals","ticker":"JBCHEPHARM","addr":"Plot No.5, Phase IV, G.I.D.C Industrial Area Panoli, Gujarat, Bharuch 394116, India (IND)","city":"G.I.D.C Industrial Area Panoli","state":"Gujarat","pin":"394116","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.53479,"lon":72.95568,"prec":"postcode","geo":"394116, Ankleshwar Taluka, Bharuch, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/28/2013","notes":"All drugs and drug products","charges":[{"code":"50","notes":"","product":"Color Additiv Food/Drug/Cosmetic","published":"06/28/2013"},{"code":"55","notes":"All drugs and drug products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/28/2013"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"06/28/2013"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"61","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"62","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"63","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"64","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"65","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"66","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"}],"firm_as_published":"Unique Chemicals","address_as_published":"Shiv Mahape Gansoli , Thane Belapur Road , Navi Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-41","list":"red","since":"03/10/2017","notes":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.","charges":[{"code":"21 D - - 13","notes":"","product":"Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates","published":"03/10/2017"},{"code":"21 K - - 14","notes":"","product":"Plum, Juice, Pit Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"21 V - - 34","notes":"","product":"Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars","published":"03/10/2017"},{"code":"22 D - - 05","notes":"","product":"Bitter Melon, Juice, Vine Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"54 K - - 08","notes":"","product":"Aloe (Herbal and Botanical (not teas) II (continued))","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"395 Food Park , Rai Industrial Estate , Sonepat, Haryana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"08/25/2017","notes":"Disease claims made on product labeling.","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"08/25/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/25/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"1 Plot No 21 , Road No , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"03/10/2017","notes":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.","charges":[{"code":"21 D - - 13","notes":"","product":"Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates","published":"03/10/2017"},{"code":"21 K - - 14","notes":"","product":"Plum, Juice, Pit Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"21 V - - 34","notes":"","product":"Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars","published":"03/10/2017"},{"code":"22 D - - 05","notes":"","product":"Bitter Melon, Juice, Vine Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"54 K - - 08","notes":"","product":"Aloe (Herbal and Botanical (not teas) II (continued))","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"B- 63,2 nd Floor, Prashat Vihar. , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2017-08-25","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Disease claims made on product labeling."},{"d":"2017-03-10","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper."},{"d":"2017-03-10","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper."},{"d":"2013-06-28","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All drugs and drug products"}],"first":"2013-06-28","last":"2022-05-26","sibs":[],"colo":["3030554615","3038149173","3003952717","3003053502","3015776899","3013151303","3009627283"]},{"id":"3022185627","fei":"3022185627","duns":"871412220","firm":"Verdant Life Sciences Private Limited","registrant":"Verdant Life sciences private Limited","parent":null,"ticker":null,"addr":"Plot No.55, Jawaharlal Nehru Pharma City, Parawada, Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3032514730","fei":"3032514730","duns":"771698955","firm":"DOCTIVO LIFESCIENCES PRIVATE LIMITED","registrant":"Doctivo Lifesciences Pvt Ltd","parent":null,"ticker":null,"addr":"Plot No.56 & 61, Industrial Area, Phase-III, Sansarpur Terrace, Distt. Kangra, Kangra, Himachal Pradesh 176051, India (IND)","city":"Kangra","state":"Himachal Pradesh","pin":"176051","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":32.21191,"lon":75.91284,"prec":"postcode","geo":"176051, Nurpur, Kangra, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3012178852","fei":"3012178852","duns":"650970176","firm":"Galentic Pharma (India) Private Limited","registrant":"Galentic Pharma (India) Private Limited","parent":null,"ticker":null,"addr":"Plot No.5B & 5C Sector III, Kandla SEZ, Gandhidham, Gujarat 370230, India (IND)","city":"Gandhidham","state":"Gujarat","pin":"370230","ops":["ANALYSIS","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":23.07187,"lon":70.13171,"prec":"tail2","geo":"ગાંધીધામ, Gandhidham Taluka, Kutch, Gujarat, 370210, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3018393466","fei":"3018393466","duns":"856827513","firm":"STYRAX LIFE SCIENCES PRIVATE LIMITED","registrant":"STYRAX LIFE SCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.5G, Atchuthapuram, Rambilli Mandal, Anakapalli,  531061, India (IND)","city":"Anakapalli","state":null,"pin":"531061","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.46661,"lon":82.92852,"prec":"postcode","geo":"531061, Rambilli, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3030141315","3027536190"]},{"id":"3032184895","fei":"3032184895","duns":"565278997","firm":"BELL PHARMACEUTICALS & COSMETICS PVT.LTD","registrant":"BELL PHARMACEUTICALS & COSMETICS PVT.LTD","parent":null,"ticker":null,"addr":"Plot No.6, Biotech Park, Phase III, Karkapatla, Markook Mandal, Siddipet District, Telangana 502281, India (IND)","city":"Siddipet District","state":"Telangana","pin":"502281","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.81912,"lon":78.7342,"prec":"postcode","geo":"502281, Gajwel mandal, Siddipet, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/11/2018","notes":"For industry code 53; only products found to be drug products are subject to DWPE under this listing.","charges":[{"code":"53","notes":"","product":"Cosmetics","published":"06/11/2018"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/11/2018"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"06/11/2018"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"}],"firm_as_published":"JT Cosmetics & Chemicals Pvt Ltd.","address_as_published":"53 Kalol Gidc Estate , Panchmahal, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"}],"letters":[{"date":"2024-02-15T05:00:00Z","posted":"2024-03-05T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Division of Pharmaceutical Quality Operations III","response":"","closeout":"03/12/2026","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bell-international-laboratories-inc-669736-02152024","company_as_published":"Bell International Laboratories, Inc.","match":"token"},{"date":"2024-04-30T04:00:00Z","posted":"2024-05-07T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-cosmetics-company-limited-677948-04302024","company_as_published":"Global Cosmetics Company Limited","match":"token"}],"events":[{"d":"2024-04-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-cosmetics-company-limited-677948-04302024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2024-02-15","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bell-international-laboratories-inc-669736-02152024","x":"Division of Pharmaceutical Quality Operations III"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2018-06-11","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"For industry code 53; only products found to be drug products are subject to DWPE under this listing."}],"first":"2018-06-11","last":"2024-04-30","sibs":[],"colo":["3031960635","3014404150","Plot No.- 09, Biotech Park, Phase-III, Sy No.-321, Karkapatla (V), Markook (M),, Siddipet, Telangana 502281, India (IND)","3027345324","3027380201","3014483338"]},{"id":"3012065723","fei":"3012065723","duns":"675980468","firm":"Rusan Pharma Ltd.","registrant":"Rusan Pharma Ltd.","parent":null,"ticker":null,"addr":"Plot No.6406, 6407, 6411 G.I.D.C. Estate,, Ankleshwar, District - Bharuch, Gujarat 393 002, India (IND)","city":"District - Bharuch","state":"Gujarat","pin":null,"ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.62932,"lon":72.99451,"prec":"tail3","geo":"Ankleshwar, Ankleshwar Taluka, Bharuch, Gujarat, 393001, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3013580504","fei":"3013580504","duns":"873738457","firm":"ScieGen Pharmaceuticals India Private Limited","registrant":"ScieGen Pharmaceuticals India Private Limited","parent":null,"ticker":null,"addr":"Plot No.70 & 71, Ground Floor, ALEAP Industrial Area, Pragathi Nagar, Hyderabad, Telangana 500090, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500090","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.53062,"lon":78.38101,"prec":"postcode","geo":"500090, Bachupally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3032546867"],"colo":["3014250111","3026584977","3013593602","3013758337","3008569405","3027524740","3017981159","3002949099","3009483004","3003971663","3004021229","3004446312"]},{"id":"3027620173","fei":"3027620173","duns":"929597674","firm":"SANDOZ PRIVATE LIMITED","registrant":"Sandoz Private Limited","parent":null,"ticker":null,"addr":"Plot No.8-A 1/1, TTC Industrial Area, Kalwe Block, Village Dighe, Navi Mumbai, Maharashtra 400708, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400708","ops":["ANALYSIS","MANUFACTURE","PACK","REPACK"],"expires":"12/31/2026","lat":19.16979,"lon":73.00462,"prec":"postcode","geo":"400708, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004944629"],"colo":["3005658262","3009890383","3014425346"]},{"id":"3027524740","fei":"3027524740","duns":"931856169","firm":"M/s.EXTROVIS PRIVATE LIMITED(Unit-II)","registrant":"M/s.EXTROVIS PRIVATE LIMITED(Unit-II)","parent":null,"ticker":null,"addr":"Plot No.80&81,Sy.No.342,ALEAP Industrial Estate, Pragathinagar, Quthbullapur, Medchal-Malkajgiri, Telangana 500090, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500090","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.53062,"lon":78.38101,"prec":"postcode","geo":"500090, Bachupally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3014250111","3026584977","3013593602","3013758337","3008569405","3013580504","3017981159","3002949099","3009483004","3003971663","3004021229","3004446312"]},{"id":"3015283219","fei":"3015283219","duns":"876818318","firm":"CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED","registrant":"CRONUS PHARMA SPECIALITIES INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.9(B), Survey No. 99/1, GMR Hyderabad Aviation SEZ Ltd, Mamidipalle Village, Balapur Mandal, Shamshabad, Rangareddy, Telangana 500108, India (IND)","city":"Rangareddy","state":"Telangana","pin":"500108","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","RELABEL","REPACK"],"expires":"12/31/2026","lat":17.26546,"lon":78.36964,"prec":"tail3","geo":"Kapugadda (Shamshabad - HUA), Shamshabad, Shamshabad mandal, Ranga Reddy, Telangana, 509218, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3019037664"]},{"id":"3020177602","fei":"3020177602","duns":"860282986","firm":"Biofact Research Private Limited","registrant":"Biofact Research Private Limited","parent":null,"ticker":null,"addr":"Plot No.90/3, II Floor, Block D, APIIC Industrial Park, Gajuwaka, Visakhapatnam, Andhra Pradesh 530012, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"530012","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.71153,"lon":83.20165,"prec":"postcode","geo":"530012, Gajuwaka, Visakhapatnam, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3028729506","fei":"3028729506","duns":"861206009","firm":"Sumar Biotech LLP","registrant":"Sumar Biotech LLP","parent":null,"ticker":null,"addr":"Plot No.: 112, 113, 114; GIDC Estate Gozariya, Dist. Mehsana, Mehsana, Gujarat 382825, India (IND)","city":"Mehsana","state":"Gujarat","pin":"382825","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":23.47748,"lon":72.56429,"prec":"postcode","geo":"382825, Mahesana Taluka, Mahesana, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3031813491","fei":"3031813491","duns":"756085545","firm":"ACUTAAS CHEMICALS LIMITED","registrant":"ACUTAAS CHEMICALS LIMITED","parent":null,"ticker":null,"addr":"Plot No.: 127/1, G.I.D.C., Industrial Estate, Ankleshwar, Gujarat 393002, India (IND)","city":"Ankleshwar","state":"Gujarat","pin":"393002","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008953049"],"colo":["3003722314","3003696998","3014078015","3003650383","3010079586","3006851796","3030461518","3004086396","3006509185","3002806711","3008314161","3004006229"]},{"id":"3014247908","fei":"3014247908","duns":"915787058","firm":"Naari Pharma Private Limited","registrant":"Naari Pte Limited","parent":null,"ticker":null,"addr":"Plot No.: 14-16, 55-57, Sector-5, IIE, Pantnagar, Dist. Udham Singh Nagar, Rudrapur, Uttarakhand 263153, India (IND)","city":"Rudrapur","state":"Uttarakhand","pin":"263153","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":28.98504,"lon":79.39496,"prec":"postcode","geo":"263153, Kichha, Udham Singh Nagar, Uttarakhand, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3006165229","fei":"3006165229","duns":"677318200","firm":"MSN Pharmachem Private Limited","registrant":"MSN Pharmachem Private Limited","parent":null,"ticker":null,"addr":"Plot No.: 182 to 186, 192-A, 193 to 197 & 212/ A,B,C,D, Phase-II IDA Pashamylaram, Pashamylaram (Village), Patancheru (Mandal), Sangareddy District, Telangana 502307, India (IND)","city":"Sangareddy District","state":"Telangana","pin":"502307","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3038370049","3008800173","3008771562","1000623515","3009864167","3005075182"]},{"id":"3030141315","fei":"3030141315","duns":"737924813","firm":"Ocimum Labs Private Limited","registrant":"Ocimum Labs Private Limited","parent":null,"ticker":null,"addr":"Plot No.: 27A 42, 27A 42B & 27A 43, Industrial Park, APIIC, Rambilli Mandal, Atchuthapuram - APSEZ, Visakhapatnam, Andhra Pradesh 531061, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531061","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.46661,"lon":82.92852,"prec":"postcode","geo":"531061, Rambilli, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3018393466","3027536190"]},{"id":"3038370049","fei":"3038370049","duns":"650212926","firm":"VALENTIS LABORATORIES PRIVATE LIMITED","registrant":"VALENTIS LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.: 29, 30, 31, 32, 39, 40, 41, 42, Phase II IDA, Pashamailaram (Village), Patancheru (Mandal), Sangareddy, Telangana 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3008800173","3008771562","1000623515","3009864167","3005075182"]},{"id":"3016905331","fei":"3016905331","duns":"878839066","firm":"ORCH LABORATORIES INDIA PRIVATE LIMITED","registrant":"ORCH LABORATORIES INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.: 51 A to J & 56F, IDA Kondapally, Ibrahimpatnam (Mandal), NTR (Dist.), Vijayawada, Andhra Pradesh 521228, India (IND)","city":"Vijayawada","state":"Andhra Pradesh","pin":"521228","ops":["API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":16.62148,"lon":80.53822,"prec":"postcode","geo":"521228, Ibrahimpatnam, NTR, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3030493098","3007025492"]},{"id":"3022989727","fei":"3022989727","duns":"861995115","firm":"SHILPA BIOLOGICALS PRIVATE LIMITED","registrant":"SHILPA MEDICARE LIMITED","parent":"Shilpa Medicare","ticker":"SHILPAMED","addr":"Plot No.: 532-A, Belur Industrial Area, Dharwad, Karnataka 580011, India (IND)","city":"Dharwad","state":"Karnataka","pin":"580011","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":15.51877,"lon":74.92146,"prec":"postcode","geo":"580011, Dharawada taluku, Dharwad, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3030907257"]},{"id":"3008861587","fei":"3008861587","duns":"650537058","firm":"Torrent Pharmaceuticals Limited","registrant":"Torrent Pharma, Inc.","parent":"Torrent Pharmaceuticals","ticker":"TORNTPHARM","addr":"Plot No.: 810, Sector - III, Industrial Area, District : Dhar, Pithampur, Madhya Pradesh 454775, India (IND)","city":"Pithampur","state":"Madhya Pradesh","pin":"454775","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005029956","3010228235","3006763261","3012740315"],"colo":["3010453141","3007574780","3016480976","3006456888","3008565058","3005259207","3008581988","3005594847","3038913994","3016268582","3014281041","3043782814"]},{"id":"3009402416","fei":"3009402416","duns":"915842021","firm":"Anjan Drug Private Limited","registrant":"Anjan Drug Private Limited","parent":null,"ticker":null,"addr":"Plot No.: 85-88 & 105-109 & 112-116, SIPCOT Export Promotion Industrial Park (EPIP), Gummidipoondi, District Tiruvallur, Tamil Nadu 601201, India (IND)","city":"District Tiruvallur","state":"Tamil Nadu","pin":"601201","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.42741,"lon":80.10821,"prec":"postcode","geo":"601201, Gummidipoondi, Thiruvallur, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005782924"],"colo":["F7, SIPCOT Industrial Complex, Gummidipoondi, Gummidipoondi, Tamil Nadu 601201, India (IND)","3005035920"]},{"id":"3015380536","fei":"3015380536","duns":"675484209","firm":"NATCO PHARMA LIMITED","registrant":"NATCO PHARMA LIMITED","parent":"Natco Pharma","ticker":"NATCOPHARM","addr":"Plot No.: 89 & 90, JNPC, SEZ, Visakha Pharmacity, Parawada Mandal, Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2024-04-08T04:00:00Z","posted":"2024-04-16T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"09/29/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natco-pharma-limited-672564-04082024","company_as_published":"Natco Pharma Limited","match":"exact"}],"events":[{"d":"2024-04-08","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natco-pharma-limited-672564-04082024","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2024-04-08","last":"2024-04-08","sibs":["3009870595","3004065860","3004540906"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3027402875","fei":"3027402875","duns":"854341654","firm":"Topiox Research Centre Private Limited","registrant":"Topiox Research Centre Private Limited","parent":null,"ticker":null,"addr":"Plot No.: A-755, TTC Industrial Estate, Khairane MIDC, Navi Mumbai, Maharastra 400710, India (IND)","city":"Navi Mumbai","state":null,"pin":"400710","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.10848,"lon":73.02077,"prec":"postcode","geo":"400710, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009565091","3010408344","3008763840"]},{"id":"3008800173","fei":"3008800173","duns":"676117313","firm":"GENSYNTH LABORATORIES PRIVATE LIMITED","registrant":"GENSYNTH LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.:220, 221, 238, 239 & 243, IDA, Phase - II, Pashamylaram village, Patancheru Mandal,, Sangareddy, Telangana 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008771562","1000623515","3009864167","3005075182"]},{"id":"3014683316","fei":"3014683316","duns":"861213693","firm":"Crenza Pharmaceuticals Private Limited","registrant":"Crenza Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"Plot No.A-27P, Apie Balanagar, Medchal Malkajgiri, Hyderabad, Telangana 500037, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500037","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.47821,"lon":78.44338,"prec":"postcode","geo":"500037, Ward 120 Balanagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Balanagar mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3016067081","3012278124","3017146711","3014798074","3031055543","3009883190","3013495798","3015069609"]},{"id":"3004540907","fei":"3004540907","duns":"854403569","firm":"OrBion Pharmaceuticals Private Limited","registrant":"Bionpharma Inc.","parent":null,"ticker":null,"addr":"Plot No.B5 (Part) and B6 (Part), SIPCOT Industrial Park, Irungattukottai, Sriperumbudur, Kancheepuram, TAMIL NADU 602117, India (IND)","city":"Kancheepuram","state":"Tamil Nadu","pin":"602117","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.97084,"lon":79.97635,"prec":"postcode","geo":"602117, Sriperumbudur, Kanchipuram, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008386908","3027393896"]},{"id":"3026814124","fei":"3026814124","duns":"955475313","firm":"NAWaL ANALYTICAL LABS INDIA PRIVATE LIMITED","registrant":"NAWaL ANALYTICAL LABS INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.C-4, New SIDCO Industrial Estate Sri Nagar, Krishnagiri District, Hosur, TAMIL NADU 635109, India (IND)","city":"Hosur","state":"Tamil Nadu","pin":"635109","ops":["ANALYSIS"],"expires":"12/31/2026","lat":12.7361,"lon":77.87283,"prec":"postcode","geo":"635109, Hosur, Krishnagiri, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3020983417","fei":"3020983417","duns":"565277252","firm":"UMED PHARMA LAB PRIVATE LIMITED","registrant":"UMED PHARMA LAB PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No.G30/2, General Park, IP, Sultanpur Village Ameenpur Mandal, Sangareddy,  502319, India (IND)","city":"Sangareddy","state":null,"pin":"502319","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3009103626","3008154209","3015218020","3009261338","3007800082"]},{"id":"3009051788","fei":"3009051788","duns":"675939266","firm":"PolyPeptide Laboratories Private Limited","registrant":"Polypeptide Laboratories Private Ltd","parent":null,"ticker":null,"addr":"Plot No.K-28, Additional Midc Anand Nagar, Ambernath (East), Thane, Maharashtra 421506, India (IND)","city":"Thane","state":"Maharashtra","pin":"421506","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021189141","3009887190","3008232264","3013999816","3018052045","3016575313","3006599894","3006809732","3027577650","3010166801","3032073298","3008374690"]},{"id":"3006400591","fei":"3006400591","duns":"915899220","firm":"Biocon Limited","registrant":"Biocon Limited","parent":"Biocon","ticker":"BIOCON","addr":"Plot No: 02, Road No: 21, Jawaharlal Nehru Pharma City, Thadi Village, IDA Paravada (M), Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["1000172912","3004956855","3010164491"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3014529730","fei":"3014529730","duns":"859535995","firm":"ALR LABS PVT LTD","registrant":"ALR Labs PVT LTD","parent":null,"ticker":null,"addr":"Plot No: 10, Survey No: 444 & 445, Medchal IE, Hyderabad, Telangana 501401, India (IND)","city":"Hyderabad","state":"Telangana","pin":"501401","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62984,"lon":78.48653,"prec":"postcode","geo":"501401, Medchal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038105776","3004443761","3003802255","3022190657"]},{"id":"1000607691","fei":"1000607691","duns":"918604427","firm":"DISHMAN CARBOGEN AMCIS LIMITED","registrant":"DISHMAN CARBOGEN AMCIS LIMITED","parent":null,"ticker":null,"addr":"Plot No: 1216/11,12 & 1216/20 to 26, Phase - IV GIDC Estate, Naroda, Ahmedabad, Gujarat 382330, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382330","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":23.08459,"lon":72.68392,"prec":"postcode","geo":"382330, Asarva Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004161218"],"colo":["3038416771"]},{"id":"3039358445","fei":"3039358445","duns":"771668804","firm":"STARTECH LABS PRIVATE LIMITED","registrant":"STARTECH LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No: 179, Aleap Green Industrial Park (A-Grip), Nandigama Village, Patancheru Mandal, Sangareddy District, Hyderabad, Telangana 502300, India (IND)","city":"Hyderabad","state":"Telangana","pin":"502300","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.50828,"lon":78.24806,"prec":"postcode","geo":"502300, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011063130"],"colo":["3008656542"]},{"id":"3017116839","fei":"3017116839","duns":"871802792","firm":"FARMSON BASIC DRUGS PRIVATE LIMITED","registrant":"FARMSON BASIC DRUGS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No: 28-35, 40/1&2, B1/38, GIDC Industrial Estate, Nandesari,, Vadodara, Gujarat 391340, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391340","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.4178,"lon":73.09492,"prec":"tail3","geo":"Nandesari, NH48, Vadodara, Vadodara Rural Taluka, Vadodara, Gujarat, 390001, India","status":2,"alerts":[{"alert":"66-79","list":"red","since":"10/13/2022","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","charges":[{"code":"55","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/28/2021"},{"code":"56","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Antibiotics (Human/Animal)","published":"10/28/2021"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"61","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"62","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"63","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"64","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"65","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"66","notes":"All Drug and Drug Products; DWPE Date; 10/10/2017","product":"Human and Animal Drugs","published":"10/28/2021"}],"firm_as_published":"Basic Pharma Life Science Private Ltd.","address_as_published":"Plot No.146/B GIDC Estate , Opp. New Fire Station , Ankleshwar, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","match":"token"}],"letters":[],"events":[{"d":"2022-10-13","k":"alert","t":"Listed on import alert 66-79","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2022-05-26","k":"charge","t":"66-79 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":""},{"d":"2021-10-28","k":"charge","t":"66-79 charge 55 — Pharm Necess & Ctnr For Drug/Bio","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 56 — Antibiotics (Human/Animal)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 60 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 61 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 62 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 63 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 64 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 65 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 66 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/10/2017"}],"first":"2021-10-28","last":"2022-10-13","sibs":["3019101447","3013841460"],"colo":[]},{"id":"3016965485","fei":"3016965485","duns":"867530523","firm":"SOLARA ACTIVE PHARMA SCIENCES LIMITED","registrant":"SOLARA ACTIVE PHARMA SCIENCES LIMITED","parent":null,"ticker":null,"addr":"Plot No: 3B, 3C, 3D,2P and 2 A1, APIIC-APSEZ, Atchutapuram Rambilli-Mandal, Anakapalli District, Andhra Pradesh 531011, India (IND)","city":"Anakapalli District","state":"Andhra Pradesh","pin":"531011","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003585876","3008374690","3008252997","3002808058","3011856449"],"colo":["3012160303","3026032363","3023346708","3011538548","3015709928","3013629262","3014255847","3020444708","3030613318","3026297382","3013580138","3021487911"]},{"id":"3017299509","fei":"3017299509","duns":"860417008","firm":"Seutic Labs Pvt. Ltd.","registrant":"Seutic Labs Pvt. Ltd.","parent":null,"ticker":null,"addr":"Plot No: 4-P2, Sy. No:129, Gadwanthi village, Humnabad Industrial area, Humnabad, Bidar district, Karnataka 585330, India (IND)","city":"Bidar district","state":"Karnataka","pin":"585330","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":17.74714,"lon":77.10934,"prec":"postcode","geo":"585330, Humanabadh, Chittaguppa taluku, Bidar, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3013987923","3014002712"]},{"id":"3010823443","fei":"3010823443","duns":"860186984","firm":"AZICO BIOPHORE INDIA PRIVATE LIMITED","registrant":"AZICO BIOPHORE INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No: 40/A, J.N.Pharma City, Parawada Mandal,, Anakapalli, Andhra Pradesh 531021, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531021","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3012575874","3027357163","3038912601"]},{"id":"3016661377","fei":"3016661377","duns":"877850148","firm":"RUI Laboratories Private Limited","registrant":"RUI Laboratories Private Limited","parent":null,"ticker":null,"addr":"Plot No: 4J & 4K, Denotified Area APIIC Industrial Area, Atchutapuram, Rambilli Mandal, Anakapalli, Andhra Pradesh 531011, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3012160303","3026032363","3023346708","3011538548","3015709928","3013629262","3014255847","3020444708","3030613318","3026297382","3013580138","3021487911"]},{"id":"3012575874","fei":"3012575874","duns":"872255143","firm":"APICORE PHARMACEUTICALS PRIVATE LIMITED","registrant":"APICORE PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No: 80D, Road No. 20, Jawaharlal Nehru Pharmacity, Parawada., Anakapalli, Andhra pradesh 531021, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531021","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006767695","3007136165"],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3027357163","3038912601"]},{"id":"3017981159","fei":"3017981159","duns":"871422728","firm":"LOKA BIOSCIENCES PRIVATE LIMITED","registrant":"LOKA BIOSCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No:14 & 15, Aleap Industrial Estate Pragati Nagar, Hyderabad,  500090, India (IND)","city":"Hyderabad","state":null,"pin":"500090","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.53062,"lon":78.38101,"prec":"postcode","geo":"500090, Bachupally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3014250111","3026584977","3013593602","3013758337","3008569405","3013580504","3027524740","3002949099","3009483004","3003971663","3004021229","3004446312"]},{"id":"3008771562","fei":"3008771562","duns":"915368300","firm":"Chromo Laboratories India Private Limited","registrant":"Chromo Laboratories India Private Limited","parent":null,"ticker":null,"addr":"Plot No:33,43 & 44, IDA, Phase II, Pashamylaram, Patancheru Mandal,, Sangareddy, Telangana 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","1000623515","3009864167","3005075182"]},{"id":"3027536190","fei":"3027536190","duns":"565272966","firm":"RANSH PHARMA PRIVATE LIMITED","registrant":"RANSH PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot No:4 N, APSEZ, Denotified Area, Gurajaplem Village, Atchutapuram, Visakhapatnam, ANDHRA PRADESH 531061, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531061","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.46661,"lon":82.92852,"prec":"postcode","geo":"531061, Rambilli, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3018393466","3030141315"]},{"id":"1000623515","fei":"1000623515","duns":"677604288","firm":"Cohance Lifesciences Limited","registrant":"Cohance Lifesciences Limited","parent":null,"ticker":null,"addr":"Plot Nos. 262 To 271, IDA Pashamylaram, Sangareddy, Telangana 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["ANALYSIS","API MANUFACTURE","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2026-01-30T05:00:00Z","posted":"2026-02-03T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cohance-lifesciences-limited-718812-01302026","company_as_published":"Cohance Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-01-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cohance-lifesciences-limited-718812-01302026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-01-30","last":"2026-01-30","sibs":["3003650383","3006493505","3008768274","3005554260","3019037664"],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","3009864167","3005075182"]},{"id":"3008252997","fei":"3008252997","duns":"676159823","firm":"SOLARA ACTIVE PHARMA SCIENCES LIMITED","registrant":"SOLARA ACTIVE PHARMA SCIENCES LIMITED","parent":null,"ticker":null,"addr":"Plot Nos. 36, 120 A & B, 120 P & 121 Industrial Area, Baikampady,, New Mangalore, Karnataka 575011, India (IND)","city":"New Mangalore","state":"Karnataka","pin":"575011","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":12.94694,"lon":74.8123,"prec":"tail3","geo":"State Bank of India ATM, NH66, New Mangalore Port, Baikampady, Mangaluru taluk, Dakshina Kannada, Karnataka, 575001, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003585876","3008374690","3016965485","3002808058","3011856449"],"colo":[]},{"id":"3007025492","fei":"3007025492","duns":"915242584","firm":"Nifty Labs Private Limited","registrant":"Nifty Labs Private Limited","parent":null,"ticker":null,"addr":"Plot Nos. 50-A,B,G&H, 64-A,B,C& D, 65-A,B,C & D, 66-A&B, 67-A&B IDA Kondapally, Ibrahimpatnam, NTR Dist, Andhra Pradesh 521228, India (IND)","city":"NTR Dist","state":"Andhra Pradesh","pin":"521228","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.62148,"lon":80.53822,"prec":"postcode","geo":"521228, Ibrahimpatnam, NTR, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3030493098","3016905331"]},{"id":"3041045488","fei":"3041045488","duns":"771751750","firm":"SOFTGEL HEALTHCARE PRIVATE LIMITED","registrant":"SOFTGEL HEALTHCARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot Nos. 9, 10 & 44, Onehub, Kunnapattu, Chengalpattu, Tamilnadu 603105, India (IND)","city":"Chengalpattu","state":null,"pin":"603105","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.71995,"lon":80.18724,"prec":"postcode","geo":"603105, Tiruporur, Chengalpattu, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006381009"],"colo":["3015621300"]},{"id":"3008394488","fei":"3008394488","duns":"677318493","firm":"Eisai Pharmaceuticals India Private Limited","registrant":"Eisai Inc.","parent":null,"ticker":null,"addr":"Plot Nos. 96, 97, 98, 124 &126, Visakha Pharmacity Limited(SEZ), Parawada Mandal, Anakapalli District, Andhra Pradesh 531019, India (IND)","city":"Anakapalli District","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3009307611","fei":"3009307611","duns":"675593269","firm":"Hetero Drugs Limited","registrant":"Hetero Drugs Limited","parent":"Hetero (unlisted)","ticker":null,"addr":"Plot Nos. B 80 and 81, APIE, Balanagar, Hyderabad, Telangana 500018, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500018","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.45684,"lon":78.43297,"prec":"postcode","geo":"500018, Ward 101 Erragadda, Greater Hyderabad Municipal Corporation Central Zone, Hyderabad, Ameerpet mandal, Hyderabad, Telangana, India","status":2,"alerts":[{"alert":"66-66","list":"red","since":"09/30/2009","notes":"10/3/2000","charges":[{"code":"62 O - S 27","notes":"","product":"Doxazosin Mesylate (Anti-Hypertensive - Part II), Active Pharm Ingred/Chems for Further Manuf","published":"03/29/2019"}],"firm_as_published":"Hetero Drugs Ltd","address_as_published":"7 1 Hetero House # 8 - 3 - 166 , Hyderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"}],"letters":[],"events":[{"d":"2019-03-29","k":"charge","t":"66-66 charge 62 O - S 27 — Doxazosin Mesylate (Anti-Hypertensive - Part II), Active Pharm Ingred/Chems for Further Manuf","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":"10/3/2000"}],"first":"2009-09-30","last":"2019-03-29","sibs":["3003510514","3009225386","3009488373"],"colo":["3003445931","3004544153"]},{"id":"3003983454","fei":"3003983454","duns":"930040108","firm":"Gland Chemicals Private Limited","registrant":"Gland Chemicals Private Limited","parent":null,"ticker":null,"addr":"Plot Nos. L-8 (P), L9, Gut Nos. 36, 37, 38, MIDC, Waluj, Aurangabad, Maharashtra 431136, India (IND)","city":"Aurangabad","state":"Maharashtra","pin":"431136","ops":["ANALYSIS","API MANUFACTURE","STERILIZE"],"expires":"12/31/2026","lat":19.83683,"lon":75.25441,"prec":"postcode","geo":"431136, Chhatrapati Sambhajinagar, Maharashtra, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"08/01/2018","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"08/01/2018"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"08/01/2018"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"08/01/2018"}],"firm_as_published":"Gland Chemicals Private Limited","address_as_published":"& B - 11 Plot No B - 3 , Sipcot Industrial Park; & B - 6 To B - 18 , Chennai, Tamil Nadu INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2018-08-01","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2018-08-01","last":"2022-05-26","sibs":["3000280991","3008386908"],"colo":["3008316970","3003204330","3038105724","3007542588","3008580576","3009227929"]},{"id":"3027345324","fei":"3027345324","duns":"853179066","firm":"ASPIRO PHARMA SPECIALITIES PRIVATE LIMITED","registrant":"ASPIRO PHARMA SPECIALITIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot Nos. S-1,S-6 & S-2B, Survey Nos 321 & 284, Biotech Park Phase-III, Karkapatla(V), Markook(M), Siddipet, Telangana 502281, India (IND)","city":"Siddipet","state":"Telangana","pin":"502281","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.81912,"lon":78.7342,"prec":"postcode","geo":"502281, Gajwel mandal, Siddipet, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031960635","3014404150","Plot No.- 09, Biotech Park, Phase-III, Sy No.-321, Karkapatla (V), Markook (M),, Siddipet, Telangana 502281, India (IND)","3032184895","3027380201","3014483338"]},{"id":"3027357163","fei":"3027357163","duns":"955481156","firm":"Eugia Steriles Private Limited","registrant":"EUGIA Pharma Specialities Limited","parent":null,"ticker":null,"addr":"Plot Nos.1, 2, 2A & 2B, Industrial Park, Parawada Phase - III, Anakapalli, Andhra Pradesh 531021, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531021","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3038912601"]},{"id":"3003747558","fei":"3003747558","duns":"675829201","firm":"Orchid Pharma Limited","registrant":"Orchid Pharma Limited","parent":null,"ticker":null,"addr":"Plot Nos.121-128,128A-133,138-151&159-164, SIDCO Industrial Estate, Chengalpattu, Tamil Nadu 603110, India (IND)","city":"Chengalpattu","state":"Tamil Nadu","pin":"603110","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":12.71867,"lon":80.09467,"prec":"postcode","geo":"603110, Chengalpattu, Tamil Nadu, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"03/23/2023","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"03/23/2023"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"03/23/2023"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"03/23/2023"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/23/2023"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/23/2023"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/23/2023"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/23/2023"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/23/2023"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/23/2023"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"03/23/2023"}],"firm_as_published":"ORCHID LIFESCIENCES","address_as_published":"68-72 Tribhuvan Industrial Estate Nr Kathwada Gidc Kathwada , Kathwada, INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"}],"letters":[{"date":"2023-08-03T04:00:00Z","posted":"2023-08-08T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/orchid-lifesciences-663478-08032023","company_as_published":"Orchid Lifesciences","match":"token"},{"date":"2025-07-16T04:00:00Z","posted":"2025-08-05T04:00:00Z","subject":"Foreign Supplier Verification Program (FSVP)","office":"Division of Northeast Imports","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/orchid-grocery-712424-07162025","company_as_published":"Orchid Grocery","match":"token"}],"events":[{"d":"2025-07-16","k":"letter","t":"Foreign Supplier Verification Program (FSVP)","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/orchid-grocery-712424-07162025","x":"Division of Northeast Imports"},{"d":"2023-08-03","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/orchid-lifesciences-663478-08032023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-03-23","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2023-03-23","last":"2025-07-16","sibs":[],"colo":["3005216842","3011361515","3005151016","3005782924","3003597293","3020342635","3009042530"]},{"id":"3004896422","fei":"3004896422","duns":"915840634","firm":"MALLADI DRUGS AND PHARMACEUTICALS LIMITED","registrant":"Malladi Drugs & Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Plot Nos.49, 50, 55 & 56, IDA, Gajulamandyam, Chittoor, Andhra Pradesh 517520, India (IND)","city":"Chittoor","state":"Andhra Pradesh","pin":"517520","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.64654,"lon":79.49995,"prec":"postcode","geo":"517520, Renigunta, Tirupati, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002780785","3005115135"],"colo":["3017864048","3020873746"]},{"id":"3006643860","fei":"3006643860","duns":"675467925","firm":"EMCURE PHARMACEUTICALS LIMITED","registrant":"Emcure Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Plot Nos.: 12/1 & 2, F-II Block, M.I.D.C., Pimpri, Pune, Maharashtra 411018, India (IND)","city":"Pune","state":"Maharashtra","pin":"411018","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":18.5901,"lon":73.83578,"prec":"postcode","geo":"411018, Haveli Subdistrict, Pune, Maharashtra, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"07/13/2015","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","charges":[{"code":"55","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Pharm Necess & Ctnr For Drug/Bio","published":"07/13/2015"},{"code":"56","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Antibiotics (Human/Animal)","published":"07/13/2015"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"61","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"62","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"63","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"64","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"65","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"},{"code":"66","notes":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices","product":"Human and Animal Drugs","published":"07/13/2015"}],"firm_as_published":"Emcure Pharmaceuticals Limited","address_as_published":"Plot No. P-2, I.T.B.T. Park, Phase - II, MIDC, Hinjawadi , Pune, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2015-07-13","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs All Antibiotics Problem(s): (GMP) Good Manufacturing Practices"}],"first":"2015-07-13","last":"2022-05-26","sibs":["3022175565","3005782879","3014595023"],"colo":[]},{"id":"3002806475","fei":"3002806475","duns":"918917605","firm":"ZYDUS LIFESCIENCES LIMITED","registrant":"ZYDUS LIFESCIENCES LIMITED","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Plot Number 26 to 29 and 31, Dabhasa Umaraya Road, Village Dabhasa, Vadodara, Gujarat 391440, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391440","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":22.24672,"lon":73.08544,"prec":"postcode","geo":"391440, Padra Taluka, Vadodara, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2024-08-29T04:00:00Z","posted":"2024-09-10T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"12/16/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","company_as_published":"Zydus Lifesciences Limited","match":"exact"},{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","company_as_published":"Zydus Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-29","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-29","last":"2026-06-02","sibs":["3003696998","3006595385","3008957483","3007938603","3007621329","3006809732","3006026405","3012977526","3002984011","3013712903","3005430968"],"colo":["3005183272","3009167769","3009119873","3005906909","3009219197","3006767695","3007836955","3008494993","3008405956","3010166818","3038848101"]},{"id":"3033035639","fei":"3033035639","duns":"766369478","firm":"APDM Pharmaceuticals Private Limited","registrant":"APDM Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"Plot Number 775, 776 & 628, Village Sakodara, Taluka: Bavla,, Ahmedabad, Gujarat 382220, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382220","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","PARTICLE SIZE REDUCTION","RELABEL","REPACK"],"expires":"12/31/2026","lat":22.85878,"lon":72.34332,"prec":"postcode","geo":"382220, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008117347","3036572523","3035187076","3004161218","3044181625","3008223599"]},{"id":"3012977526","fei":"3012977526","duns":"677604722","firm":"Zydus Lifesciences Limited","registrant":"Zydus Lifesciences Limited","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Plot Survey No. 23,25/P,37,40/P,42 to 47, Sarkhej-Bavla N.H. No. 8A, Opp. Ramdev Masala, Village-Changodar, Tal:Sanand, Dist-Ahmedabad, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2024-08-29T04:00:00Z","posted":"2024-09-10T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"12/16/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","company_as_published":"Zydus Lifesciences Limited","match":"exact"},{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","company_as_published":"Zydus Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-29","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-29","last":"2026-06-02","sibs":["3003696998","3006595385","3008957483","3007938603","3007621329","3006809732","3006026405","3002806475","3002984011","3013712903","3005430968"],"colo":["3041646841","3036725850","3043068534","3017085815","3010661577","3007277149","3010254278","3029456823","3008725987","3004011473","3008394466","3007869619"]},{"id":"3034679112","fei":"3034679112","duns":"766412687","firm":"GOLD PHARMA PRIVATE LIMITED","registrant":"GOLD PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot no 27A33 & 27A34 APSEZ Denotified Area, APIIC, Lalam Koduru Village, Rambilli, Anakapalli, Andhra Pradesh 531011, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2021-03-26T04:00:00Z","posted":"2021-04-01T13:45:00Z","subject":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","office":"Center for Tobacco Products","response":"","closeout":"09/28/2022","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vapors-gold-llc-614075-03262021","company_as_published":"Vapors Gold LLC","match":"token"},{"date":"2022-04-13T04:00:00Z","posted":"2022-04-19T13:20:00Z","subject":"Finished Pharmaceuticals/Unapproved New Drug/Misbranded","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/neoteric-cosmetics-incorporatedscotts-liquid-gold-inc-628399-04132022","company_as_published":"Neoteric Cosmetics, Incorporated/Scott’s Liquid Gold, Inc.","match":"token"},{"date":"2022-11-02T04:00:00Z","posted":"2023-01-24T14:20:00Z","subject":"CGMP/Warehouse/Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gold-coast-distributors-inc-dba-shah-distributors-635805-11022022","company_as_published":"Gold Coast Distributors Inc. dba Shah Distributors","match":"token"},{"date":"2022-11-22T05:00:00Z","posted":"2023-01-10T14:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations East IV","response":"","closeout":"07/05/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/florida-gold-foods-llc-637153-11222022","company_as_published":"Florida Gold Foods LLC","match":"token"},{"date":"2023-12-05T05:00:00Z","posted":"2024-04-02T13:20:00Z","subject":"Unapproved New Drugs/Misbranded","office":"Division of Human and Animal Food Operations West IV","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ambaya-gold-health-products-llc-648130-12052023","company_as_published":"Ambaya Gold Health Products, LLC","match":"token"},{"date":"2024-07-25T04:00:00Z","posted":"2024-07-30T13:20:00Z","subject":"Finished Pharmaceuticals/Unapproved New Drugs","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/isisgold-679948-07252024","company_as_published":"ISIS.GOLD","match":"token"},{"date":"2025-05-27T04:00:00Z","posted":"2025-06-03T04:00:00Z","subject":"Foreign Supplier Verification Program (FSVP)","office":"Office of Inspections and Investigations","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grow-gold-land-inc-709308-05272025","company_as_published":"Grow Gold Land, Inc.","match":"token"}],"events":[{"d":"2025-05-27","k":"letter","t":"Foreign Supplier Verification Program (FSVP)","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grow-gold-land-inc-709308-05272025","x":"Office of Inspections and Investigations"},{"d":"2024-07-25","k":"letter","t":"Finished Pharmaceuticals/Unapproved New Drugs","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/isisgold-679948-07252024","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2023-12-05","k":"letter","t":"Unapproved New Drugs/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ambaya-gold-health-products-llc-648130-12052023","x":"Division of Human and Animal Food Operations West IV"},{"d":"2022-11-22","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/florida-gold-foods-llc-637153-11222022","x":"Division of Human and Animal Food Operations East IV"},{"d":"2022-11-02","k":"letter","t":"CGMP/Warehouse/Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gold-coast-distributors-inc-dba-shah-distributors-635805-11022022","x":"Division of Human and Animal Food Operations West V"},{"d":"2022-04-13","k":"letter","t":"Finished Pharmaceuticals/Unapproved New Drug/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/neoteric-cosmetics-incorporatedscotts-liquid-gold-inc-628399-04132022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-03-26","k":"letter","t":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vapors-gold-llc-614075-03262021","x":"Center for Tobacco Products"}],"first":"2021-03-26","last":"2025-05-27","sibs":[],"colo":["3012160303","3026032363","3023346708","3011538548","3015709928","3013629262","3014255847","3020444708","3030613318","3026297382","3013580138","3021487911"]},{"id":"3013630102","fei":"3013630102","duns":"675478491","firm":"Centaur Pharmaceuticals Private Limited","registrant":"Centaur Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"Plot no 60, Tuem Industrial Estate, Phase II, Tuem, Pernem, Goa 403512, India (IND)","city":"Pernem","state":"Goa","pin":"403512","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":15.64254,"lon":73.74248,"prec":"postcode","geo":"403512, Pernem, North Goa, Goa, India","status":1,"alerts":[],"letters":[{"date":"2023-06-05T04:00:00Z","posted":"2023-07-18T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"07/21/2026","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centaur-pharmaceuticals-private-ltd-651080-06052023","company_as_published":"Centaur Pharmaceuticals Private Ltd.","match":"exact"},{"date":"2023-07-25T04:00:00Z","posted":"2023-08-01T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centaur-pharmaceuticals-private-ltd-655231-07252023","company_as_published":"Centaur Pharmaceuticals Private Ltd.","match":"exact"}],"events":[{"d":"2023-07-25","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centaur-pharmaceuticals-private-ltd-655231-07252023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-06-05","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centaur-pharmaceuticals-private-ltd-651080-06052023","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2023-06-05","last":"2023-07-25","sibs":["3003973520","3008861619"],"colo":[]},{"id":"3015849306","fei":"3015849306","duns":"877850363","firm":"Zydus Animal Health and Investments Limited","registrant":"ZyVet Animal Health Inc.","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Plot no SP 12 & 13 PHARMA SEZ,SARKHEJ - BAVLA N. H. NO. 8A, Matoda, AHMEDABAD, Gujarat 382213, India (IND)","city":"AHMEDABAD","state":"Gujarat","pin":"382213","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3041646841","3036725850","3043068534","3017085815","3010661577","3007277149","3008957483","3007938603","3010254278","3029456823","3007621329","3008725987"]},{"id":"3007514214","fei":"3007514214","duns":"860186085","firm":"Alivus Life Sciences Limited","registrant":"Glenmark Pharmaceuticals Inc., USA","parent":"Glenmark Pharmaceuticals","ticker":"GLENMARK","addr":"Plot no Z-103-I SEZ Phase II Dahej, Taluka Vagra, Bharuch, Gujarat 392130, India (IND)","city":"Bharuch","state":"Gujarat","pin":"392130","ops":["ANALYSIS","API MANUFACTURE","LABEL"],"expires":"12/31/2026","lat":21.71286,"lon":72.61625,"prec":"postcode","geo":"392130, Vagra Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3014026060","3004006229"],"colo":["3043800366","3040332349","3005404478","3018972378","3012664809","3010027135","3014919100","3010228235","3005737619","3030599291"]},{"id":"3006607414","fei":"3006607414","duns":"862794284","firm":"DABUR RESEARCH FOUNDATION","registrant":"DABUR RESEARCH FOUNDATION","parent":null,"ticker":null,"addr":"Plot no. - 22, Site - IV, Sahibabad Industrial Area, Sahibabad,, Ghaziabad, UTTAR PRADESH 201010, India (IND)","city":"Ghaziabad","state":"Uttar Pradesh","pin":"201010","ops":["ANALYSIS"],"expires":"12/31/2026","lat":28.64936,"lon":77.3562,"prec":"postcode","geo":"201010, Ghaziabad, Uttar Pradesh, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"02/04/2020","notes":"Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: \"Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory\". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"01/27/2021"},{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"04/03/2020"},{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"02/04/2020"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"04/03/2020"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"01/27/2021"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"02/04/2020"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"01/27/2021"},{"code":"63 R - - 06","notes":"","product":"Stannous Fluoride (Dental Caries Prophylactic)","published":"01/27/2021"},{"code":"63 R - - 99","notes":"","product":"Dental Caries Prophylactic N.E.C.","published":"01/27/2021"},{"code":"63 R","notes":"","product":"Dental Caries Prophyl","published":"04/03/2020"},{"code":"63 R","notes":"","product":"Dental Caries Prophyl","published":"02/04/2020"},{"code":"63 S - - 99","notes":"","product":"Dental Protectant N.E.C.","published":"01/27/2021"},{"code":"63 U - - 99","notes":"","product":"Dentin Desensitizer N.E.C.","published":"01/27/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"02/04/2020"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"01/27/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"04/03/2020"}],"firm_as_published":"Dabur India Limited (Unit-2)","address_as_published":"Integrated Industrial Estate, Plot No 4, Sec-2, Pant Nagar, Distt. Udham Singh Nagar , Udham Singh Nagar, Uttaranchal INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[],"events":[{"d":"2021-01-27","k":"charge","t":"66-41 charge 53 I - - 01 — Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 53 I - - 99 — Other Oral Hygiene Products, without Fluoride, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 54 Y - - 99 — Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 63 R - - 06 — Stannous Fluoride (Dental Caries Prophylactic)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 63 R - - 99 — Dental Caries Prophylactic N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 63 S - - 99 — Dental Protectant N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 63 U - - 99 — Dentin Desensitizer N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 53 I - - 01 — Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 53 I - - 99 — Other Oral Hygiene Products, without Fluoride, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 63 R — Dental Caries Prophyl","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-02-04","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: \"Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory\". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020"}],"first":"2020-02-04","last":"2021-01-27","sibs":[],"colo":[]},{"id":"3002807510","fei":"3002807510","duns":"919137385","firm":"LUPIN LIMITED","registrant":"LUPIN LIMITED","parent":"Lupin","ticker":"LUPIN","addr":"Plot no. 09, 123, 123/1, 124 & 125 G.I.D.C. Industrial Estate, Ankleshwar, Gujarat 393002, India (IND)","city":"Ankleshwar","state":"Gujarat","pin":"393002","ops":["API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2021-06-11T04:00:00Z","posted":"2021-06-29T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Office of Pharmaceutical Quality Operations Division I","response":"","closeout":"04/19/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","company_as_published":"Novel Laboratories, Inc. d.b.a LUPIN","match":"token"},{"date":"2022-09-27T04:00:00Z","posted":"2022-11-01T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","company_as_published":"Lupin Limited","match":"exact"}],"events":[{"d":"2022-09-27","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-06-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","x":"Office of Pharmaceutical Quality Operations Division I"}],"first":"2021-06-11","last":"2022-09-27","sibs":["3004995645","3010977634","3004819820","3002807512","3002807511","3009843207","3009831799","3007756473","3015392060","3007549629","3009107538"],"colo":["3003722314","3003696998","3014078015","3003650383","3010079586","3006851796","3030461518","3004086396","3006509185","3002806711","3008314161","3004006229"]},{"id":"3015443248","fei":"3015443248","duns":"861185901","firm":"OBVEZ LABS PVT LTD","registrant":"OBVEZ LABS PVT.LTD","parent":null,"ticker":null,"addr":"Plot no. 22, 2nd Floor, ALEAP Industrial Estate, Gajula Ramaram, Hyderabad, Telangana 500072, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500072","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.49046,"lon":78.40127,"prec":"postcode","geo":"500072, Ward 115 Balaji Nagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Kukatpally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031662558","3037730318","3030171758","3017524864","3016445311","3009887324","3027666582","3030396086","3038110405"]},{"id":"3008280145","fei":"3008280145","duns":"677854359","firm":"BGP Healthcare Private Limited","registrant":"BGP Healthcare Private Limited","parent":null,"ticker":null,"addr":"Plot no. 3707, GIDC, Ankleshwar, Gujarat 393002, India (IND)","city":"Ankleshwar","state":"Gujarat","pin":"393002","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.61511,"lon":73.01562,"prec":"postcode","geo":"393002, Ankleshwar Taluka, Bharuch, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2021-05-19T04:00:00Z","posted":"2021-05-20T04:00:00Z","subject":"Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)","office":"Center for Drug Evaluation and Research","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bgp-llc-613144-05192021","company_as_published":"BGP, LLC","match":"token"}],"events":[{"d":"2021-05-19","k":"letter","t":"Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bgp-llc-613144-05192021","x":"Center for Drug Evaluation and Research"}],"first":"2021-05-19","last":"2021-05-19","sibs":[],"colo":["3003722314","3003696998","3014078015","3003650383","3010079586","3006851796","3030461518","3004086396","3006509185","3002806711","3008314161","3004006229"]},{"id":"3008861619","fei":"3008861619","duns":"675596622","firm":"Centaur Pharmaceuticals Private Limited","registrant":"Centaur Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"Plot no. 4, International Biotech Park, Phase-II, Hinjewadi, Pune, Maharashtra 411057, India (IND)","city":"Pune","state":"Maharashtra","pin":"411057","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.59104,"lon":73.73974,"prec":"postcode","geo":"411057, Mulshi Subdistrict, Pune, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2023-06-05T04:00:00Z","posted":"2023-07-18T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"07/21/2026","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centaur-pharmaceuticals-private-ltd-651080-06052023","company_as_published":"Centaur Pharmaceuticals Private Ltd.","match":"exact"},{"date":"2023-07-25T04:00:00Z","posted":"2023-08-01T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centaur-pharmaceuticals-private-ltd-655231-07252023","company_as_published":"Centaur Pharmaceuticals Private Ltd.","match":"exact"}],"events":[{"d":"2023-07-25","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centaur-pharmaceuticals-private-ltd-655231-07252023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-06-05","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/centaur-pharmaceuticals-private-ltd-651080-06052023","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2023-06-05","last":"2023-07-25","sibs":["3003973520","3013630102"],"colo":["3032233889"]},{"id":"3005983749","fei":"3005983749","duns":"918629309","firm":"OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVATE LIMITED","registrant":"OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot no. L-1, L-21 to L28 & L-44 Additional Phase MIDC, Mahad, Raigad, Maharashtra 402301, India (IND)","city":"Raigad","state":"Maharashtra","pin":"402301","ops":["ANALYSIS","API MANUFACTURE","PACK","REPACK"],"expires":"12/31/2026","lat":18.08273,"lon":73.42004,"prec":"postcode","geo":"402301, Mahad Taluka, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3014571250","fei":"3014571250","duns":"675475889","firm":"Rasino Drugs Pvt. Ltd.","registrant":"Rasino Drugs Pvt. Ltd.","parent":null,"ticker":null,"addr":"Plot no. N-18, Additional MIDC, Anand Nagar, Rubicon Company, Ambarnath Rubicon Company, Ambarnath, Thane, Maharashtra 421506, India (IND)","city":"Thane","state":"Maharashtra","pin":"421506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021189141","3009887190","3008232264","3013999816","3018052045","3016575313","3006599894","3006809732","3027577650","3010166801","3032073298","3008374690"]},{"id":"3017501030","fei":"3017501030","duns":"867530307","firm":"ONESOURCE SPECIALTY PHARMA LIMITED","registrant":"ONESOURCE SPECIALTY PHARMA LIMITED","parent":null,"ticker":null,"addr":"Plot no.: 2-D1, Obadenahalli Industrial Area, Doddaballapura, 3rd Phase, Kasa, Doddaballapura Taluk, Bengaluru Rural, Karnataka 561203, India (IND)","city":"Bengaluru Rural","state":"Karnataka","pin":"561203","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":13.33957,"lon":77.49855,"prec":"postcode","geo":"561203, Doddaballapura taluk, Bengaluru North, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005652193","3003813519"],"colo":["3004483648"]},{"id":"3042718107","fei":"3042718107","duns":"854018362","firm":"SRINI PHARMACEUTICALS PRIVATE LIMITED","registrant":"SRINI PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot no.: 47, J.N. Pharma City, Parawada, Visakhapatnam, Andhra Pradesh 531019, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004015257"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3009864167","fei":"3009864167","duns":"858971074","firm":"GLAND PHARMA LIMITED","registrant":"GLAND PHARMA LIMITED","parent":"Gland Pharma","ticker":"GLAND","addr":"Plot no: 42-52, 54, 55, 64-68, Sy. No. 166, 171, 172 & 177, Phase III, TSIIC, Pashamylaram Village, Patancheru Mandal, Sangareddy District, Hyderabad, Telangana 502307, India (IND)","city":"Hyderabad","state":"Telangana","pin":"502307","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3010142300","3002647489","3009056604"],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3005075182"]},{"id":"3010142300","fei":"3010142300","duns":"860038013","firm":"Gland Pharma Limited","registrant":"GLAND PHARMA LIMITED","parent":"Gland Pharma","ticker":"GLAND","addr":"Plot no: 49 & 50, J. N. Pharmacity, Parawada (M), Anakapalli District, Andhra Pradesh 531019, India (IND)","city":"Anakapalli District","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009864167","3002647489","3009056604"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"Plot. No :131/A-1,130 C&D, Kolhar Industrial Area,, Bidar, Karnataka 585401, India (IND)","fei":"","duns":"864378753","firm":"ADEEP LIFE SCIENCES PRIVATE LIMITED","registrant":"ADEEP LIFE SCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot. No :131/A-1,130 C&D, Kolhar Industrial Area,, Bidar, Karnataka 585401, India (IND)","city":"Bidar","state":"Karnataka","pin":"585401","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.91451,"lon":77.51581,"prec":"postcode","geo":"585401, Bidar taluku, Bidar, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3032234173"]},{"id":"3014002712","fei":"3014002712","duns":"860037749","firm":"PUROGENE LABS PRIVATE LIMITED","registrant":"PUROGENE LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot. No. 122/A, B & C, KIADB, Industrial Area, Humanabad, Bidar, KARNATAKA 585330, India (IND)","city":"Bidar","state":"Karnataka","pin":"585330","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.74714,"lon":77.10934,"prec":"postcode","geo":"585330, Humanabadh, Chittaguppa taluku, Bidar, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3013987923","3017299509"]},{"id":"3025560903","fei":"3025560903","duns":"650439131","firm":"SHILPA PHARMA LIFESCIENCES LIMITED","registrant":"SHILPA PHARMA LIFESCIENCES LIMITED","parent":null,"ticker":null,"addr":"Plot. No. 1A &1A P, 1B,2,2A,2B,3A to 3E, 4A, 5A,4B & 5B Deosugur Industrial Area, Deosugur, Raichur, Karnataka 584170, India (IND)","city":"Raichur","state":"Karnataka","pin":"584170","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":16.05472,"lon":76.90036,"prec":"tail2","geo":"Raichur, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3007197995"],"colo":[]},{"id":"3015069609","fei":"3015069609","duns":"861213695","firm":"ASPHAR RESEARCH LABS PRIVATE LIMITED","registrant":"ASPHAR RESEARCH LABS PRIVATE LIMITED (A subsidiary of Ascent Pharmaceuticals Inc)","parent":null,"ticker":null,"addr":"Plot. No.47, Third floor Industrial development area, Balanagar, Hyderabad, Telangana 500037, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500037","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.47821,"lon":78.44338,"prec":"postcode","geo":"500037, Ward 120 Balanagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Balanagar mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3016067081","3012278124","3017146711","3014798074","3031055543","3009883190","3013495798","3014683316"]},{"id":"3030450565","fei":"3030450565","duns":"642485186","firm":"DEVI PHARMATECH PRIVATE LIMITED","registrant":"DEVI PHARMATECH PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot.No:12&15, APIIC Industrial Park, Phase-III, Sy.No:09 (Part), 16 (Part), 17(Part), 18(Part) of Lemarthi Vil, Vishakapatnam, Andhra Pradesh 531019, India (IND)","city":"Vishakapatnam","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3010630993","fei":"3010630993","duns":"650697027","firm":"Chemeca Drugs Private Limited","registrant":"Chemeca Drugs Private Limited","parent":null,"ticker":null,"addr":"Plot.No:7, J.N.Pharma City, Tadi (Village) Parawada (Mandal), Anakapalli District, Andhra Pradesh 531019, India (IND)","city":"Anakapalli District","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3038912601","fei":"3038912601","duns":"876817975","firm":"SRI SAI CHANDANA API PRIVATE LIMITED","registrant":"SRI SAI CHANDANA API PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot.no. 52 Jawaharlal Nehru Pharma City, Thanam (V) Parawada Mandal, Visakhapatnam, Andhra Pradesh 531021, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531021","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163"]},{"id":"3013633378","fei":"3013633378","duns":"915826505","firm":"J P N PHARMA PRIVATE LIMITED","registrant":"J P N PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Plot.no.t - 108/109, M I D C., Tarapur, Boisar, Thane, Maharashtra 401506, India (IND)","city":"Thane","state":"Maharashtra","pin":"401506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3001174909","3003721861","3006418686","3006057101","3009118300","3016577628","3016790354","3017545500","3003336449","3018369072","3003677831","3002807512"]},{"id":"3011560035","fei":"3011560035","duns":"872260931","firm":"Promas Research Laboratories Pvt Ltd","registrant":"Promas Research Laboratories Pvt Ltd","parent":null,"ticker":null,"addr":"Promas House, 2nd Floor, Plot No.R-877, TTC Industrial Area, MIDC Rabale, Navi Mumbai, Maharashtra 400701, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400701","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.11985,"lon":73.00488,"prec":"postcode","geo":"400701, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3027513144","3009510975","3006620783","3003484180","3024731845","3007026867","3005502733","3030219467","3013153296"]},{"id":"3030396086","fei":"3030396086","duns":"756062826","firm":"PROVIS BIOLABS PRIVATE LIMITED","registrant":"PROVIS BIOLABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Provis Biolabs Private Limited, No.5-9-262/54P & 55P, First floor, Rajiv Gandhi Nagar, Prashanthi Nagar, Kukatpally, Hyderabad, Telangana 500072, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500072","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.49046,"lon":78.40127,"prec":"postcode","geo":"500072, Ward 115 Balaji Nagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Kukatpally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031662558","3037730318","3030171758","3017524864","3016445311","3009887324","3027666582","3015443248","3038110405"]},{"id":"3032233889","fei":"3032233889","duns":"929604617","firm":"CLINOVI RESEARCH PRIVATE LIMITED","registrant":"CLINOVI RESEARCH PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Quantum Tower 1, Plot no. 5A & 5B Rajiv Gandhi, Infotech Park, MIDC Hinjewadi Phase II, Infotech Park (Hinjawadi), Haveli., Pune, MAHARASHTRA 411057, India (IND)","city":"Pune","state":"Maharashtra","pin":"411057","ops":["ANALYSIS"],"expires":"12/31/2026","lat":18.59104,"lon":73.73974,"prec":"postcode","geo":"411057, Mulshi Subdistrict, Pune, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008861619"]},{"id":"3007720135","fei":"3007720135","duns":"675595676","firm":"Mylan Laboratories Limited","registrant":"Viatris Inc.","parent":null,"ticker":null,"addr":"R & D Center, Plot No 34-A, ANRICH Industrial Estate, Bollaram, Jinnaram Mandal, Sangareddy District, Hyderabad, Telangana 502325, India (IND)","city":"Hyderabad","state":"Telangana","pin":"502325","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.55317,"lon":78.34216,"prec":"postcode","geo":"502325, Jinnaram mandal, Sangareddy, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"12/19/2024","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/19/2024"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"12/19/2024"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/19/2024"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"}],"firm_as_published":"Mylan Laboratories Limited","address_as_published":"(FDF-3) Plot Nos. 11, 12, 13, Indore SEZ , Pharma Zone, Phase II, Sector III , Pithampur, District Dhar, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2024-12-19","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2024-12-19","last":"2024-12-19","sibs":["3005587313","3008316970","3010453141","3007512701","3006355432","3008255419","3007648351"],"colo":["3017000602","3041729025","3008408466","3002806851","3007136165","3008479404","3009609117","3005818804","3008932115","3005301950"]},{"id":"3009522832","fei":"3009522832","duns":"871410649","firm":"BE BIOSOL PRIVATE LIMITED","registrant":"BE BIOSOL PRIVATE LIMITED","parent":null,"ticker":null,"addr":"R & D Lab No. 2, Phase I, IKP Knowledge Park, Turakapally Village, Shameerpet Mandal, Medchal-Malkajgiri, Telangana 500101, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500101","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.65514,"lon":78.60618,"prec":"postcode","geo":"500101, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008377265"],"colo":["3038528882","PLOT NO 4C,MN SC & TECH BIOTECH PARK GENOME VALLEY, TURKAPALLY, SHAMIRPET RANGAREDDY, Hyderabad, Telangana 500101, India (IND)","3006587427","3017754175","3039644403","3039411568","3006527015","3012704791","3030495702","3009883135","3011960448"]},{"id":"3005075182","fei":"3005075182","duns":"650683167","firm":"MSN Laboratories Private Limited","registrant":"MSN Laboratories Private Limited","parent":"MSN Laboratories (unlisted)","ticker":null,"addr":"R&D Centre, Plot No. 12, Phase-IV, Sy.No. 119 to 140, 258, 275 to 280, IDA Pashamylaram, Pashamylaram (Village), Patancheru (Mandal), Sangareddy District, Telangana 502307, India (IND)","city":"Sangareddy District","state":"Telangana","pin":"502307","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011033544","3019516576","3005254981","3035592613","3008656542","3023132203"],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167"]},{"id":"3012448465","fei":"3012448465","duns":"871402375","firm":"Strides Pharma Science Limited","registrant":"Strides Pharma Science Limited","parent":"Strides Pharma Science","ticker":"STAR","addr":"R. S. No. 31, 32 and 33 PIMS Road, Periyakalapet, Puducherry, Puducherry 605014, India (IND)","city":"Periyakalapet","state":"Puducherry","pin":"605014","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.02854,"lon":79.85543,"prec":"postcode","geo":"605014, Ozhukarai Taluk, Puducherry, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004554612","3005151016"],"colo":["3002808058"]},{"id":"3010166818","fei":"3010166818","duns":"871407261","firm":"BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED","registrant":"BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED","parent":null,"ticker":null,"addr":"R. S. No. 578, Near Effluent Channel Village - Luna, Padra Taluka, Vadodara, Gujarat 391440, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391440","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.24672,"lon":73.08544,"prec":"postcode","geo":"391440, Padra Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3030526918","3031858655","3038848101"],"colo":["3005183272","3009167769","3009119873","3005906909","3009219197","3006767695","3007836955","3008494993","3008405956","3002806475"]},{"id":"3002808058","fei":"3002808058","duns":"915786829","firm":"Solara Active Pharma Sciences Limited","registrant":"SOLARA ACTIVE PHARMA SCIENCES LIMITED","parent":null,"ticker":null,"addr":"R.S.No 33 & 34, Mathur Road, Periyakalapet, Puducherry,  605014, India (IND)","city":"Periyakalapet","state":"Puducherry","pin":"605014","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":12.02854,"lon":79.85543,"prec":"postcode","geo":"605014, Ozhukarai Taluk, Puducherry, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003585876","3008374690","3016965485","3008252997","3011856449"],"colo":["3012448465"]},{"id":"3005554260","fei":"3005554260","duns":"650488088","firm":"COHANCE LIFESCIENCES LIMITED","registrant":"COHANCE LIFESCIENCES LIMITED","parent":null,"ticker":null,"addr":"R.S.No.50/1, Mukteswarapuram Village Jaggaiahpet Mandal, NTR, Andhra Pradesh 521457, India (IND)","city":"NTR","state":"Andhra Pradesh","pin":"521457","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":15.92409,"lon":80.18638,"prec":"state","geo":"Andhra Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2026-01-30T05:00:00Z","posted":"2026-02-03T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cohance-lifesciences-limited-718812-01302026","company_as_published":"Cohance Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-01-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cohance-lifesciences-limited-718812-01302026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-01-30","last":"2026-01-30","sibs":["3003650383","3006493505","3008768274","1000623515","3019037664"],"colo":[]},{"id":"3012075440","fei":"3012075440","duns":"955415688","firm":"RUBAMIN PRIVATE LIMITED","registrant":"RUBAMIN PRIVATE LIMITED","parent":null,"ticker":null,"addr":"R.s. No 115, Village Pratappura, Halol, Panchmahal, Gujarat 389350, India (IND)","city":"Panchmahal","state":"Gujarat","pin":"389350","ops":["API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":22.51554,"lon":73.46023,"prec":"postcode","geo":"389350, Halol Taluka, Panchmahal, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003821360","3004956904","3002809586","3014447455","3002957541","3014866088"]},{"id":"3010166683","fei":"3010166683","duns":"650526341","firm":"TRUECARE BIOMEDIX","registrant":"TRUECARE BIOMEDIX","parent":null,"ticker":null,"addr":"RS#2115,COLLEGE ROAD, BALASINOR, GUJARAT 388255, India (IND)","city":"BALASINOR","state":"Gujarat","pin":"388255","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":22.96264,"lon":73.32024,"prec":"postcode","geo":"388255, Balasinor Taluka, Mahisagar, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3027395727","fei":"3027395727","duns":"641108202","firm":"Solvitall Research Labs Private Limited","registrant":"Solvitall Research Labs Private Limited","parent":null,"ticker":null,"addr":"RVI Towers,2nd Floor, West Wing,Pallikaranai No. 149, VelacheryTambaram Main Road,, chennai, Tamilnadu 600100, India (IND)","city":"chennai","state":null,"pin":"600100","ops":["ANALYSIS"],"expires":"12/31/2026","lat":12.92249,"lon":80.19701,"prec":"postcode","geo":"600100, Sholinganallur, Chennai, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3016504267","fei":"3016504267","duns":"878291745","firm":"LOZEN PHARMA PRIVATE LIMITED","registrant":"LOZEN PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Raghav Estate, KSSIDC INDUSTRIAL ESTATE, SHIGGAON ROAD, SAVANUR, Haveri,  581118, India (IND)","city":"Haveri","state":null,"pin":"581118","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":14.98454,"lon":75.39209,"prec":"postcode","geo":"581118, Savanura taluk, Haveri, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3030907257"],"colo":[]},{"id":"3015415016","fei":"3015415016","duns":"675484517","firm":"MANISHA ANALYTICAL LABORATORIES PRIVATE LIMITED","registrant":"MANISHA ANALYTICAL LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Ramdev Plaza, Kashigaon, Mira Road East, Mumbai, Maharashtra 401107, India (IND)","city":"Mumbai","state":"Maharashtra","pin":"401107","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.28042,"lon":72.87211,"prec":"postcode","geo":"401107, Mira-Bhayander, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"1000202341","fei":"1000202341","duns":"915387109","firm":"Oriental Aromatics Limited","registrant":"Oriental Aromatics Limited","parent":null,"ticker":null,"addr":"Rampur Road, Clutterbuckgunj, Bareilly, Uttar Pradesh 243502, India (IND)","city":"Bareilly","state":"Uttar Pradesh","pin":"243502","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":28.38447,"lon":79.39367,"prec":"postcode","geo":"243502, Bareilly, Uttar Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3018694293","fei":"3018694293","duns":"932444829","firm":"MART SPECIALITIES LAB LLP","registrant":"MART SPECIALITIES LAB LLP","parent":null,"ticker":null,"addr":"Road No.3, Plot. No 31, Ground & 1st Floor, ALEAP Industrial Area Pragathi Nagar, Gajularamaram, Medchal–Malkajgiri, TG 500055, India (IND)","city":"Medchal–Malkajgiri","state":null,"pin":"500055","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2023-05-25T04:00:00Z","posted":"2023-06-13T13:20:00Z","subject":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","office":"Center for Tobacco Products","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/u-mart-international-inc-659734-05252023","company_as_published":"U Mart International, Inc.","match":"token"}],"events":[{"d":"2023-05-25","k":"letter","t":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/u-mart-international-inc-659734-05252023","x":"Center for Tobacco Products"}],"first":"2023-05-25","last":"2023-05-25","sibs":[],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869"]},{"id":"3009876430","fei":"3009876430","duns":"650644136","firm":"SHILPA MEDICARE LIMITED","registrant":"SHILPA MEDICARE LIMITED","parent":"Shilpa Medicare","ticker":"SHILPAMED","addr":"S-20 to S-26, Pharmaceutical Formulations SEZ; TSIIC, Green Industrial Park, Polepally, Jadcherla, Mahabubnagar, Telangana 509301, India (IND)","city":"Mahabubnagar","state":"Telangana","pin":"509301","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":16.76333,"lon":78.1484,"prec":"postcode","geo":"509301, Jadcherla mandal, Mahabubnagar, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"02/16/2021","notes":"These products are excluded from DWPE:","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"01/14/2025"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"01/14/2025"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"01/14/2025"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"01/14/2025"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"01/14/2025"},{"code":"55","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Pharm Necess & Ctnr For Drug/Bio","published":"02/16/2021"},{"code":"56","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Antibiotics (Human/Animal)","published":"02/16/2021"},{"code":"58","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"61","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"62","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"63","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"64","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"65","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"66","notes":"All Drug and DrAll Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"}],"firm_as_published":"Shilpa Medicare Limited","address_as_published":"Plot No. S20 to S26, Pharmaceutical Formulations SEZ , TSIIC Green Industrial Park, Polepally (Village) , Jadcherla, Mahabubnagar District , Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products; These products are excluded from DWPE:"},{"d":"2021-02-16","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE:"}],"first":"2021-02-16","last":"2025-01-14","sibs":["3010619401","3018694237","3019773458"],"colo":["3005903939","3008307735","3008294355"]},{"id":"3014447455","fei":"3014447455","duns":"871532063","firm":"N R OILS","registrant":"N R OILS","parent":null,"ticker":null,"addr":"S. NO. 234, Pratappura, Dist Panchmahal, Halol, Gujarat 389350, India (IND)","city":"Halol","state":"Gujarat","pin":"389350","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.51554,"lon":73.46023,"prec":"postcode","geo":"389350, Halol Taluka, Panchmahal, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2022-05-26T04:00:00Z","posted":"2022-05-26T15:00:00Z","subject":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","office":"Center for Veterinary Medicine","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/haniel-concepts-inc-dba-free-state-oils-llc-623510-05262022","company_as_published":"Haniel Concepts, Inc. DBA Free State Oils, LLC","match":"token"},{"date":"2022-06-10T04:00:00Z","posted":"2022-07-19T13:20:00Z","subject":"New Drug/Misbranded","office":"Office of Human and Animal Food Operations – West Division 4","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/young-living-essential-oils-corporate-615777-06102022","company_as_published":"Young Living Essential Oils Corporate","match":"token"},{"date":"2026-06-17T04:00:00Z","posted":"2026-06-23T04:00:00Z","subject":"Unapproved New Drugs","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hadassah-healing-oils-ltd-729191-06172026","company_as_published":"Hadassah Healing Oils Ltd","match":"token"}],"events":[{"d":"2026-06-17","k":"letter","t":"Unapproved New Drugs","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hadassah-healing-oils-ltd-729191-06172026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2022-06-10","k":"letter","t":"New Drug/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/young-living-essential-oils-corporate-615777-06102022","x":"Office of Human and Animal Food Operations – West Division 4"},{"d":"2022-05-26","k":"letter","t":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/haniel-concepts-inc-dba-free-state-oils-llc-623510-05262022","x":"Center for Veterinary Medicine"}],"first":"2022-05-26","last":"2026-06-17","sibs":[],"colo":["3003821360","3004956904","3002809586","3012075440","3002957541","3014866088"]},{"id":"3023491920","fei":"3023491920","duns":"877797679","firm":"HOF PHARMACEUTICALS LIMITED","registrant":"HOF PHARMACEUTICALS LIMITED","parent":null,"ticker":null,"addr":"S.NO. 211/4/5/6, OPP. RATHI AGRO INDUSTRIES, SANAND-BAVLA ROAD, VILL. PIPAN, TA. SANAND, AHMEDABAD, GUJARAT 382210, India (IND)","city":"AHMEDABAD","state":"Gujarat","pin":"382210","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.96445,"lon":72.4238,"prec":"postcode","geo":"382210, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3016710326","3006595385","3003157498","3006026405","3002984011"]},{"id":"3026504936","fei":"3026504936","duns":"854311780","firm":"AXXELENT PHARMA SCIENCE PRIVATE LIMITED","registrant":"AXXELENT PHARMA SCIENCE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"SEZ UNIT No.910, Portia Road, Sri City, Tirupati, Andhra Pradesh 517646, India (IND)","city":"Tirupati","state":"Andhra Pradesh","pin":"517646","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":13.54338,"lon":79.99787,"prec":"postcode","geo":"517646, Varadaiahpalem, Tirupati, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3009344588","fei":"3009344588","duns":"650573681","firm":"Alchem International Private Ltd","registrant":"Alchem International Private Ltd","parent":null,"ticker":null,"addr":"SP 2-5, RIICO Industrial Area, Alwar, Rajasthan 301705, India (IND)","city":"Alwar","state":"Rajasthan","pin":"301705","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":28.02229,"lon":76.37642,"prec":"postcode","geo":"301705, Neemrana Tehsil, Kotputli-Behror, Rajasthan, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003310718"],"colo":[]},{"id":"3040065742","fei":"3040065742","duns":"863683610","firm":"CLASSIC CHEMICALS","registrant":"CLASSIC CHEMICALS","parent":null,"ticker":null,"addr":"SR NO 281, SHAPAR PLOT NO 1, 2 & 3, SHAPAR VILLAGE ROAD, CLASSIC CHEMICALS, RAJKOT, GUJARAT 3600024, India (IND)","city":"RAJKOT","state":"Gujarat","pin":null,"ops":["API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":22.30533,"lon":70.80284,"prec":"tail2","geo":"Rajkot, Rajkot East Taluka, Rajkot, Gujarat, 360001, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3005621526","fei":"3005621526","duns":"915028974","firm":"HERMES CHEMICAL COMPANY PRIVATE LIMITED","registrant":"HERMES CHEMICAL COMPANY PRIVATE LIMITED","parent":null,"ticker":null,"addr":"SUREY NO 134/149 RAMLINGAMPALLY AILLAGE, BOMMALARAM MANDAL, NALGONDA,  508126, India (IND)","city":"NALGONDA","state":null,"pin":"508126","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51941,"lon":78.776,"prec":"postcode","geo":"508126, Bommalaramaram mandal, Yadadri Bhuvanagiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008822771","3014675555"]},{"id":"3005035920","fei":"3005035920","duns":"650744670","firm":"CAPLIN STERILES LIMITED","registrant":"CAPLIN STERILES LIMITED","parent":"Caplin Point Laboratories","ticker":"CAPLIPOINT","addr":"SURVEY No.895 & 897. GURUVARAJAKANDIGAI, SIRUPUZHALPETTAI (POST), THIRUVALLUR (DISTRICT), GUMMIDIPOONDI, TAMIL NADU 601201, India (IND)","city":"GUMMIDIPOONDI","state":"Tamil Nadu","pin":"601201","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":13.42741,"lon":80.10821,"prec":"postcode","geo":"601201, Gummidipoondi, Thiruvallur, Tamil Nadu, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"06/30/2014","notes":"OAISS declared Mfg is drogueria saimed; El Salvador. MFg. indicated on product label is drogueria saimed; El Salvador and Caplin Point Laboratories Ltd; India.","charges":[{"code":"56 B - - 03","notes":"","product":"Amoxicillin Trihydrate (Penicillin, Synthetically Produced)","published":"03/25/2015"},{"code":"61 W - - 45","notes":"","product":"Fluconazole (Anti-Fungal) (Not Antibiotic)","published":"06/30/2014"}],"firm_as_published":"Caplin Steriles Limited","address_as_published":"895 - 897 Guruvarajakandigai , Survey No 895 - 897 , Gummidipoondi, Tamil Nadu INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2015-03-25","k":"charge","t":"66-41 charge 56 B - - 03 — Amoxicillin Trihydrate (Penicillin, Synthetically Produced)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-06-30","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"OAISS declared Mfg is drogueria saimed; El Salvador. MFg. indicated on product label is drogueria saimed; El Salvador and Caplin Point Laboratories Ltd; India."}],"first":"2014-06-30","last":"2015-03-25","sibs":[],"colo":["F7, SIPCOT Industrial Complex, Gummidipoondi, Gummidipoondi, Tamil Nadu 601201, India (IND)","3009402416"]},{"id":"3019018837","fei":"3019018837","duns":"854127127","firm":"VINEET LIFE SCIENCES PRIVATE LIMITED","registrant":"VINEET LIFE SCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"SY NO. 1019, 1020/A, 1020/B, 1021 VINUKONDA ROAD, JANGAMAHESHWARAPADU (V), DURGI (M),, GUNTUR (DT,.), ANDHRA PRADESH 522612, India (IND)","city":")","state":"Andhra Pradesh","pin":"522612","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.06203,"lon":79.61924,"prec":"postcode","geo":"522612, Vinukonda, Palnadu, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3032546867","fei":"3032546867","duns":"756049272","firm":"ScieGen Pharmaceuticals India Private Limited","registrant":"ScieGen Pharmaceuticals India Private Limited","parent":null,"ticker":null,"addr":"SY. No. 408 to 412, 418 to 433 & 434 Plot No. 10,11,12,13 & 14 TSIIC, GIP, Polepally(V), Jadcherla, Mahabubnagar, Telangana 509302, India (IND)","city":"Mahabubnagar","state":"Telangana","pin":"509302","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":16.76992,"lon":78.13772,"prec":"tail3","geo":"Jadcherla, Jadcherla mandal, Mahabubnagar, Telangana, 509340, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3013580504"],"colo":["3011905047","3011255967","3007373532"]},{"id":"3044466625","fei":"3044466625","duns":"771477554","firm":"Qule Pharma Private Limited","registrant":"Qule Pharma Private Limited","parent":null,"ticker":null,"addr":"SY. No’s. 351/P, 353/P, 354/P, 364/P, A. V. Nagaram Village Kakinada SEZ Area, Thondangi Mandal, Kakinada, Andhra Pradesh 533449, India (IND)","city":"Kakinada","state":"Andhra Pradesh","pin":"533449","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.2452,"lon":82.45384,"prec":"tail3","geo":"Government Hospital,Thondangi, Annavaram road, Srungavruksham, East Godavari, Kakinada, Andhra Pradesh, 533408, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3008654585","fei":"3008654585","duns":"677605406","firm":"SMS Pharmaceuticals Limited","registrant":"SMS Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"SY.NO.160, 161, 163 TO 167, KANDIVALASA VILLAGE, POOSAPATIREGA MANDAL, Floor Unit-VII, Vizianagaram, Andhra Pradesh 535204, India (IND)","city":"Vizianagaram","state":"Andhra Pradesh","pin":"535204","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":18.09318,"lon":83.54215,"prec":"postcode","geo":"535204, Pusapatirega, Vizianagaram, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3014615000","3003971663"],"colo":["3002785310"]},{"id":"3002871444","fei":"3002871444","duns":"650654804","firm":"Sun Pharmaceutical Industries Limited","registrant":"Sun Pharmaceutical Industries Limited","parent":"Sun Pharmaceutical Industries","ticker":"SUNPHARMA","addr":"Sarhaul, Sector-18, Gurugram, Haryana 122015, India (IND)","city":"Gurugram","state":"Haryana","pin":"122015","ops":["ANALYSIS"],"expires":"12/31/2026","lat":28.3816,"lon":77.02049,"prec":"postcode","geo":"122015, Gurgaon, Gurugram, Haryana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs.","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs.","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs.","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"Village Ganguwala , Tehsil-Paonta Sahib , Sirmaur, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs.","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"3 Industrial Area , Dewas, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"03/12/2014","notes":"","charges":[{"code":"60","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"}],"firm_as_published":"Sun Pharmaceutical Industries Limited - Karkhadi","address_as_published":"A Plot No 817 , Village Karkhadi , Padra, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"12/07/2022","notes":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","charges":[{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"05/12/2025"},{"code":"55","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/07/2022"},{"code":"56","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Antibiotics (Human/Animal)","published":"12/07/2022"},{"code":"58","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/07/2022"},{"code":"60","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"61","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"62","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"63","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"64","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"65","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"66","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"}],"firm_as_published":"Sun Pharmaceutical Industries Ltd.","address_as_published":"Halol - Baroda Highway , Halol, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-06-08T04:00:00Z","posted":"2022-07-19T13:20:00Z","subject":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","office":"Office of Human and Animal Foods- East Division 3","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","company_as_published":"New Sun Inc.","match":"token"},{"date":"2022-08-17T04:00:00Z","posted":"2022-09-06T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Office of Human and Animal Food Operations – West Division 5","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","company_as_published":"Sun Sen Co., Inc.","match":"token"},{"date":"2023-04-07T04:00:00Z","posted":"2023-08-15T13:20:00Z","subject":"Unapproved New Drugs/Misbranded","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","company_as_published":"STPCA Inc. dba Sun Ten Laboratories","match":"token"},{"date":"2023-05-10T04:00:00Z","posted":"2023-05-30T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations West II","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","company_as_published":"Rhodes Legacy Inc DBA Sun Sprouts","match":"token"},{"date":"2023-10-16T04:00:00Z","posted":"2023-10-16T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","company_as_published":"Sun Pharmaceutical Industries Ltd.","match":"exact"},{"date":"2024-06-18T04:00:00Z","posted":"2024-07-02T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","company_as_published":"Sun Pharmaceutical Industries Limited","match":"exact"},{"date":"2025-03-12T04:00:00Z","posted":"2025-03-18T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","company_as_published":"Waxhead Sun Defense Company","match":"token"}],"events":[{"d":"2025-05-12","k":"charge","t":"66-40 charge 54 — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-03-12","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-06-18","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-10-16","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-05-10","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","x":"Division of Human and Animal Food Operations West II"},{"d":"2023-04-07","k":"letter","t":"Unapproved New Drugs/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","x":"Division of Human and Animal Food Operations West V"},{"d":"2022-12-07","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24"},{"d":"2022-08-17","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","x":"Office of Human and Animal Food Operations – West Division 5"},{"d":"2022-06-08","k":"letter","t":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","x":"Office of Human and Animal Foods- East Division 3"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2014-03-12","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs."},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs"}],"first":"2009-09-10","last":"2025-05-12","sibs":["3003227153","3004520113","3003892973","3002809586","3003952717","3012032037","3002807979","3010027135","3007627683","3004561553"],"colo":[]},{"id":"3007627683","fei":"3007627683","duns":"915044075","firm":"Sun Pharmaceutical Industries Limited","registrant":"Sun Pharmaceutical Industries Limited","parent":"Sun Pharmaceutical Industries","ticker":"SUNPHARMA","addr":"Sathammai Village, Karunkuzhi Post, Madhuranthagam Taluk, Chengalpattu, Tamil Nadu 603303, India (IND)","city":"Chengalpattu","state":"Tamil Nadu","pin":"603303","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":12.54771,"lon":79.90626,"prec":"postcode","geo":"603303, Maduranthakam, Chengalpattu, Tamil Nadu, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs.","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs.","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs.","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"Village Ganguwala , Tehsil-Paonta Sahib , Sirmaur, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs.","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"3 Industrial Area , Dewas, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"03/12/2014","notes":"","charges":[{"code":"60","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"}],"firm_as_published":"Sun Pharmaceutical Industries Limited - Karkhadi","address_as_published":"A Plot No 817 , Village Karkhadi , Padra, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"12/07/2022","notes":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","charges":[{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"05/12/2025"},{"code":"55","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/07/2022"},{"code":"56","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Antibiotics (Human/Animal)","published":"12/07/2022"},{"code":"58","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/07/2022"},{"code":"60","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"61","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"62","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"63","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"64","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"65","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"66","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"}],"firm_as_published":"Sun Pharmaceutical Industries Ltd.","address_as_published":"Halol - Baroda Highway , Halol, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-06-08T04:00:00Z","posted":"2022-07-19T13:20:00Z","subject":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","office":"Office of Human and Animal Foods- East Division 3","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","company_as_published":"New Sun Inc.","match":"token"},{"date":"2022-08-17T04:00:00Z","posted":"2022-09-06T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Office of Human and Animal Food Operations – West Division 5","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","company_as_published":"Sun Sen Co., Inc.","match":"token"},{"date":"2023-04-07T04:00:00Z","posted":"2023-08-15T13:20:00Z","subject":"Unapproved New Drugs/Misbranded","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","company_as_published":"STPCA Inc. dba Sun Ten Laboratories","match":"token"},{"date":"2023-05-10T04:00:00Z","posted":"2023-05-30T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations West II","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","company_as_published":"Rhodes Legacy Inc DBA Sun Sprouts","match":"token"},{"date":"2023-10-16T04:00:00Z","posted":"2023-10-16T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","company_as_published":"Sun Pharmaceutical Industries Ltd.","match":"exact"},{"date":"2024-06-18T04:00:00Z","posted":"2024-07-02T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","company_as_published":"Sun Pharmaceutical Industries Limited","match":"exact"},{"date":"2025-03-12T04:00:00Z","posted":"2025-03-18T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","company_as_published":"Waxhead Sun Defense Company","match":"token"}],"events":[{"d":"2025-05-12","k":"charge","t":"66-40 charge 54 — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-03-12","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-06-18","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-10-16","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-05-10","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","x":"Division of Human and Animal Food Operations West II"},{"d":"2023-04-07","k":"letter","t":"Unapproved New Drugs/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","x":"Division of Human and Animal Food Operations West V"},{"d":"2022-12-07","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24"},{"d":"2022-08-17","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","x":"Office of Human and Animal Food Operations – West Division 5"},{"d":"2022-06-08","k":"letter","t":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","x":"Office of Human and Animal Foods- East Division 3"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2014-03-12","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs."},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs"}],"first":"2009-09-10","last":"2025-05-12","sibs":["3003227153","3004520113","3003892973","3002809586","3003952717","3012032037","3002807979","3010027135","3002871444","3004561553"],"colo":[]},{"id":"3039398033","fei":"3039398033","duns":"771705052","firm":"CHROMOLUTION RESEARCH LABORATORIES PRIVATE LIMITED","registrant":"CHROMOLUTION RESEARCH LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Second Floor, 301, Solaris Business Hub, Sola Road, Parshwanath Jain temple, Bhuyangdev, Ahmadabad, Gujarat 380013, India (IND)","city":"Ahmadabad","state":"Gujarat","pin":"380013","ops":["ANALYSIS"],"expires":"12/31/2026","lat":23.0555,"lon":72.55984,"prec":"postcode","geo":"380013, SabarmatiTaluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3027380201","fei":"3027380201","duns":"955475628","firm":"ITAAN PHARMA PRIVATE LIMITED","registrant":"ITAAN PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Sez Plot No 9, Ip Btpark Ph III, Karakapatla, Siddipet, Telangana 502281, India (IND)","city":"Siddipet","state":"Telangana","pin":"502281","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":17.81912,"lon":78.7342,"prec":"postcode","geo":"502281, Gajwel mandal, Siddipet, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031960635","3014404150","Plot No.- 09, Biotech Park, Phase-III, Sy No.-321, Karkapatla (V), Markook (M),, Siddipet, Telangana 502281, India (IND)","3032184895","3027345324","3014483338"]},{"id":"3029740212","fei":"3029740212","duns":"854255181","firm":"HBC HEALTHCARE PRIVATE LIMITED","registrant":"HBC Healthcare Private Limited","parent":null,"ticker":null,"addr":"Shankus Water Park, 609/002, Ground Floor, Ambasan, Mehsana, Gujarat 384435, India (IND)","city":"Mehsana","state":"Gujarat","pin":"384435","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":23.47851,"lon":72.37963,"prec":"postcode","geo":"384435, Mahesana Taluka, Mahesana, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3009214844","fei":"3009214844","duns":"725912948","firm":"Orchev Pharma Private Limited","registrant":"Orchev Pharma Private Limited","parent":null,"ticker":null,"addr":"Shapar Industrial Area, Rajkot-Gondal Highway, Veraval, Rajkot, Gujarat 360002, India (IND)","city":"Rajkot","state":"Gujarat","pin":"360002","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.27301,"lon":70.79989,"prec":"postcode","geo":"360002, Rajkot East Taluka, Rajkot, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3020873746","fei":"3020873746","duns":"873678400","firm":"CHROMO MEDCARE PRIVATE LIMITED","registrant":"CHROMO MEDCARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Shed No 66A APIIC Industrial Park Gajulamandyam Village Renigunta Mandal, Chittoor, ANDHRA PRADESH 517520, India (IND)","city":"Chittoor","state":"Andhra Pradesh","pin":"517520","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":13.64654,"lon":79.49995,"prec":"postcode","geo":"517520, Renigunta, Tirupati, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3017864048","3004896422"]},{"id":"3009042530","fei":"3009042530","duns":"932436552","firm":"SPINCOTECH PRIVATE LIMITED","registrant":"SPINCOTECH PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Shed No B -21, Sidco Pharmaceutical Complex Sidco Industrial Estate, Alathur, Chennai, TAMIL NADU 603110, India (IND)","city":"Chennai","state":"Tamil Nadu","pin":"603110","ops":["ANALYSIS"],"expires":"12/31/2026","lat":12.71867,"lon":80.09467,"prec":"postcode","geo":"603110, Chengalpattu, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005216842","3011361515","3005151016","3005782924","3003597293","3020342635","3003747558"]},{"id":"3024206690","fei":"3024206690","duns":"738304214","firm":"PURE AND CURE HEALTHCARE PRIVATE LIMITED","registrant":"PURE AND CURE HEALTHCARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Shed No-280,281, Alipur Industrial Estate, Barwala, Ram Garh, Panchkula, Haryana 134118, India (IND)","city":"Panchkula","state":"Haryana","pin":"134118","ops":["ANALYSIS"],"expires":"12/31/2026","lat":30.57058,"lon":76.94024,"prec":"postcode","geo":"134118, Barwala, Panchkula, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008176882","3007577941"],"colo":["3041703540"]},{"id":"3033876577","fei":"3033876577","duns":"914078633","firm":"LJ Pharma","registrant":"LJ Pharma","parent":null,"ticker":null,"addr":"Shed No. 5, Sankeshwar Industrial Estate Tajpur Bhat Road, Changodar, Ahmedabad,  382213, India (IND)","city":"Ahmedabad","state":null,"pin":"382213","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3041646841","3036725850","3043068534","3017085815","3010661577","3007277149","3008957483","3007938603","3010254278","3029456823","3007621329","3008725987"]},{"id":"3043782814","fei":"3043782814","duns":"772647654","firm":"GUFIC BIOSCIENCES LIMITED","registrant":"GUFIC BIOSCIENCES LIMITED","parent":null,"ticker":null,"addr":"Smart Industrial Park, Plot no.48, Near NATRIP, Pithampur., Dhar, Madhya Pradesh 454775, India (IND)","city":"Dhar","state":"Madhya Pradesh","pin":"454775","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3010453141","3007574780","3016480976","3006456888","3008565058","3005259207","3008581988","3005594847","3038913994","3016268582","3014281041","3008861587"]},{"id":"3013637926","fei":"3013637926","duns":"871412155","firm":"BIOCON PHARMA LIMITED","registrant":"BIOCON PHARMA LIMITED","parent":"Biocon","ticker":"BIOCON","addr":"Special Economic Zone, Block F1, Plot No.5, Phase IV, Bommasandra - Jigani Link Road, Bommasandra Post, Bengaluru, Karnataka 560099, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560099","ops":["ANALYSIS","MANUFACTURE","PACK","REPACK"],"expires":"12/31/2026","lat":12.83934,"lon":77.70554,"prec":"postcode","geo":"560099, Singena Agrahara, Anekal, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009310198","3003600340","3043619916","3007078919","3003981475","3008300442","3006076314","3010164491","3035152598"]},{"id":"3010164491","fei":"3010164491","duns":"915076162","firm":"Biocon Limited","registrant":"Biocon Limited","parent":"Biocon","ticker":"BIOCON","addr":"Special Economic Zone, Plot No. 2, 3, 4 & 5, Phase IV, Bommasandra-Jigani Link Road, Bommasandra Post, Bengaluru, Karnataka 560099, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560099","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":12.83934,"lon":77.70554,"prec":"postcode","geo":"560099, Singena Agrahara, Anekal, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["1000172912","3004956855","3006400591"],"colo":["3009310198","3003600340","3043619916","3007078919","3003981475","3008300442","3006076314","3013637926","3035152598"]},{"id":"3010165392","fei":"3010165392","duns":"677385498","firm":"MEDGEL PRIVATE LIMITED","registrant":"MEDGEL PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Special Economic Zone, Plot No.-19-20, Pharma Zone, Phase-II, Sector -III, Pithampur, Dhar, MP 454775, India (IND)","city":"Dhar","state":null,"pin":"454775","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2023-07-20T04:00:00Z","posted":"2023-08-01T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"05/29/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medgel-private-limited-654085-07202023","company_as_published":"Medgel Private Limited","match":"exact"}],"events":[{"d":"2023-07-20","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medgel-private-limited-654085-07202023","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2023-07-20","last":"2023-07-20","sibs":[],"colo":["3010453141","3007574780","3016480976","3006456888","3008565058","3005259207","3008581988","3005594847","3038913994","3016268582","3014281041","3008861587"]},{"id":"3007648351","fei":"3007648351","duns":"677605290","firm":"Mylan Laboratories Limited","registrant":"Viatris Inc.","parent":null,"ticker":null,"addr":"Specialty Formulation Facility, Plot No: 284B/1, 289-292 Bommasandra-Jigani Link Road, Industrial Area, Anekal Taluk, Bengaluru, Karnataka 560105, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560105","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":12.78642,"lon":77.63458,"prec":"postcode","geo":"560105, Jigani, Anekal, Bengaluru Urban, Karnataka, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"12/19/2024","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/19/2024"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"12/19/2024"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/19/2024"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"12/19/2024"}],"firm_as_published":"Mylan Laboratories Limited","address_as_published":"(FDF-3) Plot Nos. 11, 12, 13, Indore SEZ , Pharma Zone, Phase II, Sector III , Pithampur, District Dhar, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2024-12-19","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"}],"first":"2024-12-19","last":"2024-12-19","sibs":["3005587313","3008316970","3010453141","3007512701","3006355432","3008255419","3007720135"],"colo":["3005857289","3003560263","3009882550","3015345916","3009609358","3004939494","3003768909"]},{"id":"3006370524","fei":"3006370524","duns":"915628612","firm":"Alkem Laboratories Limited","registrant":"Alkem Laboratories Limited","parent":"Alkem Laboratories","ticker":"ALKEM","addr":"Srv. No. 167, Plot No. 164, 165/1, 165/2, 165/3, 168/215, 168/216, 168/234, Village Dabhel, Daman, Dadra & Nagar Haveli and Daman & Diu 396210, India (IND)","city":"Village Dabhel","state":"Daman","pin":"396210","ops":["ANALYSIS","MANUFACTURE","PACK","REPACK"],"expires":"12/31/2026","lat":20.42558,"lon":72.84559,"prec":"postcode","geo":"396210, Daman, Dadra and Nagar Haveli and Daman and Diu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006370533","3008450172","3006851796"],"colo":["3004086192","3006896204","3009681646","3006363714","3003647459"]},{"id":"3003813519","fei":"3003813519","duns":"676199117","firm":"ONESOURCE SPECIALTY PHARMA LIMITED","registrant":"ONESOURCE SPECIALTY PHARMA LIMITED","parent":null,"ticker":null,"addr":"Sterile Product Division, Opp IIM, Bilekahalli, Bannerghatta Road,, Bengaluru, Karnataka 560076, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560076","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":12.88064,"lon":77.60387,"prec":"postcode","geo":"560076, Hulimavu, Bengaluru South City Corporation, Bengaluru, Bangalore South, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005652193","3017501030"],"colo":["3041525876"]},{"id":"3022238550","fei":"3022238550","duns":"650173735","firm":"Zydus Pharmaceuticals Limited","registrant":"Zydus Pharmaceuticals USA Inc.","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Sub Plot No. - 20 & 21, Pharmez - Special Economic Zone, Sarkhej Bavla Road N.H. No. 8A Village.- Matoda, Taluka. - Sanand 382213 Ahmedabad, Matoda, Gujarat 382213, India (IND)","city":"Matoda","state":"Gujarat","pin":"382213","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3041646841","3036725850","3043068534","3017085815","3010661577","3007277149","3008957483","3007938603","3010254278","3029456823","3007621329","3008725987"]},{"id":"3011256052","fei":"3011256052","duns":"860037166","firm":"Edward Food Research & Analysis Centre Limited","registrant":"Edward Food Research & Analysis Centre Limited","parent":null,"ticker":null,"addr":"Subhash Nagar Po: Nilgunj Bazar, Barasat, Kolkata, West Bengal 700121, India (IND)","city":"Kolkata","state":"West Bengal","pin":"700121","ops":["ANALYSIS"],"expires":"12/31/2026","lat":22.76661,"lon":88.42298,"prec":"postcode","geo":"700121, Kolkata Metropolitan Area, Barrackpur - II, North 24 Parganas, West Bengal, India","status":1,"alerts":[],"letters":[{"date":"2026-06-15T04:00:00Z","posted":"2026-06-30T04:00:00Z","subject":"Foreign Supplier Verification Program (FSVP)","office":"Office of Inspections and Investigations","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/life-food-inc-731887-06152026","company_as_published":"Life & Food Inc.","match":"token"}],"events":[{"d":"2026-06-15","k":"letter","t":"Foreign Supplier Verification Program (FSVP)","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/life-food-inc-731887-06152026","x":"Office of Inspections and Investigations"}],"first":"2026-06-15","last":"2026-06-15","sibs":[],"colo":[]},{"id":"3027756269","fei":"3027756269","duns":"737969163","firm":"KADAMB PHARMACHEM","registrant":"KADAMB PHARMACHEM","parent":null,"ticker":null,"addr":"Survey Block No 438, Old Survey No 801, Border Of Indrad, Taluka Kadi, Mehsana, Gujarat 382715, India (IND)","city":"Mehsana","state":"Gujarat","pin":"382715","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":23.29798,"lon":72.33217,"prec":"postcode","geo":"382715, Kadi Taluka, Mahesana, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038200383"]},{"id":"3009103626","fei":"3009103626","duns":"677605400","firm":"Lee Pharma Limited","registrant":"Lee Pharma Ltd.","parent":null,"ticker":null,"addr":"Survey No 10/G1, Gaddapotharam Village Jinnaram Mandal, Sangareddy, Telangana 502319, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502319","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2023-08-28T04:00:00Z","posted":"2024-03-05T14:20:00Z","subject":"Food Labeling/Misbranded","office":"Division of Human and Animal Food Operations East VI","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gilster-mary-lee-corporation-658271-08282023","company_as_published":"Gilster-Mary Lee Corporation","match":"token"}],"events":[{"d":"2023-08-28","k":"letter","t":"Food Labeling/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gilster-mary-lee-corporation-658271-08282023","x":"Division of Human and Animal Food Operations East VI"}],"first":"2023-08-28","last":"2023-08-28","sibs":["3018490749","3030599910"],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3008154209","3015218020","3009261338","3007800082"]},{"id":"3037590407","fei":"3037590407","duns":"854517410","firm":"ANDROST BIOTECH PRIVATE LIMITED","registrant":"ANDROST BIOTECH PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No 102 Village Zarol Taluka Vaso Area, Nadiad, Gujarat 387320, India (IND)","city":"Nadiad","state":"Gujarat","pin":"387320","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.7244,"lon":72.80213,"prec":"postcode","geo":"387320, Nadiad Taluka, Kheda, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3022699158","fei":"3022699158","duns":"869589559","firm":"ARENE LIFE SCIENCES (UNIT 3) PRIVATE LIMITED","registrant":"Arene Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Survey No 12 & 13, Vikarabad Road, Yavapur Village, Sadasivpet, Sangareddy, Telangana 502291, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502291","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.61837,"lon":77.97063,"prec":"postcode","geo":"502291, Sadasivpet mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008616840"]},{"id":"3039302579","fei":"3039302579","duns":"771658386","firm":"SRI HAAS LIFE SCIENCES PRIVATE LIMITED","registrant":"SRI HAAS LIFE SCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No 151/1, Bijilipur Village, Shivampet Mandal, Medak, Telangana 502336, India (IND)","city":"Medak","state":"Telangana","pin":"502336","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.73533,"lon":78.49894,"prec":"postcode","geo":"502336, Manoharabad mandal, Medak, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3008243902","fei":"3008243902","duns":"650372951","firm":"AIZANT DRUG RESEARCH SOLUTIONS PVT LTD","registrant":"AIZANT DRUG RESEARCH SOLUTIONS PVT LTD","parent":null,"ticker":null,"addr":"Survey No 172 & 173, Apparel Park Road, Dulapally Village, Dundigal-Gandimaisamma Mandal, Medchal-Malkhajgiri District, Hyderabad, Telangana 500100, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500100","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.53513,"lon":78.48305,"prec":"postcode","geo":"500100, Dundigal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3025169808"],"colo":["3004987008"]},{"id":"3001413302","fei":"3001413302","duns":"650599231","firm":"Dabur India Limited","registrant":"Dabur India Limited","parent":null,"ticker":null,"addr":"Survey No 225- 4 -1, Saily Village, Silvassa,  396240, India (IND)","city":"Silvassa","state":null,"pin":"396240","ops":["LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":20.2205,"lon":73.0184,"prec":"postcode","geo":"396240, Nagar Haveli, Dadra and Nagar Haveli, Dadra and Nagar Haveli and Daman and Diu, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/05/2026","notes":"All Drug and Drug Products","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"06/05/2026"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"06/05/2026"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"06/05/2026"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"06/05/2026"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"06/05/2026"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/05/2026"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"06/05/2026"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"06/05/2026"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/05/2026"}],"firm_as_published":"Dabur India Limited","address_as_published":"225 - 4 - 1 Saily Village , Survey No , Dadra And Nagar Haveli, Dadra and Nagar Haveli And Dam INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-41","list":"red","since":"08/26/2025","notes":"","charges":[{"code":"33","notes":"","product":"Candy W/O Chocolate/Candy Specialties/Chewing Gums","published":"08/26/2025"},{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"08/26/2025"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"08/26/2025"},{"code":"60 S - - 99","notes":"","product":"Antacid, N.E.C.","published":"08/26/2025"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/26/2025"}],"firm_as_published":"DABUR INDIA LIMITED","address_as_published":"45 46 47 Plot No 44 , And 97; Smart Industrial Park , Pithampur, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"11/01/2021","notes":"All skin creams or lotions that list �bleach or skin bleaching� in the name of the product or �bleach or skin bleaching� in the product�s intended use are subject to DWPE under this listing.","charges":[{"code":"41 Y - - 99","notes":"","product":"Dietary Conventional Foods, N.E.C.","published":"08/09/2024"},{"code":"53 L D - 01","notes":"","product":"Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Liquid, Lotion","published":"08/02/2024"},{"code":"53 L - - 01","notes":"","product":"Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)","published":"08/02/2024"},{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"11/01/2021"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"08/09/2024"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"11/01/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"11/01/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/02/2024"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/09/2024"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/02/2024"}],"firm_as_published":"Dabur India","address_as_published":"Lane no. 3, phase-2 , SIDCO Industrial Complex, Bari Brahmana , Jammu, Jammu and Kashmir INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"02/28/2020","notes":"The product appears to be an unapproved new drug as the product label and promotional website include claims such as (not an all-inclusive list): Label - 'Helps keep you fit by protecting from day to day elements like cough & cold.'; Website - 'Dabur Chyawanprash is a time-tested Ayurvedic formulation of more than 41 Ayurvedic herbs that aid in boosting the immune system, thereby protecting the body from everyday infections like cough & cold etc. caused by bacteria, viruses, dust and weather change.'.","charges":[{"code":"22 C - - 99","notes":"","product":"Vine Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C.","published":"02/28/2020"},{"code":"27 Y - - 99","notes":"","product":"Condiments, N.E.C.","published":"02/28/2020"},{"code":"37 K - - 99","notes":"","product":"Pastes, n.e.c.","published":"02/28/2020"},{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"04/03/2020"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"04/03/2020"},{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"02/26/2024"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"02/28/2020"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"02/26/2024"},{"code":"60 S - - 99","notes":"","product":"Antacid, N.E.C.","published":"02/26/2024"},{"code":"63 R","notes":"","product":"Dental Caries Prophyl","published":"04/03/2020"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"02/26/2024"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"02/28/2020"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"04/03/2020"}],"firm_as_published":"Dabur India","address_as_published":"Honey Unit, Tehsil Baddi , Manakpur , Solan, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"09/13/2019","notes":"5/4/2006","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"09/13/2019"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"09/13/2019"}],"firm_as_published":"Dabur India Limited","address_as_published":"P.O. Daburgram , Bihar, INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"11/01/2021","notes":"A labeling statement documenting the intended use of the product includes, but may not be limited to the following: �Ayurvedic Medicine� Indications:� � useful for gout and arthritis, and helps purify blood�.","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"11/01/2021"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"11/01/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"11/01/2021"}],"firm_as_published":"Dabur India Limited","address_as_published":"SP -C 162 , Matsya Industrial Area , Alwar, Rajasthan INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"11/22/2010","notes":"India","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"11/22/2010"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"11/22/2010"},{"code":"63 R - - 06","notes":"","product":"Stannous Fluoride (Dental Caries Prophylactic)","published":"11/22/2010"},{"code":"63 S - - 99","notes":"","product":"Dental Protectant N.E.C.","published":"11/22/2010"}],"firm_as_published":"Dabur India Limited","address_as_published":"60 Maiku Majra , Malku Majra Road; Nalagarth Road , Baddi, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"06/13/2013","notes":"06/13/2013","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"06/13/2013"},{"code":"53 L - - 03","notes":"","product":"Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)","published":"01/27/2021"},{"code":"53 L - - 03","notes":"","product":"Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)","published":"01/27/2021"}],"firm_as_published":"Dabur India Limited","address_as_published":"Village Billanwali Lavana, Baddi , Solan, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"10/14/2012","notes":"The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): �antiplaque & whitening��.","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"05/16/2025"},{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"10/14/2012"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"10/14/2012"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"05/16/2025"},{"code":"63 R - - 06","notes":"","product":"Stannous Fluoride (Dental Caries Prophylactic)","published":"10/14/2012"},{"code":"63 R - - 99","notes":"","product":"Dental Caries Prophylactic N.E.C.","published":"05/16/2025"},{"code":"63 S - - 99","notes":"","product":"Dental Protectant N.E.C.","published":"10/14/2012"},{"code":"63 U - - 99","notes":"","product":"Dentin Desensitizer N.E.C.","published":"10/14/2012"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"05/16/2025"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"10/14/2012"}],"firm_as_published":"Dabur India Limited","address_as_published":"225 - 4 - 1 Saily Village , Survey No , Dadra And Nagar Haveli, Dadra and Nagar Haveli And Dam INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"05/29/2014","notes":"","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"05/29/2014"}],"firm_as_published":"Dabur India Limited","address_as_published":"86 A, Kheda Industrial Area, Pithampur , Dhar, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"02/04/2020","notes":"","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"02/04/2020"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"02/04/2020"},{"code":"63 R","notes":"","product":"Dental Caries Prophyl","published":"02/04/2020"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"02/04/2020"}],"firm_as_published":"Dabur India Limited","address_as_published":"Sanitpur , Garaimari, Assam INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"02/04/2020","notes":"Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: \"Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory\". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020","charges":[{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"01/27/2021"},{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"04/03/2020"},{"code":"53 I - - 01","notes":"","product":"Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","published":"02/04/2020"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"04/03/2020"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"01/27/2021"},{"code":"53 I - - 99","notes":"","product":"Other Oral Hygiene Products, without Fluoride, N.E.C.","published":"02/04/2020"},{"code":"54 Y - - 99","notes":"","product":"Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","published":"01/27/2021"},{"code":"63 R - - 06","notes":"","product":"Stannous Fluoride (Dental Caries Prophylactic)","published":"01/27/2021"},{"code":"63 R - - 99","notes":"","product":"Dental Caries Prophylactic N.E.C.","published":"01/27/2021"},{"code":"63 R","notes":"","product":"Dental Caries Prophyl","published":"04/03/2020"},{"code":"63 R","notes":"","product":"Dental Caries Prophyl","published":"02/04/2020"},{"code":"63 S - - 99","notes":"","product":"Dental Protectant N.E.C.","published":"01/27/2021"},{"code":"63 U - - 99","notes":"","product":"Dentin Desensitizer N.E.C.","published":"01/27/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"02/04/2020"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"01/27/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"04/03/2020"}],"firm_as_published":"Dabur India Limited (Unit-2)","address_as_published":"Integrated Industrial Estate, Plot No 4, Sec-2, Pant Nagar, Distt. Udham Singh Nagar , Udham Singh Nagar, Uttaranchal INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"01/10/2017","notes":"Medical claims made on product label","charges":[{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"01/10/2017"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"01/10/2017"}],"firm_as_published":"Dabur India Ltd","address_as_published":"8/3 Asaf Ali Road , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-41","list":"red","since":"10/14/2015","notes":"","charges":[{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"10/14/2015"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"10/14/2015"}],"firm_as_published":"Dabur India Ltd","address_as_published":"109 Hpsidc Industrial Area , Baddi, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[{"date":"2026-07-24T04:00:00Z","posted":"2026-08-04T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dabur-india-limited-728828-07242026","company_as_published":"Dabur India Limited","match":"exact"}],"events":[{"d":"2026-07-24","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dabur-india-limited-728828-07242026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2026-06-05","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"},{"d":"2025-08-26","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2025-05-16","k":"charge","t":"66-41 charge 53 I - - 01 — Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2025-05-16","k":"charge","t":"66-41 charge 53 I - - 99 — Other Oral Hygiene Products, without Fluoride, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2025-05-16","k":"charge","t":"66-41 charge 63 R - - 99 — Dental Caries Prophylactic N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2025-05-16","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-09","k":"charge","t":"66-41 charge 41 Y - - 99 — Dietary Conventional Foods, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-09","k":"charge","t":"66-41 charge 54 Y - - 99 — Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-09","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-02","k":"charge","t":"66-41 charge 53 L D - 01 — Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations), Liquid, Lotion","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-02","k":"charge","t":"66-41 charge 53 L - - 01 — Cleansing (Cold Creams, Cleansing Lotions, Liquids, Pads) (Skin Care Preparations)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-02","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-08-02","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-02-26","k":"charge","t":"66-41 charge 54 F - - 99 — Herbals & Botanicals (not Teas), N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-02-26","k":"charge","t":"66-41 charge 54 Y - - 99 — Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-02-26","k":"charge","t":"66-41 charge 60 S - - 99 — Antacid, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-02-26","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-11-01","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"All skin creams or lotions that list �bleach or skin bleaching� in the name of the product or �bleach or skin bleaching� in the product�s intended use are subject to DWPE under this listing."},{"d":"2021-11-01","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"A labeling statement documenting the intended use of the product includes, but may not be limited to the following: �Ayurvedic Medicine� Indications:� � useful for gout and arthritis, and helps purify blood�."},{"d":"2021-01-27","k":"charge","t":"66-41 charge 53 L - - 03 — Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 53 L - - 03 — Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 53 I - - 01 — Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 53 I - - 99 — Other Oral Hygiene Products, without Fluoride, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 54 Y - - 99 — Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 63 R - - 06 — Stannous Fluoride (Dental Caries Prophylactic)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 63 R - - 99 — Dental Caries Prophylactic N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 63 S - - 99 — Dental Protectant N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 63 U - - 99 — Dentin Desensitizer N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2021-01-27","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 53 I - - 01 — Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 53 I - - 99 — Other Oral Hygiene Products, without Fluoride, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 63 R — Dental Caries Prophyl","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 53 I - - 01 — Dentifrices (Aerosol, Liquid, Toothpastes, Toothpowders), without Fluoride (Oral Hygiene Products)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 53 I - - 99 — Other Oral Hygiene Products, without Fluoride, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 63 R — Dental Caries Prophyl","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-04-03","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-02-28","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"The product appears to be an unapproved new drug as the product label and promotional website include claims such as (not an all-inclusive list): Label - 'Helps keep you fit by protecting from day to day elements like cough & cold.'; Website - 'Dabur Chyawanprash is a time-tested Ayurvedic formulation of more than 41 Ayurvedic herbs that aid in boosting the immune system, thereby protecting the body from everyday infections like cough & cold etc. caused by bacteria, viruses, dust and weather change.'."},{"d":"2020-02-04","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2020-02-04","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Product appears to be is a drug, as per section 201(g)(1) of the FDCA, 21U.S.C.321(g)(1), and an unapproved new drug, as per section 505(a) of the FDCA, 21U.S.C.355(a). Claims on LBL (21CFR201.128) include: \"Fights 7 Dental Problems, Cavities, Bad Breath, Bleeding Gums, Toothache, Yellowing, Plaque, Germs...antiseptic and antibacterial properties...anti-inflammatory\". Based on the claims, the product is a drug as defined by section 201(g)(1)(B) of the FDCA, 21 U.S.C. 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FDCA, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. OTC drug products intended for use as anticaries are subject to the final rule for Anticaries Drug Products for OTC Human Use (anticaries final rule), 21CFR355. However, it is not labeled or formulated in accordance with this final rule for the reasons explained below. Product is a four-way combination drug product because it is intended for use as an anticaries, oral healthcare analgesic, oral antiseptic, and antiplaque/antigingivitic drug product. The anticaries final rule does not permit a four-way combination drug product such as this product. Thus, as formulated and labeled, it does not comply with the final rule described above. Furthermore, we are not aware of sufficient evidence to show the product as formulated and labeled, is GRAS and effective. Therefore, it appears to be a new drug within the meaning of section 201(p) of the FDCA, 21U.S.C. 321(p). Under sections 505(a) and 301(d) of the FDCA, a new drug may not be introduced/delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Product is not the subject of an FDA-approved application. 3/23/2020"},{"d":"2019-09-13","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"5/4/2006"},{"d":"2017-01-10","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Medical claims made on product label"},{"d":"2015-10-14","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2013-06-13","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"06/13/2013"},{"d":"2012-10-14","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"The product appears to be an unapproved new drug as the product label includes claims such as (not an all-inclusive list): �antiplaque & whitening��."},{"d":"2010-11-22","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"India"}],"first":"2010-11-22","last":"2026-07-24","sibs":["3046619098"],"colo":[]},{"id":"3014930305","fei":"3014930305","duns":"675479528","firm":"HIBROW HEALTHCARE PRIVATE LIMITED","registrant":"Hibrow Healthcare LLC","parent":null,"ticker":null,"addr":"Survey No 258, Thiruvandavar Village, Sirupinayur Panchayat Uthiramerur Taluk, Kanchipuram, Tamilnadu 603308, India (IND)","city":"Kanchipuram","state":null,"pin":"603308","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.59577,"lon":79.92361,"prec":"postcode","geo":"603308, Maduranthakam, Chengalpattu, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3005408438","fei":"3005408438","duns":"915840825","firm":"Sri Krishna Pharmaceuticals Limited","registrant":"Sri Krishna Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Survey No 296/7/10, IDA Bollaram (V), Jinnaram (M),, Sangareddy (Dist),, Telangana 502 325, India (IND)","city":"Sangareddy (Dist)","state":"Telangana","pin":null,"ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.63222,"lon":78.33224,"prec":"tail3","geo":"Jinnaram, Jinnaram mandal, Sangareddy, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"08/13/2015","notes":"All Drugs","charges":[{"code":"55","notes":"All Drugs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"08/13/2015"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"10/02/2024"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"61","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"62","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"63","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"64","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"65","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"66","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"}],"firm_as_published":"Sri Krishna Pharmaceuticals Limited","address_as_published":"Unit Ii, Plot No:A-34,A-35, Ida Nacharam, Uppal (M), Medchal-Malkajgiri District , Hyderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2024-10-02","k":"charge","t":"66-40 charge 56 — Antibiotics (Human/Animal)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2015-08-13","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs"}],"first":"2015-08-13","last":"2024-10-02","sibs":["3003723117","3005403224"],"colo":[]},{"id":"3007068506","fei":"3007068506","duns":"877850380","firm":"Bliss GVS Pharma Limited","registrant":"Bliss GVS Pharma Limited","parent":null,"ticker":null,"addr":"Survey No 43-44 Vevoor Village, Palghar, Maharashtra 401404, India (IND)","city":"Palghar","state":"Maharashtra","pin":"401404","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.69445,"lon":72.78565,"prec":"postcode","geo":"401404, Palghar Subdistrict, Palghar, Maharashtra, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"09/14/2021","notes":"The product appears to be an unapproved new drug as the product�s labeling includes claims such as (not an all-inclusive list): �Indications . . . FUNBACT-A� provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision��.","charges":[{"code":"53 L - - 03","notes":"","product":"Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations)","published":"09/14/2021"},{"code":"56 D - - 41","notes":"","product":"Neomycin Sulfate (Aminoglycosides)","published":"09/14/2021"},{"code":"56 G - - 99","notes":"","product":"Antifungal N.E.C.","published":"09/14/2021"},{"code":"61 H - - 99","notes":"","product":"Anti-Bacterial, N.E.C.","published":"09/14/2021"},{"code":"61 W - - 04","notes":"","product":"Clotrimazole (Anti-Fungal) (Not Antibiotic)","published":"09/14/2021"},{"code":"64 L - - 06","notes":"","product":"Betamethasone Dipropionate (Glucocorticoid)","published":"09/14/2021"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"09/14/2021"}],"firm_as_published":"Bliss GVS Pharma Limited","address_as_published":"Plot No 11, Survey No 38, , Gut No. 312, Dewan Udyog Nagar; Aliyali Village , Palghar, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[],"events":[{"d":"2021-09-14","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"The product appears to be an unapproved new drug as the product�s labeling includes claims such as (not an all-inclusive list): �Indications . . . FUNBACT-A� provides a comprehensive treatment for various inflammatory dermatological disorders superadded with bacterial or superficial fungal infections of the skin . . . Betamethasone Dipropionate is one of the most potent topical corticosteroid available and rapidly controls the symptoms such as itching, redness, and scaling . . . Clotrimazole is a broad spectrum synthetic antifungal agent which has fungicidal action against all the fungi responsible for superficial fungal infections of skin. . . . Neomycin Sulphate is a broad spectrum antibacterial antibiotic. . . FUNBACT-A TRIPLE ACTION CREAM . . . Antifungal-Antibacterial-Anti-inflammatory. . . Apply to the infected area 2-3 times a day with a gentle rub. . .To be used only under medical supervision��."}],"first":"2021-09-14","last":"2021-09-14","sibs":["3008380269"],"colo":["3042541221","3043682089"]},{"id":"3003829978","fei":"3003829978","duns":"650849198","firm":"PLUTUS TECHLABS PRIVATE LIMITED","registrant":"PLUTUS TECHLABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No 76/2 & 76/3, Paidiparru Tanuku Mandal, West Godavari, ANDHRA PRADESH 534211, India (IND)","city":"West Godavari","state":"Andhra Pradesh","pin":"534211","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.75153,"lon":81.68092,"prec":"postcode","geo":"534211, Tanuku, West Godavari, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3014643247","fei":"3014643247","duns":"860551301","firm":"Basis Laboratories Private Limited","registrant":"Basis Laboratories Private Limited","parent":null,"ticker":null,"addr":"Survey No 904, Jangampally village, Bhiknoor Mandal Kamareddy District, Nizamabad, Telangana 503102, India (IND)","city":"Nizamabad","state":"Telangana","pin":"503102","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":18.19527,"lon":78.40087,"prec":"tail3","geo":"Primary Health Centre, Bhiknoor, Old NH7, Bhiknoor, Bhiknoor mandal, Nizamabad, Telangana, 503101, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3004590215","fei":"3004590215","duns":"676373951","firm":"Covalent Laboratories Private Limited","registrant":"Covalent Laboratories Private Limited","parent":null,"ticker":null,"addr":"Survey No. - 374, Gundla Machanoor Village, Hathnoor Mandal, Sangareddy District, Telangana 502296, India (IND)","city":"Sangareddy District","state":"Telangana","pin":"502296","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.68077,"lon":78.19935,"prec":"postcode","geo":"502296, Hathnoora mandal, Sangareddy, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2025-07-09T04:00:00Z","posted":"2025-07-15T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/covalent-medical-695839-07092025","company_as_published":"Covalent Medical","match":"token"}],"events":[{"d":"2025-07-09","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/covalent-medical-695839-07092025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-07-09","last":"2025-07-09","sibs":[],"colo":["3011766778","3004021253","3006370489"]},{"id":"3008154209","fei":"3008154209","duns":"675982590","firm":"VIRUPAKSHA ORGANICS LIMITED","registrant":"VIRUPAKSHA ORGANICS LIMITED","parent":null,"ticker":null,"addr":"Survey No. 10 Gaddapotharam (Village), Jinnaram Mandal, Sangareddy, Telangana 502319, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502319","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3018360272"],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3015218020","3009261338","3007800082"]},{"id":"3004561553","fei":"3004561553","duns":"650445203","firm":"Sun Pharmaceutical Industries Limited","registrant":"Sun Pharmaceutical Industries Limited","parent":"Sun Pharmaceutical Industries","ticker":"SUNPHARMA","addr":"Survey No. 1012, Dadra, Union Territory of Dadra and Nagar Haveli and Daman and Diu 396193, India (IND)","city":"Dadra","state":"Daman","pin":"396193","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":20.32892,"lon":72.96609,"prec":"postcode","geo":"396193, Dadra, Dadra and Nagar Haveli, Dadra and Nagar Haveli and Daman and Diu, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs.","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs.","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs.","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"Village Ganguwala , Tehsil-Paonta Sahib , Sirmaur, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"09/10/2009","notes":"All finished pharmaceutical products and APIs","charges":[{"code":"55","notes":"All finished pharmaceutical products and APIs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"09/10/2009"},{"code":"56","notes":"All finished pharmaceutical products and APIs","product":"Antibiotics (Human/Animal)","published":"09/10/2009"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All finished pharmaceutical products and APIs.","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"61","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"62","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"63","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"64","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"65","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"},{"code":"66","notes":"All finished pharmaceutical products and APIs","product":"Human and Animal Drugs","published":"09/10/2009"}],"firm_as_published":"Sun Pharmaceutical Industries (prev. Ranbaxy)","address_as_published":"3 Industrial Area , Dewas, Madhya Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"03/12/2014","notes":"","charges":[{"code":"60","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"03/12/2014"}],"firm_as_published":"Sun Pharmaceutical Industries Limited - Karkhadi","address_as_published":"A Plot No 817 , Village Karkhadi , Padra, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-40","list":"red","since":"12/07/2022","notes":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","charges":[{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"05/12/2025"},{"code":"55","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/07/2022"},{"code":"56","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Antibiotics (Human/Animal)","published":"12/07/2022"},{"code":"58","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"12/07/2022"},{"code":"60","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"61","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"62","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"63","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"64","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"65","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"},{"code":"66","notes":"All Drug Products; All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24","product":"Human and Animal Drugs","published":"12/07/2022"}],"firm_as_published":"Sun Pharmaceutical Industries Ltd.","address_as_published":"Halol - Baroda Highway , Halol, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-06-08T04:00:00Z","posted":"2022-07-19T13:20:00Z","subject":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","office":"Office of Human and Animal Foods- East Division 3","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","company_as_published":"New Sun Inc.","match":"token"},{"date":"2022-08-17T04:00:00Z","posted":"2022-09-06T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Office of Human and Animal Food Operations – West Division 5","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","company_as_published":"Sun Sen Co., Inc.","match":"token"},{"date":"2023-04-07T04:00:00Z","posted":"2023-08-15T13:20:00Z","subject":"Unapproved New Drugs/Misbranded","office":"Division of Human and Animal Food Operations West V","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","company_as_published":"STPCA Inc. dba Sun Ten Laboratories","match":"token"},{"date":"2023-05-10T04:00:00Z","posted":"2023-05-30T13:20:00Z","subject":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","office":"Division of Human and Animal Food Operations West II","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","company_as_published":"Rhodes Legacy Inc DBA Sun Sprouts","match":"token"},{"date":"2023-10-16T04:00:00Z","posted":"2023-10-16T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","company_as_published":"Sun Pharmaceutical Industries Ltd.","match":"exact"},{"date":"2024-06-18T04:00:00Z","posted":"2024-07-02T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","company_as_published":"Sun Pharmaceutical Industries Limited","match":"exact"},{"date":"2025-03-12T04:00:00Z","posted":"2025-03-18T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","company_as_published":"Waxhead Sun Defense Company","match":"token"}],"events":[{"d":"2025-05-12","k":"charge","t":"66-40 charge 54 — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-03-12","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/waxhead-sun-defense-company-688286-03122025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-06-18","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-limited-677337-06182024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-10-16","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-pharmaceutical-industries-ltd-636199-10162023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-05-10","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rhodes-legacy-inc-dba-sun-sprouts-651402-05102023","x":"Division of Human and Animal Food Operations West II"},{"d":"2023-04-07","k":"letter","t":"Unapproved New Drugs/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stpca-inc-dba-sun-ten-laboratories-645336-04072023","x":"Division of Human and Animal Food Operations West V"},{"d":"2022-12-07","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products; These products are excluded from the DWPE, Doxorubicin HCl Liposomal Injection-56H[][]24"},{"d":"2022-08-17","k":"letter","t":"CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sun-sen-co-inc-631981-08172022","x":"Office of Human and Animal Food Operations – West Division 5"},{"d":"2022-06-08","k":"letter","t":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","x":"Office of Human and Animal Foods- East Division 3"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2014-03-12","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs."},{"d":"2009-09-10","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All finished pharmaceutical products and APIs"}],"first":"2009-09-10","last":"2025-05-12","sibs":["3003227153","3004520113","3003892973","3002809586","3003952717","3012032037","3002807979","3010027135","3002871444","3007627683"],"colo":[]},{"id":"3003903069","fei":"3003903069","duns":"677386756","firm":"Inventaa Industries Private Limited","registrant":"Inventaa Industries Private Limited","parent":null,"ticker":null,"addr":"Survey No. 137 & 133/1 Keesara Village, Kanchikacherla Mandalam, Krishna, Andra Pradesh 521180, India (IND)","city":"Krishna","state":null,"pin":"521180","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.68598,"lon":80.36679,"prec":"postcode","geo":"521180, Kanchikacherla, NTR, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3005205440","fei":"3005205440","duns":"726025211","firm":"Jell Pharmaceuticals Pvt Ltd.","registrant":"Jell Pharmaceuticals Pvt Ltd.","parent":null,"ticker":null,"addr":"Survey No. 142/2, Athal Industrial Estate Village Athal, Silvasa, Dadra Nagar Haveli 396230, India (IND)","city":"Silvasa","state":"Dadra","pin":"396230","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":20.24604,"lon":73.03104,"prec":"postcode","geo":"396230, Nagar Haveli, Dadra and Nagar Haveli, Dadra and Nagar Haveli and Daman and Diu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005977675","3010758031"]},{"id":"3002647489","fei":"3002647489","duns":"918601238","firm":"GLAND PHARMA LIMITED","registrant":"GLAND PHARMA LIMITED","parent":"Gland Pharma","ticker":"GLAND","addr":"Survey No. 143 - 148, 150 & 151, Near Gandimaisamma Cross Roads, D. P. Pally, Dundigal Post, Dundigal - Gandimaisamma Mandal, Medchal - Malkajgiri District, Hyderabad, Telangana 500043, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500043","ops":["ANALYSIS","API MANUFACTURE","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.56089,"lon":78.43615,"prec":"postcode","geo":"500043, Dundigal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009864167","3010142300","3009056604"],"colo":["3014615000","3004097901"]},{"id":"3017421355","fei":"3017421355","duns":"772463005","firm":"SENORES PHARMACEUTICALS LIMITED","registrant":"SENORES PHARMACEUTICALS LIMITED","parent":null,"ticker":null,"addr":"Survey No. 1530, Rajpur, Kadi, Mehsana, GUJARAT 384440, India (IND)","city":"Mehsana","state":"Gujarat","pin":"384440","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK","PARTICLE SIZE REDUCTION"],"expires":"12/31/2026","lat":23.29756,"lon":72.3299,"prec":"tail3","geo":"Puja Hospital kadi, SH133, Kadi, Kadi Taluka, Mahesana, Gujarat, 382715, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3017573557","fei":"3017573557","duns":"675474666","firm":"Amneal Pharmaceuticals Private Limited","registrant":"Amneal Pharmaceuticals of New York, LLC","parent":null,"ticker":null,"addr":"Survey No. 168/1/1, Pipan, Sanand, Ahmedabad, Gujarat 382110, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382110","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","REPACK","STERILIZE"],"expires":"12/31/2026","lat":22.98725,"lon":72.33585,"prec":"postcode","geo":"382110, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2025-08-27T04:00:00Z","posted":"2025-09-02T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","company_as_published":"Amneal Pharmaceuticals, LLC","match":"exact"}],"events":[{"d":"2025-08-27","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-27","last":"2025-08-27","sibs":["3030461061","3010661577","3010254278","3029456823","3018907202","3008223599"],"colo":["3013353854","3020233232","3014595023"]},{"id":"3005818804","fei":"3005818804","duns":"725585876","firm":"Glochem Industries Private Limited","registrant":"Glochem Industries Private Limited","parent":null,"ticker":null,"addr":"Survey No. 174 to 176, IDA Bollaram, Sangareddy district, Telangana State 502325, India (IND)","city":"Sangareddy district","state":"Telangana","pin":"502325","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.55317,"lon":78.34216,"prec":"postcode","geo":"502325, Jinnaram mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3017000602","3041729025","3008408466","3002806851","3007136165","3008479404","3009609117","3007720135","3008932115","3005301950"]},{"id":"3042643316","fei":"3042643316","duns":"640451203","firm":"MORTAR & PESTLE","registrant":"MORTAR PESTLE","parent":null,"ticker":null,"addr":"Survey No. 175, Khed-Tasiya Road, Khed, Himatnagar, Sabarkantha, Gujarat 383001, India (IND)","city":"Sabarkantha","state":"Gujarat","pin":"383001","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":23.59478,"lon":72.96799,"prec":"postcode","geo":"383001, Himatnagar, Himatnagar Taluka, Sabarkantha, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3006381009","fei":"3006381009","duns":"676666501","firm":"SOFTGEL HEALTHCARE PRIVATE LIMITED","registrant":"SOFTGEL HEALTHCARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No. 20/1, Vandalur Kelambakkam Road, Pudupakkam, Chengalpattu, Tamilnadu 603103, India (IND)","city":"Chengalpattu","state":null,"pin":"603103","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":12.81951,"lon":80.22035,"prec":"postcode","geo":"603103, Tiruporur, Chengalpattu, Tamil Nadu, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3041045488"],"colo":["3007027193"]},{"id":"3013791804","fei":"3013791804","duns":"871408062","firm":"VKT Pharma Private Limited","registrant":"VKT Pharma Private Limited","parent":null,"ticker":null,"addr":"Survey No. 21 to 27, Derasam Village, Srikakulam, Andhra Pradesh 532409, India (IND)","city":"Srikakulam","state":"Andhra Pradesh","pin":"532409","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.15105,"lon":83.65614,"prec":"postcode","geo":"532409, Ranastalam, Srikakulam, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3002949085","3005336882","3011171511","3009193040","3012414462","3008430469","3012390454","3030708811","3004611182"]},{"id":"3002957541","fei":"3002957541","duns":"725420835","firm":"Sun Pharmaceutical Industries Limited (formerly known as Sun Pharmaceutical Medicare Limited)","registrant":"Sun Pharmaceutical Industries Limited (formarly known as Sun Pharmaceutical Medicare Limited)","parent":"Sun Pharmaceutical Industries","ticker":"SUNPHARMA","addr":"Survey No. 22 and 24 - Village :- Ujeti Post - Baska, Halol Panchmahal, Gujarat 389350, India (IND)","city":"Halol Panchmahal","state":"Gujarat","pin":"389350","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":22.51554,"lon":73.46023,"prec":"postcode","geo":"389350, Halol Taluka, Panchmahal, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2022-06-08T04:00:00Z","posted":"2022-07-19T13:20:00Z","subject":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","office":"Office of Human and Animal Foods- East Division 3","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","company_as_published":"New Sun Inc.","match":"token"}],"events":[{"d":"2022-06-08","k":"letter","t":"Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-sun-inc-626254-06082022","x":"Office of Human and Animal Foods- East Division 3"}],"first":"2022-06-08","last":"2022-06-08","sibs":[],"colo":["3003821360","3004956904","3002809586","3012075440","3014447455","3014866088"]},{"id":"3012704791","fei":"3012704791","duns":"677609477","firm":"Alphamed Formulations Private Limited","registrant":"Alphamed Formulations Private Limited","parent":null,"ticker":null,"addr":"Survey No. 225, Sampanbole Village, Shamirpet District, Medchal, Medchal-Melkajgiri, Telangana 500101, India (IND)","city":"Medchal-Melkajgiri","state":"Telangana","pin":"500101","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.65514,"lon":78.60618,"prec":"postcode","geo":"500101, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038528882","PLOT NO 4C,MN SC & TECH BIOTECH PARK GENOME VALLEY, TURKAPALLY, SHAMIRPET RANGAREDDY, Hyderabad, Telangana 500101, India (IND)","3006587427","3017754175","3039644403","3039411568","3006527015","3009522832","3030495702","3009883135","3011960448"]},{"id":"3027226774","fei":"3027226774","duns":"959971069","firm":"SNJ LIFECARE PRIVATE LIMITED","registrant":"SNJ LIFECARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No. 247/1, Rajkot-Morbi Highway B/H Madhav Hotel, Hadala, Rajkot, Gujarat 363650, India (IND)","city":"Rajkot","state":"Gujarat","pin":"363650","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.62561,"lon":70.63713,"prec":"postcode","geo":"363650, Tankara Taluka, Morbi, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3020982425","fei":"3020982425","duns":"565278455","firm":"Antique Healthcare LLP","registrant":"Antique Healthcare LLP","parent":null,"ticker":null,"addr":"Survey No. 254/5 P1 P2, Village Jalida, Opp. Actionwear, Taluka Wankaner, Dist.- Morbi, Gujarat,, Morbi,  363621, India (IND)","city":"Dist.- Morbi","state":"Gujarat","pin":"363621","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.62776,"lon":70.94902,"prec":"postcode","geo":"363621, Wankaner Taluka, Morbi, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3012258477","fei":"3012258477","duns":"581707187","firm":"Viyash Scientific Limited","registrant":"Viyash Scientific Limited","parent":null,"ticker":null,"addr":"Survey No. 311/5, Plot 89/A, Phase-1, IDA, Jeedimetla,, Hyderabad, Telangana 500055, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500055","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003908605","3008652704","3007164063","3012725393","3005522065","3015443266","3003109450","3008932115"],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869"]},{"id":"3014483338","fei":"3014483338","duns":"872341023","firm":"Aspiro Pharma Limited","registrant":"Aspiro Pharma Limited","parent":null,"ticker":null,"addr":"Survey No. 321, Biotech Park, Phase – III, Karkapatla Village, Markook (Mandal), Siddipet, Telangana 502281, India (IND)","city":"Siddipet","state":"Telangana","pin":"502281","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.81912,"lon":78.7342,"prec":"postcode","geo":"502281, Gajwel mandal, Siddipet, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3031960635","3014404150","Plot No.- 09, Biotech Park, Phase-III, Sy No.-321, Karkapatla (V), Markook (M),, Siddipet, Telangana 502281, India (IND)","3032184895","3027345324","3027380201"]},{"id":"3007556480","fei":"3007556480","duns":"915142178","firm":"Arch Pharmalabs Limited","registrant":"Arch Pharmalabs Limited","parent":null,"ticker":null,"addr":"Survey No. 323, Gundlamachnoor Village, Hathnoora Mandal, Ismailkhanpet, Sangareddy District, Telangana 502 296, India (IND)","city":"Sangareddy District","state":"Telangana","pin":null,"ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62707,"lon":78.15801,"prec":"tail3","geo":"Ismailkhanpet, Sangareddy mandal, Sangareddy, Telangana, 502294, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002808114"],"colo":[]},{"id":"Survey No. 339, Nallabandagudem (V), Kodad(M), Suryapet (D),, Suryapet, Telangana 508206, India (IND)","fei":"","duns":"772366497","firm":"I THIRST LABS PRIVATE LIMITED","registrant":"Avinash Putta","parent":null,"ticker":null,"addr":"Survey No. 339, Nallabandagudem (V), Kodad(M), Suryapet (D),, Suryapet, Telangana 508206, India (IND)","city":"Suryapet","state":"Telangana","pin":"508206","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.99717,"lon":79.96868,"prec":"postcode","geo":"508206, Kodad mandal, Suryapet, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3043565193","fei":"3043565193","duns":"861510425","firm":"TRILEND PHARMACEUTICALS PRIVATE LIMITED","registrant":"TRILEND PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No. 339/2, Kuna, Mahemdabad, Kheda, Gujarat 387110, India (IND)","city":"Kheda","state":"Gujarat","pin":"387110","ops":["LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.91757,"lon":72.76077,"prec":"postcode","geo":"387110, Daskroi Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3008355986","fei":"3008355986","duns":"916011399","firm":"XYLOPIA LABS PRIVATE LIMITED","registrant":"XYLOPIA LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No. 377/1B, Beside Udhyan Bungalow, Off. S.G. Highway, Iscon Cross Roads, Ahmedabad, Gujarat 380015, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"380015","ops":["ANALYSIS"],"expires":"12/31/2026","lat":23.02223,"lon":72.52801,"prec":"postcode","geo":"380015, Vejalpur Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009857729","3042700568","House No. 5, Ground Floor, First Floor, Second Floor and Third floor, Magnet Corporate Park, Near Thaltej Cross Road, SG Highway,, Ahmedabad, Gujarat 380015, India (IND)"]},{"id":"3002949099","fei":"3002949099","duns":"918608162","firm":"DR. REDDY'S LABORATORIES LIMITED","registrant":"Dr. Reddy's Laboratories Limited","parent":"Dr. Reddy's Laboratories","ticker":"DRREDDY","addr":"Survey No. 41, 42 part, 45 part & 46 part, Bachupally Village and Mandal, Medchal-Malkajgiri District,, Medchal-Malkajgiri, Telangana 500090, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500090","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.53062,"lon":78.38101,"prec":"postcode","geo":"500090, Bachupally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002949085","3014250111","3005336882","3011171511","3009193040","3012414462","3006549835","3005447965","3005448030","3002806851","3003184497","3009483004"],"colo":["3026584977","3013593602","3013758337","3008569405","3013580504","3027524740","3017981159","3003971663","3004021229","3004446312"]},{"id":"3002984011","fei":"3002984011","duns":"918596198","firm":"Zydus Lifesciences Limited","registrant":"Zydus Lifesciences Limited","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Survey No. 417, 419 and 420, Sarkhej Bavla N. H. No. 8A Village-Moraiya, Taluka-Sanand Ahmedabad, Ahmedabad, Gujarat 382210, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382210","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.96445,"lon":72.4238,"prec":"postcode","geo":"382210, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2024-08-29T04:00:00Z","posted":"2024-09-10T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"12/16/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","company_as_published":"Zydus Lifesciences Limited","match":"exact"},{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","company_as_published":"Zydus Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-29","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-29","last":"2026-06-02","sibs":["3003696998","3006595385","3008957483","3007938603","3007621329","3006809732","3006026405","3002806475","3012977526","3013712903","3005430968"],"colo":["3016710326","3003157498","3023491920"]},{"id":"3045522755","fei":"3045522755","duns":"861404156","firm":"Livmore Life Sciences Private Limited","registrant":"Livmore Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Survey No. 424, 431, Ganpatpura Nana Fofaliya Road Vill. Ganpatpura, Tal. Karjan, Vadodara, Gujarat 391210, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391210","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":22.29731,"lon":73.19426,"prec":"tail2","geo":"Vadodara, Vadodara Rural Taluka, Vadodara, Gujarat, 390001, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3017150186","fei":"3017150186","duns":"675480028","firm":"Fishfa Biogenics","registrant":"Fishfa Biogenics (A division of Fishfa Rubbers Limited)","parent":null,"ticker":null,"addr":"Survey No. 43/2/2, 47/2, 50/1/2, 50/2, Kuvadwa-Wankaner Highway, Village- Rampara (Surya), Rajkot, Gujarat 360003, India (IND)","city":"Rajkot","state":"Gujarat","pin":"360003","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.32861,"lon":70.81534,"prec":"postcode","geo":"360003, Rajkot East Taluka, Rajkot, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3011743992","fei":"3011743992","duns":"915793916","firm":"Intas Pharmaceuticals Limited","registrant":"Intas Pharmaceuticals Limited","parent":"Intas (unlisted)","ticker":null,"addr":"Survey No. 44B, 49A & 49B, Village-Naldhari, Survey No. 126,127, 130,131, 132,133, Village-Valia, Plot No. 7/1 & 7/2, Valia GIDC, Tal- Valia, Bharuch, Gujarat 393135, India (IND)","city":"Bharuch","state":"Gujarat","pin":"393135","ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":21.55377,"lon":73.15458,"prec":"postcode","geo":"393135, Valia Taluka, Bharuch, Gujarat, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/01/2023","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"11/15/2024"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"11/15/2024"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"11/15/2024"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"11/15/2024"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"11/15/2024"},{"code":"55","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/01/2023"},{"code":"56","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Antibiotics (Human/Animal)","published":"06/01/2023"},{"code":"58","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"06/01/2023"},{"code":"60","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"61","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"62","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"63","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"64","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"65","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"},{"code":"66","notes":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32","product":"Human and Animal Drugs","published":"06/01/2023"}],"firm_as_published":"Intas Pharmaceuticals Limited","address_as_published":"Pharmez Plot No 5-14 , Near Village Matoda; Sarkhej-Bavla Highway No 8-A , Sanand, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"11/14/2023","notes":"These products are excluded from DWPE: Azacitidine Injection 62I[][]99 Clonazepam Tablet 61M[][]06 Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"04/09/2024"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"04/09/2024"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"04/09/2024"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"04/09/2024"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"04/09/2024"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"11/14/2023"},{"code":"56","notes":"All Drug and Drug Products;","product":"Antibiotics (Human/Animal)","published":"11/14/2023"},{"code":"58","notes":"All Drug and Drug Products","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"11/14/2023"},{"code":"60","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"61","notes":"All Drug and Drug Products; These products are excluded from DWPE: Clonazepam Tablet 61M[][]06","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"62","notes":"All Drug and Drug Products; These products are excluded from DWPE: Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95 Azacitidine Injection 62I[][]99","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"63","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"64","notes":"All Drug and Drug Products;","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/14/2023"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"11/14/2023"}],"firm_as_published":"Intas Pharmaceuticals Limited","address_as_published":"Plot No. 457/458-Matoda / Plot No.191/218P-Chacharwadi , Sarkhej-Bavla Highway, Taluka-Sanand, Matoda , Ahmedabad, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2023-07-28T04:00:00Z","posted":"2023-08-01T14:31:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"},{"date":"2023-11-21T05:00:00Z","posted":"2023-11-28T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"},{"date":"2026-03-30T04:00:00Z","posted":"2026-04-28T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026","company_as_published":"Intas Pharmaceuticals Limited","match":"exact"}],"events":[{"d":"2026-03-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-721151-03302026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-11-15","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2024-04-09","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2023-11-21","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-662868-11212023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-11-14","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE: Azacitidine Injection 62I[][]99 Clonazepam Tablet 61M[][]06 Etoposide Injection 62I[][]77 Letrozole Tablet 62I[][]85 Topotecan Solution, Concentrate 62I[][]95"},{"d":"2023-07-28","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-652067-07282023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2023-06-01","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE:Atropine Injection 61 K [] [] 05 Methotrexate Injection 62 I [] [] 31; 62 I [] [] 32"}],"first":"2023-06-01","last":"2026-03-30","sibs":["3003722314","3005890633","3007277149","3003157498","3004011473"],"colo":[]},{"id":"3004161218","fei":"3004161218","duns":"915628142","firm":"DISHMAN CARBOGEN AMCIS LIMITED","registrant":"DISHMAN CARBOGEN AMCIS LIMITED","parent":null,"ticker":null,"addr":"Survey No. 47 & 48, Paiki Sub plot No. 1, Village- Lodariyal, Taluka - Sanand, Ahmedabad,  382220, India (IND)","city":"Ahmedabad","state":null,"pin":"382220","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.85878,"lon":72.34332,"prec":"postcode","geo":"382220, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["1000607691"],"colo":["3008117347","3036572523","3035187076","3033035639","3044181625","3008223599"]},{"id":"3018907202","fei":"3018907202","duns":"854377396","firm":"Amneal Pharmaceuticals Private Limited","registrant":"Amneal Pharmaceuticals of New York, LLC","parent":null,"ticker":null,"addr":"Survey No. 506, Palli Near Sachana Kalyanpura Road, Mehsana, GJ 382165, India (IND)","city":"Mehsana","state":null,"pin":"382165","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":23.13831,"lon":72.31277,"prec":"postcode","geo":"382165, Kadi Taluka, Mahesana, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2025-08-27T04:00:00Z","posted":"2025-09-02T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","company_as_published":"Amneal Pharmaceuticals, LLC","match":"exact"}],"events":[{"d":"2025-08-27","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-27","last":"2025-08-27","sibs":["3030461061","3010661577","3010254278","3029456823","3017573557","3008223599"],"colo":[]},{"id":"3033031378","fei":"3033031378","duns":"854240492","firm":"INNOXEL LIFESCIENCES PRIVATE LIMITED","registrant":"MANISH UMRETHIA","parent":null,"ticker":null,"addr":"Survey No. 534/1, Near VCA Stadium, Kotambi, Waghodia, Vadodara, Gujarat 391510, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391510","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":22.36446,"lon":73.35992,"prec":"postcode","geo":"391510, Vagodhia Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3016088083","3013712903"]},{"id":"3017304975","fei":"3017304975","duns":"930064735","firm":"Asence Pharma Private Limited","registrant":"Asence Pharma Private Limited","parent":null,"ticker":null,"addr":"Survey No. 543 & 603, Sarabhai Campus, Opp Ranoli Railway Station, Vadodara, Gujarat 391350, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391350","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.42725,"lon":73.11892,"prec":"postcode","geo":"391350, Vadodara Rural Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008132370"]},{"id":"3025817290","fei":"3025817290","duns":"756032338","firm":"KNOVEA PHARMACEUTICAL PRIVATE LIMITED","registrant":"KNOVEA PHARMACEUTICAL PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No. 55/1/1, Pipliya Malhar, Dr. Ambedkar Nagar-Mhow, Indore, Madhya Pradesh 453331, India (IND)","city":"Indore","state":"Madhya Pradesh","pin":"453331","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.62244,"lon":75.80397,"prec":"postcode","geo":"453331, Pigdambar, Pigdamber, Rau Tahsil, Indore, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005122933","3015348439"]},{"id":"3008132370","fei":"3008132370","duns":"650502151","firm":"Vovantis Laboratories Private Limited","registrant":"Vovantis Laboratories Private Limited","parent":null,"ticker":null,"addr":"Survey No. 574/P, 577/P, 578/P, Opp. Ranoli Railway Station, Ranoli, Vadodara, Gujarat 391350, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391350","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":22.42725,"lon":73.11892,"prec":"postcode","geo":"391350, Vadodara Rural Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3017304975"]},{"id":"3012932394","fei":"3012932394","duns":"650884781","firm":"Graviti Pharmaceuticals Private Limited","registrant":"Graviti Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"Survey No. 621/E & 621/EE, Isnapur Village, Patancheru Mandal, Sangareddy, Telangana 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167"]},{"id":"3029798246","fei":"3029798246","duns":"860477697","firm":"SYNFINE DRUGS PRIVATE LIMITED","registrant":"SYNFINE DRUGS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No. 637, Bonthapally Village, Gummadidala Mandal, Sangareddy, Telangana 502313, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502313","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009996280","3014539030","3003723146","3006744199","3032314066","3012234942","3013944676","3007164063","3003510514","3042223406","3003289270","3007931994"]},{"id":"3010923869","fei":"3010923869","duns":"650804672","firm":"Auro Peptides Limited","registrant":"Auro Peptides Limited","parent":null,"ticker":null,"addr":"Survey No. 71 & 72, 4th Floor, Indrakaran Village, Kandi Mandal, Sangareddy District, Telangana 502329, India (IND)","city":"Sangareddy District","state":"Telangana","pin":"502329","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.55007,"lon":78.16544,"prec":"postcode","geo":"502329, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3048141588","3008765247","3005254981"]},{"id":"3008765247","fei":"3008765247","duns":"650518025","firm":"Apitoria Research Centre (A Division of Apitoria Pharma Private Limited)","registrant":"Apitoria Pharma Private Limited","parent":null,"ticker":null,"addr":"Survey No. 71 & 72, Indrakaran Village, Kandi Mandal, Sangareddy, Telangana 502329, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502329","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.55007,"lon":78.16544,"prec":"postcode","geo":"502329, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3048141588","3010923869","3005254981"]},{"id":"3044181625","fei":"3044181625","duns":"581636860","firm":"Ami Drugs Private Limited","registrant":"Ami Drugs Private Limited","parent":null,"ticker":null,"addr":"Survey No. 748/2, Adroda, Bavla, Ahmedabad, Gujarat 382220, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382220","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.85878,"lon":72.34332,"prec":"postcode","geo":"382220, Sanand Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008117347","3036572523","3035187076","3033035639","3004161218","3008223599"]},{"id":"3014866088","fei":"3014866088","duns":"675480402","firm":"Alembic Pharmaceuticals Limited","registrant":"Alembic Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Survey No. 84,87 and 88, Panelav, Taluka Halol, Panchmahal, Gujarat 389350, India (IND)","city":"Panchmahal","state":"Gujarat","pin":"389350","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":22.51554,"lon":73.46023,"prec":"postcode","geo":"389350, Halol Taluka, Panchmahal, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2026-07-10T04:00:00Z","posted":"2026-07-21T04:00:00Z","subject":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","company_as_published":"Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.","match":"token"}],"events":[{"d":"2026-07-10","k":"letter","t":"In Vivo Bioavailability-Bioequivalence Studies – Clinical","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-07-10","last":"2026-07-10","sibs":["3007501748","3003821360","3013826490","3015685305","3016088083","3004956904"],"colo":["3002809586","3012075440","3014447455","3002957541"]},{"id":"3006091736","fei":"3006091736","duns":"854220481","firm":"Choksi Laboratories Limited","registrant":"Choksi Laboratories Limited","parent":null,"ticker":null,"addr":"Survey No. 9/1 Balaji Tulsiyana Industrial Estate, Near Madhuri Refiners Pvt. Ltd., Kumedi,, Indore, Madhya Pradesh 452010, India (IND)","city":"Indore","state":"Madhya Pradesh","pin":"452010","ops":["ANALYSIS"],"expires":"12/31/2026","lat":22.75471,"lon":75.8946,"prec":"postcode","geo":"452010, Indore City, Juni Indore Tahsil, Indore, Madhya Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3019037664","fei":"3019037664","duns":"854125972","firm":"Cohance Lifesciences Limited","registrant":"Cohance Lifesciences Limited","parent":null,"ticker":null,"addr":"Survey No. 99/1, Plot No-9A(1), Mamidipally Village, Balapur Mandal, Samshabad, Rangareddy, Telangana 500108, India (IND)","city":"Rangareddy","state":"Telangana","pin":"500108","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","RELABEL","REPACK"],"expires":"12/31/2026","lat":16.93442,"lon":77.77883,"prec":"tail2","geo":"Rangareddy Palle, Gandeed mandal, Mahabubnagar, Telangana, 509337, India","status":1,"alerts":[],"letters":[{"date":"2026-01-30T05:00:00Z","posted":"2026-02-03T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cohance-lifesciences-limited-718812-01302026","company_as_published":"Cohance Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-01-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cohance-lifesciences-limited-718812-01302026","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2026-01-30","last":"2026-01-30","sibs":["3003650383","3006493505","3008768274","1000623515","3005554260"],"colo":["3015283219"]},{"id":"3030495702","fei":"3030495702","duns":"644776835","firm":"GRANULES LIFE SCIENCES PRIVATE LIMITED","registrant":"Granules India Ltd","parent":"Granules India","ticker":"GRANULES","addr":"Survey No. No. 325, 326, 333 To 336, 340 To 346 Lalgadimalakpet, Shameerpet Medchal-Malkajgiri, Telangana 500101, India (IND)","city":"Shameerpet Medchal-Malkajgiri","state":"Telangana","pin":"500101","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.65514,"lon":78.60618,"prec":"postcode","geo":"500101, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038528882","PLOT NO 4C,MN SC & TECH BIOTECH PARK GENOME VALLEY, TURKAPALLY, SHAMIRPET RANGAREDDY, Hyderabad, Telangana 500101, India (IND)","3006587427","3017754175","3039644403","3039411568","3006527015","3009522832","3012704791","3009883135","3011960448"]},{"id":"3003647459","fei":"3003647459","duns":"676244443","firm":"Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)","registrant":"Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)","parent":"JB Chemicals & Pharmaceuticals","ticker":"JBCHEPHARM","addr":"Survey No.101/2 & 102/1, Daman Industrial Estate, Airport Road, Kadaiya, Daman, Dadra & Nagar Haveli and Daman & Diu 396210, India (IND)","city":"Survey No.101/2 & 102/1","state":"Daman","pin":"396210","ops":["MANUFACTURE","PACK"],"expires":"12/31/2026","lat":20.42558,"lon":72.84559,"prec":"postcode","geo":"396210, Daman, Dadra and Nagar Haveli and Daman and Diu, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/28/2013","notes":"All drugs and drug products","charges":[{"code":"50","notes":"","product":"Color Additiv Food/Drug/Cosmetic","published":"06/28/2013"},{"code":"55","notes":"All drugs and drug products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/28/2013"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"06/28/2013"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"61","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"62","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"63","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"64","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"65","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"},{"code":"66","notes":"All drugs and drug products","product":"Human and Animal Drugs","published":"06/28/2013"}],"firm_as_published":"Unique Chemicals","address_as_published":"Shiv Mahape Gansoli , Thane Belapur Road , Navi Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"},{"alert":"66-41","list":"red","since":"03/10/2017","notes":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.","charges":[{"code":"21 D - - 13","notes":"","product":"Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates","published":"03/10/2017"},{"code":"21 K - - 14","notes":"","product":"Plum, Juice, Pit Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"21 V - - 34","notes":"","product":"Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars","published":"03/10/2017"},{"code":"22 D - - 05","notes":"","product":"Bitter Melon, Juice, Vine Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"54 K - - 08","notes":"","product":"Aloe (Herbal and Botanical (not teas) II (continued))","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"395 Food Park , Rai Industrial Estate , Sonepat, Haryana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"08/25/2017","notes":"Disease claims made on product labeling.","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"08/25/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/25/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"1 Plot No 21 , Road No , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"03/10/2017","notes":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper.","charges":[{"code":"21 D - - 13","notes":"","product":"Berries and Subtropica/Tropical Fruits, Mixed, Juices or Concentrates","published":"03/10/2017"},{"code":"21 K - - 14","notes":"","product":"Plum, Juice, Pit Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"21 V - - 34","notes":"","product":"Amla, Subtropical and Tropical Fruit, Juices, Milk, Creme, Drinks and Nectars","published":"03/10/2017"},{"code":"22 D - - 05","notes":"","product":"Bitter Melon, Juice, Vine Fruit Juices or Concentrates","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"29","notes":"","product":"Drinks, Soft Drinks, and Waters","published":"03/10/2017"},{"code":"54 K - - 08","notes":"","product":"Aloe (Herbal and Botanical (not teas) II (continued))","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"},{"code":"54","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)","published":"03/10/2017"}],"firm_as_published":"Unique Fragrances","address_as_published":"B- 63,2 nd Floor, Prashat Vihar. , New Delhi, Delhi INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2017-08-25","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Disease claims made on product labeling."},{"d":"2017-03-10","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper."},{"d":"2017-03-10","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"Label declares the products are marketed by Life Style Foods Pvt. Ltd. at the same address as the shipper."},{"d":"2013-06-28","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All drugs and drug products"}],"first":"2013-06-28","last":"2022-05-26","sibs":["3015776899"],"colo":["3004086192","3006896204","3009681646","3006363714","3006370524"]},{"id":"3042715330","fei":"3042715330","duns":"771928492","firm":"ENDOC BIOTECH PRIVATE LIMITED","registrant":"ENDOC BIOTECH PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No.255 Paiki 2 And 3, Jiyana, Tal And Dist Rajkot, Jiyana, Rajkot, GUJARAT 360023, India (IND)","city":"Rajkot","state":"Gujarat","pin":"360023","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.06929,"lon":71.02887,"prec":"tail2","geo":"Rajkot, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3035217826","fei":"3035217826","duns":"868353969","firm":"APISYN HEALTHCARE PRIVATE LIMITED","registrant":"APISYN HEALTHCARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No.325, Village-Zekda, Tal. Bavla, Ahmedabad, Gujarat 382230, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382230","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":22.5587,"lon":72.21833,"prec":"postcode","geo":"382230, Dholka Taluka, Ahmedabad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3016632979","fei":"3016632979","duns":"931859840","firm":"REVIN LABS PRIVATE LIMITED","registrant":"REVIN LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No.342,Plot No.84, Aleap Industrial Estate, Road No.8, Qutubullapur, Hyderabad, Medchal Malkajgiri, Telangana 500055, India (IND)","city":"Medchal Malkajgiri","state":"Telangana","pin":"500055","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869"]},{"id":"3015218020","fei":"3015218020","duns":"676114354","firm":"AET LABORATORIES PRIVATE LIMITED","registrant":"AET LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No.42, Gaddapotharam Village, Kazipally Industrial Area, Sangareddy, Telangana 502319, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502319","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3009261338","3007800082"]},{"id":"3014659521","fei":"3014659521","duns":"650130438","firm":"LACTOSE (INDIA) LIMITED","registrant":"LACTOSE (INDIA) LIMITED","parent":null,"ticker":null,"addr":"Survey No.5, 6 & 7 Village Poicha (Rania),Taluka Savli,, Vadodara, Gujarat 391780, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391780","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":22.51602,"lon":73.1477,"prec":"postcode","geo":"391780, Savli Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3009883135","fei":"3009883135","duns":"650645067","firm":"Daicel Chiral Technologies (India) Private Limited","registrant":"Daicel Chiral Technologies (India) Private Limited","parent":null,"ticker":null,"addr":"Survey No.542/2, IKP Knowledge Park Koltur Village, Shamirpet Mandal, Medchal Malkajgiri District,, Hyderabad, Telangana 500101, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500101","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.65514,"lon":78.60618,"prec":"postcode","geo":"500101, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038528882","PLOT NO 4C,MN SC & TECH BIOTECH PARK GENOME VALLEY, TURKAPALLY, SHAMIRPET RANGAREDDY, Hyderabad, Telangana 500101, India (IND)","3006587427","3017754175","3039644403","3039411568","3006527015","3009522832","3012704791","3030495702","3011960448"]},{"id":"3008223599","fei":"3008223599","duns":"915076126","firm":"Amneal Pharmaceuticals Private Limited","registrant":"Amneal Pharmaceuticals of New York, LLC","parent":null,"ticker":null,"addr":"Survey No.634, 637 To 641, Near Hotel Kankavati Sarkhej-Bavla Highway, Village Rajoda, Tal Bavla, Ahmedabad, Gujarat 382220, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382220","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.85878,"lon":72.34332,"prec":"postcode","geo":"382220, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2025-08-27T04:00:00Z","posted":"2025-09-02T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","company_as_published":"Amneal Pharmaceuticals, LLC","match":"exact"}],"events":[{"d":"2025-08-27","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amneal-pharmaceuticals-llc-709894-08272025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-27","last":"2025-08-27","sibs":["3030461061","3010661577","3010254278","3029456823","3017573557","3018907202"],"colo":["3008117347","3036572523","3035187076","3033035639","3004161218","3044181625"]},{"id":"3030266602","fei":"3030266602","duns":"643512763","firm":"La Chandra Pharmalab Private Limited","registrant":"La Chandra Pharmalab Private Limited","parent":null,"ticker":null,"addr":"Survey No.: 64/2/2, Village: Vaghrol, Taluka: Dantiwada, Dist.: Banaskantha, Banaskantha, Gujarat 385510, India (IND)","city":"Banaskantha","state":"Gujarat","pin":"385510","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":24.52306,"lon":71.76428,"prec":"postcode","geo":"385510, Tharad Taluka, Vav-Tharad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3013671902","fei":"3013671902","duns":"860408720","firm":"Almelo Pvt. Ltd.","registrant":"Almelo Pvt. Ltd.","parent":null,"ticker":null,"addr":"Survey No: 227, 228 & 136, 137,, Medak, Telangana 502334, India (IND)","city":"Medak","state":"Telangana","pin":"502334","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.83088,"lon":78.4566,"prec":"postcode","geo":"502334, Toorpran mandal, Medak, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3004015257","fei":"3004015257","duns":"725914795","firm":"SRINI PHARMACEUTICALS PRIVATE LIMITED","registrant":"SRINI PHARMACEUTICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey No: 247,, Choutuppal Village & Mandal, Nalgonda, Telangana 508252, India (IND)","city":"Nalgonda","state":"Telangana","pin":"508252","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.2684,"lon":78.91357,"prec":"postcode","geo":"508252, Choutuppal mandal, Yadadri Bhuvanagiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3042718107"],"colo":["3011845012","3030125048","3015443266","3003109450","3003131136"]},{"id":"3006763261","fei":"3006763261","duns":"675534540","firm":"Torrent Pharmaceuticals Limited","registrant":"Torrent Pharma, Inc.","parent":"Torrent Pharmaceuticals","ticker":"TORNTPHARM","addr":"Survey Nos 36, 37 & 46, Plot No. 77, Jawaharlal Nehru Pharma City, Thanam Village, Parawada Mandal, Visakhapatnam, Andhra Pradesh 531021, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531021","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005029956","3010228235","3008861587","3012740315"],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163"]},{"id":"3033870708","fei":"3033870708","duns":"675486957","firm":"ARENE LIFE SCIENCES PRIVATE LIMITED","registrant":"Arene Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Survey Nos 412/A, Veliminedu Village, Chityala (M), Nalgonda, Telangana 508114, India (IND)","city":"Nalgonda","state":"Telangana","pin":"508114","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.21132,"lon":79.07301,"prec":"postcode","geo":"508114, Chityal mandal, Nalgonda, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3047392863","3013438177"],"colo":["3014002307","3009250999","3042853625","3012753303","3032871131","3012725393","3021257926"]},{"id":"3009483004","fei":"3009483004","duns":"676240577","firm":"DR. REDDY'S LABORATORIES LIMITED","registrant":"Dr. Reddy's Laboratories Limited","parent":"Dr. Reddy's Laboratories","ticker":"DRREDDY","addr":"Survey Nos 42, 45, 46 & 54, Innovation Plaza, Bachupally,, Medchal-Malkajgiri, Telangana 500090, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500090","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.53062,"lon":78.38101,"prec":"postcode","geo":"500090, Bachupally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3002949085","3014250111","3005336882","3011171511","3009193040","3012414462","3006549835","3005447965","3005448030","3002806851","3003184497","3002949099"],"colo":["3026584977","3013593602","3013758337","3008569405","3013580504","3027524740","3017981159","3003971663","3004021229","3004446312"]},{"id":"3013712903","fei":"3013712903","duns":"873671928","firm":"Zydus Lifesciences Limited","registrant":"Zydus Lifesciences Limited","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Survey Nos. 434/6/B and 434/1/K, Vadodara - Halol Highway, Village - Jarod, Taluka - Waghodia, Vadodara, Gujarat 391510, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391510","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":22.36446,"lon":73.35992,"prec":"postcode","geo":"391510, Vagodhia Taluka, Vadodara, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2024-08-29T04:00:00Z","posted":"2024-09-10T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"12/16/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","company_as_published":"Zydus Lifesciences Limited","match":"exact"},{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","company_as_published":"Zydus Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-29","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-29","last":"2026-06-02","sibs":["3003696998","3006595385","3008957483","3007938603","3007621329","3006809732","3006026405","3002806475","3012977526","3002984011","3005430968"],"colo":["3016088083","3033031378"]},{"id":"3011845012","fei":"3011845012","duns":"650769644","firm":"Shree jaya laboratories private limited","registrant":"Shree jaya laboratories private limited","parent":null,"ticker":null,"addr":"Survey no. 299, Malkapur Village, Choutuppal mandal, Yadadri Bhuvanagiri, Yadadri Bhuvanagiri, Telangana 508252, India (IND)","city":"Yadadri Bhuvanagiri","state":"Telangana","pin":"508252","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.2684,"lon":78.91357,"prec":"postcode","geo":"508252, Choutuppal mandal, Yadadri Bhuvanagiri, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2025-02-28T05:00:00Z","posted":"2025-03-11T04:00:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shree-jaya-laboratories-pvt-ltd-698690-02282025","company_as_published":"Shree Jaya Laboratories PVT. LTD.","match":"exact"}],"events":[{"d":"2025-02-28","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shree-jaya-laboratories-pvt-ltd-698690-02282025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-02-28","last":"2025-02-28","sibs":[],"colo":["3004015257","3030125048","3015443266","3003109450","3003131136"]},{"id":"3006744199","fei":"3006744199","duns":"854279690","firm":"MAKSON HEALTH CARE PRIVATE LIMITED","registrant":"MAKSON HEALTH CARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Survey no: 182-183, Annaram Village, Gummadidala Mandal,, Sangareddy,  502313, India (IND)","city":"Sangareddy","state":null,"pin":"502313","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"05/29/2014","notes":"","charges":[{"code":"60 L - - 99","notes":"","product":"Analgesic, N.E.C.","published":"09/25/2015"},{"code":"62 G - - 99","notes":"","product":"Anti-Inflammatory N.E.C.","published":"05/29/2014"},{"code":"62 G - - 99","notes":"","product":"Anti-Inflammatory N.E.C.","published":"09/25/2015"},{"code":"62 M - - 01","notes":"","product":"Camphor (Anti-Pruritic)","published":"09/25/2015"},{"code":"62 M - - 08","notes":"","product":"Menthol (Anti-Pruritic)","published":"09/05/2024"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"09/25/2015"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"09/05/2024"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"05/29/2014"},{"code":"66 Y - - 99","notes":"","product":"Exhibits - Other Drug Related Items N.E.C.","published":"09/25/2015"}],"firm_as_published":"Makson Health Care Private Ltd.","address_as_published":"182 - 183 Gummadidala Mandal , Survey , Annaram, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[{"date":"2025-08-06T04:00:00Z","posted":"2025-08-12T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","company_as_published":"K & Care Organics","match":"token"}],"events":[{"d":"2025-08-06","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-09-05","k":"charge","t":"66-41 charge 62 M - - 08 — Menthol (Anti-Pruritic)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2024-09-05","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2015-09-25","k":"charge","t":"66-41 charge 60 L - - 99 — Analgesic, N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2015-09-25","k":"charge","t":"66-41 charge 62 G - - 99 — Anti-Inflammatory N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2015-09-25","k":"charge","t":"66-41 charge 62 M - - 01 — Camphor (Anti-Pruritic)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2015-09-25","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2015-09-25","k":"charge","t":"66-41 charge 66 Y - - 99 — Exhibits - Other Drug Related Items N.E.C.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2014-05-29","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""}],"first":"2014-05-29","last":"2025-08-06","sibs":["3009528099"],"colo":["3009996280","3014539030","3003723146","3029798246","3032314066","3012234942","3013944676","3007164063","3003510514","3042223406","3003289270","3007931994"]},{"id":"3030125048","fei":"3030125048","duns":"869737612","firm":"Spica Laboratories Private Limited","registrant":"SPICA LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Sy No 270/C2, S Lingotam Village, Choutuppal, Telangana 508252, India (IND)","city":"Choutuppal","state":"Telangana","pin":"508252","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.2684,"lon":78.91357,"prec":"postcode","geo":"508252, Choutuppal mandal, Yadadri Bhuvanagiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3004015257","3011845012","3015443266","3003109450","3003131136"]},{"id":"3016470054","fei":"3016470054","duns":"861991500","firm":"Saptagir Laboratories Private Limited","registrant":"Saptagir Laboratories Private Limited","parent":null,"ticker":null,"addr":"Sy No Parts of 27, 46 and 50 to 56, Ananthasagar village Chegunta Mandal, Medak, Telangana 502247, India (IND)","city":"Medak","state":"Telangana","pin":"502247","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.95109,"lon":78.51918,"prec":"postcode","geo":"502247, Chegunta mandal, Medak, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3022190657","fei":"3022190657","duns":"565230627","firm":"Caponex Labs Private Limited","registrant":"CAPONEX LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Sy No-478 & 480,Basuregadi , H/o Gowdavally mandal, Medchal & Malkajgiri Dist, Hyderabad, Telangana 501401, India (IND)","city":"Hyderabad","state":"Telangana","pin":"501401","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.62984,"lon":78.48653,"prec":"postcode","geo":"501401, Medchal mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3038105776","3004443761","3003802255","3014529730"]},{"id":"3032314066","fei":"3032314066","duns":"854384601","firm":"VANSHIKA LABORATORIES PRIVATE LIMITED","registrant":"VANSHIKA LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Sy No. 172, Plot No. 2-56. Anantharam Village, Gummadidala Mandal, Sangareddy, Hyderabad, Telangana 502313, India (IND)","city":"Hyderabad","state":"Telangana","pin":"502313","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009996280","3014539030","3003723146","3029798246","3006744199","3012234942","3013944676","3007164063","3003510514","3042223406","3003289270","3007931994"]},{"id":"3011665699","fei":"3011665699","duns":"650174378","firm":"WIPRO LIMITED","registrant":"WIPRO LIMITED","parent":null,"ticker":null,"addr":"Sy No. 76P, 80P, Doddakannelli, Sarjapur Road, Varthur Hobli, Bangalore,  560035, India (IND)","city":"Bangalore","state":null,"pin":"560035","ops":["ANALYSIS"],"expires":"12/31/2026","lat":12.89602,"lon":77.69982,"prec":"postcode","geo":"560035, Hadosiddapura, Bangalore East, Bengaluru Urban, Karnataka, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"08/03/2017","notes":"The product appears to be an unapproved new drug as the product label and website include claims such as; 'has more than double the amount of coconut oil and ayurvedic herbs; which gently treat skin problems... Removes blemishes Treats acne/pimples protects from common skin problems like pimples; dark spots; rashes; pigmentation etc'.","charges":[{"code":"53 J - - 01","notes":"","product":"Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)","published":"08/03/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/03/2017"}],"firm_as_published":"WIPRO ENTERPRISES LTD","address_as_published":"SURYA LABORATRIES PLOT , BELWADI INDL AREA , MYSORE, INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"},{"alert":"66-41","list":"red","since":"08/03/2017","notes":"The product appears to be an unapproved new drug as the product label and website include claims such as; 'has more than double the amount of coconut oil and ayurvedic herbs; which gently treat skin problems... Removes blemishes Treats acne/pimples? protects from common skin problems like pimples; dark spots; rashes; pigmentation etc'.","charges":[{"code":"53 J - - 01","notes":"","product":"Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness)","published":"08/03/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"08/03/2017"}],"firm_as_published":"WIPRO LTD.","address_as_published":"4 Antharasanahalli Industrial Area , Ahobala Agrahara, Karnataka INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"}],"letters":[{"date":"2023-12-21T05:00:00Z","posted":"2023-12-26T14:20:00Z","subject":"Refusal to Provide Access to and Copying of Records","office":"Drug","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wipro-unza-singapore-private-limited-660735-12212023","company_as_published":"Wipro Unza Singapore Private, Limited","match":"token"}],"events":[{"d":"2023-12-21","k":"letter","t":"Refusal to Provide Access to and Copying of Records","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wipro-unza-singapore-private-limited-660735-12212023","x":"Drug"},{"d":"2017-08-03","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"The product appears to be an unapproved new drug as the product label and website include claims such as; 'has more than double the amount of coconut oil and ayurvedic herbs; which gently treat skin problems... Removes blemishes Treats acne/pimples protects from common skin problems like pimples; dark spots; rashes; pigmentation etc'."},{"d":"2017-08-03","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":"The product appears to be an unapproved new drug as the product label and website include claims such as; 'has more than double the amount of coconut oil and ayurvedic herbs; which gently treat skin problems... Removes blemishes Treats acne/pimples? protects from common skin problems like pimples; dark spots; rashes; pigmentation etc'."}],"first":"2017-08-03","last":"2023-12-21","sibs":[],"colo":[]},{"id":"3016446284","fei":"3016446284","duns":"854298448","firm":"TAGOOR LABORATORIES PRIVATE LIMITED","registrant":"TAGOOR LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Sy No.29, Tupakulagudem Pochavaram Panchayat Tallapudi Mandal, West Godavari, Andhra Pradesh 534341, India (IND)","city":"West Godavari","state":"Andhra Pradesh","pin":"534341","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.17732,"lon":81.59105,"prec":"postcode","geo":"534341, Gopalapuram, East Godavari, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3030640551","3025582980"],"colo":[]},{"id":"3011905047","fei":"3011905047","duns":"650921856","firm":"EUGIA SEZ PRIVATE LIMITED","registrant":"EUGIA Pharma Specialities Limited","parent":null,"ticker":null,"addr":"Sy No: 408 to 412, 418 to 435, 437 to 445, 452 to 459, TSIIC, SEZ, Plot No: S-5/B, S-6 & S-7, S-13/B and S-14/B, Polepally Village, Jadcherla Mandal, Mahabubnagar, Telangana 509302, India (IND)","city":"Mahabubnagar","state":"Telangana","pin":"509302","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":16.77945,"lon":78.1514,"prec":"tail3","geo":"Jadcherla mandal, Mahabubnagar, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3032546867","3011255967","3007373532"]},{"id":"3011856449","fei":"3011856449","duns":"650923399","firm":"SOLARA ACTIVE PHARMA SCIENCES LIMITED","registrant":"SOLARA ACTIVE PHARMA SCIENCES LIMITED","parent":null,"ticker":null,"addr":"Sy Nos. 223-3, 252-1, 253 & 254-1, Thandya Industrial Area, Thandavapura, Mysuru, Karnataka 571301, India (IND)","city":"Mysuru","state":"Karnataka","pin":"571301","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":12.1031,"lon":76.68212,"prec":"postcode","geo":"571301, Nanjanagudu taluk, Mysuru District, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003585876","3008374690","3016965485","3008252997","3002808058"],"colo":[]},{"id":"3030599910","fei":"3030599910","duns":"854083725","firm":"LEE PHARMA LIMITED","registrant":"Lee Pharma Limited","parent":null,"ticker":null,"addr":"Sy Nos: 30P, 31P, 32P, 34P & 35P, Plot No. 22A & 22B, APSEZ De-Notified Area, Lalam Koduru (V), Rambili (M), Dist, Anakapalli, Andhra Pradesh 531011, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2023-08-28T04:00:00Z","posted":"2024-03-05T14:20:00Z","subject":"Food Labeling/Misbranded","office":"Division of Human and Animal Food Operations East VI","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gilster-mary-lee-corporation-658271-08282023","company_as_published":"Gilster-Mary Lee Corporation","match":"token"}],"events":[{"d":"2023-08-28","k":"letter","t":"Food Labeling/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gilster-mary-lee-corporation-658271-08282023","x":"Division of Human and Animal Food Operations East VI"}],"first":"2023-08-28","last":"2023-08-28","sibs":["3018490749","3009103626"],"colo":["3012160303","3026032363","3023346708","3011538548","3015709928","3013629262","3014255847","3020444708","3030613318","3026297382","3013580138","3021487911"]},{"id":"3023352430","fei":"3023352430","duns":"642827531","firm":"BANGALORE PHARMACEUTICAL AND RESEARCH LABORATORY PRIVATE LIMITED","registrant":"BANGALORE PHARMACEUTICAL AND RESEARCH LABORATORY PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Sy. No. 107/1A & 107/2, Mallapura Village, Kasaba Hobli, Tavarekere Road Off NH 4, Nelamangala Taluk, Bengaluru Rural, Karnataka 562123, India (IND)","city":"Bengaluru Rural","state":"Karnataka","pin":"562123","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":13.11741,"lon":77.38033,"prec":"postcode","geo":"562123, Vishveshwarapura, Mallapura, Nelamangala taluk, Bengaluru North, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043513108","3003821988","3009150119"]},{"id":"3009261338","fei":"3009261338","duns":"915846150","firm":"KEKULE PHARMA LIMITED","registrant":"KEKULE PHARMA LIMITED","parent":null,"ticker":null,"addr":"Sy. No. 180/1 to 15, MIA Kazipally Village, Jinnaram Mandal, Sangareddy District, Telangana 502319, India (IND)","city":"Sangareddy District","state":"Telangana","pin":"502319","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3007800082"]},{"id":"3012234942","fei":"3012234942","duns":"650843621","firm":"Maithri Drugs Private Limited","registrant":"Maithri Drugs Private Limited","parent":null,"ticker":null,"addr":"Sy. No. 205, 222 to 226, IDA Bonthapally, Bonthapally (Village), Gummadidala (Mandal),, Sangareddy District, Telangana 502313, India (IND)","city":"Sangareddy District","state":"Telangana","pin":"502313","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009996280","3014539030","3003723146","3029798246","3006744199","3032314066","3013944676","3007164063","3003510514","3042223406","3003289270","3007931994"]},{"id":"3008822771","fei":"3008822771","duns":"650475408","firm":"MSN Organics Private Limited","registrant":"MSN Organics Private Limited","parent":null,"ticker":null,"addr":"Sy. No. 224/A, Bibinagar (Village), Bibinagar(Mandal), Yadadri Bhuvanagiri District, Telangana 508126, India (IND)","city":"Yadadri Bhuvanagiri District","state":"Telangana","pin":"508126","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.51941,"lon":78.776,"prec":"postcode","geo":"508126, Bommalaramaram mandal, Yadadri Bhuvanagiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005621526","3014675555"]},{"id":"3014002307","fei":"3014002307","duns":"650973451","firm":"Hindys Lab Private Limited","registrant":"Hindys Lab Private Limited","parent":null,"ticker":null,"addr":"Sy. No. 290 & 291,Veliminedu, Chityal,, Nalgonda,, Telangana 508114, India (IND)","city":"Nalgonda","state":"Telangana","pin":"508114","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.21132,"lon":79.07301,"prec":"postcode","geo":"508114, Chityal mandal, Nalgonda, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3033870708","3009250999","3042853625","3012753303","3032871131","3012725393","3021257926"]},{"id":"3005254981","fei":"3005254981","duns":"863363165","firm":"MSN Laboratories Private Limited","registrant":"MSN Laboratories Private Limited","parent":"MSN Laboratories (unlisted)","ticker":null,"addr":"Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal),, Sangareddy District, Telangana 502329, India (IND)","city":"Sangareddy District","state":"Telangana","pin":"502329","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.55007,"lon":78.16544,"prec":"postcode","geo":"502329, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011033544","3019516576","3005075182","3035592613","3008656542","3023132203"],"colo":["3048141588","3010923869","3008765247"]},{"id":"3009250999","fei":"3009250999","duns":"650568053","firm":"Nosch Labs Pvt. Ltd.","registrant":"Nosch Labs Pvt. Ltd.","parent":null,"ticker":null,"addr":"Sy. No. 332, 333 & 335, Veliminedu (Village), Chityala (Mandal), Nalgonda (District), Hyderabad, Telangana 508114, India (IND)","city":"Hyderabad","state":"Telangana","pin":"508114","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.21132,"lon":79.07301,"prec":"postcode","geo":"508114, Chityal mandal, Nalgonda, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3033870708","3014002307","3042853625","3012753303","3032871131","3012725393","3021257926"]},{"id":"3042853625","fei":"3042853625","duns":"771813202","firm":"NEWATOM LABS PRIVATE LIMITED","registrant":"NewAtom Labs Private Limited","parent":null,"ticker":null,"addr":"Sy. No. 399 to 403, Veliminedu Road, Veliminedu, Chityala, Nalgonda, Telangana, Nalgonda, Telangana 508114, India (IND)","city":"Nalgonda","state":"Telangana","pin":"508114","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.21132,"lon":79.07301,"prec":"postcode","geo":"508114, Chityal mandal, Nalgonda, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3033870708","3014002307","3009250999","3012753303","3032871131","3012725393","3021257926"]},{"id":"3012753303","fei":"3012753303","duns":"651008539","firm":"Dasami Lab Private Limited","registrant":"Dasami Lab Private Limited","parent":null,"ticker":null,"addr":"Sy. No. 405 & 408, Veliminedu Village, Chityala Mandal,, Nalgonda, Telangana 508114, India (IND)","city":"Nalgonda","state":"Telangana","pin":"508114","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.21132,"lon":79.07301,"prec":"postcode","geo":"508114, Chityal mandal, Nalgonda, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3033870708","3014002307","3009250999","3042853625","3032871131","3012725393","3021257926"]},{"id":"3018722849","fei":"3018722849","duns":"854332682","firm":"APICHEM Laboratories Private Limited","registrant":"APICHEM Laboratories Private Limited","parent":null,"ticker":null,"addr":"Sy. No. 539, 539/LU, 542/A, 542/AA, 542/U, 542/UU, 38/AA, Cholleru (Village), Yadagirigutta (Mandal),, Yadadri Bhuvanagiri District, Telangana 508286, India (IND)","city":"Yadadri Bhuvanagiri District","state":"Telangana","pin":"508286","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.5488,"lon":79.02517,"prec":"postcode","geo":"508286, Motakondur mandal, Yadadri Bhuvanagiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3013495819","fei":"3013495819","duns":"871401859","firm":"Analys Lab Private Limited","registrant":"Analys Lab Private Limited","parent":null,"ticker":null,"addr":"Sy. No. 71/1, 71/2, 71/6 & 71/11, Lankelapalem (Village),, Anakapalli, Andhra Pradesh 531021, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531021","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3031055543","3013495798"],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163"]},{"id":"3012390454","fei":"3012390454","duns":"862603023","firm":"Aparna Pharmaceuticals Private Limited","registrant":"Aparna Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"Sy. No. 78, 79, 80 & 145, Chittivalasa Village, Pydibimavaram Panchayat Ranastalam Mandal, IP Pyidibhimavaram, Srikakulam, Andhra Pradesh 532409, India (IND)","city":"Srikakulam","state":"Andhra Pradesh","pin":"532409","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":18.15105,"lon":83.65614,"prec":"postcode","geo":"532409, Ranastalam, Srikakulam, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3002949085","3005336882","3011171511","3009193040","3012414462","3008430469","3013791804","3030708811","3004611182"]},{"id":"3013944676","fei":"3013944676","duns":"650980746","firm":"Annora Pharma Private Limited","registrant":"Annora Pharma Private Limited","parent":null,"ticker":null,"addr":"Sy. No.261, Plot No. 5,7,8,9,13 and 14, Annaram village, Gummadidal Mandal,, Sangareddy, Telangana 502313, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502313","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009996280","3014539030","3003723146","3029798246","3006744199","3032314066","3012234942","3007164063","3003510514","3042223406","3003289270","3007931994"]},{"id":"3043682089","fei":"3043682089","duns":"772066533","firm":"ARTEVET THERAPEUTICS PRIVATE LIMITED","registrant":"ARTEVET THERAPEUTICS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Sy. No.37/2, Plot No.1 & 2, Vevoor, Nandore Road, Palghar, Maharashtra 401404, India (IND)","city":"Palghar","state":"Maharashtra","pin":"401404","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.69445,"lon":72.78565,"prec":"postcode","geo":"401404, Palghar Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3042541221","3008380269","3007068506"]},{"id":"3013648186","fei":"3013648186","duns":"650917938","firm":"VISION DRUGS PRIVATE LIMITED","registrant":"VISION DRUGS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Sy. No.733, Mandollagudem (village), Choutuppal (Mandal),, Yadadri Bhuvanagiri, Telangana 508 252, India (IND)","city":"Yadadri Bhuvanagiri","state":"Telangana","pin":null,"ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.27214,"lon":78.86468,"prec":"tail3","geo":"Choutuppal mandal, Yadadri Bhuvanagiri, Telangana, 508252, India","status":1,"alerts":[],"letters":[{"date":"2023-06-08T04:00:00Z","posted":"2023-06-08T19:00:00Z","subject":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","office":"Center for Tobacco Products","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lb-vision-holdings-inc-dba-vapermate-206-llc-658051-06082023","company_as_published":"LB Vision Holdings, Inc. d/b/a VaperMate #206, LLC","match":"token"}],"events":[{"d":"2023-06-08","k":"letter","t":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lb-vision-holdings-inc-dba-vapermate-206-llc-658051-06082023","x":"Center for Tobacco Products"}],"first":"2023-06-08","last":"2023-06-08","sibs":[],"colo":[]},{"id":"3030708811","fei":"3030708811","duns":"644177158","firm":"Auroactive Pharma Private Limited","registrant":"Auroactive Pharma Private Limited","parent":null,"ticker":null,"addr":"Sy. Nos. 231, 285 to 291, Sancham Village Ranasthalam Mandal Srikakulam,, Srikakulam, Andhra Pradesh 532409, India (IND)","city":"Srikakulam","state":"Andhra Pradesh","pin":"532409","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":18.15105,"lon":83.65614,"prec":"postcode","geo":"532409, Ranastalam, Srikakulam, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3002949085","3005336882","3011171511","3009193040","3012414462","3008430469","3013791804","3012390454","3004611182"]},{"id":"3007800082","fei":"3007800082","duns":"675870897","firm":"Maithri Laboratories Private Limited","registrant":"Maithri Laboratories Private Limited","parent":null,"ticker":null,"addr":"Sy.No. 10/1 & 14, IDA Gaddapotharam, Gaddapotharam (Village), Jinnaram (Mandal),, Sangareddy District,, Telangana 502319, India (IND)","city":"Sangareddy District","state":"Telangana","pin":"502319","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338"]},{"id":"3004097901","fei":"3004097901","duns":"918609236","firm":"Granules India Limited","registrant":"Granules India Ltd","parent":"Granules India","ticker":"GRANULES","addr":"Sy.No. 160/A, 161/E, 162, 174/A, Gagillapur Village, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District, Telangana 500043, India (IND)","city":"Medchal-Malkajgiri District","state":"Telangana","pin":"500043","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.56089,"lon":78.43615,"prec":"postcode","geo":"500043, Dundigal mandal, Medchal–Malkajgiri, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2025-02-26T05:00:00Z","posted":"2025-03-04T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/granules-india-limited-697115-02262025","company_as_published":"Granules India Limited","match":"exact"}],"events":[{"d":"2025-02-26","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/granules-india-limited-697115-02262025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-02-26","last":"2025-02-26","sibs":["3003723146","3001319869","3006583291","3012884557"],"colo":["3014615000","3002647489"]},{"id":"3003803288","fei":"3003803288","duns":"919067108","firm":"Piramal Pharma Limited","registrant":"Piramal Pharma Limited","parent":"Piramal Pharma","ticker":"PPLPHARMA","addr":"Sy.Nos. 7-70, 70/1 and 70/2, Digwal Village, Kohir Mandal, Sangareddy, Telangana 502321, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502321","ops":["ANALYSIS","API MANUFACTURE","LABEL","MANUFACTURE","PACK","PARTICLE SIZE REDUCTION"],"expires":"12/31/2026","lat":17.65346,"lon":77.70532,"prec":"postcode","geo":"502321, Kohir mandal, Sangareddy, Telangana, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"10/27/2009","notes":"","charges":[{"code":"54 F - - 99","notes":"","product":"Herbals & Botanicals (not Teas), N.E.C.","published":"10/27/2009"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"10/29/2009"}],"firm_as_published":"Piramal Enterprises Ltd","address_as_published":"1 Nirlon Complex , Western Express Highway , Mumbai, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"token"}],"letters":[],"events":[{"d":"2009-10-29","k":"charge","t":"66-41 charge 66 V - - 99 — Miscellaneous Patent Medicines, Etc.","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2009-10-27","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""}],"first":"2009-10-27","last":"2009-10-29","sibs":["3008763768","3005259207","3008394466"],"colo":[]},{"id":"3032871131","fei":"3032871131","duns":"756089281","firm":"SHOBHA LIFE SCIENCES PRIVATE LIMITED","registrant":"SHOBHA LIFE SCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Sy.No’s.137/EE,137/A2,137/AA,137/U/1,137/RU,137/U/2,138/U/2,139/A1/2, and 141/AA1/2, Pittampally Village, Nalgonda District, Chityala Mandal, TELANGANA 508114, India (IND)","city":"Chityala Mandal","state":"Telangana","pin":"508114","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.21132,"lon":79.07301,"prec":"postcode","geo":"508114, Chityal mandal, Nalgonda, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3033870708","3014002307","3009250999","3042853625","3012753303","3012725393","3021257926"]},{"id":"3018369072","fei":"3018369072","duns":"915902300","firm":"Samanta Organics Private Limited","registrant":"Samanta Organics Private Limited","parent":null,"ticker":null,"addr":"T-119, MIDC, Tarapur, Boisar, Palghar, Maharashtra 401506, India (IND)","city":"Palghar","state":"Maharashtra","pin":"401506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012255151"],"colo":["3001174909","3003721861","3006418686","3006057101","3009118300","3016577628","3016790354","3017545500","3003336449","3013633378","3003677831","3002807512"]},{"id":"3025922195","fei":"3025922195","duns":"930070709","firm":"Elementis Specialties (India) Private Limited","registrant":"Elementis Specialties (India) Private Limited","parent":null,"ticker":null,"addr":"T-29 - 29 Part, Taloja Industrial Area, MIDC Mouje Ghot and Tondre, Panvel, Raigad, Maharashtra 410208, India (IND)","city":"Raigad","state":"Maharashtra","pin":"410208","ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.06884,"lon":73.11504,"prec":"postcode","geo":"410208, Panvel, Panvel Subdistrict, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3014207480","3008177314","3009934288","3044141181","3005048741","3004947391","3027545288","3004455093","3015986431","3003908605"]},{"id":"3003677831","fei":"3003677831","duns":"917996527","firm":"Keshava Organics Private Limited","registrant":"Keshava Organics Private Limited","parent":null,"ticker":null,"addr":"T-97, 98, 99 & 100, MIDCTarapur Boisar, Palghar, MH 401506, India (IND)","city":"Palghar","state":null,"pin":"401506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3001174909","3003721861","3006418686","3006057101","3009118300","3016577628","3016790354","3017545500","3003336449","3013633378","3018369072","3002807512"]},{"id":"3002807512","fei":"3002807512","duns":"917063646","firm":"LUPIN LIMITED","registrant":"LUPIN LIMITED","parent":"Lupin","ticker":"LUPIN","addr":"T/142, MIDC Tarapur, Via Boisar, Palghar, Tarapur, Maharashtra 401506, India (IND)","city":"Tarapur","state":"Maharashtra","pin":"401506","ops":["API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2021-06-11T04:00:00Z","posted":"2021-06-29T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Office of Pharmaceutical Quality Operations Division I","response":"","closeout":"04/19/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","company_as_published":"Novel Laboratories, Inc. d.b.a LUPIN","match":"token"},{"date":"2022-09-27T04:00:00Z","posted":"2022-11-01T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","company_as_published":"Lupin Limited","match":"exact"}],"events":[{"d":"2022-09-27","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-06-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","x":"Office of Pharmaceutical Quality Operations Division I"}],"first":"2021-06-11","last":"2022-09-27","sibs":["3004995645","3010977634","3004819820","3002807510","3002807511","3009843207","3009831799","3007756473","3015392060","3007549629","3009107538"],"colo":["3001174909","3003721861","3006418686","3006057101","3009118300","3016577628","3016790354","3017545500","3003336449","3013633378","3018369072","3003677831"]},{"id":"Tainwala House Road No 18, Mumbai, Maharashtra 400093, India (IND)","fei":"","duns":"862208329","firm":"Tainwala Personal Care Products Private Limited","registrant":"Dr. Natural LLC","parent":null,"ticker":null,"addr":"Tainwala House Road No 18, Mumbai, Maharashtra 400093, India (IND)","city":"Mumbai","state":"Maharashtra","pin":"400093","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":19.12672,"lon":72.86595,"prec":"postcode","geo":"400093, K/E Ward, Mumbai Zone 3, Mumbai, Mumbai Suburban District, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2025-08-06T04:00:00Z","posted":"2025-08-12T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","company_as_published":"K & Care Organics","match":"token"}],"events":[{"d":"2025-08-06","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-08-06","last":"2025-08-06","sibs":[],"colo":[]},{"id":"Tehsil Bhagwanpur, Khasra No 189/3, 189/4, 190, 190/1, Haridwar, UT 247661, India (IND)","fei":"","duns":"929605578","firm":"Bakson Drugs and Pharmaceuticals Private Limited","registrant":"Bakson Drugs and Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"Tehsil Bhagwanpur, Khasra No 189/3, 189/4, 190, 190/1, Haridwar, UT 247661, India (IND)","city":"Haridwar","state":null,"pin":"247661","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":29.97104,"lon":77.79879,"prec":"postcode","geo":"247661, Roorkee, Haridwar, Uttarakhand, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3015077059","3012020703","3006895982"]},{"id":"3038848101","fei":"3038848101","duns":"771648872","firm":"BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED","registrant":"BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Testing Laboratory, R. S. No. 578, Near Effluent Channel, Village - Luna, Padra Taluka, Vadodara, Gujarat 391440, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391440","ops":["ANALYSIS"],"expires":"12/31/2026","lat":22.24672,"lon":73.08544,"prec":"postcode","geo":"391440, Padra Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3030526918","3031858655","3010166818"],"colo":["3005183272","3009167769","3009119873","3005906909","3009219197","3006767695","3007836955","3008494993","3008405956","3002806475"]},{"id":"3008232281","fei":"3008232281","duns":"677605646","firm":"IOL Chemicals and Pharmaceuticals Ltd.","registrant":"IOL Chemicals and Pharmaceuticals Ltd.","parent":null,"ticker":null,"addr":"Trident Complex Mansa Rd., Vill Fategarh Channa, Barnala, Punjab 148101, India (IND)","city":"Barnala","state":"Punjab","pin":"148101","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":30.36963,"lon":75.54196,"prec":"postcode","geo":"148101, Barnala Tahsil, Barnala, Punjab, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3007623760","fei":"3007623760","duns":"915839373","firm":"Lincoln Pharmaceuticals Limited","registrant":"Lincoln Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Trimul Estate, Khatraj Taluka Kalol, Gandhinagar, Gujarat 382721, India (IND)","city":"Gandhinagar","state":"Gujarat","pin":"382721","ops":["ANALYSIS","PACK","REPACK"],"expires":"12/31/2026","lat":23.22926,"lon":72.50863,"prec":"postcode","geo":"382721, Kalol Taluka, Gandhinagar, Gujarat, India","status":2,"alerts":[{"alert":"66-79","list":"red","since":"10/13/2022","notes":"All Drug and Drug Products; DWPE Date; 04/17/2018","charges":[{"code":"55","notes":"All Drug and Drug Products; DWPE Date; 04/17/2018","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/28/2021"},{"code":"56","notes":"All Drug and Drug Products; DWPE Date; 04/17/2018","product":"Antibiotics (Human/Animal)","published":"10/28/2021"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products; DWPE Date; 04/17/2018","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"61","notes":"All Drug and Drug Products; DWPE Date; 04/17/2018","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"62","notes":"All Drug and Drug Products; DWPE Date; 04/17/2018","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"63","notes":"All Drug and Drug Products; DWPE Date; 04/17/2018","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"64","notes":"All Drug and Drug Products; DWPE Date; 04/17/2018","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"65","notes":"All Drug and Drug Products; DWPE Date; 04/17/2018","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"66","notes":"All Drug and Drug Products; DWPE Date; 04/17/2018","product":"Human and Animal Drugs","published":"10/28/2021"}],"firm_as_published":"Lincoln Pharmaceuticals Ltd.","address_as_published":"10 12 13 Trimul Estate , Khatraj , Gandhinagar, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","match":"exact"}],"letters":[{"date":"2021-06-14T04:00:00Z","posted":"2021-06-15T13:20:00Z","subject":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","office":"Center for Tobacco Products","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lincoln-vapor-llc-615115-06142021","company_as_published":"Lincoln Vapor LLC","match":"token"}],"events":[{"d":"2022-10-13","k":"alert","t":"Listed on import alert 66-79","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 04/17/2018"},{"d":"2022-05-26","k":"charge","t":"66-79 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":""},{"d":"2021-10-28","k":"charge","t":"66-79 charge 55 — Pharm Necess & Ctnr For Drug/Bio","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 04/17/2018"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 56 — Antibiotics (Human/Animal)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 04/17/2018"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 60 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 04/17/2018"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 61 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 04/17/2018"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 62 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 04/17/2018"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 63 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 04/17/2018"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 64 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 04/17/2018"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 65 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 04/17/2018"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 66 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 04/17/2018"},{"d":"2021-06-14","k":"letter","t":"Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lincoln-vapor-llc-615115-06142021","x":"Center for Tobacco Products"}],"first":"2021-06-14","last":"2022-10-13","sibs":[],"colo":["3005029956","3043513089"]},{"id":"UNIT 7, SAHA SHAHBAD HIGHWAY NH 444A, NEAR BAZEEDPUR BUS STOP, KESRI, AMBALA, HARYANA 133102, India (IND)","fei":"","duns":"581636831","firm":"ADVANCED MICRODEVICES PRIVATE LIMITED","registrant":"Advanced Microdevices Private Limited.","parent":null,"ticker":null,"addr":"UNIT 7, SAHA SHAHBAD HIGHWAY NH 444A, NEAR BAZEEDPUR BUS STOP, KESRI, AMBALA, HARYANA 133102, India (IND)","city":"AMBALA","state":"Haryana","pin":"133102","ops":["STERILIZE"],"expires":"12/31/2026","lat":30.2343,"lon":76.90467,"prec":"postcode","geo":"133102, Saha, Ambala, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3003908605","fei":"3003908605","duns":"915163443","firm":"VIYASH SCIENTIFIC LIMITED","registrant":"VIYASH SCIENTIFIC LIMITED","parent":null,"ticker":null,"addr":"UNIT-I, Plot No. 1-A/2 and 1-A/3, MIDC, Industrial Area, Taloja, Panvel, Raigad, Maharashtra 410208, India (IND)","city":"Raigad","state":"Maharashtra","pin":"410208","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.06884,"lon":73.11504,"prec":"postcode","geo":"410208, Panvel, Panvel Subdistrict, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012258477","3008652704","3007164063","3012725393","3005522065","3015443266","3003109450","3008932115"],"colo":["3014207480","3008177314","3009934288","3044141181","3005048741","3004947391","3027545288","3004455093","3015986431","3025922195"]},{"id":"3016979924","fei":"3016979924","duns":"915850005","firm":"MEDICAMEN BIOTECH LIMITED","registrant":"MEDICAMEN BIOTECH LIMITED","parent":null,"ticker":null,"addr":"UNIT-II PLOT NO. 84 - 85, SECTOR-6A, IIE SIDCUL, BHEL, RANIPUR, HARIDWAR, UTTARAKHAND 249403, India (IND)","city":"HARIDWAR","state":"Uttarakhand","pin":"249403","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":29.93213,"lon":78.09692,"prec":"postcode","geo":"249403, Hardwar, Haridwar, Uttarakhand, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3005737619","fei":"3005737619","duns":"650909067","firm":"Raks Pharma Pvt. Ltd.","registrant":"RAKS Pharma Pvt. Limited","parent":null,"ticker":null,"addr":"UNIT-II, PLOT NO. Z-111/A, SEZ-II, TALUKA - VAGRA, DAHEJ, BHARUCH, GUJARAT 392130, India (IND)","city":"BHARUCH","state":"Gujarat","pin":"392130","ops":["ANALYSIS","API MANUFACTURE","LABEL"],"expires":"12/31/2026","lat":21.71286,"lon":72.61625,"prec":"postcode","geo":"392130, Vagra Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008250894"],"colo":["3043800366","3040332349","3005404478","3018972378","3012664809","3010027135","3014919100","3010228235","3007514214","3030599291"]},{"id":"3008652704","fei":"3008652704","duns":"915093988","firm":"VIYASH SCIENTIFIC LIMITED","registrant":"VIYASH SCIENTIFIC LIMITED","parent":null,"ticker":null,"addr":"UNIT-II, Plot No. 28, Sy. No. 1, 3, 9 & 26, Thanam Village, Parawada Mandal, Anakapalli, Andra Pradesh 531021, India (IND)","city":"Anakapalli","state":null,"pin":"531021","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012258477","3003908605","3007164063","3012725393","3005522065","3015443266","3003109450","3008932115"],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163"]},{"id":"3020052335","fei":"3020052335","duns":"854352695","firm":"CONCORD BIOTECH LIMITED","registrant":"CONCORD BIOTECH LIMITED","parent":"Concord Biotech","ticker":"CONCORDBIO","addr":"UNIT-III, Plot No.84 and 668, Ranasar and Malawada, Limbasi Sojitra Road, Near Limbasi, Taluka- Matar,, Kheda,, Gujarat 387520, India (IND)","city":"Kheda","state":"Gujarat","pin":"387520","ops":["ANALYSIS","API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.58001,"lon":72.53947,"prec":"postcode","geo":"387520, Matar Taluka, Kheda, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2022-01-06T05:00:00Z","posted":"2022-01-25T14:20:00Z","subject":"Foreign Supplier Verification Program (FSVP)","office":"Division of West Coast Imports","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/concord-farms-inc-619065-01062022","company_as_published":"Concord Farms, Inc.","match":"token"}],"events":[{"d":"2022-01-06","k":"letter","t":"Foreign Supplier Verification Program (FSVP)","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/concord-farms-inc-619065-01062022","x":"Division of West Coast Imports"}],"first":"2022-01-06","last":"2022-01-06","sibs":["3012520698","3004126703"],"colo":[]},{"id":"3007164063","fei":"3007164063","duns":"650530301","firm":"VIYASH SCIENTIFIC LIMITED","registrant":"VIYASH SCIENTIFIC LIMITED","parent":null,"ticker":null,"addr":"UNIT-III, Survey No. 353, 354 & 467, Domadugu (Village), Gummadidala (Mandal), Sangareddy, Telangana 502313, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502313","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012258477","3003908605","3008652704","3012725393","3005522065","3015443266","3003109450","3008932115"],"colo":["3009996280","3014539030","3003723146","3029798246","3006744199","3032314066","3012234942","3013944676","3003510514","3042223406","3003289270","3007931994"]},{"id":"3012725393","fei":"3012725393","duns":"650840346","firm":"VIYASH SCIENTIFIC LIMITED","registrant":"VIYASH SCIENTIFIC LIMITED","parent":null,"ticker":null,"addr":"UNIT-IV, Sy.No: 163, 163/A, 164/A , Pittampally Village, Chityal Mandal, Nalgonda, Telangana 508114, India (IND)","city":"Nalgonda","state":"Telangana","pin":"508114","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.21132,"lon":79.07301,"prec":"postcode","geo":"508114, Chityal mandal, Nalgonda, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012258477","3003908605","3008652704","3007164063","3005522065","3015443266","3003109450","3008932115"],"colo":["3033870708","3014002307","3009250999","3042853625","3012753303","3032871131","3021257926"]},{"id":"3005522065","fei":"3005522065","duns":"676396796","firm":"VIYASH SCIENTIFIC LIMITED","registrant":"VIYASH SCIENTIFIC LIMITED","parent":null,"ticker":null,"addr":"UNIT-V, Plot No. 25/B, Phase-III, IDA, Jeedimetla (Village), Quthbullapur (Mandal), Medchal-Malkajgiri, Telangana 500055, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500055","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012258477","3003908605","3008652704","3007164063","3012725393","3015443266","3003109450","3008932115"],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869"]},{"id":"3015443266","fei":"3015443266","duns":"650840379","firm":"VIYASH SCIENTIFIC LIMITED","registrant":"VIYASH SCIENTIFIC LIMITED","parent":null,"ticker":null,"addr":"UNIT-VI, Survey No. 744, 745, 750, 751, 752 & 753, Mandollagudem (Village), Choutuppal (Mandal), Yadadri Bhuvangiri, Telangana 508252, India (IND)","city":"Yadadri Bhuvangiri","state":"Telangana","pin":"508252","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.2684,"lon":78.91357,"prec":"postcode","geo":"508252, Choutuppal mandal, Yadadri Bhuvanagiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012258477","3003908605","3008652704","3007164063","3012725393","3005522065","3003109450","3008932115"],"colo":["3004015257","3011845012","3030125048","3003131136"]},{"id":"3003109450","fei":"3003109450","duns":"676272063","firm":"VIYASH SCIENTIFIC LIMITED","registrant":"VIYASH SCIENTIFIC LIMITED","parent":null,"ticker":null,"addr":"UNIT-VII, Survey No. 501, 506 & 507, Koyyalagudem Village, Choutuppal Mandal, Yadadri Bhuvanagiri, Telangana 508252, India (IND)","city":"Yadadri Bhuvanagiri","state":"Telangana","pin":"508252","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.2684,"lon":78.91357,"prec":"postcode","geo":"508252, Choutuppal mandal, Yadadri Bhuvanagiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012258477","3003908605","3008652704","3007164063","3012725393","3005522065","3015443266","3008932115"],"colo":["3004015257","3011845012","3030125048","3003131136"]},{"id":"3008932115","fei":"3008932115","duns":"581707188","firm":"VIYASH SCIENTIFIC LIMITED","registrant":"VIYASH SCIENTIFIC LIMITED","parent":null,"ticker":null,"addr":"UNIT-VIII, Plot No. 3, 4 & 5, Anrich Industrial Estate, First Cross, IDA Bollaram, Sangareddy, Telangana 502325, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502325","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.55317,"lon":78.34216,"prec":"postcode","geo":"502325, Jinnaram mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012258477","3003908605","3008652704","3007164063","3012725393","3005522065","3015443266","3003109450"],"colo":["3017000602","3041729025","3008408466","3002806851","3007136165","3008479404","3009609117","3007720135","3005818804","3005301950"]},{"id":"3009883410","fei":"3009883410","duns":"864425497","firm":"EUGIA PHARMA SPECIALITIES LIMITED","registrant":"EUGIA Pharma Specialities Limited","parent":null,"ticker":null,"addr":"Unit - 2, A-1128 & B-1127, RIICO Industrial Area, Phase-III, Bhiwadi, Rajasthan 301019, India (IND)","city":"Bhiwadi","state":"Rajasthan","pin":"301019","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":28.20518,"lon":76.82931,"prec":"postcode","geo":"301019, Tijara Tehsil, Khairthal-Tijara, Rajasthan, India","status":1,"alerts":[],"letters":[{"date":"2024-08-15T04:00:00Z","posted":"2024-08-20T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-681905-08152024","company_as_published":"Eugia Pharma Specialities Limited","match":"exact"},{"date":"2026-08-13T04:00:00Z","posted":"2026-08-18T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-730469-08132026","company_as_published":"Eugia Pharma Specialities Limited","match":"exact"}],"events":[{"d":"2026-08-13","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-730469-08132026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-15","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-681905-08152024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-15","last":"2026-08-13","sibs":["3011960448","3008461619"],"colo":["3030304532"]},{"id":"3010419177","fei":"3010419177","duns":"863767205","firm":"Optimus Drugs Private Limited","registrant":"Optimus Drugs Private Limited","parent":null,"ticker":null,"addr":"Unit - I, Survey No. 239 and 240, Dothigudem Village, Pochampally Mandal, Yadadri-Bhuvanagiri (D), Telangana 508284, India (IND)","city":"Yadadri-Bhuvanagiri (D)","state":"Telangana","pin":"508284","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.35845,"lon":78.85712,"prec":"postcode","geo":"508284, B. Pochampally mandal, Yadadri Bhuvanagiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3014675555"],"colo":["3014595540"]},{"id":"Unit - I, Sy No. 10, Ida, Gaddapotharam Village Jinnaram Mandal Medak, Telangana, 502319 India, Jinnaram,  502319, India (IND)","fei":"","duns":"650992311","firm":"Emnar Pharma Private Limited","registrant":"Vishnu","parent":null,"ticker":null,"addr":"Unit - I, Sy No. 10, Ida, Gaddapotharam Village Jinnaram Mandal Medak, Telangana, 502319 India, Jinnaram,  502319, India (IND)","city":"Gaddapotharam Village Jinnaram Mandal Medak","state":"Telangana","pin":"502319","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012336575"],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338"]},{"id":"3012520698","fei":"3012520698","duns":"650996940","firm":"CONCORD BIOTECH LIMITED","registrant":"CONCORD BIOTECH LIMITED","parent":"Concord Biotech","ticker":"CONCORDBIO","addr":"Unit - II, 297-298 / 2P At Valthera Ta. Dholka, Ahmedabad, Gujarat 382225, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382225","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.72227,"lon":72.45136,"prec":"postcode","geo":"382225, Dholka Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2022-01-06T05:00:00Z","posted":"2022-01-25T14:20:00Z","subject":"Foreign Supplier Verification Program (FSVP)","office":"Division of West Coast Imports","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/concord-farms-inc-619065-01062022","company_as_published":"Concord Farms, Inc.","match":"token"}],"events":[{"d":"2022-01-06","k":"letter","t":"Foreign Supplier Verification Program (FSVP)","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/concord-farms-inc-619065-01062022","x":"Division of West Coast Imports"}],"first":"2022-01-06","last":"2022-01-06","sibs":["3020052335","3004126703"],"colo":["3007684569"]},{"id":"3014675555","fei":"3014675555","duns":"675467507","firm":"Optimus Drugs Private Limited","registrant":"Optimus Drugs Private Limited","parent":null,"ticker":null,"addr":"Unit - III, Survey No. 145/A, 145/AA, 147, 148 & 208, Ramalingampally (V), Bommalaramaram (M), Yadadri-Bhuvanagiri (D), Telangana 508126, India (IND)","city":"Yadadri-Bhuvanagiri (D)","state":"Telangana","pin":"508126","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.51941,"lon":78.776,"prec":"postcode","geo":"508126, Bommalaramaram mandal, Yadadri Bhuvanagiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3010419177"],"colo":["3005621526","3008822771"]},{"id":"3014289163","fei":"3014289163","duns":"725238161","firm":"Metrochem API Private Limited","registrant":"Metrochem API Private Limited","parent":null,"ticker":null,"addr":"Unit - IV, Plot No. 34B, 40B & 60B, J.N. Pharma City, Thanam Village, Parawada Mandal, Anakapalli District, Andhra Pradesh 531021, India (IND)","city":"Anakapalli District","state":"Andhra Pradesh","pin":"531021","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3042223406","3007800884"],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163"]},{"id":"3005256484","fei":"3005256484","duns":"650459006","firm":"AARTI PHARMALABS LIMITED","registrant":"AARTI PHARMALABS LIMITED","parent":null,"ticker":null,"addr":"Unit - IV, Plot No: E - 50, 50/1, 59/1, M.I.D.C. Tarapur, Taluka & District: Palghar, Tarapur, Maharashtra 401506, India (IND)","city":"Tarapur","state":"Maharashtra","pin":"401506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3007005296"],"colo":["3001174909","3003721861","3006418686","3006057101","3009118300","3016577628","3016790354","3017545500","3003336449","3013633378","3018369072","3003677831"]},{"id":"3012740315","fei":"3012740315","duns":"860316408","firm":"Torrent Pharmaceuticals Limited","registrant":"Torrent Pharma, Inc.","parent":"Torrent Pharmaceuticals","ticker":"TORNTPHARM","addr":"Unit -2, Survey No. 102, 105, 106, 119 to 121, Ahmedabad - Mehsana Highway, Bileshwarpura,Taluka - Kalol, Gandhinagar, Gujarat 382729, India (IND)","city":"Gandhinagar","state":"Gujarat","pin":"382729","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":23.29313,"lon":72.43882,"prec":"postcode","geo":"382729, Kalol Taluka, Gandhinagar, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005029956","3010228235","3008861587","3006763261"],"colo":["3009326970"]},{"id":"3005343706","fei":"3005343706","duns":"650460947","firm":"Haleos Labs Limited","registrant":"Haleos Labs Limited","parent":null,"ticker":null,"addr":"Unit 1, Sy. No.180/2, Khazipally Village Jinnaram Mandal, Sangareddy District, Hyderabad, Telangana 502319, India (IND)","city":"Hyderabad","state":"Telangana","pin":"502319","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338"]},{"id":"3009590042","fei":"3009590042","duns":"860037302","firm":"Matrix Pharmacorp Private Limited","registrant":"Matrix Pharmacorp Private Limited","parent":null,"ticker":null,"addr":"Unit 10, Plot No. 86, SEZ, Jawaharlal Nehru Pharma City, Parawada Mandal, Anakapalli District, Visakhapatnam, Andhra Pradesh 531019, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003227156","3002785310","3008861594","3004713397"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3007532627","fei":"3007532627","duns":"915834105","firm":"Encube Ethicals Limited","registrant":"Encube Ethicals Limited","parent":null,"ticker":null,"addr":"Unit 24, Steelmade Industrial Estate, Marol, Andheri East,, Mumbai, Maharashtra 400059, India (IND)","city":"Mumbai","state":"Maharashtra","pin":"400059","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.11535,"lon":72.92366,"prec":"postcode","geo":"400059, S Ward, Mumbai Zone 6, Mumbai, Mumbai Suburban District, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3037647985","3005669319","3030695079"],"colo":[]},{"id":"3035152598","fei":"3035152598","duns":"756130437","firm":"SYNGENE INTERNATIONAL LIMITED","registrant":"Syngene International Limited","parent":"Syngene International","ticker":"SYNGENE","addr":"Unit 3, No: 68/A, Bommasandra Industrial Area, I Phase, Hosur Road, Anekal, Bengaluru, Karnataka 560099, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560099","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":12.83934,"lon":77.70554,"prec":"postcode","geo":"560099, Singena Agrahara, Anekal, Bengaluru Urban, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003600340","3012608389","3007907068"],"colo":["3009310198","3043619916","3007078919","3003981475","3008300442","3006076314","3013637926","3010164491"]},{"id":"3003227156","fei":"3003227156","duns":"650438141","firm":"Matrix Pharmacorp Private Limited","registrant":"Matrix Pharmacorp Private Limited","parent":null,"ticker":null,"addr":"Unit 7, Plot No. 14, 99 and 100, IDA, Pashamylaram Phase II, Patancheru, Sangareddy District, Hyderabad, Telangana 502307, India (IND)","city":"Hyderabad","state":"Telangana","pin":"502307","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009590042","3002785310","3008861594","3004713397"],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167"]},{"id":"3002785310","fei":"3002785310","duns":"650438158","firm":"Matrix Pharmacorp Private Limited","registrant":"Matrix Pharmacorp Private Limited","parent":null,"ticker":null,"addr":"Unit 8, Gaitula Chodavaram, Poosapatirega Mandal, Vizianagaram, Andhra Pradesh 535204, India (IND)","city":"Vizianagaram","state":"Andhra Pradesh","pin":"535204","ops":["ANALYSIS","API MANUFACTURE","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.09318,"lon":83.54215,"prec":"postcode","geo":"535204, Pusapatirega, Vizianagaram, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009590042","3003227156","3008861594","3004713397"],"colo":["3008654585"]},{"id":"3008861594","fei":"3008861594","duns":"862499912","firm":"Matrix Pharmacorp Private Limited","registrant":"Matrix Pharmacorp Private Limited","parent":null,"ticker":null,"addr":"Unit 9, Plot No. 5, Road No. 12, Jawaharlal Nehru Pharma City, Tadi Village, Parawada Mandal, Anakapalli District, Visakhapatnam, Andhra Pradesh 531019, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009590042","3003227156","3002785310","3004713397"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3009056604","fei":"3009056604","duns":"650540227","firm":"Gland Pharma Limited","registrant":"GLAND PHARMA LIMITED","parent":"Gland Pharma","ticker":"GLAND","addr":"Unit I & Unit II, Block C, Phase I, Visakhapatnam Special Economic Zone (VSEZ ), Duvvada, Visakhapatnam, Andhra Pradesh 530049, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"530049","ops":["ANALYSIS","API MANUFACTURE","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.7036,"lon":83.15138,"prec":"tail3","geo":"Duvvada, Kurmannapalem Road, Duvvada, Kotturu, Gajuwaka, Visakhapatnam, Andhra Pradesh, 530046, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009864167","3010142300","3002647489"],"colo":["3018490749"]},{"id":"3003510514","fei":"3003510514","duns":"650433076","firm":"Hetero Drugs Limited","registrant":"Hetero Drugs Limited","parent":"Hetero (unlisted)","ticker":null,"addr":"Unit I, Sy. No. 213, 214 & 255, Bonthapally Village, Gummadidala Mandal,, Sangareddy district, Telangana 502313, India (IND)","city":"Sangareddy district","state":"Telangana","pin":"502313","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":2,"alerts":[{"alert":"66-66","list":"red","since":"09/30/2009","notes":"10/3/2000","charges":[{"code":"62 O - S 27","notes":"","product":"Doxazosin Mesylate (Anti-Hypertensive - Part II), Active Pharm Ingred/Chems for Further Manuf","published":"03/29/2019"}],"firm_as_published":"Hetero Drugs Ltd","address_as_published":"7 1 Hetero House # 8 - 3 - 166 , Hyderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"}],"letters":[],"events":[{"d":"2019-03-29","k":"charge","t":"66-66 charge 62 O - S 27 — Doxazosin Mesylate (Anti-Hypertensive - Part II), Active Pharm Ingred/Chems for Further Manuf","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":"10/3/2000"}],"first":"2009-09-30","last":"2019-03-29","sibs":["3009307611","3009225386","3009488373"],"colo":["3009996280","3014539030","3003723146","3029798246","3006744199","3032314066","3012234942","3013944676","3007164063","3042223406","3003289270","3007931994"]},{"id":"3010633689","fei":"3010633689","duns":"871402980","firm":"Rampex Labs Pvt. Ltd.","registrant":"Rampex Labs Pvt. Ltd.","parent":null,"ticker":null,"addr":"Unit II Plot No. 34-C JN Pharma City, APIIC Lala, Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008479404"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3032592163","fei":"3032592163","duns":"929607573","firm":"KLM Laboratories Private Limited","registrant":"KLM Laboratories Private Limited","parent":null,"ticker":null,"addr":"Unit II, City Survey No. 12/2, Village Manglej, Nareshwar Road, NH 48, Tal - Karjan, Vadodara, Gujarat 391243, India (IND)","city":"Vadodara","state":"Gujarat","pin":"391243","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":22.13388,"lon":73.18071,"prec":"postcode","geo":"391243, Vadodara Rural Taluka, Vadodara, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3017001542"],"colo":["3018899465"]},{"id":"3012336575","fei":"3012336575","duns":"650688406","firm":"EMNAR PHARMA PRIVATE LIMITED","registrant":"Maha Vishnu Mundla","parent":null,"ticker":null,"addr":"Unit II, Plot No. 15, Jawaharlal Nehru Pharma City, Tadi Village, Parawada Mandal, Anakapalli (District), ANDHRA PRADESH 531019, India (IND)","city":"Anakapalli (District)","state":"Andhra Pradesh","pin":"531019","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["Unit - I, Sy No. 10, Ida, Gaddapotharam Village Jinnaram Mandal Medak, Telangana, 502319 India, Jinnaram,  502319, India (IND)"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3018360272","fei":"3018360272","duns":"650622769","firm":"VIRUPAKSHA ORGANICS LIMITED","registrant":"VIRUPAKSHA ORGANICS LIMITED","parent":null,"ticker":null,"addr":"Unit II, Plot No. 30 to 33, IDA Pashamylaram, Pashamylaram Village, Patancheru Mandal, Sangareddy,, Hyderabad, Telangana 502307, India (IND)","city":"Hyderabad","state":"Telangana","pin":"502307","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008154209"],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167"]},{"id":"3041778294","fei":"3041778294","duns":"675888632","firm":"MDC PHARMACEUTICALS LIMITED","registrant":"MDC PHARMACEUTICALS LIMITED","parent":null,"ticker":null,"addr":"Unit II, Sai Road Baddi, Solan, Pradesh 173205, India (IND)","city":"Solan","state":null,"pin":"173205","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":30.94458,"lon":76.80677,"prec":"postcode","geo":"173205, Baddi, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3006370533","3013950309","3003897648","3006785414","3031304848","3007187282","3012536712","3018004432","3005757050","3005430968","3004738570"]},{"id":"3038110405","fei":"3038110405","duns":"931832162","firm":"DifGen Pharmaceuticals Pvt Ltd","registrant":"DifGen Pharmaceuticals LLC","parent":null,"ticker":null,"addr":"Unit II, Type 1, Shed No. 13 B, Sy No 386, I.E. Kukatpally (V&M) Medchal – Malkajgiri District, Hyderabad, Telangana State 500072, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500072","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.49046,"lon":78.40127,"prec":"postcode","geo":"500072, Ward 115 Balaji Nagar, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Kukatpally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3039411568"],"colo":["3031662558","3037730318","3030171758","3017524864","3016445311","3009887324","3027666582","3015443248","3030396086"]},{"id":"3031080212","fei":"3031080212","duns":"756023213","firm":"Immacule Lifesciences Private Limited","registrant":"Immacule Lifesciences Private Limited","parent":null,"ticker":null,"addr":"Unit II, Village Ghogharwal, Nalagarh, Solan, Himachal Pradesh 174101, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"174101","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":31.06505,"lon":76.69603,"prec":"postcode","geo":"174101, Nalagarh, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3014210753"],"colo":["3046619098","3016859498","3013744962","3012112224","3008250236","3010868532","3007517881"]},{"id":"3005406526","fei":"3005406526","duns":"676162024","firm":"Hetero Labs Limited","registrant":"Hetero Labs Limited","parent":"Hetero (unlisted)","ticker":null,"addr":"Unit III, Plot No. 22-110, Part-II, IDA, Jeedimetla, Hyderabad, Telangana 500055, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500055","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3022837118","3011002833","3009093782","3008307735","3008294355","3004378446"],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869"]},{"id":"3011002833","fei":"3011002833","duns":"915838368","firm":"Hetero Labs Limited","registrant":"Hetero Labs Limited","parent":"Hetero (unlisted)","ticker":null,"addr":"Unit III, Survey No.120, 128, 150(Part), 150/1,151/2 &158/1, N. Narasapuram, Nallamattipalem, Nakkapalli (Mandal), Anakapalli District, Andhra Pradesh 531081, India (IND)","city":"Anakapalli District","state":"Andhra Pradesh","pin":"531081","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.40802,"lon":82.69548,"prec":"postcode","geo":"531081, Nakkapalle, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3022837118","3005406526","3009093782","3008307735","3008294355","3004378446"],"colo":["3009225386","3010828439"]},{"id":"3008765255","fei":"3008765255","duns":"915838046","firm":"NEULAND LABORATORIES LIMITED","registrant":"Neuland Laboratories Limited","parent":"Neuland Laboratories","ticker":"NEULANDLAB","addr":"Unit III, Sy No.10, Plot No.3-72, Gaddapotharam Village, Jinnaram Mandal,, Sangareddy District, Telangana State 502 319, India (IND)","city":"Sangareddy District","state":"Telangana","pin":null,"ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.84959,"lon":79.11517,"prec":"state","geo":"Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003289270","3003309323"],"colo":[]},{"id":"3006398900","fei":"3006398900","duns":"915850412","firm":"Sai Life Sciences Limited","registrant":"Sai Life Sciences Limited","parent":"Sai Life Sciences","ticker":"SAILIFE","addr":"Unit IV, Plot No. 78C, 79A, 79B, 80-A, 80-B, 81-A & 82, Sy. No. 280, Kolhar Industrial Area, Bidar, Karnataka 585403, India (IND)","city":"Bidar","state":"Karnataka","pin":"585403","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.89564,"lon":77.51307,"prec":"postcode","geo":"585403, Bidar taluku, Bidar, Karnataka, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3027037264","3004602077","3005301950"],"colo":[]},{"id":"3009225386","fei":"3009225386","duns":"650531291","firm":"Hetero Drugs Limited","registrant":"Hetero Drugs Limited","parent":"Hetero (unlisted)","ticker":null,"addr":"Unit IX, Plot No. 1, Hetero Infrastructure SEZ Ltd., N. Narasapuram Village, Nakkapalli Mandal, Anakapalli district, Andhra Pradesh 531081, India (IND)","city":"Anakapalli district","state":"Andhra Pradesh","pin":"531081","ops":["API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":17.40802,"lon":82.69548,"prec":"postcode","geo":"531081, Nakkapalle, Anakapalli, Andhra Pradesh, India","status":2,"alerts":[{"alert":"66-66","list":"red","since":"09/30/2009","notes":"10/3/2000","charges":[{"code":"62 O - S 27","notes":"","product":"Doxazosin Mesylate (Anti-Hypertensive - Part II), Active Pharm Ingred/Chems for Further Manuf","published":"03/29/2019"}],"firm_as_published":"Hetero Drugs Ltd","address_as_published":"7 1 Hetero House # 8 - 3 - 166 , Hyderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"}],"letters":[],"events":[{"d":"2019-03-29","k":"charge","t":"66-66 charge 62 O - S 27 — Doxazosin Mesylate (Anti-Hypertensive - Part II), Active Pharm Ingred/Chems for Further Manuf","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":"10/3/2000"}],"first":"2009-09-30","last":"2019-03-29","sibs":["3009307611","3003510514","3009488373"],"colo":["3011002833","3009093782","3010828439"]},{"id":"3009093782","fei":"3009093782","duns":"650563526","firm":"Hetero Labs Limited","registrant":"Hetero Labs Limited","parent":"Hetero (unlisted)","ticker":null,"addr":"Unit IX, Plot No. 2, Hetero Infrastructure SEZ Ltd., N. Narasapuram Village, Nakkapalli (Mandal), Anakapalli District, Andhra Pradesh 531081, India (IND)","city":"Anakapalli District","state":"Andhra Pradesh","pin":"531081","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.40802,"lon":82.69548,"prec":"postcode","geo":"531081, Nakkapalle, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3022837118","3005406526","3011002833","3008307735","3008294355","3004378446"],"colo":["3009225386","3010828439"]},{"id":"3012971586","fei":"3012971586","duns":"771648858","firm":"NGL FINE-CHEM LIMITED","registrant":"NGL FINECHEM LIMITED","parent":null,"ticker":null,"addr":"Unit No. 4, S-18/3, MIDC, Tarapur Industrial Area, Boisar, Palghar, Maharashtra 401506, India (IND)","city":"Palghar","state":"Maharashtra","pin":"401506","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.78168,"lon":72.78899,"prec":"postcode","geo":"401506, Palghar Subdistrict, Palghar, Maharashtra, India","status":2,"alerts":[{"alert":"66-66","list":"red","since":"09/30/2009","notes":"11/2/2000","charges":[{"code":"60 W - S 26","notes":"","product":"Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","published":"03/27/2019"}],"firm_as_published":"Fine Chemicals","address_as_published":"89 Princess Street , Bombay, MS INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"token"}],"letters":[],"events":[{"d":"2019-03-27","k":"charge","t":"66-66 charge 60 W - S 26 — Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":"11/2/2000"}],"first":"2009-09-30","last":"2019-03-27","sibs":[],"colo":["3001174909","3003721861","3006418686","3006057101","3009118300","3016577628","3016790354","3017545500","3003336449","3013633378","3018369072","3003677831"]},{"id":"3018238790","fei":"3018238790","duns":"854208771","firm":"ITRACE PHARMACEUTICAL SOLUTIONS PRIVATE LIMITED","registrant":"ITRACE PHARMACEUTICAL SOLUTIONS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Unit No. F-7, D-Wing, Udyog Bhavan 2, Plot No. K-2 Additional Ambernath MIDC, Ambernath East, Thane, Maharashtra 421506, India (IND)","city":"Thane","state":"Maharashtra","pin":"421506","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.206,"lon":73.18699,"prec":"postcode","geo":"421506, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021189141","3009887190","3008232264","3013999816","3018052045","3016575313","3006599894","3006809732","3027577650","3010166801","3032073298","3008374690"]},{"id":"3008307735","fei":"3008307735","duns":"650452530","firm":"Hetero Labs Limited","registrant":"Hetero Labs Limited","parent":"Hetero (unlisted)","ticker":null,"addr":"Unit V, Sy. No.: 439, 440, 441 & 458, TSIIC Formulation SEZ, Polepally Village, Mahabubnagar, Telangana 509301, India (IND)","city":"Mahabubnagar","state":"Telangana","pin":"509301","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":16.76333,"lon":78.1484,"prec":"postcode","geo":"509301, Jadcherla mandal, Mahabubnagar, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3022837118","3005406526","3011002833","3009093782","3008294355","3004378446"],"colo":["3005903939","3009876430"]},{"id":"3008294355","fei":"3008294355","duns":"650452548","firm":"Hetero Labs Limited","registrant":"Hetero Labs Limited","parent":"Hetero (unlisted)","ticker":null,"addr":"Unit VI, Sy. No.: 410 & 411, TSIIC Formulation SEZ, Polepally Village, Jadcherla Mandal,, Mahabubnagar, Telangana 509301, India (IND)","city":"Mahabubnagar","state":"Telangana","pin":"509301","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":16.76333,"lon":78.1484,"prec":"postcode","geo":"509301, Jadcherla mandal, Mahabubnagar, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3022837118","3005406526","3011002833","3009093782","3008307735","3004378446"],"colo":["3005903939","3009876430"]},{"id":"3008932049","fei":"3008932049","duns":"675679589","firm":"Nectar Life Sciences Limited","registrant":"Nectar Lifesciences Limited","parent":null,"ticker":null,"addr":"Unit VI, Village Bhatoli kalan, adjoining Jharmajri E.P.I.P.,Post office Barotiwala, Tehsil Baddi, Solan, Himachal Pradesh 174103, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"174103","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":30.92027,"lon":76.82333,"prec":"postcode","geo":"174103, Kalka, Panchkula, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3009648228"]},{"id":"3003723117","fei":"3003723117","duns":"650633472","firm":"Sri Krishna Pharmaceuticals Limited","registrant":"Sri Krishna Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Unit – I, C-4, Industrial Area, Uppal Khalsa (V), Uppal (M), Medchal-Malkajgiri (Dist.),, Hyderabad, Telangana 500039, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500039","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.40557,"lon":78.56557,"prec":"postcode","geo":"500039, Ward 10 Uppal, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"08/13/2015","notes":"All Drugs","charges":[{"code":"55","notes":"All Drugs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"08/13/2015"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"10/02/2024"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"61","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"62","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"63","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"64","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"65","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"66","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"}],"firm_as_published":"Sri Krishna Pharmaceuticals Limited","address_as_published":"Unit Ii, Plot No:A-34,A-35, Ida Nacharam, Uppal (M), Medchal-Malkajgiri District , Hyderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2024-10-02","k":"charge","t":"66-40 charge 56 — Antibiotics (Human/Animal)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2015-08-13","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs"}],"first":"2015-08-13","last":"2024-10-02","sibs":["3005408438","3005403224"],"colo":["3009864255"]},{"id":"3035592613","fei":"3035592613","duns":"766384261","firm":"MSN LABORATORIES PRIVATE LIMITED","registrant":"MSN LABORATORIES PRIVATE LIMITED","parent":"MSN Laboratories (unlisted)","ticker":null,"addr":"Unit- 05, Sy. Nos. (Parts of) 7,8,13 and 189, Chinna Chilkamarri, Chilkamarri (Chelka) Village, Farooqnagar Mandal,, Rangareddy, Telangana 509216, India (IND)","city":"Rangareddy","state":"Telangana","pin":"509216","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":17.07185,"lon":78.21072,"prec":"postcode","geo":"509216, Farooqnagar mandal, Ranga Reddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011033544","3019516576","3005075182","3005254981","3008656542","3023132203"],"colo":[]},{"id":"3004713397","fei":"3004713397","duns":"918608878","firm":"Matrix Pharmacorp Private Limited","registrant":"Matrix Pharmacorp Private Limited","parent":null,"ticker":null,"addr":"Unit-1 & Unit-2, Survey No.10 and 42, Kazipally Industrial Area, Gaddapotharam, Sangareddy District, Hyderabad, Telangana 502319, India (IND)","city":"Hyderabad","state":"Telangana","pin":"502319","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009590042","3003227156","3002785310","3008861594"],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338"]},{"id":"3002807511","fei":"3002807511","duns":"725504448","firm":"LUPIN LIMITED","registrant":"LUPIN LIMITED","parent":"Lupin","ticker":"LUPIN","addr":"Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep, Madhya Pradesh 462046, India (IND)","city":"Mandideep","state":"Madhya Pradesh","pin":"462046","ops":["API MANUFACTURE","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":23.11984,"lon":77.50068,"prec":"postcode","geo":"462046, Samarda Kaliyasot, Kolar Tahsil, Bhopal, Madhya Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2021-06-11T04:00:00Z","posted":"2021-06-29T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Office of Pharmaceutical Quality Operations Division I","response":"","closeout":"04/19/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","company_as_published":"Novel Laboratories, Inc. d.b.a LUPIN","match":"token"},{"date":"2022-09-27T04:00:00Z","posted":"2022-11-01T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","company_as_published":"Lupin Limited","match":"exact"}],"events":[{"d":"2022-09-27","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-06-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","x":"Office of Pharmaceutical Quality Operations Division I"}],"first":"2021-06-11","last":"2022-09-27","sibs":["3004995645","3010977634","3004819820","3002807510","3002807512","3009843207","3009831799","3007756473","3015392060","3007549629","3009107538"],"colo":["3009528099"]},{"id":"3013438177","fei":"3013438177","duns":"677389733","firm":"ARENE LIFE SCIENCES PRIVATE LIMITED","registrant":"Arene Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Unit-1, 48, 49, 50, 209, 210 & 211 Phase II, I D A Pashamylaram, Sangareddy, Sangareddy, Telangana 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3047392863","3033870708"],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167"]},{"id":"3003131136","fei":"3003131136","duns":"918598199","firm":"DIVI'S LABORATORIES LIMITED","registrant":"DIVI'S LABORATORIES LIMITED","parent":"Divi's Laboratories","ticker":"DIVISLAB","addr":"Unit-1, Lingojigudem Village, Choutuppal Mandal,, Yadadri Bhuvanagiri District, Telangana 508252, India (IND)","city":"Yadadri Bhuvanagiri District","state":"Telangana","pin":"508252","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.2684,"lon":78.91357,"prec":"postcode","geo":"508252, Choutuppal mandal, Yadadri Bhuvanagiri, Telangana, India","status":2,"alerts":[{"alert":"66-79","list":"red","since":"10/13/2022","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","charges":[{"code":"55","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/28/2021"},{"code":"56","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Antibiotics (Human/Animal)","published":"10/28/2021"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"61","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"62","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"63","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"64","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"65","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"66","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"}],"firm_as_published":"Divis Pharmaceuticals Private Limited","address_as_published":"7 - 1 - 77 E 1 303 Divi Towers , Hyderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","match":"token"}],"letters":[],"events":[{"d":"2022-10-13","k":"alert","t":"Listed on import alert 66-79","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2022-05-26","k":"charge","t":"66-79 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":""},{"d":"2021-10-28","k":"charge","t":"66-79 charge 55 — Pharm Necess & Ctnr For Drug/Bio","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 56 — Antibiotics (Human/Animal)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 60 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 61 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 62 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 63 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 64 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 65 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 66 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"}],"first":"2021-10-28","last":"2022-10-13","sibs":["3004149463"],"colo":["3004015257","3011845012","3030125048","3015443266","3003109450"]},{"id":"3030710778","fei":"3030710778","duns":"955455004","firm":"YMC India private limited","registrant":"YMC India private limited","parent":null,"ticker":null,"addr":"Unit-1, Plot 78/A/6, 2nd & 3rd Floor, Phase-VI, Industrial Park, Gajularamaram Village, Jeedimetla Quthbullapur, Medchal-Malkajgiri, Telangana 500055, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500055","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869"]},{"id":"3015941740","fei":"3015941740","duns":"675488974","firm":"Biophore India Pharmaceuticals Private Limited","registrant":"Biophore India Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"Unit-1, Plot No 80-A, Jnpc Parawada Road No 5, Visakhapatnam, Andhra Pradesh 531021, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531021","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163"]},{"id":"3009843207","fei":"3009843207","duns":"650759348","firm":"LUPIN LIMITED","registrant":"LUPIN LIMITED","parent":"Lupin","ticker":"LUPIN","addr":"Unit-1, Plot No. 6A1, 6A2, Sector - 17, Special Economic Zone, Mihan, Nagpur, Maharashtra 441108, India (IND)","city":"Nagpur","state":"Maharashtra","pin":"441108","ops":["MANUFACTURE","PACK"],"expires":"12/31/2026","lat":20.96447,"lon":79.01865,"prec":"postcode","geo":"441108, Nagpur Rural Taluka, Nagpur, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2021-06-11T04:00:00Z","posted":"2021-06-29T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Office of Pharmaceutical Quality Operations Division I","response":"","closeout":"04/19/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","company_as_published":"Novel Laboratories, Inc. d.b.a LUPIN","match":"token"},{"date":"2022-09-27T04:00:00Z","posted":"2022-11-01T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","company_as_published":"Lupin Limited","match":"exact"}],"events":[{"d":"2022-09-27","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-06-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","x":"Office of Pharmaceutical Quality Operations Division I"}],"first":"2021-06-11","last":"2022-09-27","sibs":["3004995645","3010977634","3004819820","3002807510","3002807512","3002807511","3009831799","3007756473","3015392060","3007549629","3009107538"],"colo":[]},{"id":"3009831799","fei":"3009831799","duns":"650582310","firm":"LUPIN LIMITED","registrant":"LUPIN LIMITED","parent":"Lupin","ticker":"LUPIN","addr":"Unit-1, Plot No. M-2 and M-2-A, Special Economic Zone, Phase II, MISC Zone Apparel Park, Pithampur, Dhar, Madhya Pradesh 454775, India (IND)","city":"Dhar","state":"Madhya Pradesh","pin":"454775","ops":["API MANUFACTURE","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2021-06-11T04:00:00Z","posted":"2021-06-29T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Office of Pharmaceutical Quality Operations Division I","response":"","closeout":"04/19/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","company_as_published":"Novel Laboratories, Inc. d.b.a LUPIN","match":"token"},{"date":"2022-09-27T04:00:00Z","posted":"2022-11-01T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","company_as_published":"Lupin Limited","match":"exact"}],"events":[{"d":"2022-09-27","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-06-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","x":"Office of Pharmaceutical Quality Operations Division I"}],"first":"2021-06-11","last":"2022-09-27","sibs":["3004995645","3010977634","3004819820","3002807510","3002807512","3002807511","3009843207","3007756473","3015392060","3007549629","3009107538"],"colo":["3010453141","3007574780","3016480976","3006456888","3008565058","3005259207","3008581988","3005594847","3038913994","3016268582","3014281041","3008861587"]},{"id":"3011960448","fei":"3011960448","duns":"872201704","firm":"EUGIA Pharma Specialities Limited","registrant":"EUGIA Pharma Specialities Limited","parent":null,"ticker":null,"addr":"Unit-1, Sy. No. 550, 551 & 552, Kolthur Village, Shamirpet Mandal, Medchal-Malkajgiri, Telangana 500101, India (IND)","city":"Medchal-Malkajgiri","state":"Telangana","pin":"500101","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.65514,"lon":78.60618,"prec":"postcode","geo":"500101, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2024-08-15T04:00:00Z","posted":"2024-08-20T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-681905-08152024","company_as_published":"Eugia Pharma Specialities Limited","match":"exact"},{"date":"2026-08-13T04:00:00Z","posted":"2026-08-18T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-730469-08132026","company_as_published":"Eugia Pharma Specialities Limited","match":"exact"}],"events":[{"d":"2026-08-13","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-730469-08132026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-15","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-681905-08152024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-15","last":"2026-08-13","sibs":["3009883410","3008461619"],"colo":["3038528882","PLOT NO 4C,MN SC & TECH BIOTECH PARK GENOME VALLEY, TURKAPALLY, SHAMIRPET RANGAREDDY, Hyderabad, Telangana 500101, India (IND)","3006587427","3017754175","3039644403","3039411568","3006527015","3009522832","3012704791","3030495702","3009883135"]},{"id":"3007756473","fei":"3007756473","duns":"677604666","firm":"LUPIN LIMITED","registrant":"LUPIN LIMITED","parent":"Lupin","ticker":"LUPIN","addr":"Unit-2, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep, Madhya Pradesh 462046, India (IND)","city":"Mandideep","state":"Madhya Pradesh","pin":"462046","ops":["API MANUFACTURE","PACK"],"expires":"12/31/2026","lat":23.11984,"lon":77.50068,"prec":"postcode","geo":"462046, Samarda Kaliyasot, Kolar Tahsil, Bhopal, Madhya Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2021-06-11T04:00:00Z","posted":"2021-06-29T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Office of Pharmaceutical Quality Operations Division I","response":"","closeout":"04/19/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","company_as_published":"Novel Laboratories, Inc. d.b.a LUPIN","match":"token"},{"date":"2022-09-27T04:00:00Z","posted":"2022-11-01T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","company_as_published":"Lupin Limited","match":"exact"}],"events":[{"d":"2022-09-27","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-06-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","x":"Office of Pharmaceutical Quality Operations Division I"}],"first":"2021-06-11","last":"2022-09-27","sibs":["3004995645","3010977634","3004819820","3002807510","3002807512","3002807511","3009843207","3009831799","3015392060","3007549629","3009107538"],"colo":["3009528099"]},{"id":"3004149463","fei":"3004149463","duns":"676446492","firm":"DIVI'S LABORATORIES LIMITED","registrant":"DIVI'S LABORATORIES LIMITED","parent":"Divi's Laboratories","ticker":"DIVISLAB","addr":"Unit-2, Chippada Village, Annavaram Post Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh 531162, India (IND)","city":"Visakhapatnam District","state":"Andhra Pradesh","pin":"531162","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.93025,"lon":83.42304,"prec":"postcode","geo":"531162, Bheemunipatnam, Visakhapatnam, Andhra Pradesh, India","status":2,"alerts":[{"alert":"66-79","list":"red","since":"10/13/2022","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","charges":[{"code":"55","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/28/2021"},{"code":"56","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Antibiotics (Human/Animal)","published":"10/28/2021"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"61","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"62","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"63","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"64","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"65","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"66","notes":"All Drug and Drug Products; DWPE Date; 08/29/2016","product":"Human and Animal Drugs","published":"10/28/2021"}],"firm_as_published":"Divis Pharmaceuticals Private Limited","address_as_published":"7 - 1 - 77 E 1 303 Divi Towers , Hyderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","match":"token"}],"letters":[],"events":[{"d":"2022-10-13","k":"alert","t":"Listed on import alert 66-79","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2022-05-26","k":"charge","t":"66-79 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":""},{"d":"2021-10-28","k":"charge","t":"66-79 charge 55 — Pharm Necess & Ctnr For Drug/Bio","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 56 — Antibiotics (Human/Animal)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 60 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 61 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 62 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 63 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 64 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 65 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 66 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 08/29/2016"}],"first":"2021-10-28","last":"2022-10-13","sibs":["3003131136"],"colo":[]},{"id":"3030127492","fei":"3030127492","duns":"813835054","firm":"LAURUS SYNTHESIS PRIVATE LIMITED","registrant":"LAURUS SYNTHESIS PRIVATE LIMITED","parent":"Laurus Labs","ticker":"LAURUSLABS","addr":"Unit-2, Plot No. 18A1, APSEZ De-Notified Area, Gurajapalem Village, Rambilli Mandal, Anakapalli, Andhra Pradesh 531011, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011524794"],"colo":["3012160303","3026032363","3023346708","3011538548","3015709928","3013629262","3014255847","3020444708","3030613318","3026297382","3013580138","3021487911"]},{"id":"3015392060","fei":"3015392060","duns":"675485014","firm":"LUPIN LIMITED","registrant":"LUPIN LIMITED","parent":"Lupin","ticker":"LUPIN","addr":"Unit-2, Plot No. 6B, Sector - 17, Special Economic Zone, Mihan, Nagpur, Maharashtra 441108, India (IND)","city":"Nagpur","state":"Maharashtra","pin":"441108","ops":["MANUFACTURE","PACK"],"expires":"12/31/2026","lat":20.96447,"lon":79.01865,"prec":"postcode","geo":"441108, Nagpur Rural Taluka, Nagpur, Maharashtra, India","status":1,"alerts":[],"letters":[{"date":"2021-06-11T04:00:00Z","posted":"2021-06-29T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Office of Pharmaceutical Quality Operations Division I","response":"","closeout":"04/19/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","company_as_published":"Novel Laboratories, Inc. d.b.a LUPIN","match":"token"},{"date":"2022-09-27T04:00:00Z","posted":"2022-11-01T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","company_as_published":"Lupin Limited","match":"exact"}],"events":[{"d":"2022-09-27","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-06-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","x":"Office of Pharmaceutical Quality Operations Division I"}],"first":"2021-06-11","last":"2022-09-27","sibs":["3004995645","3010977634","3004819820","3002807510","3002807512","3002807511","3009843207","3009831799","3007756473","3007549629","3009107538"],"colo":[]},{"id":"3007549629","fei":"3007549629","duns":"863645527","firm":"LUPIN LIMITED","registrant":"LUPIN LIMITED","parent":"Lupin","ticker":"LUPIN","addr":"Unit-2, Plot No. M-2 and M-2-A, Special Economic Zone Phase II, Misc. Zone, Apparel Park, Dist. Dhar, Pithampur, Madhya Pradesh 454775, India (IND)","city":"Pithampur","state":"Madhya Pradesh","pin":"454775","ops":["MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2021-06-11T04:00:00Z","posted":"2021-06-29T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Office of Pharmaceutical Quality Operations Division I","response":"","closeout":"04/19/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","company_as_published":"Novel Laboratories, Inc. d.b.a LUPIN","match":"token"},{"date":"2022-09-27T04:00:00Z","posted":"2022-11-01T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","company_as_published":"Lupin Limited","match":"exact"}],"events":[{"d":"2022-09-27","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-06-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","x":"Office of Pharmaceutical Quality Operations Division I"}],"first":"2021-06-11","last":"2022-09-27","sibs":["3004995645","3010977634","3004819820","3002807510","3002807512","3002807511","3009843207","3009831799","3007756473","3015392060","3009107538"],"colo":["3010453141","3007574780","3016480976","3006456888","3008565058","3005259207","3008581988","3005594847","3038913994","3016268582","3014281041","3008861587"]},{"id":"3009107538","fei":"3009107538","duns":"650595213","firm":"LUPIN LIMITED","registrant":"LUPIN LIMITED","parent":"Lupin","ticker":"LUPIN","addr":"Unit-3, Plot No. M-1 and M-3-A, Special Economic Zone, Phase - II, Misc. Zone, Apparel Park, Dist. Dhar, Pithampur, Madhya Pradesh 454775, India (IND)","city":"Pithampur","state":"Madhya Pradesh","pin":"454775","ops":["MANUFACTURE","PACK"],"expires":"12/31/2026","lat":22.60952,"lon":75.67966,"prec":"postcode","geo":"454775, Pitampur, Pithampur Tahsil, Dhar, Madhya Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2021-06-11T04:00:00Z","posted":"2021-06-29T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Office of Pharmaceutical Quality Operations Division I","response":"","closeout":"04/19/2023","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","company_as_published":"Novel Laboratories, Inc. d.b.a LUPIN","match":"token"},{"date":"2022-09-27T04:00:00Z","posted":"2022-11-01T13:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","company_as_published":"Lupin Limited","match":"exact"}],"events":[{"d":"2022-09-27","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lupin-limited-633703-09272022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2021-06-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/novel-laboratories-inc-dba-lupin-613385-06112021","x":"Office of Pharmaceutical Quality Operations Division I"}],"first":"2021-06-11","last":"2022-09-27","sibs":["3004995645","3010977634","3004819820","3002807510","3002807512","3002807511","3009843207","3009831799","3007756473","3015392060","3007549629"],"colo":["3010453141","3007574780","3016480976","3006456888","3008565058","3005259207","3008581988","3005594847","3038913994","3016268582","3014281041","3008861587"]},{"id":"3011255967","fei":"3011255967","duns":"878100017","firm":"APL HEALTHCARE LIMITED","registrant":"APL HEALTHCARE LIMITED","parent":null,"ticker":null,"addr":"Unit-3, Sy. No: 410/P, 411/P and 458/P, Plot No. S-1/B, Pharma SEZ, TSIIC, Polepally (Village), Jadcherla (Mandal), Mahabubnagar (District), Mahabubnagar, Telangana 509302, India (IND)","city":"Mahabubnagar","state":"Telangana","pin":"509302","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":16.74925,"lon":77.99616,"prec":"tail3","geo":"State Bank of India, NH167, NEW TOWN, Mahbubnagar, Mahabubnagar_Urban mandal, Mahabubnagar, Telangana, 509001, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011895410"],"colo":["3032546867","3011905047","3007373532"]},{"id":"3042223406","fei":"3042223406","duns":"650616035","firm":"Metrochem API Private Limited","registrant":"Metrochem API Private Limited","parent":null,"ticker":null,"addr":"Unit-B, Sy No. 530 & 534, Temple Road, Bonthapally Village, Gummadidala Mandal,, Sangareddy, Telangana 502313, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502313","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3014289163","3007800884"],"colo":["3009996280","3014539030","3003723146","3029798246","3006744199","3032314066","3012234942","3013944676","3007164063","3003510514","3003289270","3007931994"]},{"id":"3007800884","fei":"3007800884","duns":"915896858","firm":"METROCHEM API PRIVATE LIMITED","registrant":"METROCHEM API PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Unit-C, Plot No 3 & 4, Survey No 42, Alinagar Jinnaram Mandal, Chetlapotharam Revenue Village, Sangareddy, Telangana 502319, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502319","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3014289163","3042223406"],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338"]},{"id":"3004126703","fei":"3004126703","duns":"916708337","firm":"Concord Biotech Limited","registrant":"Concord Biotech Limited","parent":"Concord Biotech","ticker":"CONCORDBIO","addr":"Unit-I, 1482-1486, Trasad Road, Dholka, Ahmedabad, Gujarat 382225, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382225","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":22.72227,"lon":72.45136,"prec":"postcode","geo":"382225, Dholka Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2022-01-06T05:00:00Z","posted":"2022-01-25T14:20:00Z","subject":"Foreign Supplier Verification Program (FSVP)","office":"Division of West Coast Imports","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/concord-farms-inc-619065-01062022","company_as_published":"Concord Farms, Inc.","match":"token"}],"events":[{"d":"2022-01-06","k":"letter","t":"Foreign Supplier Verification Program (FSVP)","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/concord-farms-inc-619065-01062022","x":"Division of West Coast Imports"}],"first":"2022-01-06","last":"2022-01-06","sibs":["3020052335","3012520698"],"colo":["3007684569"]},{"id":"3026048557","fei":"3026048557","duns":"644169402","firm":"Anthea Pharma Private Limited","registrant":"Abhinav Gorukanti","parent":null,"ticker":null,"addr":"Unit-I, Plot No. 290 and 290 A, SY. No. 183 and 219, Phase III IDA, Pashamylaram Village. Patancheru Mandal, Sangareddy District., Sangareddy, Telengana 502307, India (IND)","city":"Sangareddy","state":null,"pin":"502307","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167"]},{"id":"3012889818","fei":"3012889818","duns":"871678043","firm":"A. R. LIFE SCIENCES PRIVATE LIMITED","registrant":"A.R. LIFESCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Unit-I, Plot No. 338, Sri Venkateswara Co-Operative Industrial Estate, Jeedimetla, Quthbullapur, Medchal - Malkajgiri District, Hyderabad, Telangana 500055, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500055","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3017165755","3034412574"],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869"]},{"id":"3003289270","fei":"3003289270","duns":"675596335","firm":"NEULAND LABORATORIES LIMITED","registrant":"Neuland Laboratories Inc","parent":"Neuland Laboratories","ticker":"NEULANDLAB","addr":"Unit-I, SY. No. 291, 346P, 347, 348P, 473, 474, 490/2, Veerabhadraswamy Temple Road, Domadugu Village, Bonthapally Village, Gummadidala Mandal,, Sangareddy District, Telangana State 502313, India (IND)","city":"Sangareddy District","state":"Telangana","pin":"502313","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008765255","3003309323"],"colo":["3009996280","3014539030","3003723146","3029798246","3006744199","3032314066","3012234942","3013944676","3007164063","3003510514","3042223406","3007931994"]},{"id":"3004378446","fei":"3004378446","duns":"650435873","firm":"Hetero Labs Limited","registrant":"Hetero Labs Limited","parent":"Hetero (unlisted)","ticker":null,"addr":"Unit-I, Survey No. 10, I.D.A., Gaddapotharam (Village), Jinnaram (Mandal), Sangareddy, Telangana 502319, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502319","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3022837118","3005406526","3011002833","3009093782","3008307735","3008294355"],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338"]},{"id":"3007931994","fei":"3007931994","duns":"565226017","firm":"FLEMING LABORATORIES LIMITED","registrant":"FLEMING LABORATORIES LIMITED","parent":null,"ticker":null,"addr":"Unit-I, Survey No. 270, Nawabpet Village, Shivampet Mandal,, Medak, Telangana 502313, India (IND)","city":"Medak","state":"Telangana","pin":"502313","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"10/20/2017","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/20/2017"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"10/20/2017"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"}],"firm_as_published":"Fleming Laboratories Limited","address_as_published":"Survey No 270; Nawabpet Village , Shivampet Mandal , Medak district, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"04/11/2011","notes":"All Drug Products","charges":[{"code":"55","notes":"All Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/20/2019"},{"code":"56","notes":"All Drug Products","product":"Antibiotics (Human/Animal)","published":"04/11/2011"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"61","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"62","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"63","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"64","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"65","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"66","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"}],"firm_as_published":"Fleming Laboratories Limited","address_as_published":"Plot No , 48 Temple Rock Enclave; Tarbund Road , Secunderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2019-12-20","k":"charge","t":"66-40 charge 55 — Pharm Necess & Ctnr For Drug/Bio","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 60 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 61 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 62 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 63 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 64 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 65 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 66 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2017-10-20","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"},{"d":"2011-04-11","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"}],"first":"2011-04-11","last":"2022-05-26","sibs":["3043148873","3018566556"],"colo":["3009996280","3014539030","3003723146","3029798246","3006744199","3032314066","3012234942","3013944676","3007164063","3003510514","3042223406","3003289270"]},{"id":"3004021253","fei":"3004021253","duns":"918917647","firm":"Apitoria Pharma Private Limited","registrant":"Apitoria Pharma Private Limited","parent":null,"ticker":null,"addr":"Unit-I, Survey No. 379, 385, 386, 388 to 396 Borpatla Village, Hathnoora Mandal, Sangareddy, Telangana 502296, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502296","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.68077,"lon":78.19935,"prec":"postcode","geo":"502296, Hathnoora mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004086884","3006370489","3004611182","3004051616","3014477031","3007698192"],"colo":["3011766778","3004590215"]},{"id":"3004641543","fei":"3004641543","duns":"650443851","firm":"Saraca Laboratories Limited","registrant":"Saraca Laboratories Limited","parent":null,"ticker":null,"addr":"Unit-I, Survey No: 10, Gaddapotharam (Village), Jinnaram Mandal, Sangareddy, Telangana 502319, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502319","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338"]},{"id":"3031580787","fei":"3031580787","duns":"756049253","firm":"TEENA BIO LABS PRIVATE LIMITED","registrant":"TEENA BIO LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Unit-II, Car Expert Showroom, Plot No. 268 Panchkula Industrial Area Phase 1, Panchkula,  134113, India (IND)","city":"Panchkula","state":null,"pin":"134113","ops":["ANALYSIS"],"expires":"12/31/2026","lat":30.68484,"lon":76.84167,"prec":"postcode","geo":"134113, Sector 15, Panchkula, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008569405"],"colo":["3008465427"]},{"id":"3018566556","fei":"3018566556","duns":"676048917","firm":"Fleming Laboratories Limited","registrant":"Fleming Laboratories Limited","parent":null,"ticker":null,"addr":"Unit-II, Plot No. 152 & 160 Phase-V IDA, Jeedimetla, Hyderabad, Telangana 500055, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500055","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"10/20/2017","notes":"All Drug and Drug Products","charges":[{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/20/2017"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"10/20/2017"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"10/20/2017"}],"firm_as_published":"Fleming Laboratories Limited","address_as_published":"Survey No 270; Nawabpet Village , Shivampet Mandal , Medak district, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"},{"alert":"66-40","list":"red","since":"04/11/2011","notes":"All Drug Products","charges":[{"code":"55","notes":"All Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"12/20/2019"},{"code":"56","notes":"All Drug Products","product":"Antibiotics (Human/Animal)","published":"04/11/2011"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"61","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"62","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"63","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"64","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"65","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"},{"code":"66","notes":"All Drug Products","product":"Human and Animal Drugs","published":"12/20/2019"}],"firm_as_published":"Fleming Laboratories Limited","address_as_published":"Plot No , 48 Temple Rock Enclave; Tarbund Road , Secunderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2019-12-20","k":"charge","t":"66-40 charge 55 — Pharm Necess & Ctnr For Drug/Bio","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 60 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 61 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 62 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 63 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 64 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 65 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2019-12-20","k":"charge","t":"66-40 charge 66 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"},{"d":"2017-10-20","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products"},{"d":"2011-04-11","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products"}],"first":"2011-04-11","last":"2022-05-26","sibs":["3043148873","3007931994"],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869"]},{"id":"3004602077","fei":"3004602077","duns":"915853004","firm":"Sai Life Sciences Limited","registrant":"Sai Life Sciences Limited","parent":"Sai Life Sciences","ticker":"SAILIFE","addr":"Unit-II, Plot No. DS-7, DS-4 and DS-16, IKP Knowledge Park, Genome Valley, Turkapally (V), Shamirpet (M), Medchal-Malkajgiri Dt., Hyderabad, Telangana 500078, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500078","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.58696,"lon":78.55137,"prec":"postcode","geo":"500078, Shamirpet mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3027037264","3006398900","3005301950"],"colo":["3011062091","3046312775","3025926685","3012071812","3038847754","3012796281","3008377265"]},{"id":"3003971663","fei":"3003971663","duns":"650460954","firm":"SMS Pharmaceuticals Limited","registrant":"SMS Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Unit-II, Plot No.24&24B and 36&37, S.V.Co-Operative Industrial Estate, Bachupally, Medchal-Malkajgiri District, Hyderabad, Telangana 500090, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500090","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":17.53062,"lon":78.38101,"prec":"postcode","geo":"500090, Bachupally mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3014615000","3008654585"],"colo":["3014250111","3026584977","3013593602","3013758337","3008569405","3013580504","3027524740","3017981159","3002949099","3009483004","3004021229","3004446312"]},{"id":"3017165755","fei":"3017165755","duns":"675467071","firm":"A.R. Life Sciences Private Limited","registrant":"A.R. Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Unit-II, Plot No.33, Sri Venkateswara Co-Operative Industrial Estate, Jeedimetla, Quthbullapur, Medchal - Malkajgiri District, Hyderabad, Telangana 500055, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500055","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.51679,"lon":78.43521,"prec":"postcode","geo":"500055, Ward 125 Gajularamaram, Greater Hyderabad Municipal Corporation North Zone, Hyderabad, Quthbullapur mandal, Medchal–Malkajgiri, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012889818","3034412574"],"colo":["3003937580","3037699325","3003447972","3005000147","3010836438","3001329340","3002093078","3003649250","3006590829","3002806664","3006251127","3001319869"]},{"id":"3010634351","fei":"3010634351","duns":"854128517","firm":"Synergene Active Ingredients Private Limited","registrant":"Synergene Active Ingredients Private Limited","parent":null,"ticker":null,"addr":"Unit-II, Plot No.59-D, Jawaharlal Nehru Pharma City, Parawada (V&M), Anakapalli District, Visakhapatnam, Anakapalli, Andhra Pradesh 531021, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531021","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163"]},{"id":"3003309323","fei":"3003309323","duns":"862346285","firm":"NEULAND LABORATORIES LIMITED","registrant":"Neuland Laboratories Inc","parent":"Neuland Laboratories","ticker":"NEULANDLAB","addr":"Unit-II, Plot No.92-94, 257-259, I.D.A Pashamylaram, Pashamylaram Village, Patancheru Mandal, Sangareddy, Telangana State 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3008765255","3003289270"],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167"]},{"id":"3004086884","fei":"3004086884","duns":"918917662","firm":"Apitoria Pharma Private Limited","registrant":"Apitoria Pharma Private Limited","parent":null,"ticker":null,"addr":"Unit-II, Survey No. 10 & 13, Gaddapotharam Village IDA- Kazipally, Jinnaram Mandal, Sangareddy, Telangana 502319, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502319","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.53598,"lon":78.26556,"prec":"postcode","geo":"502319, Ward 113 Patancheruvu, Greater Hyderabad Municipal Corporation West Zone, Hyderabad, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004021253","3006370489","3004611182","3004051616","3014477031","3007698192"],"colo":["3043512610","3003945855","3018005839","3012363567","3010770804","3011960469","3047392863","3020983417","3009103626","3008154209","3015218020","3009261338"]},{"id":"3030640551","fei":"3030640551","duns":"955457149","firm":"TAGOOR LABORATORIES PRIVATE LIMITED","registrant":"TAGOOR LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Unit-II, Sy No 32, Tupakulagudem (Village) Pochavaram Panchayt, Tallapudi (Mandal), East Godavari, Andhra Pradesh 531341, India (IND)","city":"East Godavari","state":"Andhra Pradesh","pin":"531341","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.1348,"lon":81.66283,"prec":"tail3","geo":"Mandal Agriculture office, Tallapudi, NH365BB, Chintalapudi Lift irrigation scheme, Tadipudi, Tallapudi, West Godavari, Andhra Pradesh, 534341, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3016446284","3025582980"],"colo":[]},{"id":"3008656542","fei":"3008656542","duns":"650534907","firm":"MSN Laboratories Private Limited","registrant":"MSN Laboratories Private Limited","parent":"MSN Laboratories (unlisted)","ticker":null,"addr":"Unit-II, Sy. No. 50, 53, 53/A, 54 & 54/A, Kardanur (Village), Patancheru (Mandal),, Sangareddy District, Telangana 502300, India (IND)","city":"Sangareddy District","state":"Telangana","pin":"502300","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.50828,"lon":78.24806,"prec":"postcode","geo":"502300, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011033544","3019516576","3005075182","3005254981","3035592613","3023132203"],"colo":["3039358445"]},{"id":"3011543392","fei":"3011543392","duns":"650810141","firm":"MSN LIFE SCIENCES PRIVATE LIMITED","registrant":"MSN Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Unit-II, Sy.No. * Parts of 454, 455, 457, 458 & 459, Chandampet (Village), Shankarampet-R (Mandal), Medak District, Telangana 502255, India (IND)","city":"Medak District","state":"Telangana","pin":"502255","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.96928,"lon":78.43563,"prec":"postcode","geo":"502255, Shankarampet_R mandal, Medak, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3014775167"],"colo":[]},{"id":"3030599291","fei":"3030599291","duns":"932534396","firm":"MEGHMANI LLP","registrant":"MEGHMANI LLP","parent":null,"ticker":null,"addr":"Unit-III, Plot No : D-2/CH-5, GIDC, Dahej-II, Tal-Vagra, Dist-Bharuch, BHARUCH, Dahej 392130, India (IND)","city":"BHARUCH","state":null,"pin":"392130","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":21.71286,"lon":72.61625,"prec":"postcode","geo":"392130, Vagra Taluka, Bharuch, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3005404478"],"colo":["3043800366","3040332349","3018972378","3012664809","3010027135","3014919100","3010228235","3007514214","3005737619"]},{"id":"3025582980","fei":"3025582980","duns":"955457151","firm":"TAGOOR LABORATORIES PRIVATE LIMITED","registrant":"TAGOOR LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Unit-III, Plot No. 12, JN Pharma City, Parawada, Anakapalli, Visakhapatnam, Andhra Pradesh 531021, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531021","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3016446284","3030640551"],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163"]},{"id":"3010619401","fei":"3010619401","duns":"650613446","firm":"SHILPA MEDICARE LIMITED","registrant":"SHILPA MEDICARE LIMITED","parent":"Shilpa Medicare","ticker":"SHILPAMED","addr":"Unit-III, Plot No. 29 A5, 4th Phase, Avverhalli – Sompura Industrial Area, Dabaspet, Bengaluru, Karnataka 562111, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"562111","ops":["ANALYSIS"],"expires":"12/31/2026","lat":13.23559,"lon":77.2605,"prec":"postcode","geo":"562111, Pemmanahalli, Nelamangala taluk, Bengaluru North, Karnataka, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"02/16/2021","notes":"These products are excluded from DWPE:","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"01/14/2025"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"01/14/2025"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"01/14/2025"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"01/14/2025"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"01/14/2025"},{"code":"55","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Pharm Necess & Ctnr For Drug/Bio","published":"02/16/2021"},{"code":"56","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Antibiotics (Human/Animal)","published":"02/16/2021"},{"code":"58","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"61","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"62","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"63","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"64","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"65","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"66","notes":"All Drug and DrAll Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"}],"firm_as_published":"Shilpa Medicare Limited","address_as_published":"Plot No. S20 to S26, Pharmaceutical Formulations SEZ , TSIIC Green Industrial Park, Polepally (Village) , Jadcherla, Mahabubnagar District , Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products; These products are excluded from DWPE:"},{"d":"2021-02-16","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE:"}],"first":"2021-02-16","last":"2025-01-14","sibs":["3009876430","3018694237","3019773458"],"colo":["3009995739"]},{"id":"3010828439","fei":"3010828439","duns":"650739191","firm":"Honour Lab Limited","registrant":"Honour Lab Limited","parent":null,"ticker":null,"addr":"Unit-III, Plot No. 4, Hetero Infrastructure SEZ Limited, N. Narasapuram Village, Nakkapalli (Mandal), Anakapalli District, Andhra Pradesh 531081, India (IND)","city":"Anakapalli District","state":"Andhra Pradesh","pin":"531081","ops":["API MANUFACTURE","MANUFACTURE"],"expires":"12/31/2026","lat":17.40802,"lon":82.69548,"prec":"postcode","geo":"531081, Nakkapalle, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009996280","3011766778","3021257926"],"colo":["3011002833","3009225386","3009093782"]},{"id":"3016246945","fei":"3016246945","duns":"855532627","firm":"RAKSHIT DRUGS PRIVATE LIMITED","registrant":"RAKSHIT DRUGS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Unit-III, Plot No. 4, J.N.Pharma City, Thadi, Parawada,, Anakapalli, Andhra Pradesh 531021, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531021","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.62738,"lon":83.08471,"prec":"postcode","geo":"531021, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3021138307","3007083664","3014406503","3029445647","3011524794","3015447224","3022125340","3013656125","3008570863","3010823443","3012575874","3027357163"]},{"id":"3034412574","fei":"3034412574","duns":"738656239","firm":"A. R. LIFE SCIENCES PRIVATE LIMITED","registrant":"A. R. LIFE SCINCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Unit-III, Plot No.1B, APSEZ, De-Notifies Area, APIIC, Pudi (V), Rambilli (M), Atchuthapuram, Anakapalli District, Visakhapatnam, Andhra Pradesh 531011, India (IND)","city":"Visakhapatnam","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3012889818","3017165755"],"colo":["3012160303","3026032363","3023346708","3011538548","3015709928","3013629262","3014255847","3020444708","3030613318","3026297382","3013580138","3021487911"]},{"id":"3008461619","fei":"3008461619","duns":"650498244","firm":"EUGIA PHARMA SPECIALITIES LIMITED","registrant":"EUGIA Pharma Specialities Limited","parent":null,"ticker":null,"addr":"Unit-III, Plot No: 4, 34 to 40, 41P, 44 to 48, EPIP, TSIIC, IDA, Pashamylaram Village, Patancheru Mandal, Sangareddy, Telangana 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2024-08-15T04:00:00Z","posted":"2024-08-20T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-681905-08152024","company_as_published":"Eugia Pharma Specialities Limited","match":"exact"},{"date":"2026-08-13T04:00:00Z","posted":"2026-08-18T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-730469-08132026","company_as_published":"Eugia Pharma Specialities Limited","match":"exact"}],"events":[{"d":"2026-08-13","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-730469-08132026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-15","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-681905-08152024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-15","last":"2026-08-13","sibs":["3009883410","3011960448"],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167"]},{"id":"3005301950","fei":"3005301950","duns":"858366185","firm":"Sai Life Sciences Limited","registrant":"Sai Life Sciences Limited","parent":"Sai Life Sciences","ticker":"SAILIFE","addr":"Unit-III, Survey No. 296/7/3 & 4, IDA Bollaram, Jinnaram Mandal, Sangareddy District, Hyderabad, Telangana 502325, India (IND)","city":"Hyderabad","state":"Telangana","pin":"502325","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.55317,"lon":78.34216,"prec":"postcode","geo":"502325, Jinnaram mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3027037264","3006398900","3004602077"],"colo":["3017000602","3041729025","3008408466","3002806851","3007136165","3008479404","3009609117","3007720135","3005818804","3008932115"]},{"id":"3005403224","fei":"3005403224","duns":"650548766","firm":"Sri Krishna Pharmaceuticals Limited","registrant":"Sri Krishna Pharmaceuticals Limited","parent":null,"ticker":null,"addr":"Unit-III, Survey No. 57, Golkonda Kalan, Raikunta Village, Shamshabad Mandal,, R.R.District,, Telangana 501 218, India (IND)","city":"R.R.District","state":"Telangana","pin":null,"ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":18.33307,"lon":79.26546,"prec":"tail3","geo":"Shamshabad, shamshabad village, Shamshabad, Manakondur mandal, Karimnagar, Telangana, 505474, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"08/13/2015","notes":"All Drugs","charges":[{"code":"55","notes":"All Drugs","product":"Pharm Necess & Ctnr For Drug/Bio","published":"08/13/2015"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"10/02/2024"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"61","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"62","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"63","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"64","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"65","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"},{"code":"66","notes":"All Drugs","product":"Human and Animal Drugs","published":"08/13/2015"}],"firm_as_published":"Sri Krishna Pharmaceuticals Limited","address_as_published":"Unit Ii, Plot No:A-34,A-35, Ida Nacharam, Uppal (M), Medchal-Malkajgiri District , Hyderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2024-10-02","k":"charge","t":"66-40 charge 56 — Antibiotics (Human/Animal)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2015-08-13","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drugs"}],"first":"2015-08-13","last":"2024-10-02","sibs":["3005408438","3003723117"],"colo":[]},{"id":"3006370489","fei":"3006370489","duns":"918917667","firm":"Apitoria Pharma Private Limited","registrant":"Apitoria Pharma Private Limited","parent":null,"ticker":null,"addr":"Unit-III, Survey No.: 374, Gundla Machnur Village Hathnoora Mandal, Sangareddy, Telangana 502296, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502296","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.68077,"lon":78.19935,"prec":"postcode","geo":"502296, Hathnoora mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004021253","3004086884","3004611182","3004051616","3014477031","3007698192"],"colo":["3011766778","3004590215"]},{"id":"3023132203","fei":"3023132203","duns":"738690985","firm":"MSN Laboratories Private Limited","registrant":"MSN Laboratories Private Limited","parent":"MSN Laboratories (unlisted)","ticker":null,"addr":"Unit-III, Sy. No. 111/E & 111/EE, Cheriyal (Village), Kandi (Mandal),, Sangareddy District, Telangana 502285, India (IND)","city":"Sangareddy District","state":"Telangana","pin":"502285","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.58273,"lon":78.11658,"prec":"postcode","geo":"502285, Kandi mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011033544","3019516576","3005075182","3005254981","3035592613","3008656542"],"colo":[]},{"id":"3004021229","fei":"3004021229","duns":"918917642","firm":"Aurobindo Pharma Limited","registrant":"Aurobindo Pharma Limited","parent":"Aurobindo Pharma","ticker":"AUROPHARMA","addr":"Unit-III, Sy. No.313 & 314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District, Medchal, Telangana 500090, India (IND)","city":"Medchal","state":"Telangana","pin":"500090","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":17.53062,"lon":78.38101,"prec":"postcode","geo":"500090, Bachupally mandal, Medchal–Malkajgiri, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2022-01-12T05:00:00Z","posted":"2022-01-25T14:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"11/17/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharmaceutical-limited-618091-01122022","company_as_published":"Aurobindo Pharmaceutical Limited","match":"token"}],"events":[{"d":"2022-01-12","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharmaceutical-limited-618091-01122022","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2022-01-12","last":"2022-01-12","sibs":["3004021263","3007373532","3004446312"],"colo":["3014250111","3026584977","3013593602","3013758337","3008569405","3013580504","3027524740","3017981159","3002949099","3009483004","3003971663"]},{"id":"3014775167","fei":"3014775167","duns":"675480074","firm":"MSN Life Sciences Private Limited","registrant":"MSN Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Unit-III, Sy.No. 544, 545 & 546, Bhiknoor (Village), Bhiknoor (Mandal), Kamareddy District, Telangana 503101, India (IND)","city":"Kamareddy District","state":"Telangana","pin":"503101","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":18.18835,"lon":78.39952,"prec":"postcode","geo":"503101, Bhiknoor mandal, Kamareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011543392"],"colo":[]},{"id":"3009083745","fei":"3009083745","duns":"916512493","firm":"Mankind Pharma Limited","registrant":"Mankind Pharma Limited","parent":"Mankind Pharma","ticker":"MANKIND","addr":"Unit-III, Village Kunja, Rampur Ghat Road, Opp. Dental College, Paonta Sahib, Sirmaur, Himachal Pradesh 173025, India (IND)","city":"Sirmaur","state":"Himachal Pradesh","pin":"173025","ops":["ANALYSIS","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":30.45461,"lon":77.64089,"prec":"postcode","geo":"173025, Paonta Sahib, Sirmaur, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3013913573","3014150265"],"colo":[]},{"id":"3006583291","fei":"3006583291","duns":"650376275","firm":"Granules India Limited","registrant":"Granules India Ltd","parent":"Granules India","ticker":"GRANULES","addr":"Unit-IV, Plot No. 8, Jawaharlal Nehru Pharma City Tadi Village, Parawada Mandal, Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE","LABEL","PACK"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2025-02-26T05:00:00Z","posted":"2025-03-04T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/granules-india-limited-697115-02262025","company_as_published":"Granules India Limited","match":"exact"}],"events":[{"d":"2025-02-26","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/granules-india-limited-697115-02262025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-02-26","last":"2025-02-26","sibs":["3003723146","3001319869","3004097901","3012884557"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3011895410","fei":"3011895410","duns":"650918514","firm":"APL HEALTHCARE LIMITED","registrant":"Aurobindo Pharma Limited","parent":"Aurobindo Pharma","ticker":"AUROPHARMA","addr":"Unit-IV, Plot No.16, 16 – A, APIIC, M.P.Sez, Menakuru Village, Naidupeta Mandal, Tirupati District, Tirupati, Andhra Pradesh 524421, India (IND)","city":"Tirupati","state":"Andhra Pradesh","pin":"524421","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":13.5527,"lon":80.01441,"prec":"tail3","geo":"Kobelco Construction Equipment India Private Limited, Siddama Agraharam, Varadaiahpalem, Tirupati, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3011255967"],"colo":["3048757914"]},{"id":"3009488373","fei":"3009488373","duns":"916011413","firm":"Hetero Drugs Limited","registrant":"Hetero Drugs Limited","parent":"Hetero (unlisted)","ticker":null,"addr":"Unit-IV, Survey No. 599, Temple Road, Bonthapally Village, Gummadidala Mandal,, Sangareddy district, Telangana 502313, India (IND)","city":"Sangareddy district","state":"Telangana","pin":"502313","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":17.7343,"lon":78.30687,"prec":"postcode","geo":"502313, Narsapur mandal, Medak, Telangana, India","status":2,"alerts":[{"alert":"66-66","list":"red","since":"09/30/2009","notes":"10/3/2000","charges":[{"code":"62 O - S 27","notes":"","product":"Doxazosin Mesylate (Anti-Hypertensive - Part II), Active Pharm Ingred/Chems for Further Manuf","published":"03/29/2019"}],"firm_as_published":"Hetero Drugs Ltd","address_as_published":"7 1 Hetero House # 8 - 3 - 166 , Hyderabad, Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"}],"letters":[],"events":[{"d":"2019-03-29","k":"charge","t":"66-66 charge 62 O - S 27 — Doxazosin Mesylate (Anti-Hypertensive - Part II), Active Pharm Ingred/Chems for Further Manuf","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":"10/3/2000"}],"first":"2009-09-30","last":"2019-03-29","sibs":["3009307611","3003510514","3009225386"],"colo":["3009996280","3014539030","3003723146","3029798246","3006744199","3032314066","3012234942","3013944676","3007164063","3042223406","3003289270","3007931994"]},{"id":"3004611182","fei":"3004611182","duns":"918917626","firm":"Apitoria Pharma Private Limited","registrant":"Apitoria Pharma Private Limited","parent":null,"ticker":null,"addr":"Unit-IV, Sy.No's.52,53,58,59,61 to 78,127&128, Pydibhimavaram V & Sy.No 1,2,4to9,11,29,30,31&32, Chittivalasa V, Ranasthalam Mandal, Srikakulam, Andhra Pradesh 532409, India (IND)","city":"Srikakulam","state":"Andhra Pradesh","pin":"532409","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":18.15105,"lon":83.65614,"prec":"postcode","geo":"532409, Ranastalam, Srikakulam, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004021253","3004086884","3006370489","3004051616","3014477031","3007698192"],"colo":["3002949085","3005336882","3011171511","3009193040","3012414462","3008430469","3013791804","3012390454","3030708811"]},{"id":"3021257926","fei":"3021257926","duns":"914423340","firm":"Honour Lab Limited","registrant":"Honour Lab Limited","parent":null,"ticker":null,"addr":"Unit-IX, Survey No. 332, 335, 336 & 341, Veliminedu Village, Chityal Mandal, Nalgonda, Telangana 508114, India (IND)","city":"Nalgonda","state":"Telangana","pin":"508114","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.21132,"lon":79.07301,"prec":"postcode","geo":"508114, Chityal mandal, Nalgonda, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3009996280","3011766778","3010828439"],"colo":["3033870708","3014002307","3009250999","3042853625","3012753303","3032871131","3012725393"]},{"id":"3012884557","fei":"3012884557","duns":"860316511","firm":"Granules India Limited","registrant":"Granules India Ltd","parent":"Granules India","ticker":"GRANULES","addr":"Unit-V, Plot No. 30, Jawaharlal Nehru Pharma City Parawada (M), Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2025-02-26T05:00:00Z","posted":"2025-03-04T05:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/granules-india-limited-697115-02262025","company_as_published":"Granules India Limited","match":"exact"}],"events":[{"d":"2025-02-26","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/granules-india-limited-697115-02262025","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2025-02-26","last":"2025-02-26","sibs":["3003723146","3001319869","3004097901","3006583291"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3004051616","fei":"3004051616","duns":"918917634","firm":"Apitoria Pharma Private Limited","registrant":"Apitoria Pharma Private Limited","parent":null,"ticker":null,"addr":"Unit-V, Plot No. 68-70,73-91,95,96,260,261 I.D.A., Pashamylaram Village, Patancheru Mandal, Sangareddy, Telangana 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004021253","3004086884","3006370489","3004611182","3014477031","3007698192"],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167"]},{"id":"3018694237","fei":"3018694237","duns":"854193706","firm":"SHILPA MEDICARE LIMITED","registrant":"SHILPA MEDICARE LIMITED","parent":"Shilpa Medicare","ticker":"SHILPAMED","addr":"Unit-VI, Plot No. 29-A5, 4th Phase, Avverhalli – Sompura Industrial Area, Dabaspet, Bengaluru, Karnataka 562111, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"562111","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":13.23559,"lon":77.2605,"prec":"postcode","geo":"562111, Pemmanahalli, Nelamangala taluk, Bengaluru North, Karnataka, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"02/16/2021","notes":"These products are excluded from DWPE:","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"01/14/2025"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"01/14/2025"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"01/14/2025"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"01/14/2025"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"01/14/2025"},{"code":"55","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Pharm Necess & Ctnr For Drug/Bio","published":"02/16/2021"},{"code":"56","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Antibiotics (Human/Animal)","published":"02/16/2021"},{"code":"58","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"61","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"62","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"63","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"64","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"65","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"66","notes":"All Drug and DrAll Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"}],"firm_as_published":"Shilpa Medicare Limited","address_as_published":"Plot No. S20 to S26, Pharmaceutical Formulations SEZ , TSIIC Green Industrial Park, Polepally (Village) , Jadcherla, Mahabubnagar District , Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products; These products are excluded from DWPE:"},{"d":"2021-02-16","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE:"}],"first":"2021-02-16","last":"2025-01-14","sibs":["3009876430","3010619401","3019773458"],"colo":["3009995739"]},{"id":"3014477031","fei":"3014477031","duns":"675474155","firm":"Apitoria Pharma Private Limited","registrant":"Apitoria Pharma Private Limited","parent":null,"ticker":null,"addr":"Unit-VI, Plot No.: 17, E-Bonangi Village, Jawaharlal Nehru Pharma City, Parawada (M), Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004021253","3004086884","3006370489","3004611182","3004051616","3007698192"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3004021263","fei":"3004021263","duns":"918917639","firm":"Aurobindo Pharma Limited","registrant":"Aurobindo Pharma Limited","parent":"Aurobindo Pharma","ticker":"AUROPHARMA","addr":"Unit-VI, Sy. No.329/39 & 329/47, Chitkul Village, Patancheru Mandal, Sanga Reddy District, Sangareddy, Telangana 502307, India (IND)","city":"Sangareddy","state":"Telangana","pin":"502307","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":17.55088,"lon":78.21005,"prec":"postcode","geo":"502307, Patancheruvu mandal, Sangareddy, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2022-01-12T05:00:00Z","posted":"2022-01-25T14:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"11/17/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharmaceutical-limited-618091-01122022","company_as_published":"Aurobindo Pharmaceutical Limited","match":"token"}],"events":[{"d":"2022-01-12","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharmaceutical-limited-618091-01122022","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2022-01-12","last":"2022-01-12","sibs":["3004021229","3007373532","3004446312"],"colo":["3029943792","3039378398","3015216749","3004956855","3029929541","3013914542","3006165229","3038370049","3008800173","3008771562","1000623515","3009864167"]},{"id":"3019773458","fei":"3019773458","duns":"854248050","firm":"SHILPA MEDICARE LIMITED","registrant":"SHILPA MEDICARE LIMITED","parent":"Shilpa Medicare","ticker":"SHILPAMED","addr":"Unit-VII, 1st Floor, Plot No. 79, Survey No 125, IDA Mallapur, Nacharam, Uppal,, Hyderabad, Telangana 500076, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500076","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.43874,"lon":78.56145,"prec":"postcode","geo":"500076, Ward 6 Nacharam, Greater Hyderabad Municipal Corporation East Zone, Hyderabad, Uppal mandal, Medchal–Malkajgiri, Telangana, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"02/16/2021","notes":"These products are excluded from DWPE:","charges":[{"code":"54 - D","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","published":"01/14/2025"},{"code":"54 - E","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","published":"01/14/2025"},{"code":"54 - F","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","published":"01/14/2025"},{"code":"54 - G","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","published":"01/14/2025"},{"code":"54 - I","notes":"","product":"Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","published":"01/14/2025"},{"code":"55","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Pharm Necess & Ctnr For Drug/Bio","published":"02/16/2021"},{"code":"56","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Antibiotics (Human/Animal)","published":"02/16/2021"},{"code":"58","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"61","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"62","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"63","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"64","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"65","notes":"All Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"},{"code":"66","notes":"All Drug and DrAll Drug and Drug Products; These products are excluded from DWPE:","product":"Human and Animal Drugs","published":"02/16/2021"}],"firm_as_published":"Shilpa Medicare Limited","address_as_published":"Plot No. S20 to S26, Pharmaceutical Formulations SEZ , TSIIC Green Industrial Park, Polepally (Village) , Jadcherla, Mahabubnagar District , Telangana INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - D — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - E — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Human N/Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - F — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx 1 Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - G — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Hum Rx Comb Ingr","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2025-01-14","k":"charge","t":"66-40 charge 54 - I — Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human), Investigational","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug and Drug Products; These products are excluded from DWPE:"},{"d":"2021-02-16","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"These products are excluded from DWPE:"}],"first":"2021-02-16","last":"2025-01-14","sibs":["3009876430","3010619401","3018694237"],"colo":["3048143097","3003504071","3006493505","3011573185","3007308467","3005851210","3011823550","3008311641","3008768274","3024919921"]},{"id":"3007698192","fei":"3007698192","duns":"860120480","firm":"Apitoria Pharma Private Limited","registrant":"Silicon Life Sciences Private Limited","parent":null,"ticker":null,"addr":"Unit-VII, Plot No.: 41, Jawaharlal Nehru Pharma City Thanam Village, Parawada Mandal, Anakapalli, Andhra Pradesh 531019, India (IND)","city":"Anakapalli","state":"Andhra Pradesh","pin":"531019","ops":["ANALYSIS","API MANUFACTURE","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":17.68565,"lon":83.09746,"prec":"postcode","geo":"531019, Paravada, Anakapalli, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3004021253","3004086884","3006370489","3004611182","3004051616","3014477031"],"colo":["3045048982","3014738606","3008772334","3011747378","3008316085","3040483155","3030560746","3014527724","3015955297","3019200343","3008250894","3009822397"]},{"id":"3007373532","fei":"3007373532","duns":"650381903","firm":"Aurobindo Pharma Limited","registrant":"Aurobindo Pharma Limited","parent":"Aurobindo Pharma","ticker":"AUROPHARMA","addr":"Unit-VII, Sy No. 411/P, 425/P, 434/P, 435/P & 458/P, Plot S1 Part SEZ, TSIIC, Green Industrial Park, Polepally, Jedcherla Mandal, Mahabubnagar, Telangana 509302, India (IND)","city":"Mahabubnagar","state":"Telangana","pin":"509302","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":16.69657,"lon":77.95911,"prec":"tail2","geo":"Mahabubnagar, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2022-01-12T05:00:00Z","posted":"2022-01-25T14:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"11/17/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharmaceutical-limited-618091-01122022","company_as_published":"Aurobindo Pharmaceutical Limited","match":"token"}],"events":[{"d":"2022-01-12","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharmaceutical-limited-618091-01122022","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2022-01-12","last":"2022-01-12","sibs":["3004021229","3004021263","3004446312"],"colo":["3032546867","3011905047","3011255967"]},{"id":"3004446312","fei":"3004446312","duns":"918917683","firm":"Aurobindo Pharma Limited","registrant":"Aurobindo Pharma Limited","parent":"Aurobindo Pharma","ticker":"AUROPHARMA","addr":"Unit-XII, Sy.No.314, Bachupally, Bachupally Mandal, Medchal-Malkajgiri District, Medchal, Telangana 500090, India (IND)","city":"Medchal","state":"Telangana","pin":"500090","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":17.53062,"lon":78.38101,"prec":"postcode","geo":"500090, Bachupally mandal, Medchal–Malkajgiri, Telangana, India","status":1,"alerts":[],"letters":[{"date":"2022-01-12T05:00:00Z","posted":"2022-01-25T14:20:00Z","subject":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"11/17/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharmaceutical-limited-618091-01122022","company_as_published":"Aurobindo Pharmaceutical Limited","match":"token"}],"events":[{"d":"2022-01-12","k":"letter","t":"CGMP/Active Pharmaceutical Ingredient (API)/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aurobindo-pharmaceutical-limited-618091-01122022","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2022-01-12","last":"2022-01-12","sibs":["3004021229","3004021263","3007373532"],"colo":["3014250111","3026584977","3013593602","3013758337","3008569405","3013580504","3027524740","3017981159","3002949099","3009483004","3003971663"]},{"id":"3008282851","fei":"3008282851","duns":"650589448","firm":"Council of Scientific & Industrial Research","registrant":"Council of Scientific & Industrial Research","parent":null,"ticker":null,"addr":"Uppal Road, Tarnaka,, Hyderabad, Telangana 500007, India (IND)","city":"Hyderabad","state":"Telangana","pin":"500007","ops":["ANALYSIS"],"expires":"12/31/2026","lat":17.41766,"lon":78.53083,"prec":"postcode","geo":"500007, Hyderabad, Bahadurpura mandal, Hyderabad, Telangana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3003789475","fei":"3003789475","duns":"650049398","firm":"THE ANDHRA SUGARS LIMITED","registrant":"THE ANDHRA SUGARS LIMITED","parent":null,"ticker":null,"addr":"VENKATARAYAPURAM, WEST GODAVARI DISTRICT, TANUKU, ANDHRA PRADESH 534215, India (IND)","city":"TANUKU","state":"Andhra Pradesh","pin":"534215","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":16.73574,"lon":81.6734,"prec":"postcode","geo":"534215, Tanuku, West Godavari, Andhra Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3015793804","fei":"3015793804","duns":"876894109","firm":"ABRYL LABORATORIES PRIVATE LIMITED","registrant":"ABRYL LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"VILLAGE BHAGWANPUR, TEHSIL DERA BASSI, DISTRICT SAS NAGAR, PUNJAB 140507, India (IND)","city":"DISTRICT SAS NAGAR","state":"Punjab","pin":"140507","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":30.58076,"lon":76.85014,"prec":"postcode","geo":"140507, Dera Bassi Tahsil, Sahibzada Ajit Singh Nagar, Punjab, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005656140","3007147039","3005895238","3007577941"]},{"id":"3008250236","fei":"3008250236","duns":"675679359","firm":"Sentiss Pharma Private Limited","registrant":"SENTISS PHARMA PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Village - Khera Nihla Tehsil - Nalagarh, Solan, Himachal Pradesh 174101, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"174101","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":31.06505,"lon":76.69603,"prec":"postcode","geo":"174101, Nalagarh, Solan, Himachal Pradesh, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/20/2013","notes":"","charges":[{"code":"50","notes":"","product":"Color Additiv Food/Drug/Cosmetic","published":"06/20/2013"},{"code":"55","notes":"","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/20/2013"},{"code":"56","notes":"","product":"Antibiotics (Human/Animal)","published":"06/20/2013"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"","product":"Human and Animal Drugs","published":"06/20/2013"},{"code":"61","notes":"","product":"Human and Animal Drugs","published":"06/20/2013"},{"code":"62","notes":"","product":"Human and Animal Drugs","published":"06/20/2013"},{"code":"63","notes":"","product":"Human and Animal Drugs","published":"06/20/2013"},{"code":"64","notes":"","product":"Human and Animal Drugs","published":"06/20/2013"},{"code":"65","notes":"","product":"Human and Animal Drugs","published":"06/20/2013"},{"code":"66","notes":"","product":"Human and Animal Drugs","published":"06/20/2013"},{"code":"86","notes":"","product":"Ophthalmic","published":"06/20/2013"}],"firm_as_published":"Sentiss Pharma Private Ltd.","address_as_published":"Village Khera Nihla , Tehsil Nalargarh , District Solan, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[],"events":[{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2013-06-20","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""}],"first":"2013-06-20","last":"2022-05-26","sibs":[],"colo":["3046619098","3016859498","3013744962","3012112224","3031080212","3014210753","3010868532","3007517881"]},{"id":"3005895238","fei":"3005895238","duns":"918604344","firm":"SYNTHIMED LABS PRIVATE LIMITED","registrant":"SYNTHIMED LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Village Bhagwanpura, Barwala Road, Derabassi, Mohali, Punjab 140507, India (IND)","city":"Mohali","state":"Punjab","pin":"140507","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":30.58076,"lon":76.85014,"prec":"postcode","geo":"140507, Dera Bassi Tahsil, Sahibzada Ajit Singh Nagar, Punjab, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3005656140","3007147039","3015793804","3007577941"]},{"id":"3008176882","fei":"3008176882","duns":"737928559","firm":"Pure and Cure Healthcare Private Limited","registrant":"Pure and Cure Healthcare Private Limited","parent":null,"ticker":null,"addr":"Village Chachrauli, P.O. Jeoli, Tehsil-Derabassi, Distt. Sahibzada Ajit Singh Nagar, PB 140501, India (IND)","city":"Distt. Sahibzada Ajit Singh Nagar","state":null,"pin":"140501","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":30.4626,"lon":76.8182,"prec":"postcode","geo":"140501, Dera Bassi Tahsil, Sahibzada Ajit Singh Nagar, Punjab, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3024206690","3007577941"],"colo":["3027350682"]},{"id":"3017493887","fei":"3017493887","duns":"878533295","firm":"ASTONEA LABS PRIVATE LIMITED","registrant":"ASTONEA LABS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Village Haripur, Tehsil Raipurani, Near Mouli Police Station, Panchkula,  134204, India (IND)","city":"Panchkula","state":null,"pin":"134204","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":30.56803,"lon":77.03631,"prec":"postcode","geo":"134204, Raipur Rani, Panchkula, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3027350682","fei":"3027350682","duns":"853972315","firm":"Cadchem Laboratories Limited","registrant":"Cadchem Laboratories Limited","parent":null,"ticker":null,"addr":"Village Jaula Khurd, Tehsil Derabassi, District sahibzada Ajit Singh Nagar, Punjab 140501, India (IND)","city":"District sahibzada Ajit Singh Nagar","state":"Punjab","pin":"140501","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":30.4626,"lon":76.8182,"prec":"postcode","geo":"140501, Dera Bassi Tahsil, Sahibzada Ajit Singh Nagar, Punjab, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3008176882"]},{"id":"3005757050","fei":"3005757050","duns":"676115028","firm":"Glenmark Pharmaceuticals Limited","registrant":"Glenmark Pharmaceuticals Inc., USA","parent":"Glenmark Pharmaceuticals","ticker":"GLENMARK","addr":"Village Kishanpura Baddi Nalagarh Road, Baddi, Solan, Himachal Pradesh 173205, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"173205","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":30.94458,"lon":76.80677,"prec":"postcode","geo":"173205, Baddi, Solan, Himachal Pradesh, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"10/25/2022","notes":"All Drug Products;","charges":[{"code":"55","notes":"All Drug Products;","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/25/2022"},{"code":"56","notes":"All Drug Products;","product":"Antibiotics (Human/Animal)","published":"10/25/2022"},{"code":"58","notes":"All Drug Products;","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"10/25/2022"},{"code":"60","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"61","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"62","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"63","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"64","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"65","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"},{"code":"66","notes":"All Drug Products;","product":"Human and Animal Drugs","published":"10/25/2022"}],"firm_as_published":"Glenmark Pharmaceuticals Limited","address_as_published":"Village Kishanpura, Baddi Nalagarh Road , Baddi , Solan, Himachal Pradesh INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"exact"}],"letters":[{"date":"2022-11-22T05:00:00Z","posted":"2022-12-06T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-637314-11222022","company_as_published":"Glenmark Pharmaceuticals Limited","match":"exact"},{"date":"2025-07-11T04:00:00Z","posted":"2025-07-22T04:00:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-708270-07112025","company_as_published":"Glenmark Pharmaceuticals Limited","match":"exact"}],"events":[{"d":"2025-07-11","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-708270-07112025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2022-11-22","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/glenmark-pharmaceuticals-limited-637314-11222022","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2022-10-25","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"All Drug Products;"}],"first":"2022-10-25","last":"2025-07-11","sibs":["3004672766","3008565058","3009915929"],"colo":["3006370533","3013950309","3003897648","3006785414","3031304848","3007187282","3012536712","3018004432","3041778294","3005430968","3004738570"]},{"id":"3002807612","fei":"3002807612","duns":"916177632","firm":"Morepen Laboratories Limited","registrant":"Morepen Laboratories Limited","parent":null,"ticker":null,"addr":"Village Masulkhana, P.O. Parwanoo, Solan, Himachal Pradesh 173220, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"173220","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":30.83895,"lon":76.96579,"prec":"postcode","geo":"173220, Parwanoo, Kasauli, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3003897648","3006785414"],"colo":[]},{"id":"3005674618","fei":"3005674618","duns":"918459095","firm":"Vitalife Laboratories (A Division of Arch Pharmalabs Limited)","registrant":"Arch Pharmalabs Limited","parent":null,"ticker":null,"addr":"Village Pathreri Bilaspur Tauru Road, Gurugram, Haryana 122413, India (IND)","city":"Gurugram","state":"Haryana","pin":"122413","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":28.29572,"lon":76.86018,"prec":"postcode","geo":"122413, Farrukhnagar, Gurugram, Haryana, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3004711869","fei":"3004711869","duns":"677678548","firm":"Kopran Limited","registrant":"Kopran Limited","parent":null,"ticker":null,"addr":"Village Savroli, Khalapur, Raigad, Maharashtra 410202, India (IND)","city":"Raigad","state":"Maharashtra","pin":"410202","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":18.82813,"lon":73.29511,"prec":"postcode","geo":"410202, Khalapur Taluka, Raigad, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3006895982","fei":"3006895982","duns":"650369221","firm":"Jubilant Generics Limited","registrant":"JUBILANT GENERICS LIMITED","parent":null,"ticker":null,"addr":"Village Sikandarpur Bhainswal, Roorkee- Dehradun Highway, Bhagwanpur, Distt. Haridwar, Roorkee, Uttarakhand 247661, India (IND)","city":"Roorkee","state":"Uttarakhand","pin":"247661","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":29.97104,"lon":77.79879,"prec":"postcode","geo":"247661, Roorkee, Haridwar, Uttarakhand, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3015077059","3012020703","Tehsil Bhagwanpur, Khasra No 189/3, 189/4, 190, 190/1, Haridwar, UT 247661, India (IND)"]},{"id":"3007577941","fei":"3007577941","duns":"644929886","firm":"PURE AND CURE HEALTHCARE PRIVATE LIMITED","registrant":"PURE AND CURE HEALTHCARE PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Village Sundran, P.O. Mubarakpur, Tehsil-Derabassi, Distt. Sahibzada Ajit Singh Nagar,  140507, India (IND)","city":"Distt. Sahibzada Ajit Singh Nagar","state":null,"pin":"140507","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":30.58076,"lon":76.85014,"prec":"postcode","geo":"140507, Dera Bassi Tahsil, Sahibzada Ajit Singh Nagar, Punjab, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3024206690","3008176882"],"colo":["3005656140","3007147039","3015793804","3005895238"]},{"id":"3005430968","fei":"3005430968","duns":"677605858","firm":"Zydus Lifesciences Limited","registrant":"Zydus Lifesciences Limited","parent":"Zydus Lifesciences","ticker":"ZYDUSLIFE","addr":"Village Swaraj Majra, P.O. Baddi, Tehsil-Nalagarh, Solan, Himachal Pradesh 173205, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"173205","ops":["ANALYSIS","MANUFACTURE"],"expires":"12/31/2026","lat":30.94458,"lon":76.80677,"prec":"postcode","geo":"173205, Baddi, Solan, Himachal Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2024-08-29T04:00:00Z","posted":"2024-09-10T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"12/16/2025","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","company_as_published":"Zydus Lifesciences Limited","match":"exact"},{"date":"2026-06-02T04:00:00Z","posted":"2026-06-09T04:00:00Z","subject":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","company_as_published":"Zydus Lifesciences Limited","match":"exact"}],"events":[{"d":"2026-06-02","k":"letter","t":"Request for Records/CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-722576-06022026","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-08-29","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zydus-lifesciences-limited-685224-08292024","x":"Center for Drug Evaluation and Research (CDER)"}],"first":"2024-08-29","last":"2026-06-02","sibs":["3003696998","3006595385","3008957483","3007938603","3007621329","3006809732","3006026405","3002806475","3012977526","3002984011","3013712903"],"colo":["3006370533","3013950309","3003897648","3006785414","3031304848","3007187282","3012536712","3018004432","3041778294","3005757050","3004738570"]},{"id":"3005651681","fei":"3005651681","duns":"650516235","firm":"K PATEL PHYTO EXTRACTIONS PRIVATE LIMITED","registrant":"K PATEL PHYTO EXTRACTIONS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Village Talwada, Behind Old Sales Tax Check Post, NH-48, Valsad, Gujarat 396105, India (IND)","city":"Valsad","state":"Gujarat","pin":"396105","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":20.27579,"lon":72.87394,"prec":"postcode","geo":"396105, Umbergaon Taluka, Valsad, Gujarat, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3014210753","fei":"3014210753","duns":"650694503","firm":"Immacule Lifesciences Private Limited","registrant":"Immacule Lifesciences Private Limited","parent":null,"ticker":null,"addr":"Village Thanthewal, Ropar Road, Nalagarh, Solan, Himachal Pradesh 174101, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"174101","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":31.06505,"lon":76.69603,"prec":"postcode","geo":"174101, Nalagarh, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3031080212"],"colo":["3046619098","3016859498","3013744962","3012112224","3008250236","3010868532","3007517881"]},{"id":"3010868532","fei":"3010868532","duns":"860120472","firm":"OXALIS LABS","registrant":"OXALIS LABS","parent":null,"ticker":null,"addr":"Village Theda, P.O. Lodhimajra, Tehsil - Baddi, Solan, Himachal Pradesh 174101, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"174101","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":31.06505,"lon":76.69603,"prec":"postcode","geo":"174101, Nalagarh, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3046619098","3016859498","3013744962","3012112224","3031080212","3008250236","3014210753","3007517881"]},{"id":"3007517881","fei":"3007517881","duns":"676369519","firm":"Macleods Pharmaceuticals Limited","registrant":"Macleods Pharmaceuticals Limited","parent":"Macleods (unlisted)","ticker":null,"addr":"Village Theda, Post Office Lodhimajra,Tehsil Baddi, District Solan, Himachal Pradesh 174101, India (IND)","city":"District Solan","state":"Himachal Pradesh","pin":"174101","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":31.06505,"lon":76.69603,"prec":"postcode","geo":"174101, Nalagarh, Solan, Himachal Pradesh, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":["3006363714","3018011011","3006607469","3018972378"],"colo":["3046619098","3016859498","3013744962","3012112224","3031080212","3008250236","3014210753","3010868532"]},{"id":"3004610460","fei":"3004610460","duns":"918603338","firm":"BAXTER PHARMACEUTICALS INDIA PRIVATE LIMITED","registrant":"Baxter Healthcare Corporation","parent":null,"ticker":null,"addr":"Village Vasana-Chacharwadi, Taluka Sanand, Ahmedabad, Gujarat 382213, India (IND)","city":"Ahmedabad","state":"Gujarat","pin":"382213","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK","STERILIZE"],"expires":"12/31/2026","lat":22.96705,"lon":72.4693,"prec":"postcode","geo":"382213, Sanand Taluka, Ahmedabad, Gujarat, India","status":1,"alerts":[],"letters":[{"date":"2023-07-25T04:00:00Z","posted":"2023-08-01T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/baxter-healthcare-corporation-654136-07252023","company_as_published":"Baxter Healthcare Corporation","match":"token"}],"events":[{"d":"2023-07-25","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/baxter-healthcare-corporation-654136-07252023","x":"Center for Drug Evaluation and Research | CDER"}],"first":"2023-07-25","last":"2023-07-25","sibs":[],"colo":["3041646841","3036725850","3043068534","3017085815","3010661577","3007277149","3008957483","3007938603","3010254278","3029456823","3007621329","3008725987"]},{"id":"3043423323","fei":"3043423323","duns":"931837757","firm":"ARESKO LIFE SCIENCES PRIVATE LIMITED","registrant":"ARESKO LIFE SCIENCES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"Village-Sakhanpur, Pirumadara, Tehsil, Ramnagar, Distt. – Nainital, Uttarakhand 244715, India (IND)","city":"Distt. – Nainital","state":"Uttarakhand","pin":"244715","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":29.38914,"lon":79.12312,"prec":"postcode","geo":"244715, Ramnagar, Nainital, Uttarakhand, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3004738570","fei":"3004738570","duns":"650651164","firm":"FDC Limited","registrant":"FDC Limited","parent":null,"ticker":null,"addr":"Village: Khol-Bhud,Tehsil:Baddi, Solan, Himachal Pradesh 173205, India (IND)","city":"Solan","state":"Himachal Pradesh","pin":"173205","ops":["ANALYSIS","LABEL","MANUFACTURE","PACK"],"expires":"12/31/2026","lat":30.94458,"lon":76.80677,"prec":"postcode","geo":"173205, Baddi, Solan, Himachal Pradesh, India","status":1,"alerts":[],"letters":[{"date":"2021-02-18T05:00:00Z","posted":"2021-02-19T17:00:00Z","subject":"New Drug/Misbranded","office":"Center for Food Safety and Applied Nutrition (CFSAN)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fdc-nutrition-inc-612264-02182021","company_as_published":"FDC Nutrition Inc.","match":"token"}],"events":[{"d":"2021-02-18","k":"letter","t":"New Drug/Misbranded","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fdc-nutrition-inc-612264-02182021","x":"Center for Food Safety and Applied Nutrition (CFSAN)"}],"first":"2021-02-18","last":"2021-02-18","sibs":["3003204330","3008524952","3002806958"],"colo":["3006370533","3013950309","3003897648","3006785414","3031304848","3007187282","3012536712","3018004432","3041778294","3005757050","3005430968"]},{"id":"3002806691","fei":"3002806691","duns":"915154892","firm":"CIPLA LIMITED","registrant":"CIPLA LIMITED","parent":"Cipla","ticker":"CIPLA","addr":"Virgonagar, Old Madras Road, Bengaluru, Karnataka 560049, India (IND)","city":"Bengaluru","state":"Karnataka","pin":"560049","ops":["ANALYSIS","API MANUFACTURE"],"expires":"12/31/2026","lat":13.06004,"lon":77.73104,"prec":"postcode","geo":"560049, Byyappanahalli, Bangalore East, Bengaluru Urban, Karnataka, India","status":2,"alerts":[{"alert":"66-41","list":"red","since":"03/14/2017","notes":"","charges":[{"code":"66 S - - 51","notes":"","product":"Tadalafil","published":"03/14/2017"},{"code":"66 V - - 99","notes":"","product":"Miscellaneous Patent Medicines, Etc.","published":"03/14/2017"}],"firm_as_published":"Cipla LTD","address_as_published":"Khasra No. 509/1-2 & 520 , Vii-Bhagwanpur , Bhagwanpur, Uttaranchal INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","match":"exact"},{"alert":"66-66","list":"red","since":"10/09/2013","notes":"","charges":[{"code":"60 W - - 16","notes":"","product":"Mebendazole (Anthelmintic)","published":"10/09/2013"}],"firm_as_published":"Cipla Limited","address_as_published":"Patalganga Industrial Area , Plot No A-2, A-33, A-37/2/2, A-42 , Raigad, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"},{"alert":"66-66","list":"red","since":"10/18/2010","notes":"","charges":[{"code":"64 U C S 06","notes":"","product":"Finasteride (Inhibitor (Decarboxylase)), Human - Rx/Single Ingredient, Active Pharm Ingred/Chems for Further Manuf","published":"10/18/2010"}],"firm_as_published":"Cipla, Ltd.","address_as_published":"Plots D-7, D-22, D-27 , M.I.D.C. Industrial Area, Taluka-Daund , Kurkumbh Village, Dist. Pune, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"exact"}],"letters":[{"date":"2023-11-17T05:00:00Z","posted":"2023-11-21T14:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-660904-11172023","company_as_published":"Cipla Limited","match":"exact"}],"events":[{"d":"2023-11-17","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cipla-limited-660904-11172023","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2017-03-14","k":"alert","t":"Listed on import alert 66-41","u":"https://www.accessdata.fda.gov/cms_ia/importalert_190.html","x":""},{"d":"2013-10-09","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2010-10-18","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""}],"first":"2010-10-18","last":"2023-11-17","sibs":["3005857289","3004081307","3002806702","3008581988","3002806710"],"colo":[]},{"id":"3008991454","fei":"3008991454","duns":"915902945","firm":"DNS FINE CHEMICALS AND LABORATORIES PRIVATE LIMITED","registrant":"DNS FINE CHEMICALS AND LABORATORIES PRIVATE LIMITED","parent":null,"ticker":null,"addr":"W 15, BADLAPUR MIDC BADLAPUR EAST, THANE, Maharashtra 421503, India (IND)","city":"THANE","state":"Maharashtra","pin":"421503","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.16406,"lon":73.23958,"prec":"postcode","geo":"421503, Badlapur, Kulgaon Badlapur, Ambernath Subdistrict, Thane, Maharashtra, India","status":2,"alerts":[{"alert":"66-66","list":"red","since":"09/30/2009","notes":"11/2/2000","charges":[{"code":"60 W - S 26","notes":"","product":"Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","published":"03/27/2019"}],"firm_as_published":"Fine Chemicals","address_as_published":"89 Princess Street , Bombay, MS INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"token"},{"alert":"66-79","list":"red","since":"10/13/2022","notes":"All Drug and Drug Products; DWPE Date; 10/30/2019","charges":[{"code":"55","notes":"All Drug and Drug Products; DWPE Date; 10/30/2019","product":"Pharm Necess & Ctnr For Drug/Bio","published":"10/28/2021"},{"code":"56","notes":"All Drug and Drug Products; DWPE Date; 10/30/2019","product":"Antibiotics (Human/Animal)","published":"10/28/2021"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products; DWPE Date; 10/30/2019","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"61","notes":"All Drug and Drug Products; DWPE Date; 10/30/2019","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"62","notes":"All Drug and Drug Products; DWPE Date; 10/30/2019","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"63","notes":"All Drug and Drug Products; DWPE Date; 10/30/2019","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"64","notes":"All Drug and Drug Products; DWPE Date; 10/30/2019","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"65","notes":"All Drug and Drug Products; DWPE Date; 10/30/2019","product":"Human and Animal Drugs","published":"10/28/2021"},{"code":"66","notes":"All Drug and Drug Products; DWPE Date; 10/30/2019","product":"Human and Animal Drugs","published":"10/28/2021"}],"firm_as_published":"DNS Fine Chemicals & Laboratories Private Ltd.","address_as_published":"W-15 Badlapur MIDC-Badlapur East , Thane, Maharashtra INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","match":"exact"}],"letters":[],"events":[{"d":"2022-10-13","k":"alert","t":"Listed on import alert 66-79","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/30/2019"},{"d":"2022-05-26","k":"charge","t":"66-79 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":""},{"d":"2021-10-28","k":"charge","t":"66-79 charge 55 — Pharm Necess & Ctnr For Drug/Bio","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/30/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 56 — Antibiotics (Human/Animal)","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/30/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 60 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/30/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 61 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/30/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 62 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/30/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 63 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/30/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 64 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/30/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 65 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/30/2019"},{"d":"2021-10-28","k":"charge","t":"66-79 charge 66 — Human and Animal Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_1174.html","x":"All Drug and Drug Products; DWPE Date; 10/30/2019"},{"d":"2019-03-27","k":"charge","t":"66-66 charge 60 W - S 26 — Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":"11/2/2000"}],"first":"2009-09-30","last":"2022-10-13","sibs":[],"colo":[]},{"id":"3004985767","fei":"3004985767","duns":"915893696","firm":"Unilab Chemicals and Pharmaceuticals Private Limited","registrant":"Unilab Chemicals and Pharmaceuticals Private Limited","parent":null,"ticker":null,"addr":"W 32, MIDC, Phase II, Dombivli (East), Mumbai, Maharashtra 421204, India (IND)","city":"Mumbai","state":"Maharashtra","pin":"421204","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.1703,"lon":73.09164,"prec":"postcode","geo":"421204, Dombivali, Kalyan Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3037647985","3007005296"]},{"id":"3030219467","fei":"3030219467","duns":"915039748","firm":"SAVVY CARE & COSMETICS PRIVATE LIMITED","registrant":"SAVVYCARE & COSMETICS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"W 56 TTC INDUSTRIAL AREA RABALE NAVI NAVI, THANE, MAHARASHTRA 400701, India (IND)","city":"THANE","state":"Maharashtra","pin":"400701","ops":["MANUFACTURE"],"expires":"12/31/2026","lat":19.11985,"lon":73.00488,"prec":"postcode","geo":"400701, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":2,"alerts":[{"alert":"66-40","list":"red","since":"06/11/2018","notes":"For industry code 53; only products found to be drug products are subject to DWPE under this listing.","charges":[{"code":"53","notes":"","product":"Cosmetics","published":"06/11/2018"},{"code":"55","notes":"All Drug and Drug Products","product":"Pharm Necess & Ctnr For Drug/Bio","published":"06/11/2018"},{"code":"56","notes":"All Drug and Drug Products","product":"Antibiotics (Human/Animal)","published":"06/11/2018"},{"code":"58","notes":"","product":"Human and Animal Therapeutic Biologic and Biosimilar Drugs","published":"05/26/2022"},{"code":"60","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"61","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"62","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"63","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"64","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"65","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"},{"code":"66","notes":"All Drug and Drug Products","product":"Human and Animal Drugs","published":"06/11/2018"}],"firm_as_published":"JT Cosmetics & Chemicals Pvt Ltd.","address_as_published":"53 Kalol Gidc Estate , Panchmahal, Gujarat INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","match":"token"}],"letters":[{"date":"2024-04-30T04:00:00Z","posted":"2024-05-07T13:20:00Z","subject":"CGMP/Finished Pharmaceuticals/Adulterated","office":"Center for Drug Evaluation and Research | CDER","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-cosmetics-company-limited-677948-04302024","company_as_published":"Global Cosmetics Company Limited","match":"token"},{"date":"2025-08-06T04:00:00Z","posted":"2025-08-12T04:00:00Z","subject":"Nonprescription/OTC","office":"Center for Drug Evaluation and Research (CDER)","response":"","closeout":"","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","company_as_published":"K & Care Organics","match":"token"}],"events":[{"d":"2025-08-06","k":"letter","t":"Nonprescription/OTC","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/k-care-organics-711000-08062025","x":"Center for Drug Evaluation and Research (CDER)"},{"d":"2024-04-30","k":"letter","t":"CGMP/Finished Pharmaceuticals/Adulterated","u":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/global-cosmetics-company-limited-677948-04302024","x":"Center for Drug Evaluation and Research | CDER"},{"d":"2022-05-26","k":"charge","t":"66-40 charge 58 — Human and Animal Therapeutic Biologic and Biosimilar Drugs","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":""},{"d":"2018-06-11","k":"alert","t":"Listed on import alert 66-40","u":"https://www.accessdata.fda.gov/cms_ia/importalert_189.html","x":"For industry code 53; only products found to be drug products are subject to DWPE under this listing."}],"first":"2018-06-11","last":"2025-08-06","sibs":[],"colo":["3027513144","3009510975","3006620783","3003484180","3024731845","3007026867","3005502733","3011560035","3013153296"]},{"id":"3013153296","fei":"3013153296","duns":"651003894","firm":"GVS CIBATECH PVT LTD","registrant":"GVS CIBATECH PVT LTD","parent":null,"ticker":null,"addr":"W-316, TTC, MIDC Area, Rabale, Navi Mumbai, Maharashtra 400701, India (IND)","city":"Navi Mumbai","state":"Maharashtra","pin":"400701","ops":["ANALYSIS"],"expires":"12/31/2026","lat":19.11985,"lon":73.00488,"prec":"postcode","geo":"400701, Navi Mumbai, Thane Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":["3027513144","3009510975","3006620783","3003484180","3024731845","3007026867","3005502733","3011560035","3030219467"]},{"id":"3005537897","fei":"3005537897","duns":"862273604","firm":"MONTAGE CHEMICALS PRIVATE LIMITED","registrant":"MONTAGE CHEMICALS PRIVATE LIMITED","parent":null,"ticker":null,"addr":"W-38, MIDC Area, Morivili,Ambernath, Thane, Maharashtra 421505, India (IND)","city":"Thane","state":"Maharashtra","pin":"421505","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":19.20797,"lon":73.20109,"prec":"postcode","geo":"421505, Ambernath, Ulhasnagar Subdistrict, Thane, Maharashtra, India","status":0,"alerts":[],"letters":[],"events":[],"first":null,"last":null,"sibs":[],"colo":[]},{"id":"3043976909","fei":"3043976909","duns":"771676432","firm":"Lee Fine Chem Private Limited","registrant":"Lee Fine Chem Private Limited","parent":null,"ticker":null,"addr":"sy. No. 12P to 13P Plot No.27A27,27A28, 27A40 & 27A41 Denotified Area - APSEZ, Atchutapuram, Lalam Koduru (Village) Rambilli (Mandal), Anakapal, Atchutapuram, Andhra Pradesh 531011, India (IND)","city":"Atchutapuram","state":"Andhra Pradesh","pin":"531011","ops":["API MANUFACTURE"],"expires":"12/31/2026","lat":17.56342,"lon":82.97907,"prec":"postcode","geo":"531011, Atchutapuram, Anakapalli, Andhra Pradesh, India","status":2,"alerts":[{"alert":"66-66","list":"red","since":"09/30/2009","notes":"11/2/2000","charges":[{"code":"60 W - S 26","notes":"","product":"Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","published":"03/27/2019"}],"firm_as_published":"Fine Chemicals","address_as_published":"89 Princess Street , Bombay, MS INDIA","url":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","match":"token"}],"letters":[],"events":[{"d":"2019-03-27","k":"charge","t":"66-66 charge 60 W - S 26 — Piperazine (Anthelmintic), Active Pharm Ingred/Chems for Further Manuf","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":""},{"d":"2009-09-30","k":"alert","t":"Listed on import alert 66-66","u":"https://www.accessdata.fda.gov/cms_ia/importalert_202.html","x":"11/2/2000"}],"first":"2009-09-30","last":"2019-03-27","sibs":[],"colo":["3012160303","3026032363","3023346708","3011538548","3015709928","3013629262","3014255847","3020444708","3030613318","3026297382","3013580138","3021487911"]}]}