Site records / Maharashtra / FEI 3009227929
Ipca Laboratories LimitedChhatrapati Sambhajinagar, Maharashtra
FDA-registered drug establishment in Chhatrapati Sambhajinagar, Maharashtra: api manufacture. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 1
- Last inspection
- Nov 2016 · NAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0 of 1 under the name
- US border refusals, 2 years
- 0
This site, graded.
Every fact sourced.
- A grade from A to E on a registered ten-factor rubric, with the fact behind every factor
- Every posted FDA citation, sorted into failure categories and set against Indian drug inspections
- Warning-letter violations, numbered and labelled
- Import-alert history rebuilt from the archive, each listing checked against this address
- Border refusals by product, and the company's other sites, each graded
- A hash of every source read, so the PDF can be checked against the record
On 2022–26 inspections the rubric never saw, grade E sites were classified OAI 26.5% of the time and grade A sites 4.0%.
PDF and data by email, usually within minutes, as of the day you buy. Card payment through Razorpay.
By buying you agree to the Terms and the refund policy: sales are final once delivered, except non-delivery.
Consultant plan · US$799 a month · five dossiers a month and watchlist alerts. Ask about the plan
Inspections
1 FDA inspection of this FEI, by end date; 1 with a posted classification.
- 4 Nov 2016NAI · No Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 29 Jan 2016Warning letter to Ipca Laboratories Limited SourceCGMP/APIs and Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
Import alerts in force
Import-alert pages list a firm name and an address, never an FEI. Each listing under this firm's name is shown with the address FDA published and whether it is this site's.
- 30 Sep 2009Import alert 66-41 · Published address is not this site SourceDetention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.Published address: P.O. Sejavta , Ratlam, Madhya Pradesh INDIA
Other registered sites of Ipca Laboratories
- Ipca Laboratories LimitedRatlam, Madhya Pradesh
- Ipca Laboratories LimitedSilvassa, Daman
- Ipca Laboratories LimitedPalghar, Maharashtra
- Ipca Laboratories LimitedDhar, Madhya Pradesh
Registration
- FEI
- 3009227929
- DUNS
- 677603004
- Registered as
- IPCA LABORATORIES LIMITED
- Registrant
- Ipca Laboratories Limited
- Address
- Plot No. H-4, MIDC, Waluj, Chhatrapati Sambhajinagar, Maharashtra 431136, India (IND)
- Operations
- API MANUFACTURE
- Registration expires
- 31 Dec 2026
Sources: FDA drug establishment registrations, FDA Data Dashboard inspections and compliance actions, import-alert pages, warning letters, import refusals and the FDA reading room, as held in Counterfoil's point-in-time corpus. No matched action does not establish compliance, and FDA registration is not FDA approval. Sources and coverage.