Site records / Telangana / FEI 3006355432
Mylan Laboratories LimitedHyderabad, Telangana
FDA-registered drug establishment in Hyderabad, Telangana: analysis. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 2
- Last inspection
- Oct 2019 · 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%.
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Inspections
2 FDA inspections of this FEI, by end date; 2 with a posted classification.
- 11 Oct 2019NAI · No Action IndicatedBioresearch Monitoring · no citations posted
- 16 Mar 2018NAI · No Action IndicatedBioresearch Monitoring · no citations posted
Warning letters and compliance actions
- 19 Dec 2024Warning letter to Viatris, Inc. SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
- 6 Aug 2015Warning letter to Mylan Laboratories Limited SourceCGMP/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.
- 19 Dec 2024Import alert 66-40 · Published address is another site of this firm SourcePublished address: (FDF-3) Plot Nos. 11, 12, 13, Indore SEZ , Pharma Zone, Phase II, Sector III , Pithampur, District Dhar, Madhya Pradesh INDIA
Other registered sites of Viatris Inc.
- Mylan Laboratories LimitedNashik, Maharashtra
- Mylan Laboratories LimitedBangalore, Karnataka
- Mylan Laboratories LimitedBengaluru, Karnataka
- Mylan Laboratories LimitedHyderabad, Telangana
- Mylan Laboratories LimitedHosur, Tamil Nadu
- Mylan Laboratories LimitedChhatrapati Sambhajinagar, Maharashtra
- Mylan Laboratories LimitedDistrict - Dhar, Madhya Pradesh
Registration
- FEI
- 3006355432
- DUNS
- 650438166
- Registered as
- Mylan Laboratories Limited
- Registrant
- Viatris Inc.
- Address
- Clinical Research Centre, Saradhi Chambers, A-4 Rukminipuri Near Polomi Hospital Main Road, Dr AS Rao Nagar, Hyderabad, Telangana 500062, India (IND)
- Operations
- ANALYSIS
- 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.