Site records / Maharashtra / FEI 3009915929
Glenmark Pharmaceuticals LimitedChhatrapati Sambhajinagar (previously known as Aurangabad), Maharashtra
FDA-registered drug establishment in Chhatrapati Sambhajinagar (previously known as Aurangabad), Maharashtra: analysis, label, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 5
- Last inspection
- Sep 2024 · NAI
- Warning letters to this FEI
- 0
- Import alerts at this address
- 0 of 1 under the name
- US border refusals, 2 years
- 2
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
5 FDA inspections of this FEI, by end date; 5 with a posted classification.
- 20 Sep 2024NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 15 Dec 2023NAI · No Action IndicatedBioresearch Monitoring · no citations posted
- 21 Feb 2020NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 17 Aug 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 17 Jun 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 11 Jul 2025Warning letter to Glenmark Pharmaceuticals Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
- 22 Nov 2022Warning letter to Glenmark Pharmaceuticals Limited SourceCGMP/Finished Pharmaceuticals/Adulterated · issued to the firm name; FDA does not tie it to this FEI
- 16 Mar 2010Warning letter to Glenmark Pharmaceuticals Inc. SourceUnapproved New Drug/Misbranded · 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.
- 25 Oct 2022Import alert 66-40 · Published address is another site of this firm SourcePublished address: Village Kishanpura, Baddi Nalagarh Road , Baddi , Solan, Himachal Pradesh INDIA
Other registered sites of Glenmark Pharmaceuticals
- Alivus Life Sciences LimitedAnkleshwar, Gujarat
- Alivus Life Sciences LimitedBharuch, Gujarat
- Glenmark Pharmaceuticals LimitedColvale-Bardez, Goa
- Glenmark Pharmaceuticals LimitedSolan, Himachal Pradesh
- Glenmark Pharmaceuticals LimitedDhar, Madhya Pradesh
Registration
- FEI
- 3009915929
- DUNS
- 650565703
- Registered as
- Glenmark Pharmaceuticals Limited
- Registrant
- Glenmark Pharmaceuticals Inc., USA
- Address
- Plot No. B-25, MIDC, Shendra, Chhatrapati Sambhajinagar (previously known as Aurangabad), Maharashtra 431154, India (IND)
- Operations
- ANALYSIS, LABEL, MANUFACTURE, PACK
- 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.