Site records / Himachal Pradesh / FEI 3005757050
Glenmark Pharmaceuticals LimitedSolan, Himachal Pradesh
FDA-registered drug establishment in Solan, Himachal Pradesh: analysis, label, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.
- Inspections posted
- 6
- Last inspection
- Jun 2022 · OAI
- Warning letters to this FEI
- 1
- Import alerts at this address
- 1
- US border refusals, 2 years
- 45
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
6 FDA inspections of this FEI, by end date; 6 with a posted classification.
- 22 Jun 2022OAI · Official Action IndicatedDrug Quality Assurance · 6 citations posted
- 21 Sep 2018NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 11 Nov 2017VAI · Voluntary Action IndicatedDrug Quality Assurance · 7 citations posted
- 29 May 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
- 24 Aug 2012NAI · No Action IndicatedDrug Quality Assurance · no citations posted
- 13 Nov 2009VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
Warning letters and compliance actions
- 3 Oct 2019Warning Letter · CDER
- 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 this site SourcePublished address: Village Kishanpura, Baddi Nalagarh Road , Baddi , Solan, Himachal Pradesh INDIA
Form 483s released by FDA
- 11 Nov 2017Form 483 · 11 pages Source
Other registered sites of Glenmark Pharmaceuticals
- Alivus Life Sciences LimitedAnkleshwar, Gujarat
- Alivus Life Sciences LimitedBharuch, Gujarat
- Glenmark Pharmaceuticals LimitedColvale-Bardez, Goa
- Glenmark Pharmaceuticals LimitedDhar, Madhya Pradesh
- Glenmark Pharmaceuticals LimitedChhatrapati Sambhajinagar (previously known as Aurangabad), Maharashtra
Registration
- FEI
- 3005757050
- DUNS
- 676115028
- Registered as
- Glenmark Pharmaceuticals Limited
- Registrant
- Glenmark Pharmaceuticals Inc., USA
- Address
- Village Kishanpura Baddi Nalagarh Road, Baddi, Solan, Himachal Pradesh 173205, 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.