Site records / Madhya Pradesh / FEI 3008565058

Glenmark Pharmaceuticals LimitedDhar, Madhya Pradesh

FDA-registered drug establishment in Dhar, Madhya Pradesh: analysis, label, manufacture, pack. Registration valid to 31 Dec 2026. Record as observed 27 Sep 2026.

Inspections posted
8
Last inspection
Feb 2025 · OAI
Warning letters to this FEI
1
Import alerts at this address
0 of 1 under the name
US border refusals, 2 years
1
The site dossier

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

8 FDA inspections of this FEI, by end date; 8 with a posted classification.

  1. 14 Feb 2025OAI · Official Action IndicatedDrug Quality Assurance · 5 citations posted
  2. 25 Feb 2020NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  3. 13 Sep 2019NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  4. 24 May 2018VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  5. 26 Aug 2017NAI · No Action IndicatedDrug Quality Assurance · no citations posted
  6. 26 Feb 2016VAI · Voluntary Action IndicatedDrug Quality Assurance · 3 citations posted
  7. 24 Jul 2015VAI · Voluntary Action IndicatedDrug Quality Assurance · no citations posted
  8. 25 Oct 2013NAI · No Action IndicatedDrug Quality Assurance · no citations posted

Warning letters and compliance actions

  1. 11 Jul 2025Warning Letter · CDER SourceCGMP/Finished Pharmaceuticals/Adulterated
  2. 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
  3. 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.

  1. 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

Form 483s released by FDA

  1. 24 May 2018Form 483 · 7 pages Source
  2. 14 Feb 2025Form 483 · 14 pages Source

Other registered sites of Glenmark Pharmaceuticals

Registration

FEI
3008565058
DUNS
862603186
Registered as
Glenmark Pharmaceuticals Limited
Registrant
Glenmark Pharmaceuticals Inc., USA
Address
Plot No. 2, Phase-2, Pharma Zone SEZ Pithampur, Dhar, Madhya Pradesh 454775, 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.

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