Glenmark Pharmaceuticals Limited

Warning LetterOpen

Mr. Umesh Gupta Senior Vice President and Site Head Glenmark Pharmaceuticals Limited Plot No. 2, Phase-II, Pharma Zone, SEZ Pithampur, Indore 454774 IndiaFEI 3008565058Issued Jul 11, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3008565058.

Violations4

Issue DateJul 11, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Glenmark Pharmaceuticals Limited
Location: Mr. Umesh Gupta Senior Vice President and Site Head Glenmark Pharmaceuticals Limited Plot No. 2, Phase-II, Pharma Zone, SEZ Pithampur, Indore 454774 India
FEI Number: 3008565058
Country: India
Issue Date: July 11, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Glenmark Pharmaceuticals Limited's manufacturing facility in India was found to produce adulterated drug products due to significant Current Good Manufacturing Practice (CGMP) violations involving finished pharmaceuticals. The FDA identified failures to thoroughly investigate batch discrepancies and specification failures, specifically noting dissolution failures in potassium chloride extended-release capsules during stability testing that were inadequately explained and not properly root-caused despite existing process controls for API particle size management. The inspection, conducted February 3-14, 2025, determined that the company's methods, facilities, and controls for manufacturing did not conform to CGMP regulations under 21 CFR parts 210 and 211.

Glenmark Pharmaceuticals Limited FDA Warning Letter, July 11, 2025