Glenmark Pharmaceuticals Limited

Warning LetterOpen

Mr. Glenn Saldanha Chairman and Managing Director Glenmark Pharmaceuticals Limited Glenmark House, B D Sawant Marg Andheri (E) Mumbai 400099 Maharashtra IndiaFEI 3004672766Issued Nov 22, 2022Center 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 3004672766.

Violations4

Issue DateNov 22, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Glenmark Pharmaceuticals Limited
Location: Mr. Glenn Saldanha Chairman and Managing Director Glenmark Pharmaceuticals Limited Glenmark House, B D Sawant Marg Andheri (E) Mumbai 400099 Maharashtra India
FEI Number: 3004672766
Country: India
Issue Date: November 22, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Glenmark Pharmaceuticals Limited's Goa manufacturing facility was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of finished pharmaceutical drugs, rendering products adulterated. The company failed to conduct thorough investigations into unexplained batch failures and out-of-specification results, particularly regarding 14 rejected batches of desmopressin acetate tablets (0.1mg and 0.2mg strengths) from 2018-2021 that showed content uniformity failures; despite attributing issues to undefined compression parameters, the firm failed to extend investigations to other batches, dosage strengths, and drug products to identify root causes. The inspection occurred May 12-20, 2022, with the FDA acknowledging the company's June 2022 response but determining that the violations were not adequately addressed.

Glenmark Pharmaceuticals Limited FDA Warning Letter, November 22, 2022