Glenmark Pharmaceuticals
Overview
Glenmark Pharmaceuticals is a global innovative pharmaceutical company committed to enriching lives worldwide. Headquartered in Mumbai, India, the company focuses on creating new, affordable therapies in areas like dermatology, respiratory, and oncology.
Therapeutic areas
API / Drug Master Files
Glenmark Pharmaceuticals holds 0 active (4 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- PALONOSETRON HYDROCHLORIDEInactive2010-11-19
- TELMISARTANInactive2005-09-12
- SIMVASTATINInactive2004-12-30
- G SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR SATPUR NASIK INDIA SITEInactive1999-12-25
FDA compliance signals
50 FDA enforcement records linked to this company.
- recall — Class II2026-01-07
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
- recall — Class III2025-12-17
Cross Contamination with Other Products
- recall — Class III2025-12-10
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
- recall — Class II2025-10-22
Failed Impurities/Degradation Specifications
- recall — Class II2025-10-01
CGMP Deviations: Market complaints received for gritty texture (grainy)
- recall — Class II2025-08-20
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- recall — Class II2025-08-20
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- recall — Class II2025-08-20
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- recall — Class II2025-08-20
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
- recall — Class II2025-08-20
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
- recall — Class II2025-08-20
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
- warning_letter2025-07-11
FDA Warning Letter (drug product)
- recall — Class III2025-06-18
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
- 4832025-06-17
Authority lacking to review records, investigate errors
- 4832025-06-17
Procedures for sterile drug products
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