Loading…
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.