India, June 18 -- Glenmark Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration (USFDA) has completed a Good Manufacturing Practices (GMP) inspection at its manufacturing facility in Monroe, North Carolina, USA. The inspection was carried out from June 9 to June 17, 2025.
Following the inspection, the USFDA issued a Form 483 with five observations. According to the company, all the observations are procedural in nature, and importantly, there were no findings related to data integrity.
Glenmark stated that it will work closely with the USFDA to address the observations and will submit its response within the stipulated timeframe.
The company has confirmed the update in compliance with Regulation 30 of SEBI (Listing O...