Pursuant to Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, Glenmark Pharmaceuticals has informed that the United States Food & Drug Administration (USFDA) conducted a GMP inspection at the Company’s manufacturing facility situated in Monroe, North Carolina, USA from 09 June 2025 to 17 June 2025. At the end of the inspection, the Company was issued a Form 483 with five (5) observations. All the observations are procedural in nature. There was no observation related to data integrity reported. The Company will work in close collaboration with the agency to address the observations and will respond to the USFDA within the stipulated timeline.
The above information is a part of company’s filings submitted to BSE.
