Glenmark Pharmaceuticals informs about update
Pursuant to Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, Glenmark Pharmaceuticals has informed that the Company has received Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the United States Food & Drug Administration (U.S. FDA) for its formulations manufacturing facility situated in Monroe, North Carolina, USA. This is following an inspection conducted by the Agency from 09 June to 17 June 2025. The commercial manufacturing at the Monroe site will now restart. The company had earlier informed the stock exchange (BSE) on 18 June 2025 about the Form-483 with five observations for the above June 2025 inspection. The site was earlier under Warning Letter since June 2023.
The above information is a part of company’s filings submitted to BSE.
