Granules India has informed that the US FDA has issued an Establishment Inspection Report (EIR) to Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA, for the Pre-Approval Inspection (PAI) conducted by it in June 2025 for a first-to-file controlled substance ANDA. There was one observation during the inspection, and it has been resolved.
The above information is a part of company’s filings submitted to BSE.
