Granules India announced 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.
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