Granules India’s wholly-owned foreign subsidiary – Granules Pharmaceuticals, Inc. located in Chantilly, Virginia, USA, has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for the Pre-Approval Inspection (PAI) conducted by USFDA in June 2025 for a first-to-file controlled substance ANDA. There was one observation during the inspection, and it has been resolved.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
