US Food & Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for Granules India’s Gagillapur facility located in Hyderabad, Telangana, India. This facility, that manufacturers finished dosages (FDs) and Pharmaceutical Formulation Intermediates (PFIs) was inspected by the USFDA as a part of a PAI in January 2023 which resulted in 3 observations during the inspection.
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).