US Food and Drug Administration (USFDA) has completed inspection of the facility of Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals, Inc., US on August 21, 2019 with two minor observations.
This is a pre-approval inspection for seven products filed from this facility. Granules Pharmaceuticals, Inc. will respond to these observations within the stipulated time period.
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).