Granules India’s arm clears audit by US health regulator
22nd Jul 2021

Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals, Inc. (GPI) has cleared an audit by the US health regulator. The company had undergone a Pre-Approval Inspection (PAI) audit by the U.S. Food and Drug Administration (USFDA) from June 21, 2021 to June 25, 2021. The audit is a pre-approval inspection for three of its applications filed from this facility. The FDA issued two minor observations during the audit.

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).