Granules India’s arm concludes USFDA audit with three minor observations

31 Jan 2022 Evaluate

Granules India’s wholly-owned foreign subsidiary -- Granules Pharmaceuticals, Inc. (GPI) has concluded USFDA audit with three minor observations. GPI located in Chantilly, Virginia, USA had undergone a Preapproval Inspection (PAI) by the US Food and Drug Administration (USFDA) from January 24, 2022 to January 28, 2022. The audit is a PAI for two of its product applications filed from this facility.

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).

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