Granules India’s foreign subsidiary clears US FDA audit

15 Mar 2022 Evaluate

Granules India’s wholly-owned foreign subsidiary -- Granules Pharmaceuticals, Inc (GPI) located in Chantilly, Virginia, USA has cleared US FDA audit and received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA).

The GPI facility was inspected by the US FDA from January 24 to 28, 2022 for two of its product applications filed. There were three minor observations during the inspection and GPI had addressed the observations in the stipulated time period. This is the sixth successful US FDA audit for 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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