USFDA completes inspection at Granules India’s Virginia facility

29 Oct 2018 Evaluate

Granules India’s wholly-owned foreign subsidiary -- Granules Pharmaceuticals, Inc., facility located in Chantilly, Virginia, USA, has completed US Food and Drug Administration (USFDA) inspection from October 22, 2018 to October 26, 2018 with two Form 483 observations.

This was a prior approval inspection, intended for the ANDAs filed by Granules Pharmaceuticals, Inc. This facility is involved in development and manufacturing of Finished Dosages.

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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