Granules India’s arm gets USFDA’s nod for Colchicine Capsules

11 Feb 2020 Evaluate

Granules India’s wholly owned foreign subsidiary -- Granules Pharmaceuticals, Inc., has received tentative approval from US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) for Colchicine Capsules, 0.6 mg. It is bioequivalent to the reference listed drug product (RLD), Mitigare Capsules, 0.6 mg, of Hikma International Pharmaceuticals LLC.

The company now has a total of 22 ANDA approvals from USFDA (21 Final approvals and 1 tentative approval). Colchicine capsules are indicated for prophylaxis of gout flares in adults. The Mitigare brand and generic had U.S. sales of approximately $84 million MAT for the most recent twelve months ending in December 2019. Mitigare is a registered trademark of Hikma Pharmaceuticals USA Inc.

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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