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Granules India receives USFDA tentative approval for Colchicine Capsules

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Granules India announced that the US Food & Drug Administration (US FDA) has tentatively approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India 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.

Granules now has a total of 22 ANDA approvals from US FDA (21 Final approvals and 1 tentative approval).

Colchicine capsules are indicated for prophylaxis of gout flares in adults.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Tue, February 11 2020. 13:41 IST