Granules India Limited announced ANDA Approval for Colchicine Capsules

Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA), filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the Company, for Colchicine Capsules, 0.6 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Mitigare Capsules, 0.6 mg of Hikma International Pharmaceuticals LLC (Hikma).

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

Granules now have a total of 64 ANDA approvals from the US FDA (63 Final approvals and 1 tentative approvals).

The current annual U.S. market for Colchicine Capsules is approximately $55 Million, according to MAT Feb 2024, IQVIA/IMS Health.

Shares of Granules India Limited was last trading in BSE at Rs. 420.20 as compared to the previous close of Rs. 424.30. The total number of shares traded during the day was 43112 in over 1990 trades.

The stock hit an intraday high of Rs. 427.70 and intraday low of 418.25. The net turnover during the day was Rs. 18166232.00.

Source : Equity Bulls

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GranulesIndia INE101D01020 GranulesPharmaceuticals USFDA ANDA APproval ColchicineCapsules