Granules India’s Colchicine Capsules Gain ANDA Approval

On April 30, 2024, Granules India Limited informed in a stock exchange filing that the US Food & Drug Administration (US FDA) had approved its Abbreviated New Drug Application (ANDA) for Colchicine Capsules, 0.6 mg.

Granules India Limited’s wholly owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI) filed for the approval of Colchicine Capsules, 0.6 mg.

The company stated that Colchicine Capsules, 0.6 mg, is therapeutically equivalent and bioequivalent to the Reference Listed Drug (RLD), Mitigare Capsules, 0.6 mg of Hikma International Pharmaceuticals LLC (Hikma). Colchicine Capsules are prescribed for prophylaxis of gout flares in adults.

Granules India Limited now has 64 Abbreviated New Drug Application approvals from the United States Food and Drug Administration, of which 63 are for final approvals and 1 for tentative approval.

Granules India Limited added that the current annual U.S. market for Colchicine Capsules is approximately $55 million, according to MAT Feb 2024, IQVIA/IMS Health.

Earlier this month, the US FDA inspected the facility of Granules Pharmaceuticals, Inc., located in Chantilly, Virginia, USA and issued Form 483 with 5 observations. The company stated that GPI had received a communication from the US FDA indicating the inspection classification as Voluntary Action Indicated (VAI). The VAI inspection classification indicates that the US FDA will not take or recommend regulatory or enforcement action because the observations do not meet the threshold for action at this time.

About Granules India Ltd

Granules India Limited is a pharmaceutical company in India. The company is involved in the manufacturing of Active Pharmaceutical Ingredients (APIs), Finished Dosages (FDs) and Pharmaceutical Formulation Intermediates (PFIs). Their products are distributed to more than 300 customers in regulated and semi-regulated markets. They have an international presence extending to more than 80 countries, with offices spread across India, the US, and the UK. Granules India Limited has 10 manufacturing units, of which 8 are located in India and 2 in the USA.

On April 30, 2024, the share price of Granules India Limited opened at ₹421.00, touching the day’s high at ₹427.00, as of 11:31 AM on the NSE.

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