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The wholly-owned subsidiary of Granules India has received Abbreviated New Drug Application (ANDA) approval from the US Food & Drug Administration (USFDA) for colchicine capsules, 0.6 mg.
The application was filed by Granules Pharmaceuticals, Inc. (GPI), a subsidiary of the company.
According to the stock exchange filing, the capsule is equivalent to ‘mitigare capsules’, 0.6 mg of Hikma International Pharmaceuticals LLC (Hikma).
They are indicated for prophylaxis of gout flares in adults.
The stock rose 1.05 per cent to trade at ₹424.90 on the NSE as of 10.38 am.
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