Granules India gets tentative USFDA nod for generic Colchicine capsules
New Delhi: Drug firm Granules India on Tuesday said it has received tentative approval from the US health regulator for its generic Colchicine capsules indicated for the prevention of gout flares in adults.
The company's product is a generic version of Hikma International Pharmaceuticals LLC's Mitigare capsules in the same strength, it added.
"We are pleased to receive tentative approval for our fourth Paragraph IV ANDA and launch of the product will be as per our agreement with Hikma Pharmaceuticals USA Inc," Granules Pharmaceuticals Inc ED Priyanka Chigurupati said.
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