Granules India shines on getting USFDA nod for Colchicine tablets

Granules India’s wholly-owned foreign subsidiary-Granules Pharmaceuticals, Inc, had filed the Abbreviated New Drug Application (ANDA) for Colchicine tablets USP, 0.6 mg for which it has received US Food & Drug Administration (USFDA) approval.

Colchicine tablets USP, 0.6 mg is bioequivalent to the Reference Listed Drug (RLD), Colcrys tablets, 0.6 mg, of Takeda Pharmaceuticals USA, Inc (TPUSA). This marks the second Paragraph IV ANDA approval for Granules. TPUSA is a wholly-owned subsidiary of Takeda Pharmaceutical Company Limited, Japan's largest pharmaceutical company and currently, markets metabolic, gout, gastrointestinal and central nervous system treatments.

Colchicine tablets are used for treating Familial Mediterranean Fever (FMF), which is a genetic disorder, causing recurrent episodes of fever that are typically accompanied by a pain in the abdomen, chest or joints. The disease generally affects people of Mediterranean and Middle Eastern descent, typically Sephardic Jews, Turks, Arabs, and Armenians.

On Thursday, the stock of Granules India opened at Rs 153.60. During the day, the stock surged by 5.7 per cent making an intra-day high of Rs 162.55, from its previous close of Rs 153.80.