Strides Pharma unit gets USFDA for generic product

New Delhi: Drug firm Strides Pharma Science on Friday said its subsidiary has received approval from the US health regulator to sell colchicine tablets, used for the treatment and prevention of gout, in the American market. Singapore-based Strides Pharma Global Pte, a step down wholly-owned subsidiary of the company, has received approval from the United States Food & Drug Administration (USFDA) to market the product, Strides Pharma Science said in a statement.

The company's product, which reduces inflammation and other symptoms of gout, is therapeutically equivalent to Takeda Pharmaceuticals' Colcrys tablets.

According to IQVIA MAT January 2022 data, the US market for colchicine tablets USP, 0.6 mg is stood at around USD 85 million.

Strides said the product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market.

The company has 271 cumulative ANDA filings with USFDA, of which 245 ANDAs have been approved and 26 are pending approval, it added.