Strides Pharma Science receives USFDA approval for Colchicine Tablets

18 Mar 2022 , 01:33 AM

Strides Pharma Science Strides today announced that its stepdown wholly owned subsidiary Strides Pharma Global Pte Limited Singapore has received approval for Colchicine Tablets USP 06 mg from the United States Food Drug Administration USFDA The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug RLD Colcrys Tablets 06 mg of Takeda Pharmaceuticals USA Inc Takeda According to IQVIA MAT January 2022 data the US market for Colchicine Tablets USP 06 mg is approximately ~US$ 85 Mn The product will be manufactured at the companys 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