Strides Pharma Science, (Strides), a pharmaceutical company manufacturing IP-led niche products, on March 11, announced that its stepdown wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received approval for Colchicine Tablets USP, 0.6 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Colcrys Tablets, 0.6 mg, of Takeda Pharmaceuticals U.S.A., Inc. (Takeda).
According to IQVIA MAT January 2022 data, the US market for Colchicine Tablets USP, 0.6 mg is approximately ~USD 85 million. 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.
Shares of the company declined Rs 1.05 or 0.32%, to settle at Rs 328.45. The total volume of shares traded was 95,340 at the BSE (Friday).