The product will be marketed by Strides Pharma Inc. in the US market.
Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, 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).
Colchicine tablets are used for the treatment and prevention of gout. It reduces inflammation which causes pain, swelling and other symptoms of gout. Colchicine tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).
According to IQVIA MAT January 2022 data, the US market for Colchicine tablets USP, 0.6 mg is approximately $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.
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Strides Pharma Science is a global pharmaceutical company headquartered in Bengaluru, India.
On a consolidated basis, Strides Pharma Science reported a net loss of Rs 126.66 crore in Q3 FY22 as compared to a net profit of Rs 35.16 crore in Q3 FY21. Net sales declined 4.5% to Rs 794.39 crore in Q3 FY22 over Q3 FY21.
Shares of Strides Pharma Science were up 0.68% at Rs 331.75 on the BSE.
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