Shares of Strides Pharma Sciences rose 2% in early trading on September 25 after the company’s subsidiary received approval from the United States Food and Drug Administration (USFDA) for its treatment drug. treat heart disease.
At 9:19 am, Strides Pharma Science quoted Rs 509.95, up Rs 11.30, or 2.27 per cent, on the BSE.
Strides Pharma Global Pte Limited, Singapore, a wholly owned subsidiary of the Company, has received USFDA approval for icosapent 0.5 gram and 1 gram ethyl capsules.
Icosapent Ethyl Capsule is a prescription medicine used in combination with other medicines such as statins to reduce the risk of heart attack, stroke, and heart problems in people with cardiovascular disease. This product complements Strides’ line of approved soft gelatin capsules. The product is biologically and therapeutically equivalent to Amarin’s reference drug (RLD), Vascepa, and will be manufactured at the company’s facility in Bengaluru.
The company has 260 cumulative ANDA filings (including the Chestnut Ridge portfolio recently acquired by Endo) with the USFDA, of which more than 230 ANDAs have been approved.
The company has aimed to launch about 60 new products within three years in the United States.
Earlier this month, the subsidiary received tentative approval from the USFDA for New Drug Application (NDA) 505b2 of dolutegradir/lamivudine/tenofovir disproxil fumurat 50 mg/300 mg/300 mg tablets.
We have also received provisional approval for Dolutegraver 50 mg tablets from the United States Food and Drug Administration (USFDA). Both the products will be manufactured at the company’s facility in Bangalore.
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