Strides Pharma shares hit 52-week high as company's unit receives USFDA approval for Icosapent Ethyl capsules
Strides Pharma news: Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, received USFDA (United States Food and Drug Administration) approval for Icosapent Ethyl Capsules 0.5 gram and 1 gram.
Strides Pharma share price NSE, Strides Pharma news: Strides Pharma Science shares zoomed over 8 per cent in morning deals on Monday, September 25 to clock a fresh 52-week high of Rs 539 on the NSE, shrugging off weakness in the Nifty Pharma index after the pharma company announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, received USFDA (United States Food and Drug Administration) approval for Icosapent Ethyl Capsules 0.5 gram and 1 gram. The counter traded at Rs 530.05, up 6.28 per cent on NSE at 10:29 am.
Here's how the counter has moved so far:
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The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vascepa, of Amarin®, the company's regulatory filing read. The Icosapent Ethyl Capsules have a market size of ~USD 1.3 billion per IQVIA and will be manufactured at the company’s facility in Bengaluru. The company has 260 cumulative ANDA filings with the USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch 60 new products over three years in the US.
About Icosapent Ethyl Capsule
Icosapent Ethyl Capsule is a prescription medication used in conjunction with other medicines like statins to reduce the risk of heart attack, stroke, and heart issues in those afflicted with cardiovascular disease. The product complements Strides’ range of approved soft gelatin capsules.
Headquartered in Bengaluru, Strides, a global pharmaceutical company, mainly operates in regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donor-funded markets. The company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi), and the United States (New York).