Strides Pharma Science Limited (Strides) today announced that its step‐ down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Icosapent Ethyl Capsules 0.5 gram and 1 gram, from the United States Food & Drug Administration (USFDA), the company on Saturday announced through an exchange filing
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vascepa of Amarin®. The Icosapent Ethyl Capsules has a market size of ~USD 1.3Bn per IQVIA.
The product will be manufactured at the Company’s facility in Bengaluru.
The Company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The Company has set a target to launch approximately 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.
Strides Pharma Science Limited shares
The shares of strides on Friday at 3:30 pm closed at Rs 498.95, up by 2.43 percent.