Strides Pharma Science Singapore arm gets USFDA nod for Icosapent Ethyl Capsules to reduce heart issues

Written by Ruchika Sharma Published On 2023-09-25T11:21:47+05:30 | Updated On 20 Oct 2023 2:55 PM IST

Strides Pharma Science Singapore arm gets USFDA nod for Icosapent Ethyl Capsules to reduce heart issues

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.

Bangalore: Strides Pharma Science Limited 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 product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vascepa of Amarin.

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.

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 ~ 60 new products over three years in the US.

Read also: Strides Pharma Science Singapore gets tentative USFDA approval for Dolutegravir/ Lamivudine/ Tenofovir Disproxil Fumurate tablets

Strides is a global pharmaceutical company headquartered in Bengaluru, India. The Company mainly operates in the 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). The Company focuses on “difficult to manufacture” products sold in over 100 countries.

Read also: Strides Pharma Science Singapore arm secures USFDA tentative okay for HIV drug Dolutegravir

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751