Strides Pharma Science’s arm gets USFDA’s approval for Icosapent Ethyl Capsules

25 Sep 2023 Evaluate

Strides Pharma Science’s step?down wholly owned subsidiary -- Strides Pharma Global 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. The Icosapent Ethyl Capsules has a market size of around $1.3 billion as 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 more than 230 ANDAs have been approved. The company has set a target to launch around 60 new products over three years in the US.

Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.

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