Strides Pharma subsidiary gets FDA approval for Icosapent Ethyl Capsules


In a significant pharmaceutical breakthrough, Strides Pharma Science Limited announces that its wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has secured the coveted approval from the United States Food & Drug Administration (FDA) for Icosapent Ethyl Capsules in both 0.5 gram and 1 gram variants.

These capsules are not just any pharmaceutical innovation; they are bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Vascepa by Amarin. With the market size of Icosapent Ethyl Capsules estimated at a staggering ~USD 1.3 billion according to IQVIA, this approval is a game-changer for Strides Pharma.

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The production of these groundbreaking capsules will take place at the Company’s state-of-the-art facility in Bengaluru, further solidifying Strides Pharma’s commitment to delivering high-quality pharmaceuticals to the market.

Strides Pharma is no stranger to success in the pharmaceutical industry. With a remarkable track record of 260 cumulative ANDA filings, including the recent acquisition of the Endo portfolio at Chestnut Ridge, over 230 of these ANDAs have already received the green light from the FDA. But Strides Pharma doesn’t plan to stop there; the Company has set an ambitious target to launch approximately 60 new products over the next three years in the United States.

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Unlocking the Power of Icosapent Ethyl Capsules

Icosapent Ethyl Capsule is more than just a prescription medication; it’s a lifeline for individuals grappling with cardiovascular disease. These capsules, when used in conjunction with other medicines like statins, play a crucial role in reducing the risk of heart attack, stroke, and other heart-related complications.

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The approval of Icosapent Ethyl Capsules is a testament to Strides Pharma’s commitment to enhancing healthcare outcomes and expanding its range of approved soft gelatin capsules.

Strides Pharma’s dedication to innovation and its mission to improve the lives of individuals battling heart-related ailments take center stage with this momentous FDA approval. It’s a step towards a healthier future, powered by cutting-edge pharmaceuticals.

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