Strides Secures USFDA Nod For Icosapent Ethyl Capsules

Strides Pharma Science Limited (Strides) stated that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has acquired FDA approval for icosapent ethyl capsules 0.5 gram and 1 gram. The product is bioequivalent and therapeutically equivalent to Vascepa, an Amarin Reference Listed Drug (RLD). According to IQVIA, the market for icosapent ethyl capsules is worth US$ 1.3 billion.

The device will be manufactured in the company's Bengaluru location. The Bengaluru-based firm has 260 cumulative ANDA applications with the US FDA, including the newly acquired portfolio from Endo at Chestnut Ridge, with 230+ ANDAs approved. It has set a goal of launching 60 new goods in the United States during the next three years. 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, as per pharmabiz.

Strides Pharma Science Limited, headquartered in India, is a pharmaceutical firm focused on the development and manufacture of IP-led specialized final dosage formulations. It is also one of the largest producers of soft gelatin capsules in the world. Strides has built a reputation for establishing and scaling profitable businesses in a short period of time, thanks to world-class manufacturing facilities, a creative R&D cluster in Bangalore, and a solid commercial platform to market goods globally.