Strides Pharma Secures USFDA Nod For triglyceride Tamer Icosapent

Strides Pharma Science Ltd said that its step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd, has gained US Food and Drug Administration (USFDA) certification for its icosapent ethyl capsules in both 0.5 gram and 1 gram forms. High triglyceride levels are treated with icosapent ethyl capsules. The firm's wide array of authorized soft gelatin capsules has grown with this approval.

The USFDA has approved icosapent ethyl capsules as bioequivalent and medically equivalent to Amarin's reference listed drug (RLD), Vascepa. According to IQVIA, the icosapent ethyl capsules market is worth around $1.3 billion, therefore its acknowledgment creates a major market potential. The newly-approved drug will be manufactured at Strides Pharma's sophisticated manufacturing plant in Bengaluru. Strides Pharma's strong presence in the pharmaceutical industry is underscored by its impressive track record, with 260 cumulative Abbreviated New Drug Application (ANDA) filings with the USFDA.

This portfolio includes assets obtained through the recent acquisition of a portfolio from Endo at Chestnut Ridge. Out of these filings, over 230 ANDAs have already received USFDA approval, demonstrating the company's dedication to delivering high-quality medications, as per cnbctv18. Strides Pharma has set an aggressive objective of releasing 60 new drugs into the US market over the next three years. Strides Pharma Science Ltd shares closed at Rs 495.75, down Rs 12.35, or 2.43 percent, on the BSE.