Zydus Life gains after USFDA approval for Niacin Extended-Release tablets

Zydus Lifesciences rose 1.02% to Rs 897 after the pharma company received final approval from the US Food and Drug Administration (USFDA) to manufacture Niacin Extended-Release Tablets USP, 500 mg , 750 mg, and 1,000 mg.

The approved medication is indicated for the treatment of patients with primary hyperlipidemia and mixed dyslipidemia. It helps reduce elevated levels of total cholesterol (TC), LDL-C, apolipoprotein B (Apo B), and triglycerides (TG), while increasing HDL-C. It is also used to reduce the risk of recurrent myocardial infarction in patients with a prior history of heart attack and hyperlipidemia and to treat adults with severe hypertriglyceridemia.

According to IQVIA MAT (February 2025), the annual sales of Niacin Extended-Release tablets in the U.S. market were estimated at $5.5 million. With this latest approval, Zydus has now secured 425 product approvals and has filed a total of 492 Abbreviated New Drug Applications (ANDAs) since initiating the filing process in FY 2003?04.

Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter.

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