Zydus Lifesciences Gets Final USFDA Nod for Key Cholesterol Drug

has secured final USFDA approval to manufacture Niacin Extended-Release Tablets USP in 500 mg, 750 mg, and 1,000 mg doses—used to reduce total cholesterol, LDL, apolipoprotein B, triglycerides, and raise HDL in patients with hyperlipidaemia and dyslipidaemia. The drug also helps lower the risk of recurrent heart attacks. Manufacturing will take place at Zydus’ Moraiya facility in Ahmedabad. According to IQVIA MAT Feb 2025 data, the product recorded $5.5 million in U.S. annual sales. With this, Zydus now holds 425 USFDA approvals from a total of 492 ANDA filings since FY04. Separately, its Dabhasa API facility underwent a USFDA inspection (April 21–25) that concluded with six observations, none related to data integrity, reflecting strong compliance. Follow me for more such posts, Thank You! Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.