Zydus Lifesciences Limited — Updates, 30-04-2025: Press Release

Zydus Lifesciences has received final USFDA approval for Niacin Extended-Release Tablets in 500 mg, 750 mg, and 1,000 mg, aimed at managing cholesterol levels and reducing myocardial infarction risk. The product, manufactured at the Moraiya facility in Ahmedabad, enters a market with annual sales of around USD 5.5 million. This approval increases Zydus's total USFDA approvals to 425, from 492 ANDA filings since FY 2003-04, enhancing its growth potential.