Zydus Lifesciences receives final approval from USFDA for Niacin Extended-Release Tablets

Zydus Lifesciences Ltd on Wednesday received final approval from the United States Food and Drug Administration (USFDA) to manufacture Niacin Extended-Release Tablets USP in 500 mg, 750 mg and 1,000 mg strengths.

"Niacin is indicated to reduce elevated total cholesterol (TC), LDL cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase HDL cholesterol (HDL-C) in patients with primary hyperlipidaemia and mixed dyslipidaemia," the pharma firm stated in a BSE filing.

"It is also indicated to reduce the risk of recurrent myocardial infarction in patients with a history of myocardial infarction and hyperlipidaemia and to reduce TG in adult patients with severe hypertriglyceridemia. Niacin-Extended-Release tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad," Zydus added

Niacin-Extended-Release tablets had annual sales of $5.5 million in the United States (IQVIA MAT February 2025). And, the group now has 425 approvals and has so far filed 492 ANDAs (abbreviated new drug applications).

Stock-wise, Zydus Lifesciences was last seen 0.41 per cent up at Rs 891.55. At this price, it has slipped 8.43 per cent in 2025 so far.

Technically, the scrip traded higher than the 5-day, 10-, 20-, 30-day and 50-day simple moving averages (SMAs) but lower than the 100-day, 150-day and 200-day SMAs. Its 14-day relative strength index (RSI) came at 53.66. A level below 30 is defined as oversold while a value above 70 is considered overbought.

As per BSE, the stock has a price-to-earnings (P/E) ratio of 20.55 against a price-to-book (P/B) value of 5.01. Earnings per share (EPS) stood at 43.39 with a return on equity (RoE) of 24.40. According to Trendlyne data, Zydus has a one-year beta of 0.9, indicating low volatility.

As of March 2025, promoters held a 74.99 per cent stake in the company.