Zydus receives final approval from USFDA for Niacin Extended-Release Tablets USP, 500 mg, 750 mg, and 1,000 mg

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as "Zydus") has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Niacin Extended-Release Tablets USP, 500 mg, 750 mg, and 1,000 mg (Niaspan® Extended-Release Tablets, 500 mg, 750 mg, and 1,000 mg).

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. 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.

Niacin-Extended-Release tablets had annual sales of USD 5.5 mn in the United States (IQVIA MAT February 2025).

The group now has 425 approvals and has so far filed 492* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 885.45 as compared to the previous close of Rs. 887.70. The total number of shares traded during the day was 11464 in over 1007 trades.

The stock hit an intraday high of Rs. 893.35 and intraday low of 875.00. The net turnover during the day was Rs. 10149231.00.

(*As on 31st March, 2025.)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals USFDA Approval Niacin ExtendedReleaseTablets