USFDA Grants Approval To Zydus Lifesciences: Can Manufacture Niacin Tablets
Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Niacin. Niacin is a cholesterol-lowering tablet. These tablets will be produced at the group's manufacturing site at Moraiya, Ahmedabad.
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New Delhi: Indian multinational pharmaceutical company, Zydus Lifesciences Limited, has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Niacin Extended-Release Tablets.
These tables are also intended to reduce the risk of recurrent myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia, as well as to lower triglycerides in adult patients with severe hypertriglyceridemia, as per the company's filing with the stock exchanges.
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 dyslipidemia.
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Niacin-Extended-Release tablets had annual sales of USD 5.5 million in the United States (IQVIA MAT, February 2025), as reported by the company in its filings to the exchanges.
The Ahmedabad-based pharma company informed us that the Niacin-Extended-Release tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad.
Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.
The group now has 425 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04, the filing stated.
The company on April 11 informed that it has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Jaythari (Deflazacort) Tablets.
The Pharmaceutical company has witnessed significant financial growth, registering a turnover of over Rs 19,500 crores in FY24.
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With in-depth domain expertise in the healthcare field, it possesses strong capabilities across the entire pharmaceutical value chain.
The company, founded in 1952, was restructured and thus Cadila Healthcare was formed under the aegis of the Zydus group in 1995.
Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), a leading Indian Pharmaceutical company, is a fully integrated global healthcare provider.
Disclaimer: This story is from the syndicated feed. Nothing has been changed except the headline.
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