Latest news with #NiacinExtended-ReleaseTablets
Business Standard
30-04-2025
- Business
- Business Standard
Zydus Life gains after USFDA approval for Niacin Extended-Release tablets
Zydus Lifesciences rose 1.02% to Rs 897 after the pharma company received final approval from the US Food and Drug Administration (USFDA) to manufacture Niacin Extended-Release Tablets USP, 500 mg , 750 mg, and 1,000 mg. The approved medication is indicated for the treatment of patients with primary hyperlipidemia and mixed dyslipidemia. It helps reduce elevated levels of total cholesterol (TC), LDL-C, apolipoprotein B (Apo B), and triglycerides (TG), while increasing HDL-C. It is also used to reduce the risk of recurrent myocardial infarction in patients with a prior history of heart attack and hyperlipidemia and to treat adults with severe hypertriglyceridemia. According to IQVIA MAT (February 2025), the annual sales of Niacin Extended-Release tablets in the U.S. market were estimated at $5.5 million. With this latest approval, Zydus has now secured 425 product approvals and has filed a total of 492 Abbreviated New Drug Applications (ANDAs) since initiating the filing process in FY 200304. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter.
The Print
30-04-2025
- Health
- The Print
Zydus receives approval from the US drug authority to produce cholesterol-lowering tablets
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. New Delhi [India], April 30 (ANI): 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. 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. 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 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. Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), a leading Indian Pharmaceutical company, is a fully integrated global healthcare provider. 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. The Pharmaceutical company has witnessed significant financial growth, registering a turnover of over Rs 19,500 crores in FY24. (ANI) This report is auto-generated from ANI news service. ThePrint holds no responsibility for its content.
Business Upturn
30-04-2025
- Health
- Business Upturn
Zydus gets USFDA final approval for Niacin Extended-Release Tablets
By Aman Shukla Published on April 30, 2025, 10:58 IST Zydus Lifesciences Limited, along with its subsidiaries and affiliates (collectively referred to as 'Zydus'), has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Niacin Extended-Release Tablets USP in 500 mg, 750 mg, and 1,000 mg strengths. These tablets are the generic version of Niaspan® Extended-Release Tablets. Niacin Extended-Release Tablets are used in the management of lipid disorders. They are indicated to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), while increasing high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hyperlipidaemia and mixed dyslipidaemia. The drug is also approved to reduce the risk of recurrent myocardial infarction in patients with a prior heart attack and hyperlipidaemia, and to treat severe hypertriglyceridemia in adults. The approved product will be manufactured at Zydus' facility in Moraiya, Ahmedabad. According to IQVIA MAT data for February 2025, annual sales of Niacin Extended-Release Tablets in the United States were approximately USD 5.5 million. With this approval, Zydus now has a total of 425 Abbreviated New Drug Application (ANDA) approvals and has filed 492 ANDAs since it began filing in the financial year 2003-04. Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
