Latest news with #IQVIAMAT
The Hindu
02-06-2025
- Business
- The Hindu
Zydus gets U.S. FDA tentative nod for Rifaximin tablets 550 mg
Generic drugmaker Zydus Lifesciences has received tentative approval from the U.S. Food and Drug Administration (FDA) for Rifaximin Tablets, 550 mg. The product is indicated for treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. Rifaximin tablets had annual sales of $2672.9 million in the United States, the company said citing IQVIA MAT March 2025 numbers. The product will be produced at the Group's manufacturing site at SEZ II, Ahmedabad, it said on Monday.
Business Standard
02-06-2025
- Business
- Business Standard
Zydus Lifesciences gets USFDA nod for Rifaximin tablets
Zydus Lifesciences announced that it has received tentative approval from the United States Food and Drug Administration (USFDA) for Rifaximin tablets, 550 mg, under the reference listed drug (RLD) Xifaxan tablets, 550 mg. Rifaximin tablets are indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. The tablets will be produced at the Group's manufacturing facility at SEZ II, Ahmedabad. According to IQVIA MAT 2025, Rifaximin tablets had annual sales of USD $2,672.9 million in the United States. The group now has 427 approvals and has filed 492 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in FY 2003-04. The companys consolidated net profit shed 0.96% to Rs 1,170.9 crore on 17.21% rise in revenue from operations to Rs 6290.2 crore in Q4 FY25 over Q4 FY24. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Shares of Zydus Lifesciences shed 0.53% to Rs 924.95 on the BSE.
&w=3840&q=100)
Business Standard
20-05-2025
- Business
- Business Standard
Zydus reports 17.6% rise in net profit adjusting for one-off charge
Ahmedabad-based Zydus Lifesciences on Tuesday reported a 1 per cent year-on-year (Y-o-Y) decline in net profit, which stood at Rs 1,244 crore for the fourth quarter of financial year 2025 (Q4FY25), while revenue from operations rose by 17.2 per cent to Rs 6,290 crore. Adjusted for an exceptional charge of Rs 219.6 crore — related to the impairment of goodwill from the Brazil business — net profit would stand at Rs 1,390 crore, up 17.6 per cent Y-o-Y. Sequentially, revenue from operations grew by 23 per cent, while profit after tax (PAT) rose by 14 per cent. For FY25, Zydus reported a consolidated net profit of Rs 4,734.4 crore, up 17.2 per cent. Revenue from operations for the full year rose 14.1 per cent to Rs 18,870.3 crore. Sharvil Patel, managing director, Zydus Lifesciences, said: 'We made meaningful progress in our differentiated pipeline and added new capabilities to ensure sustainable growth. We look forward to continued execution success and deepening strategic partnerships to drive long-term growth.' The Indian business — comprising both Formulations and Consumer Wellness — accounted for 39 per cent of the company's consolidated revenues in Q4FY25. It reported revenues of Rs 2,447.5 crore, reflecting a 13 per cent Y-o-Y growth. The Formulations segment recorded revenues of Rs 1,539.4 crore, up 11 per cent Y-o-Y, contributing 25 per cent to consolidated revenues. The branded business registered 11 per cent Y-o-Y growth, driven by strong uptake in key pillar brands and innovative products. Secondary sales rose 10 per cent, supported by the robust performance of the chronic segment and overall growth in key therapeutic areas. The chronic portfolio accounted for 43 per cent of the domestic business as of March 2025 — an improvement of 400 basis points over the past three years, according to IQVIA MAT March 2025 data. The Consumer Wellness segment reported revenues of Rs 908.1 crore in Q4FY25, marking a 17 per cent Y-o-Y increase, including 13 per cent volume growth. This segment contributed 14 per cent to consolidated revenues. The personal care category, led by brands such as Nycil and EverYuth, witnessed strong consumer traction and delivered double-digit growth. Similarly, the food and nutrition segment recorded double-digit growth, driven by category expansion, product innovation and the strategic acquisition of Naturell (India), a healthy snacks company with brands including Max Protein and Rite Bite. The US formulations business reported revenues of Rs 3,130.7 crore in Q4FY25, registering 24 per cent Y-o-Y growth and contributing 50 per cent to consolidated revenues. During the quarter, five new products were launched. The company also filed three Abbreviated New Drug Applications (ANDAs) and received approvals for six new products. The international formulations segment recorded revenues of Rs 554.7 crore, reflecting 12 per cent Y-o-Y growth and contributing 9 per cent to consolidated revenues. The segment sustained its growth momentum, supported by strong demand across multiple geographies. The Active Pharmaceutical Ingredients (API) segment posted revenues of Rs 129 crore, representing a 10 per cent decline compared to the same quarter last year. The segment accounted for 2 per cent of consolidated revenues.
The Hindu
15-05-2025
- Business
- The Hindu
U.S. FDA nod for Lupin's generic of Janssen Pharma's blood thinner tablets
Drugmaker Lupin has received U.S. Food and Drug Administration (U.S. FDA) approval for Rivaroxaban Tablets USP, 10 mg, 15 mg, and 20 mg, its generic version of Janssen Pharmaceuticals' blood thinner tablet Xarelto. The product will be manufactured at its Aurangabad facility. The approved product had an estimated annual sales of $8,052 million in the U.S., Lupin said citing IQVIA MAT March 2025 numbers. Rivaroxaban Tablets USP are indicated to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation and for treatment of deep vein thrombosis as well as pulmonary embolism, it said. Rivaroxaban Tablets are bioequivalent to Xarelto, which Jannsen said is a blood thinner to treat and help prevent blood clots related to certain conditions involving the heart and blood vessels.
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.
