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Business Standard
6 days ago
- Business
- Business Standard
Lupin launches Loteprednol Etabonate Ophthalmic Suspension in the United States
Lupin announced that it has launched Loteprednol Etabonate Ophthalmic Suspension in the United States. Loteprednol Etabonate Ophthalmic Suspension, 0.5% is bioequivalent to Lotemax Ophthalmic Suspension, 0.5%, of Bausch & Lomb Inc. Loteprednol Etabonate Ophthalmic Suspension is indicated for the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Additionally, the drug is indicated for managing post-operative inflammation following ocular surgery. According to IQVIA MAT data for May 2025, the reference product, Lotemax, recorded annual U.S. sales of approximately USD 55 million. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The companys consolidated net profit surged 114.9% to Rs 772.52 crore on a 13.6% jump in net sales to Rs 5,562.20 crore in Q4 FY25 over Q4 FY24. The scrip declined 1.04% to Rs 1,931.01 on the BSE.


Business Upturn
6 days ago
- Business
- Business Upturn
Lupin launches generic Lotemax ophthalmic suspension in the U.S. market
Lupin Limited, the global pharmaceutical major, announced the launch of Loteprednol Etabonate Ophthalmic Suspension, 0.5% in the United States on July 16, 2025. The product is a generic version of Lotemax® Ophthalmic Suspension, 0.5% by Bausch & Lomb Inc., which recorded annual sales of approximately USD 55 million in the U.S., according to IQVIA MAT (May 2025). Advertisement Lupin's generic is indicated for: Steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe (e.g., allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides). Post-operative inflammation following ocular surgery. This launch strengthens Lupin's U.S. portfolio in the ophthalmic therapy area and underscores its commitment to providing affordable treatment options in key markets. Lupin continues to maintain its strong presence in the U.S. generics space while also focusing on complex generics, biotechnology products, and branded formulations globally.


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.
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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.