Latest news with #ANDAs


New Indian Express
3 days ago
- Business
- New Indian Express
Alembic Pharma stock jumps 12% on US nod for its generic cancer drug
CHENNAI: Shares of Vadodara-based drug maker Alembic Pharmaceuticals jumped over 12% after the company received approval from the US Food and Drug Administration (USFDA) for its generic version of Doxorubicin Hydrochloride Liposome injection. This drug is used in cancer treatment and is part of a high-value and competitive segment in the US pharmaceutical market. The approval marks another important step in Alembic's efforts to expand its US generics portfolio. One of India's pioneering pharma companies, Alembic has been steadily building its presence in the US market, with more than 180 Abbreviated New Drug Applications (ANDAs) filed and over 120 already approved. This latest approval is expected to add to its revenue stream and improve market visibility, especially in the oncology segment. The company, which was previously focused mainly on the domestic market through its active pharmaceutical ingredient (API) and formulation businesses—primarily in antibiotics—has only recently begun actively expanding into international markets.
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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.