Latest news with #AbbreviatedNewDrugApplications
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
4 days ago
- Business
- Business Standard
Indian pharma eyes US gains as $63.7 bn patent cliff nears: Analysts
The Indian pharmaceutical industry is poised to benefit from a major wave of patent expiries in the US, with small-molecule drugs worth $63.7 billion expected to go off-patent between 2025 and 2029—a 65 per cent increase over the previous five years. Combined with a broader Loss of Exclusivity (LoE) opportunity across the US and EU projected to reach $180 billion by 2035, this marks a significant opening for Indian drugmakers, according to a report by Antique Stock Broking Limited. This shift is expected to spur a rise in generic launches, particularly benefiting Indian players with emerging US operations and expertise in complex generics. Firms such as Alembic Pharmaceuticals and Shilpa Medicare, which have smaller US footprints, and larger players like Cipla and Lupin, which have invested early in differentiated products such as injectables and respiratory therapies, are seen as well positioned to gain market share. With global majors like Teva, Viatris and Sandoz having closed dozens of manufacturing sites since 2018, Indian companies are stepping in to fill the supply gap. However, the opportunity is unfolding amid growing strategic discipline. Filings of Abbreviated New Drug Applications (ANDAs) in the US declined 25 per cent year-on-year. FY25 filings are projected to close around 550—down from 740 in FY24 and 857 in FY22. This signals a pivot from volume to portfolio quality, regulatory compliance and margin protection. Commenting on this shift, Nilaya Varma, Group CEO and Co-founder of Primus Partners, said, 'India's pharma exports have grown from $15 billion in 2013–14 to nearly $28 billion in a decade. With 750+ USFDA-approved plants and rising strength in complex generics and biosimilars, India is primed to lead the next wave of affordable, high-quality medicines. Tapping the $180 billion LoE opportunity will require continued focus on compliance and quality systems.' Regulatory headwinds are also easing. The share of US FDA inspections resulting in Official Action Indicated (OAI) for Indian firms has fallen from 19 per cent in 2013 to 9 per cent in 2023. Companies like Cipla are further de-risking their US supply chains by adopting multi-site manufacturing and digital quality systems. Cipla, which holds a robust US portfolio of 284 ANDA and NDA filings—175 of which are approved and 73 under review—is focusing on commercialisation-ready products, including PEPFAR-approved generics. The company is betting on complex respiratory and injectable therapies to drive growth. Pharma major Lupin, which continues to benefit globally from its blockbuster autoimmune biologic Etanercept, plans to finalise its US commercialisation strategy closer to the drug's 2029 patent expiry. Meanwhile, Sun Pharma, despite offering a conservative FY26 outlook amid global macro uncertainties, is expanding its oncology pipeline. Its recently acquired UNLOXCYT (cosibelimab) is expected to significantly contribute to US revenues. The company noted that Keytruda's upcoming patent expiry was already factored into the acquisition. UNLOXCYT targets only one of Keytruda's multiple indications, and Sun remains confident in its potential to become a meaningful contributor to its US specialty business. In parallel, Sun is also strengthening its immunotherapy portfolio through a global licensing agreement with Philogen.
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Business Standard
26-05-2025
- Business
- Business Standard
Aurobindo Pharma Q4 net dips 0.5%, revenue up 10.5% to Rs 8,382 cr
Aurobindo Pharma posted a 0.5 per cent year-on-year (Y-o-Y) decline in net profit during the fourth quarter of FY25, reaching Rs 903.4 crore, even as consolidated revenue from operations grew by 10.5 per cent to Rs 8,382.1 crore. This decline in profit after tax (PAT) can be attributed to an increase in total expenses compared to the previous year. On a sequential basis, the company exhibited a 5 per cent increase in revenue, with profit growing by 6.8 per cent. K. Nithyananda Reddy, Vice-Chairman and Managing Director of the company, said: "We are reflecting the strength of our core businesses, consistent volume-led growth, and the depth of our differentiated product portfolio. Our European operations, backed by our ongoing capacity enhancements, remain firmly positioned to sustain our trajectory and create long-term value for our stakeholders.' For the full year of FY25, the company posted a 9.3 per cent Y-o-Y increase in revenue to Rs 31,723.7 crore, with net profit also rising 9.8 per cent to Rs 3,485.8 crore. This quarter, revenue from the United States rose 13.5 per cent Y-o-Y to Rs 4,072 crore, driven by higher volumes, a stable pricing environment, and new product launches. The US contributed 48.6 per cent to consolidated revenue. The company filed nine Abbreviated New Drug Applications (ANDAs) with the USFDA, received five final approvals (including two that were previously tentative), and launched five products during the quarter. As of 31 March 2025, it has cumulatively filed 861 ANDAs, with 690 final and 29 tentative approvals. Similarly, revenue from Europe grew 17.2 per cent Y-o-Y to Rs 2,147 crore, supported by strong performance across key markets. It accounted for 25.6 per cent of consolidated revenue. Revenue from growth market formulation declined 7.8 per cent Y-o-Y to Rs 786 crore due to subdued performance in select markets, contributing 9.4 per cent to consolidated revenue. Domestic formulation sales stood at Rs 56 crore for the quarter.
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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.
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.
