Latest news with #AbbreviatedNewDrugApplications
Business Upturn
3 days ago
- Business
- Business Upturn
Zydus Lifesciences gets USFDA nod for Prucalopride tablets, 1 mg and 2 mg
Zydus Lifesciences Limited has received final approval from the US Food and Drug Administration (USFDA) to market Prucalopride Tablets, 1 mg and 2 mg (reference listed drug: Motegrity® ). The tablets are indicated for the treatment of chronic idiopathic constipation (CIC) — a condition in which the cause of constipation is unknown and persistent. Prucalopride works by stimulating natural peristalsis in the colon, thereby aiding regular bowel movements. With this approval, Zydus adds another feather to its cap in the US generics market. The approved tablets will be manufactured at the company's SEZ facility in Ahmedabad, Gujarat. According to IQVIA MAT data for June 2025, Prucalopride tablets had annual sales of USD 186.8 million in the US market. This approval strengthens Zydus' position in the gastrointestinal segment and adds to its growing US portfolio. With this latest nod, the group has now received 422 approvals since it began filing ANDAs (Abbreviated New Drug Applications) in FY 2003-04. In total, Zydus has filed 483 ANDAs so far. Ahmedabad Plane Crash 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
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Business Standard
6 days ago
- Business
- Business Standard
Aurobindo Pharma stock falls 2% after Q1 results; check key numbers here
Aurobindo Pharma: Shares of pharmaceutical major Aurobindo Pharma fell over 2 per cent to hit an intraday low of ₹1,067.3 on Tuesday after the company reported a disappointing set of numbers in the first quarter of fiscal 2026 (Q1FY26). At 11:45 PM, Aurobindo Pharma was trading at 2.08 per cent lower at ₹1,067.7 on the NSE. In comparison, the NSE Nifty was trading lower by 0.38 per cent at 24,629.25. The stock has crashed over 31 per cent from its 52-week high of ₹1,592 touched on September 13, 2024. The company's market capitalisation stood at ₹62,261.93 crore. Aurobindo Pharma Q1 results Aurobindo Pharma's net profit fell 10.2 per cent year-on-year (Y-o-Y) to ₹824 crore in Q1FY26, as against ₹918 crore in the same quarter last year (Q1FY25). The revenue from operations grew 4 per cent Y-o-Y to ₹7,868 crore in Q1FY26, from ₹7,567 crore a year ago. At the operating level, earnings before interest, tax, depreciation and amortisation (Ebitda) before R&D remained almost flat at ₹1,967 crore compared to ₹1,936 crore in the same quarter of the previous fiscal year. Subsequently, Ebitda margin before R&D declined by 84 bps to 24.8 per cent in Q1FY26, from 25.6 per cent a year ago. US formulations revenue marginally declined by 1.9 per cent Y-o-Y to ₹3,488 crore, while Europe formulations revenue increased by 18 per cent Y-o-Y to ₹2,338 crore, and growth markets revenue increased by 8.8 per cent Y-o-Y to ₹772 crore. The company's R&D expenditure for the quarter stood at ₹367 crore, accounting for 4.7 per cent of total revenues. In addition, the company received final approval for 14 Abbreviated New Drug Applications (ANDAs) from the US Food and Drug Administration (FDA) during the quarter. Aurobindo Pharma dividend Despite the muted earnings, the company announced an interim dividend of ₹4 per equity share (400 per cent) and fixed August 8, 2025, as the record date. The dividend will be paid on or before August 21, 2025. About Aurobindo Pharma Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercialises a wide range of generic pharmaceuticals, branded speciality pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 31 manufacturing and packaging facilities that are approved by leading regulatory agencies, including the USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, and Brazil ANVISA. The company has a robust product portfolio spread across 7 major therapeutic areas, including CNS, Anti-Retroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
Business Standard
15-07-2025
- Business
- Business Standard
Zydus Lifesciences gets USFDA Nod for Celecoxib Capsules
Zydus Lifesciences announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Celecoxib Capsules, marking another addition to its growing U.S. generics portfolio. Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body. It is used to treat pain or inflammation caused by many conditions such as arthritis, ankylosing spondylitis, and menstrual pain. It is also used to treat juvenile rheumatoid arthritis in children who are at least 2 years old. Celecoxib capsules will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. According to IQVIA MAT data (May 2025), Celecoxib Capsules recorded annual sales of approximately USD 122.6 million in the U.S. market. With this approval, Zydus has now secured a total of 428 final approvals and has filed 492 Abbreviated New Drug Applications (ANDAs) since it began its U.S. regulatory 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 companys consolidated net profit shed 0.96% to Rs 1,170.9 crore on a 17.21% rise in revenue from operations to Rs 6,290.2 crore in Q4 FY25 over Q4 FY24. The counter shed 0.14% to Rs 967.15 on the BSE.
New Indian Express
30-06-2025
- 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
29-06-2025
- 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.
