Latest news with #AlembicPharmaceuticalsLtd


News18
4 hours ago
- Health
- News18
Alembic Pharmaceuticals gets USFDA nod for generic Macitentan tablets
Agency: PTI New Delhi, Aug 19 (PTI) Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regulator for its generic version of Macitentan tablets indicated for the treatment of high blood pressure in the lungs. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Macitentan tablets of strength 10 mg, Alembic said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product Opsumit Tablets, 10 mg, of Actelion Pharmaceuticals US, Inc., it added. Macitentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) in adults to reduce the risks of disease progression and hospitalisation for PAH, the company said. view comments First Published: August 19, 2025, 19:00 IST Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy. Loading comments...


Business Upturn
11 hours ago
- Business
- Business Upturn
Alembic Pharma gains as USFDA approves Macitentan tablets for pulmonary arterial hypertension
By Aditya Bhagchandani Published on August 19, 2025, 11:18 IST Shares of Alembic Pharmaceuticals Ltd were in focus on Tuesday, August 19, after the company announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Macitentan Tablets, 10 mg. The product is a generic version of Actelion Pharmaceuticals' Opsumit tablets and is indicated for the treatment of pulmonary arterial hypertension (PAH) in adults to reduce the risk of disease progression and hospitalization. According to IQVIA data, the drug has an estimated market size of $1.18 billion for the 12 months ending June 2025. With this nod, Alembic's cumulative USFDA approvals now stand at 224 Abbreviated New Drug Applications (ANDAs), including 203 final approvals and 21 tentative approvals. The approval adds to the company's growing US generics portfolio, which has been a key driver of international business. Founded in 1907, Alembic is a vertically integrated pharmaceutical company with a strong presence in branded generics in India and a well-established footprint in the global generics market. The company manufactures and markets products across multiple therapeutic segments through its R&D-driven operations. Disclaimer: This article is for informational purposes only and should not be construed as investment advice. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.


Business Standard
30-06-2025
- Business
- Business Standard
Volumes spurt at Jyoti CNC Automation Ltd counter
Jyoti CNC Automation Ltd notched up volume of 6.05 lakh shares by 10:46 IST on BSE, a 79.9 fold spurt over two-week average daily volume of 7568 shares Alembic Pharmaceuticals Ltd, J B Chemicals & Pharmaceuticals Ltd, TBO Tek Ltd, Torrent Pharmaceuticals Ltd are among the other stocks to see a surge in volumes on BSE today, 30 June 2025. Jyoti CNC Automation Ltd notched up volume of 6.05 lakh shares by 10:46 IST on BSE, a 79.9 fold spurt over two-week average daily volume of 7568 shares. The stock slipped 4.90% to Rs.1,069.25. Volumes stood at 5626 shares in the last session. Alembic Pharmaceuticals Ltd saw volume of 2.15 lakh shares by 10:46 IST on BSE, a 35.35 fold spurt over two-week average daily volume of 6088 shares. The stock increased 12.41% to Rs.1,092.50. Volumes stood at 3761 shares in the last session. J B Chemicals & Pharmaceuticals Ltd witnessed volume of 26053 shares by 10:46 IST on BSE, a 6.01 times surge over two-week average daily volume of 4335 shares. The stock dropped 6.14% to Rs.1,688.85. Volumes stood at 2699 shares in the last session. TBO Tek Ltd recorded volume of 26594 shares by 10:46 IST on BSE, a 5.9 times surge over two-week average daily volume of 4505 shares. The stock gained 6.81% to Rs.1,488.20. Volumes stood at 14313 shares in the last session. Torrent Pharmaceuticals Ltd clocked volume of 29915 shares by 10:46 IST on BSE, a 4.91 times surge over two-week average daily volume of 6093 shares. The stock lost 0.14% to Rs.3,339.85. Volumes stood at 37204 shares in the last session.


Business Upturn
06-05-2025
- Business
- Business Upturn
Alembic Pharmaceuticals Q4 Results: Revenue rises 16.7% YoY to ₹1,769 crore, Net profit down 11.96% YoY
Alembic Pharmaceuticals Ltd announced its financial results for the fourth quarter of FY25, reporting a mixed set of numbers. The company posted a net profit of ₹157 crore, down 11.8% year-on-year (YoY) from ₹178 crore in Q4FY24. The decline in profit was attributed to higher operating expenses and a dip in EBITDA margins. However, revenue for the quarter rose 16.7% YoY to ₹1,769.6 crore, up from ₹1,517 crore in the same period last year, reflecting continued growth across business segments. EBITDA for the quarter stood at ₹272 crore, up 4.6% YoY from ₹260 crore, but margins contracted to 15.4% compared to 17.1% last year. For the full year FY25, Alembic posted consolidated revenue of ₹6,714.63 crore, marking a 7% growth YoY, while net profit declined 5.3% YoY to ₹583.42 crore, largely due to increased raw material costs and tax outflows. Segment-wise, the India branded business grew 8% YoY to ₹545 crore, and US generics reported 20% YoY growth to ₹508 crore. The Ex-US generics segment showed a robust 43% jump, clocking ₹375 crore. The API business also contributed ₹342 crore, growing 4% YoY. The company received two ANDA approvals and launched four new products in the US during the quarter, boosting its international momentum. Managing Director Shaunak Amin credited the domestic specialty portfolio and global expansion as key performance drivers. Key Highlights: Q4 Net Profit: ₹157 crore (↓11.8% YoY) Q4 Revenue: ₹1,769.6 crore (↑16.7% YoY) Q4 EBITDA: ₹272 crore (↑4.6% YoY) EBITDA Margin: 15.4% vs 17.1% (YoY) FY25 Revenue: ₹6,714.63 crore (↑7% YoY) FY25 Net Profit: ₹583.42 crore (↓5.3% YoY) India Business: ₹545 crore (↑8% YoY) US Generics: ₹508 crore (↑20% YoY) Ex-US Generics: ₹375 crore (↑43% YoY) API Segment: ₹342 crore (↑4% YoY) Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your own research or consult a financial advisor before making investment decisions. Author or Business Upturn is not liable for any losses arising from the use of this information. Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.