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Business Standard
13 hours ago
- Business Standard
Alembic Pharma gains after receiving USFDA nod for Macitentan tablets
Alembic Pharmaceuticals added 2.42% to Rs 995.70 after the company received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Macitentan tablets, 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Opsumit tablets, 10 mg, of Actelion Pharmaceuticals US, Inc. (Actelion). Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH. Macitentan tablets, 10 mg, have an estimated market size of $1,180 million for twelve months ending June 2025 according to IQVIA. The pharmaceutical company has a cumulative total of 224 ANDA approvals (203 final approvals and 21 tentative approvals) from USFDA. Alembic Pharmaceuticals is a vertically integrated research-driven company that manufactures and markets generic medicines globally. The company's consolidated net profit jumped 14.6% to Rs 154.38 crore while revenue from operations grew 9.54% to Rs 1,710.72 crore in Q1 June 2025 over Q1 June 2024.
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Business Standard
15 hours ago
- Business Standard
Alembic Pharma shares rise 2% on pulmonary hypertension drug approval
Alembic Pharmaceuticals shares rose 2.3 per cent on Tuesday, August 19, 2025, logging an intra-day high at ₹996.15 per share on BSE. At 11:29 AM, Alembic Pharmaceuticals share price was trading 1.88 per cent higher at ₹991.55 per share. In comparison, the Sensex was 0.27 per cent higher at 81,491.26. Why were Alembic Pharmaceuticals shares rising? Alembic Pharmaceuticals shares were in demand after the company received US Food & Drug Administration (USFDA) final approval for its Abbreviated New Drug Application (ANDA) Macitentan Tablets, 10 mg, used to treat pulmonary arterial hypertension in adults. The drug has an estimated US market size of $1.18 billion for the twelve months ending June 2025, according to IQVIA. This brings Alembic's total USFDA approvals to 224 (203 final, 21 tentative). That apart, the company also received final approval for Tretinoin Cream USP (0.025 per cent). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025 per cent, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. According to IQVIA, Tretinoin cream USP, 0.025 per cent, has an estimated market size of USD 94 million for the twelve months ending June 2025. Check List of Q1 results today Alembic Pharmaceuticals Q1 results The company reported a 14 per cent increase in consolidated net profit year-on-year (Y-o-Y) to ₹154.33 crore for the Q1FY26 compared to ₹131.21 crore in the year-ago period. Revenue from operations also rose by 10 per cent Y-o-Y to ₹1,710.72 crore against ₹1,561.73 crore in Q1FY25. About Alembic Pharmaceuticals Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a field force of over 5500, are well recognized by doctors and patients.
Mint
17 hours ago
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Patel Retail IPO Day 1 LIVE Updates: GMP, price band, subscription status, apply or not as issue opens today
Vaamanaa Sethi Published 19 Aug 2025, 09:54:48 AM IST Patel Retail IPO Day 1 LIVE: Issue opens today. GMP signals strong listing Patel Retail IPO Day 1 LIVE: Patel Retail IPO will opening for subscription on August 19 and close on August 21. The IPO price band has been fixed at ₹ 237– ₹ 255 per share, with each share carrying a face value of ₹ 10. Ahead of the IPO opening, the company raised more than ₹ 43 crore from anchor investors on Monday. Follow updates here: 19 Aug 2025, 09:54:48 AM IST Patel Retail IPO Day 1 LIVE: On Monday, the company secured over ₹ 43 crore from anchor investors prior to the opening of its initial public offering (IPO). The company informed the bourses that it allocated 17,04,388 equity shares at Rs. 255 per share on Monday, August 18, 2025, to anchor investors. Some of the marquee Institutions that participated in the anchor includes Chanakya Opportunities Fund, BNP Paribas Financial Markets, Maybank Securities, Beacon Stone Capital, Saint Capital Fund and Pine Oak Global Fund.
