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Business Standard
7 hours ago
- Business
- 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.
Business Upturn
9 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.
