Alembic Pharma shares rise 2% on pulmonary hypertension drug approval

Alembic Pharma shares rose 2.3 per cent on Tuesday, after the company received US Food & Drug Administration (USFDA) final approval for its Abbreviated New Drug Application (ANDA) Macitentan Tablets

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.