Shares of Alembic Pharmaceuticals Ltd increased 2% on Tuesday, 19 August 2025, on securing a final approval from the USFDA. 

Alembic Pharmaceuticals gained final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Macitentan Tablets, 10 mg, which is used to treat pulmonary arterial hypertension in adults.

According to IQVIA, the drug’s US market size is predicted to be $1.18 billion in the 12 months ending June 2025. Alembic now has 224 USFDA clearances (203 final and 21 provisional).

Apart from that, the company gained final approval for Tretinoin Cream USP (0.025%). The authorised ANDA is therapeutically similar to Bausch Health US, LLC’s Retin-A Cream, 0.025%(RLD).

Tretinoin cream is recommended for topical use in the treatment of acne vulgaris.

According to IQVIA, the market for Tretinoin cream USP, 0.025%, is expected to be worth USD 94 million in the year ending June 2025.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been a leader in healthcare since 1907. Alembic, based in India, is a publicly traded firm that manufactures and markets generic pharmaceutical goods around the world. Alembic’s research and manufacturing facilities have been approved by regulatory agencies in numerous industrialised nations, including the US FDA. 

The company is a leader in branded generics in India. Alembic’s brands, which are promoted through a field force of over 5500, are highly known among doctors and patients.

At 2:10 pm, the shares of Alembic Pharma were trading 0.75% higher at Rs 979 on NSE. 

Tired of missing hot stocks? Unicorn Signals provides powerful tools like stock scans and more help you make informed trading decisions. Download now and take control of your portfolio!