Alembic Pharmaceuticals Ltd. has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Macitentan Tablets, 10 mg.

The product is therapeutically equivalent to the reference listed drug (RLD), Opsumit Tablets, 10 mg, marketed by Actelion Pharmaceuticals US, Inc.

Macitentan tablets, an endothelin receptor antagonist (ERA), are indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risk of disease progression and PAH-related hospitalisations.  

According to IQVIA, the market size for Macitentan Tablets, 10 mg, was estimated at USD 1,180 million for the twelve months ending June 2025.

With this approval, Alembic now holds a cumulative total of 224 ANDA approvals from the USFDA, comprising 203 final and 21 tentative approvals.

Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products worldwide.