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.