Approved ANDA matches Opsumit, a 10 mg macitentan tablet for adult PAH treatment, with an estimated market.

• Macitentan reduces disease progression and hospitalization risk in WHO Group I pulmonary arterial hypertension patients.
• Market size reaches $1,180 million for the twelve months ending June 2025, indicating strong commercial potential in the.
• Alembic Pharmaceuticals holds 224 cumulative ANDA approvals, demonstrating extensive experience in generic drug development globally.