Alembic Pharma wins USFDA approval for pulmonary arterial hypertension drug Macitentan
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-08-19 07:27 GMT | Update On 2025-08-19 07:27 GMT
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Vadodara: Alembic Pharmaceuticals Limited today announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Macitentan Tablets, 10 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Opsumit Tablets, 10 mg, of Actelion Pharmaceuticals US, Inc.
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 US$ 1,180 million for twelve months ending June 2025 according to IQVIA. Alembic has a cumulative total of 224 ANDA approvals (203 final approvals and 21 tentative approvals) from USFDA.
Separately, in July last year, the Medical Dialogues team reported that
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
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