India Pharma Outlook Team | Wednesday, 20 August 2025
Alembic Pharmaceuticals Limited announced that the US Food and Drug Administration (USFDA) gave its final approval to their Abbreviated New Drug Application (ANDA) for Macitentan Tablets, 10 mg.
This ANDA works the same way as Opsumit Tablets, 10 mg, from Actelion Pharmaceuticals US, Inc. Macitentan is a type of medicine that treats pulmonary arterial hypertension (PAH, WHO Group I) in grown-ups. It helps lower the chance of the disease getting worse and keeps people out of the hospital.
Per IQVIA, this product's market is worth around $1.18 billion over a year, ending in June 2025. With this approval, Alembic now has 224 ANDA approvals from the USFDA, with 203 being final and 21 tentative.
Back in July, Alembic also got a tentative USFDA approval for their Selexipag for Injection, 1,800 mcg/vial, which also treats PAH. Selexipag is a different kind of drug that also helps slow down the illness and reduce hospital visits for PAH patients.
Also Read: Alembic Receives USFDA Approval for Generic Epilepsy Drug
Alembic Pharmaceuticals Limited, based in India, researches, makes, and sells generic medicines across the globe. They have modern research and development, and manufacturing sites that are approved by major regulators, like the USFDA.
The approval for Macitentan helps Alembic grow in the cardiovascular and pulmonary care area and reinforces their hold in the US generic drug market.
