Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated August 19, 2025, titled "Alembic Pharmaceuticals Limited receives USFDA Final Approval for Macitentan Tablets, 10 mg".
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Alembic Pharmaceuticals has received final approval from the USFDA for its generic version of Macitentan Tablets, 10 mg. This drug is used to treat pulmonary arterial hypertension (PAH) in adults. The reference brand is Opsumit Tablets by Actelion Pharmaceuticals. The US market for this drug is estimated at US$ 1,180 million over the twelve months ending June 2025, according to IQVIA. With this approval, Alembic now has a cumulative total of 224 ANDA approvals from the USFDA (203 final and 21 tentative). The company is a vertically integrated pharmaceutical firm headquartered in India with a history dating back to 1907.
This is a positive development for shareholders as it allows Alembic to launch a generic version of a blockbuster drug (~$1.18 billion US market) in the highly lucrative US generic market, potentially boosting future revenues. It also reinforces Alembic's strong track record with USFDA approvals, supporting its credibility as a reliable generic manufacturer.