Alembic Pharmaceuticals gets USFDA nod for eye glaucoma treatment

Alembic Pharmaceuticals Limited announced on December 18, 2025, that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution). This approval allows Alembic to market a generic version of Travatan Z Ophthalmic Solution, 0.004%, which treats elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

The market for Travoprost Ophthalmic Solution USP, 0.004%, is estimated at $61 million for the twelve months ending September 2025, according to IQVIA data. This approval contributes to Alembic's cumulative total of 232 ANDA approvals, comprising 212 final approvals and 20 tentative approvals from the USFDA.

Alembic Pharmaceuticals, headquartered in India, is a vertically integrated research and development pharmaceutical company with global operations and USFDA-approved manufacturing facilities. Established in 1907, the company manufactures and markets generic pharmaceutical products worldwide.