Alembic Pharmaceuticals gets USFDA’s final nod for Travoprost Ophthalmic Solution USP

18 Dec 2025 Evaluate

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution). The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Travatan Z Ophthalmic Solution, 0.004%, of Sandoz Inc. (Sandoz). Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Travoprost Ophthalmic Solution USP, 0.004%, has an estimated market size of $61 million for twelve months ending September 2025 according to IQVIA. Alembic has a cumulative total of 232 ANDA approvals (212 final approvals and 20 tentative approvals) from USFDA. 

Alembic Pharmaceuticals (Alembic Pharma) is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.


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