Alembic Pharmaceuticals Limited 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), marking another addition to its growing US generics portfolio.
The approved product is therapeutically equivalent to Travatan Z Ophthalmic Solution, 0.004%, the reference listed drug marketed by Sandoz Inc. Travoprost ophthalmic solution is prescribed for the reduction of elevated intraocular pressure (IOP) in patients suffering from open-angle glaucoma or ocular hypertension. Detailed usage and indications are outlined in the product label.
According to IQVIA data, Travoprost Ophthalmic Solution USP, 0.004%, recorded an estimated market size of approximately US$ 61 million in the twelve months ended September 2025, highlighting the commercial relevance of the approval in the US ophthalmic drugs segment.
With this latest clearance, Alembic Pharmaceuticals has now secured a cumulative total of 232 ANDA approvals from the USFDA. This includes 212 final approvals and 20 tentative approvals, reinforcing the company’s steady execution in regulated markets and its continued focus on expanding its US product offerings.
