Alembic Pharma receives USFDA approval for Travoprost ophthalmic solution

Alembic Pharmaceuticals announced 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).

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Travatan Z Ophthalmic Solution, 0.004%, marketed by Sandoz Inc. Travoprost ophthalmic solution is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

According to IQVIA, Dasatinib tablets have an estimated market size of US$ 61 million for the 12 months ending September 2025.

With this approval, Alembic has a cumulative total of 232 ANDA approvals from the USFDA, including 212 final approvals and 20 tentative approvals.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

The companys consolidated net profit jumped 20.40% to Rs 184.71 crore in Q2 FY26, compared to Rs 153.41 crore posted in Q2 FY25. Revenue from operations grew 15.90% year on year (YoY) to Rs 1,910.15 crore in Q2 September 2025.

Shares of Alembic Pharmaceuticals shed 0.34% to Rs 844 on the BSE.

Powered by Capital Market - Live News