Alembic Pharmaceuticals Limited announces USFDA Final Approval for Travoprost Ophthalmic Solution USP, 0.004%

Alembic Pharmaceuticals Limited (Alembic) today announced that it 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. Refer label for a detailed indication.

Travoprost Ophthalmic Solution USP, 0.004%, has an estimated market size of US$ 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.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 846.90 as compared to the previous close of Rs. 846.15. The total number of shares traded during the day was 2914 in over 258 trades.

The stock hit an intraday high of Rs. 853.40 and intraday low of 840.00. The net turnover during the day was Rs. 2476028.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval TravoprostOphthalmicSolution