Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Travoprost Ophthalmic Solution USP, 0.004% (ionic buffered solution). The product is therapeutically equivalent to Travatan Z Ophthalmic Solution, 0.004%, marketed by Sandoz Inc.
Travoprost ophthalmic solution is prescribed for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. According to IQVIA data, the product has an estimated market value of approximately USD 61 million for the twelve months ending September 2025.
With this approval, Alembic’s cumulative ANDA approvals from the USFDA stand at 232, comprising 212 final approvals and 20 tentative approvals. The development further strengthens the company’s growing portfolio in the ophthalmic segment of the US generics market.
Alembic Pharmaceuticals Limited is a vertically integrated pharmaceutical company with a legacy dating back to 1907. Headquartered in India, the company manufactures and markets generic medicines globally, supported by research and manufacturing facilities approved by leading international regulators, including the USFDA. Alembic is also a major player in India’s branded generics market, with a strong presence among healthcare professionals and patients.
