Alembic Pharmaceuticals Gains USFDA Approval for Ophthalmic Suspension

Alembic Pharmaceuticals Limited has announced the receipt of final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, 0.5%/0.3%. The approval was granted on 11th December 2025.

The approved ophthalmic suspension is available in 5 mL and 10 mL packaging and is therapeutically equivalent to the reference listed drug, Zylet Ophthalmic Suspension, 0.5%/0.3%, manufactured by Bausch & Lomb Incorporated. The product is indicated for steroid-responsive inflammatory ocular conditions where a corticosteroid is necessary, and there is a risk of bacterial ocular infection.

Alembic Pharmaceuticals has been granted a Competitive Generic Therapy (CGT) designation for this application. This designation allows Alembic to benefit from 180 days of CGT exclusivity upon commercialization of the product. This exclusivity is intended to encourage the development and approval of generic drugs that lack competition.

With this latest approval, Alembic Pharmaceuticals now has a cumulative total of 231 ANDA approvals from the USFDA. This includes 211 final approvals and 20 tentative approvals, reflecting the company’s ongoing efforts in expanding its generic pharmaceutical portfolio.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It focuses on manufacturing and marketing generic pharmaceutical products globally. The company operates state-of-the-art research and manufacturing facilities approved by regulatory authorities in several developed countries, including the USFDA. Alembic is recognized as a leader in branded generics in India.