Alembic Pharmaceuticals Gains USFDA Approval for Difluprednate

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 Difluprednate Ophthalmic Emulsion, 0.05%. This approval was granted on 27th January, 2026. The approved product is therapeutically equivalent to the reference listed drug product, Durezol Ophthalmic Emulsion, 0.05%, manufactured by Sandoz Inc.

The Difluprednate Ophthalmic Emulsion is indicated for the treatment of inflammation and pain associated with ocular surgery. It is also indicated for the treatment of endogenous anterior uveitis. The approval confirms the product’s equivalence to the existing market product, ensuring its compliance with the necessary regulatory standards.

With this latest approval, Alembic Pharmaceuticals has achieved a cumulative total of 233 ANDA approvals from the USFDA. This includes 213 final approvals and 20 tentative approvals. The company’s consistent receipt of approvals underscores its ongoing commitment to expanding its portfolio of generic pharmaceutical products.

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. It has been active in the healthcare sector since 1907. The company focuses on manufacturing and marketing generic pharmaceutical products globally. Alembic’s research and manufacturing facilities have received approvals from regulatory authorities in several developed countries, including the USFDA. The company is recognized as a leader in branded generics in India, with a significant presence in the market through its extensive field force.