Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion, 0.05%. This approval marks another important regulatory milestone for the company as it continues to expand its presence in the US generic pharmaceuticals market.
The approved ANDA is therapeutically equivalent to the reference listed drug product Durezol Ophthalmic Emulsion, 0.05%, originally developed by Sandoz Inc. Difluprednate ophthalmic emulsion is prescribed for the treatment of inflammation and pain associated with ocular surgery. It is also indicated for the management of endogenous anterior uveitis, a condition that causes inflammation inside the eye. Patients are advised to refer to the product label for detailed indications and usage information.
With this latest approval, Alembic Pharmaceuticals has strengthened its US regulatory portfolio. The company now has a cumulative total of 233 ANDA approvals from the USFDA, comprising 213 final approvals and 20 tentative approvals. This growing pipeline highlights Alembic’s consistent focus on regulatory compliance, product quality, and timely execution in highly regulated markets.
Founded in 1907, Alembic Pharmaceuticals Limited is a vertically integrated research and development–driven pharmaceutical company headquartered in India. The company manufactures and markets a wide range of generic pharmaceutical products across global markets. Its advanced research and manufacturing facilities meet stringent international regulatory standards and are approved by authorities in several developed countries, including the USFDA.
In India, Alembic is recognised as one of the leading players in branded generics. Its well-established portfolio is supported by a field force of more than 5,500 professionals, with brands that are widely trusted by doctors and patients alike. The latest USFDA approval further reinforces Alembic Pharmaceuticals’ long-standing commitment to improving access to high-quality, affordable medicines worldwide.
