Alembic Pharmaceuticals Limited has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion, 0.05%. The approved product is therapeutically equivalent to the reference listed drug Durezol Ophthalmic Emulsion, 0.05%, marketed by Sandoz Inc.
Difluprednate ophthalmic emulsion is prescribed for the treatment of inflammation and pain following ocular surgery, and is also indicated for endogenous anterior uveitis. Detailed usage information is available in the product label. With this approval, Alembic’s cumulative USFDA ANDA approvals now stand at 233, comprising 213 final approvals and 20 tentative approvals.
Alembic Pharmaceuticals Limited is one of India’s oldest and most respected pharmaceutical companies, with a legacy that dates back to 1907. Headquartered in India, Alembic has built a strong global presence as a vertically integrated research-driven pharmaceutical company, focused on the development, manufacturing and marketing of high-quality generic medicines. The company operates across major therapeutic areas and supports healthcare systems worldwide through a wide portfolio of affordable formulations and active pharmaceutical ingredients.
A key strength of Alembic is its strong emphasis on research and development, backed by modern infrastructure and a consistent pipeline of new products for regulated and emerging markets. Its manufacturing facilities meet global standards and are approved by leading regulatory authorities, including the US Food & Drug Administration (USFDA). The company has secured a significant number of ANDA approvals in the United States, reflecting its capability in compliance-driven product development and execution.
In India, Alembic is also a leading player in branded generics, supported by a wide field force and a well-recognised set of brands trusted by healthcare professionals and patients. With a commitment to innovation, quality and patient-centric healthcare, Alembic continues to strengthen its role as a reliable pharmaceutical partner worldwide.
