Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for difluprednate ophthalmic emulsion, 0.05%.
The approved product is therapeutically equivalent to the reference listed drug (RLD), Durezol ophthalmic emulsion, 0.05%, marketed by Sandoz Inc.
Difluprednate ophthalmic emulsion is a corticosteroid indicated for:
The approval enables Alembic to expand its presence in the ophthalmic generics segment in the US market.
With this latest approval:
This milestone reflects the company’s continued focus on building a robust and diversified US generics pipeline.
Alembic Pharmaceuticals Limited is a vertically integrated R&D-driven pharmaceutical company with a legacy dating back to 1907. Headquartered in India, the company develops, manufactures, and markets generic pharmaceutical products globally. Alembic’s state-of-the-art research and manufacturing facilities are approved by multiple regulatory authorities, including the US FDA.
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