Alembic Pharmaceuticals Limited has received the final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Difluprednate Ophthalmic Emulsion, 0.05%. The approved ANDA is considered therapeutically equivalent to the reference listed drug product, Durezol Ophthalmic Emulsion, 0.05%, originally from Sandoz Inc. This ophthalmic emulsion is indicated for treating inflammation and pain associated with ocular surgery, as well as endogenous anterior uveitis. With this approval, Alembic Pharmaceuticals now holds a cumulative total of 233 ANDA approvals from the USFDA, comprising 213 final approvals and 20 tentative approvals. The company, a vertically integrated pharmaceutical entity established in 1907 and headquartered in India, has a strong global presence in manufacturing and marketing generic pharmaceutical products, with its facilities approved by major international regulatory authorities.
