Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Difluprednate Ophthalmic Emulsion, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Durezol Ophthalmic Emulsion, 0.05%, of Sandoz Inc. (Sandoz).
Difluprednate ophthalmic emulsion is indicated for the treatment of inflammation and pain associated with ocular surgery and also indicated for the treatment of endogenous anterior uveitis. Alembic has a cumulative total of 233 ANDA approvals (213 final approvals and 20 tentative approvals) from USFDA.
Alembic Pharmaceuticals (Alembic Pharma) is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
