Alembic Pharmaceuticals (Alembic) today announced that it 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.Powered by Capital Market - Live News

Alembic Pharmaceuticals will hold a meeting of the Board of Directors of the Company on 5 February 2026.Powered by Capital Market - Live News

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its supplemental Abbreviated New Drug Application (sANDA) Bosutinib Tablets, 400 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif Tablets, 400 mg, of PF Prism C.V. (PF Prism C.V.). Bosutinib is a kinase inhibitor indicated for the treatment of i) adult patients with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy, and ii) adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy. Alembic had previously received final approval for its ANDA Bosutinib Tablets, 100 mg and 500mg. Refer label for a detailed indication.Bosutinib Tablets, 400 mg, have an estimated market size of US$ 251 million for twelve months ending September 2025 according to IQVIA.Alembic has a cumulative total of 232 ANDA approvals (212 final approvals and 20 tentative approvals) from USFDA.Powered by Capital Market - Live News

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Travoprost Ophthalmic Solution USP, 0.004% (Ionic Buffered Solution). The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Travatan Z Ophthalmic Solution, 0.004%, of Sandoz Inc. (Sandoz). Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.Travoprost Ophthalmic Solution USP, 0.004%, has an estimated market size of US$ 61 million for twelve months ending September 2025 according to IQVIA.Alembic has a cumulative total of 232 ANDA approvals (212 final approvals and 20 tentative approvals) from USFDA.Powered by Capital Market - Live News

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, 0.5%/0.3% (5 mL and 10 mL). The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb Incorporated. Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3%, is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Alembic was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, Alembic is eligible for 180 days of CGT exclusivity upon commercialization. Powered by Capital Market - Live News