Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbidopa, Levodopa and Entacapone Tablets, 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets, 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg, of Orion Corporation. Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson`s disease. Powered by Capital Market - Live News

Net profit of Alembic Pharmaceuticals declined 3.94% to Rs 132.97 crore in the quarter ended December 2025 as against Rs 138.42 crore during the previous quarter ended December 2024. Sales rose 10.84% to Rs 1876.31 crore in the quarter ended December 2025 as against Rs 1692.74 crore during the previous quarter ended December 2024. ParticularsQuarter EndedDec. 2025Dec. 2024% Var. Sales1876.311692.74 11 OPM %15.5415.37 - PBDT283.85247.82 15 PBT203.73177.78 15 NP132.97138.42 -4 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) 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