Alembic Pharmaceuticals Ltd

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal ODT Orally Disintegrating Tablets, 25 mg, 50 mg, 100 mg, and 200 mg, of GlaxoSmithKline LLC. Lamotrigine is indicated as adjunctive therapy in patients aged 2 years and older for: i) partial-onset seizures, ii) primary generalized tonic-clonic (PGTC) seizures, and iii) generalized seizures of Lennox Gastaut syndrome. It is also indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (AED). Lamotrigine is indicated for the maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy. Lamotrigine Orally Disintegrating Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg, have an estimated market size of US$ 27 million for twelve months ending December 2025 according to IQVIA.Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Lamictal ODT Orally Disintegrating Tablets of GlaxoSmithKline LLC. Lamotrigine is indicated as adjunctive therapy for patients aged two years and above for partial-onset seizures, primary generalized tonic-clonic (PGTC) seizures, and generalized seizures of Lennox-Gastaut syndrome. It is also indicated for conversion to monotherapy in certain adult patients with partial-onset seizures and for maintenance treatment of bipolar I disorder. According to IQVIA data, the product has an estimated market size of US$ 27 million for the 12 months ended December 2025. With this approval, Alembic now has a cumulative total of 235 ANDA approvals from the USFDA, comprising 216 final approvals and 19 tentative approvals. Alembic Pharmaceuticals, a vertically integrated research and development company, is engaged in the manufacture and marketing of generic pharmaceutical products across global markets. The company's consolidated net profit fell 3.9% to Rs 132.97 crore despite a 10.8% jump in net sales to Rs 1,876.31 crore in Q3 FY26 over Q3 FY25. The counter rose 0.39% to Rs 741.30 on the BSE.Powered by Capital Market - Live

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) Efinaconazole Topical Solution, 10%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jublia Topical Solution, 10%, of Bausch Health Americas, Inc. (Bausch). Efinaconazole Topical Solution is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification. Efinaconazole Topical Solution, 10%, has an estimated market size of US$ 500 million for twelve months ending December 2025 according to IQVIA. Alembic has a cumulative total of 234 ANDA approvals (215 final approvals and 19 tentative approvals) from USFDA.Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Jublia Topical Solution, 10%, of Bausch Health Americas, Inc. (Bausch). The said drug is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. According to IQVIA, Efinaconazole Topical Solution, 10%, has an estimated market size of $500 million for twelve months ending December 2025. The company has a cumulative total of 234 ANDA approvals (215 final approvals and 19 tentative approvals) from USFDA. Alembic Pharmaceuticals, a vertically integrated research and development company, is engaged in the manufacture and marketing of generic pharmaceutical products across global markets. The company's consolidated net profit fell 3.9% to Rs 132.97 crore despite a 10.8% jump in net sales to Rs 1,876.31 crore in Q3 FY26 over Q3 FY25. The counter fell 1.31% to Rs 757 on the BSE.Powered by Capital Market - Live

The inspection was conducted from 9th February to 18th February 2026. At the end of the inspection, a 'Form 483' was issued with 2 observations and the company said that it will respond to the US FDA within the stipulated timelines. Alembic Pharmaceuticals, a vertically integrated research and development company, is engaged in the manufacture and marketing of generic pharmaceutical products across global markets. The company's consolidated net profit fell 3.9% to Rs 132.97 crore despite a 10.8% jump in net sales to Rs 1,876.31 crore in Q3 FY26 over Q3 FY25.Powered by Capital Market - Live

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Stalevo Tablets, manufactured by Orion Corporation. These tablets are indicated for the treatment of Parkinson's disease. With this approval, Alembic Pharmaceuticals now has a cumulative total of 234 ANDA approvals from the USFDA, including 214 final approvals and 20 tentative approvals. Alembic Pharmaceuticals, a vertically integrated research and development company, is engaged in the manufacture and marketing of generic pharmaceutical products across global markets. On the financial front, the company reported a consolidated net profit of Rs 184.71 crore in Q2 FY26, up 20.40% from Rs 153.41 crore in Q2 FY25. Revenue from operations rose 15.90% year-on-year to Rs 1,910.15 crore in the quarter ended September 2025. Shares of Alembic Pharmaceuticals declined 2.17% to Rs 792.15 on the BSE. Powered by Capital Market - Live

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

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

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

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