Alembic Pharmaceuticals Ltd Share Price – NSE /  BSE

Pharmaceuticals, Small Cap

Alembic Pharmaceuticals today announced the first prescription-based sale of Pivya? (pivmecillinam) tablets, an oral prescription antibiotic, following its recent commercial launch in the United States of America (US). Pivya? is Alembic's first branded pharmaceutical product in the US and is being marketed through Alembic Therapeutics LLC, a step-down wholly owned subsidiary of Alembic.

Pivya? represents a first-line oral antibiotic option for the treatment of uncomplicated urinary tract infections (uUTIs) in women. The segment has seen limited new product introductions for more than a decade, creating an opportunity for a clinically established therapy with a strong safety and efficacy profile.

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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.

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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.

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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.

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