Alembic Pharma gets USFDA nod for generic drug; check details and share price trend

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, from GlaxoSmithKline LLC.

The company said that Lamotrigine is indicated as adjunctive therapy in patients aged 2 years and older for i) partial-onset seizures, ii) primary generalised tonic-clonic (PGTC) seizures, and iii) generalised 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. Refer to the label for a detailed indication.

Lamotrigine orally disintegrating tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg, have an estimated market size of US$27 million for the twelve months ending December 2025, according to IQVIA.

Alembic, the company said, has a cumulative total of 235 ANDA approvals (216 final approvals and 19 tentative approvals) from the USFDA.

Stock performance

Shares of Alembic Pharma were trading over 1% lower at ₹731.75 apiece on the NSE. The stock has slipped over 3% in the past five sessions. Over the past six months, the stock price has slipped by around 22%. YTD, the scrip is down over 12.6%.

About Alembic Pharma

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907.

Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

Alembic's research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. Alembic is one of the leaders in branded generics in India.

Alembic's brands, marketed through a field force of over 5500, are well recognised by doctors and patients.