03-10-2024 09:51 AM | Source: Accord Fintech
Alembic Pharmaceuticals surges on getting USFDA`s final approval for Lamotrigine Extended-Release Tablets

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Alembic Pharmaceuticals is currently trading at Rs. 1220.90, up by 30.45 points or 2.56% from its previous closing of Rs. 1190.45 on the BSE.

The scrip opened at Rs. 1185.00 and has touched a high and low of Rs. 1222.85 and Rs. 1169.70 respectively. So far 978 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 1285.60 on 08-Aug-2024 and a 52 week low of Rs. 707.50 on 31-Oct-2023.

Last one week high and low of the scrip stood at Rs. 1248.95 and Rs. 1164.70 respectively. The current market cap of the company is Rs. 23399.86 crore.

The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 19.79% and 10.60% respectively.

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Lamictal XR Extended-Release Tablets, 200 mg, 250 mg, and 300 mg, of GlaxoSmithKline LLC (GSK). 

Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older. Also indicated for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. Refer label for a detailed indication.

Lamotrigine Extended-Release Tablets USP, 200 mg, 250 mg, and 300 mg have an estimated market size of $ 163 million for twelve months ending June 2024 according to IQVIA. Alembic has a cumulative total of 216 ANDA approvals (188 final approvals and 28 tentative approvals) from USFDA. 

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