Alembic Pharma gets USFDA nod for anticonvulsant drug Carbamazepine Extended Release

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-07-26T13:01:54+05:30 | Updated On 26 July 2025 1:01 PM IST

Alembic Pharma Carbamazepine Extended Release

Vadodara: An Indian multinational pharmaceutical company, Alembic Pharmaceuticals Limited, today announced that the company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol-XR Extended Release Tablets, 100 mg, 200 mg, and 400 mg, of Novartis Pharmaceuticals Corporation.

Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug and also for the treatment of the pain associated with true trigeminal neuralgia.

Read also: USFDA clears Alembic Pharma cardio drug Rivaroxaban, launch expected in next year

Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg, have an estimated market size of US$ 71 million for twelve months ending March 2025 according to IQVIA.

Alembic has a cumulative total of 225 ANDA approvals (202 final approvals and 23 tentative approvals) from USFDA.

Earlier this month, Alembic Pharmaceuticals Inc., a wholly owned subsidiary of Alembic Pharma, acquired a 100 percent stake in Utility Therapeutics Ltd, a pharmaceutical company focused on treatments for urinary tract infections (UTIs). The strategic acquisition is aimed at marketing both USFDA-approved and under-development products owned by Utility in the United States.

Read also: Alembic buys UTI-focused Utility Therapeutics in USD 12 million deal

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic's brands, marketed through a field force of over 5500 are well recognized by doctors and patients.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751