USFDA approves Alembic Pharma anticonvulsant drug Carbamazepine

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-04-18T12:47:17+05:30 | Updated On 18 April 2025 12:47 PM IST

Alembic Pharma secures USFDA final nod for anticonvulsant drug Carbamazepine

Vadodara: Alembic Pharmaceuticals Limited announced that the US Food & Drug Administration (USFDA) has approved its Abbreviated New Drug Application (ANDA) for Carbamazepine Tablets USP, 200 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol Tablets, 200 mg, of Novartis Pharmaceuticals Corporation. Carbamazepine Tablets USP, 200 mg are indicated for use as an anticonvulsant drug. It is also indicated in the treatment of the pain associated with true trigeminal neuralgia.

True Trigeminal Neuralgia (also known as Classical Trigeminal Neuralgia) is a chronic pain condition that affects the trigeminal nerve, which carries sensation from the face to the brain. It's characterized by sudden, severe, electric shock-like facial pain that typically affects one side of the face.

Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve months ending December 2024 according to IQVIA.

Alembic has a cumulative total of 222 ANDA approvals (196 final approvals and 26 tentative approvals) from USFDA.

Earlier, Medical Dialogues reported that the company also received final approval from the USFDA for its ANDA for Pantoprazole Sodium for Injection, 40 mg/vial, intended for the treatment of pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults.

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 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 5200 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