Alembic Pharma Gets USFDA Approval for Generic Anticonvulsant

New Delhi, Apr 17 (PTI) Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a generic anticonvulsant medication.

The company has received approval from the US Food and Drug Administration (USFDA) to market Carbamazepine tablets (USP, 200 mg) in the US market, the drug firm said in a regulatory filing.

The approved product is therapeutically equivalent to the reference listed drug product (RLD), Tegretol Tablets, 200 mg, of Novartis Pharmaceuticals Corporation, it added.


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.

According to IQVIA, Carbamazepine tablets USP, 200 mg have an estimated market size of USD 32 million for 12 months ended December 2024.

Shares of Alembic Pharma were trading 0.21 per cent down at Rs 849.85 apiece on BSE.