Alembic Pharmaceuticals Limited announces USFDA Final Approval for Carbamazepine Tablets USP, 200 mg

17^th April, 2025, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) 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. Refer label for a detailed indication.

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.