Alembic Pharmaceuticals 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. Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg, have an estimated market size of $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. 

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