Alembic Pharma Gets USFDA Nod for Carbamazepine 200 mg

17 Apr 2025 , 02:49 PM

Alembic Pharmaceuticals Limited on April 17, 2025, informed that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbamazepine Tablets USP, 200 mg.

The approved product is the generic equivalent of Tegretol Tablets 200 mg, which was initially developed by Novartis Pharmaceuticals Corporation. Carbamazepine is an anticonvulsant drug and is used mainly for the treatment of seizure disorders. It is also utilized to treat pain that is neuropathic, especially in conditions like trigeminal neuralgia, a long-term pain disorder of the facial nerves.

The estimated United States market size for Carbamazepine Tablets USP, 200 mg for the 12 months ending December 2024 is about $32 million, according to IQVIA.

This regulatory achievement contributes to Alembic Pharma’s increasing list of generic drug approvals. With this, Alembic now boasts a total of 222 ANDA approvals from USFDA, including 196 final approvals and 26 tentative approvals. This latest approval enhances Alembic’s foothold in the US generics segment, reiterating its commitment to increasing its product portfolio in the central nervous system (CNS) segment.