Alembic Receives USFDA Final Approval for Carbamazepine Tablets USP, 200 mg

Alembic Pharmaceuticals Limited (Alembic) has received from the U.S. Food and Drug Administration (U.S. FDA), final approval for its ANDA application for Carbamazepine Tablets, USP 200 mg.

Carbamazepine is a well-known antiepileptic drug that comes in the commercial form, Tegretol Tablets 200 mg, marketed by Novartis Pharmaceuticals Corporation, as therapeutically equivalent to the drug approved newly. The drug is also available for the treatment of pains occurring in true trigeminal neuralgia, which is a chronic pain condition affecting the facial nerves. For further complete information about therapeutic indications, healthcare professionals should refer to the product labeling.

The estimated dimensions for the market of Carbamazepine tablets USP 200 mg, in terms of size in the U.S., is close to $32 million during the twelve months ending December 2024, as per IQVIA. Thus, the opportunity presented as generics by Alembic is large.

This new approval will further enrich the U.S. generics portfolio of Alembic, and there are now 222 ANDA approvals with the U.S. FDA, of which 196 are final approvals and 26 are tentative approvals. This success adds momentum to Alembic's already strong presence in regulated markets and stands testimony to Alembic's relentless commitment toward the advancement of affordable, high-quality generic medicines worldwide, catering to the health care needs of the global community.