Alembic Accelerates: USFDA Approval for Carbamazepine 200 mg Fuels Global Ambitions

Alembic Pharmaceuticals Limited today announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbamazepine Tablets USP, 200 mg. These tablets are therapeutically equivalent to Tegretol Tablets 200 mg of Novartis Pharmaceuticals, which is commonly prescribed as an anticonvulsant and for pain related to trigeminal neuralgia.

 

The US market for Alembic's Carbamazepine 200 mg tablets is approximated at $32 million for the twelve months to December 2024, as per IQVIA. This approval is Alembic's 222nd ANDA approval from the USFDA, of which 196 are final and 26 are tentative approvals, reaffirming its position as a global generics leader.

 

Alembic's vertically integrated manufacturing facilities and USFDA approval have made the company a sought-after supplier to the American and European markets. The company's strong R&D pipeline and backward integration approach continue to propel its growth in the CNS (Central Nervous System) space and beyond.

 

Through this achievement, Alembic Pharmaceuticals consolidates its US portfolio, achieving its vision of making quality medicines affordable globally.

 

Source: NSE, BSE, Alembic Pharmaceuticals, Business Upturn