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HomeMarket NewsAlembic Pharma gets final US FDA nod for Carbamazepine tablets
Carbamazepine Tablets USP, 200 mg have an estimated market size of $32 million for 12 months ending December 2024, according to IQVIA.
By CNBCTV18.com April 17, 2025, 12:54:30 PM IST (Published)
Alembic Pharmaceuticals Ltd. on Thursday, April 17, informed the exchanges 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 ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol Tablets, 200 mg, of Novartis Pharmaceuticals Corporation, Alembic Pharma said in a regulatory filing.
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.
Carbamazepine Tablets USP, 200 mg have an estimated market size of $32 million for 12 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.
Shares of Alembic Pharmaceuticals Ltd. are trading 0.55% lower on Thursday at ₹847.30. The stock is down 20% so far in 2025.
