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

Varahi media.com online news, Mumbai, April 18 2025:Alembic Pharmaceuticals Limited has announced that it has received final approval from the U.S. Food & Drug Administration (USFDA)

Varahi media.com online news, Mumbai, April 18 2025:Alembic Pharmaceuticals Limited has announced that it has received final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbamazepine Tablets USP, 200 mg.

The approved product is therapeutically equivalent to Tegretol Tablets, 200 mg, the Reference Listed Drug (RLD) of Novartis Pharmaceuticals Corporation.

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Carbamazepine is an anticonvulsant medication, primarily indicated for the treatment of seizures and for managing pain associated with trigeminal neuralgia. For complete prescribing information, refer to the product label.

According to IQVIA data, the U.S. market for Carbamazepine Tablets USP, 200 mg was approximately USD 32 million for the twelve-month period ending December 2024.

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This latest approval marks a continued expansion of Alembic’s presence in the U.S. generics market. With this, Alembic now holds a cumulative total of 222 ANDA approvals, which includes 196 final approvals and 26 tentative approvals from the USFDA.