Alembic Pharma receives final approval for Carbamazepine tablets

Alembic Pharmaceuticals 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 ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol Tablets, 200 mg, of Novartis Pharmaceuticals Corporation. Carbamazepine Tablets USP, 200 mg, are indicated for use as an anticonvulsant drug.

They are also indicated for the treatment of pain associated with true trigeminal neuralgia. Refer to the product label for the complete list of indications.

Carbamazepine Tablets USP, 200 mg, have an estimated market size of US$ 32 million for the twelve months ending December 2024, according to IQVIA.

With this approval, Alembic now has a cumulative total of 222 ANDA approvals from the USFDA, comprising 196 final approvals and 26 tentative approvals.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company that has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.

The companys consolidated net profit tumbled 23.29% to Rs 138.42 crore in Q3 FY25, compared with Rs 180.45 crore posted in Q3 FY24. Revenue from operations was at Rs 1,692.74 crore in the third quarter of FY25, up 3.81% year on year (YoY).

Shares of Alembic Pharmaceuticals shed 0.19% to Rs 850.15 on the BSE.

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