Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol-XR ExtendedRelease Tablets, 100 mg, 200 mg, and 400 mg, of Novartis Pharmaceuticals Corporation.

Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug and also for the treatment of the pain associated with true trigeminal neuralgia. Refer label for a detailed indication.

Carbamazepine Extended-Release Tablets USP, 100 mg, 200 mg, and 400 mg, have an estimated market size of US$ 71 million for twelve months ending March 2025 according to IQVIA.

Alembic has a cumulative total of 225 ANDA approvals (202 final approvals and 23 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 998.30 as compared to the previous close of Rs. 1018.30. The total number of shares traded during the day was 4068 in over 273 trades.

The stock hit an intraday high of Rs. 1026.95 and intraday low of 993.95. The net turnover during the day was Rs. 4077589.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval Carbamazepine ExtendedReleaseTabelts