Alembic Pharmaceuticals shares gain on final approval for anticonvulsant drug

Alembic Pharmaceuticals

Alembic Pharmaceuticals share price rose in the early trade on July 28 after company received US Food & Drug Administration (USFDA) final approval for Carbamazepine Extended-Release tablets USP, 100 mg, 200 mg, and 400 mg.

At 09:21am, Alembic Pharmaceuticals was quoting at Rs 1,010.50, up Rs 12.20, or 1.22 percent, on the BSE.

".... 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," company said in its exchange filing.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tegretol-XR extended-release tablets, 100 mg, 200 mg, and 400 mg, of Novartis Pharmaceuticals Corporation.

Carbamazepine tablets are indicated for use as an anticonvulsant drug and also for the treatment of the pain associated with true trigeminal neuralgia.

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

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A meeting of board of directors of the company will be held on August 5, 2025 to consider and approve unaudited financial results of the company for the quarter ended 30th June, 2025.

CRISIL Ratings has reaffirmed its credit rating of AA+/stable on bank loan facilities of the company with enhanced limits of Rs 800 crore.

The share touched a 52-week high of Rs 1,296.15 and a 52-week low of Rs 725.60 on 09 October, 2024 and 03 March, 2025, respectively.

Currently, the stock is trading 22.04 percent below its 52-week high and 39.26 percent above its 52-week low.

The market capitalisation of the company stands at Rs 19,862.70 crore.

The company had appointed Dr. Sachin Ghosalkar as Sr. Vice President - SCM & Operations, effective July 21, 2025.