Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Carbamazepine Extended-Release Tablets USP in strengths of 100 mg, 200 mg, and 400 mg.
These tablets are the generic version of Tegretol-XR, a widely used anticonvulsant drug developed by Novartis Pharmaceuticals. Alembic’s version is therapeutically equivalent to the original, meaning it meets the same standards for quality, strength, and effectiveness.
Carbamazepine Extended-Release Tablets are primarily used to treat seizure disorders and are also prescribed for trigeminal neuralgia, a chronic pain condition affecting the facial nerves.
According to IQVIA data, the US market for this drug was valued at approximately $71 million for the 12-month period ending March 2025.
With this approval, Alembic now has a total of 225 ANDA approvals from the USFDA, which includes 202 final approvals and 23 tentative approvals.
About Alembic Pharmaceuticals
Founded in 1907 and headquartered in India, Alembic Pharmaceuticals is a vertically integrated pharmaceutical company known for its strong focus on research and development. It manufactures and markets generic drugs across global markets, with several of its facilities approved by top regulatory bodies including the USFDA.
In India, Alembic is a leader in branded generics, with a product portfolio promoted by a field force of over 5,500 professionals. Its products are widely recognized and trusted by healthcare professionals and patients alike.
