Alembic Pharma receives USFDA final approval for Carbamazepine ER tablets, a generic of Tegretol-XR, in multiple strengths.

• Approved strengths include 100 mg, 200 mg, and 400 mg; used to treat seizures and trigeminal neuralgia pain.
• The drug has a US market size of $71 million for the 12 months ending March 2025, per IQVIA.
• Alembic now holds 225 total ANDA approvals from the USFDA, including 202 final and 23 tentative.