Vadodara: Alembic Pharmaceuticals Limited announced that the US Food & Drug Administration (USFDA) has approved 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.
It is also indicated in the treatment of the pain associated with true trigeminal neuralgia.True Trigeminal Neuralgia (also known as Classical Trigeminal Neuralgia) is a chronic pain condition that affects the trigeminal nerve, which carries sensation from the face to the brain. It’s characterized by sudden, severe, electric shock-like facial pain that typically affects one side of the face.  Carbamazepine Tablets USP, 200 mg have an estimated market size of US$ 32 million for twelve
months ending December 2024 according to IQVIA.
Alembic has a cumulative total of 222 ANDA approvals (196 final approvals and 26 tentative
approvals) from USFDA. Earlier, Medical Dialogues reported that the company also received final approval from the USFDA for its ANDA for Pantoprazole Sodium for Injection, 40 mg/vial, intended for the treatment of pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome in adults.Read also: Alembic Pharma bags USFDA final approval for Pantoprazole Sodium for Injection for GERD Alembic Pharmaceuticals Limited, a vertically integrated research and development
pharmaceutical company, 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. Alembic’s state of the art research and manufacturing facilities are
approved by regulatory authorities of many developed countries including the USFDA. Alembic’s brands, marketed through a field force
of over 5200 are well recognized by doctors and patients. Read also: Alembic Pharma appoints Prag Goel as Vice President – Sales and Marketing (Megacare, Enteron and Osteofit business divisions)