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

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.  

Earlier this month, Alembic Pharmaceuticals Inc., a wholly owned subsidiary of Alembic Pharma, acquired a 100 percent stake in Utility Therapeutics Ltd, a pharmaceutical company focused on treatments for urinary tract infections (UTIs). The strategic acquisition is aimed at marketing both USFDA-approved and under-development products owned by Utility in the United States.

Alembic Pharmaceuticals Limited is a vertically integrated research and development
pharmaceutical company. 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 5500 are well recognized by doctors and patients.