Alembic Pharmaceuticals has received US Food & Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Candesartan Cilexetil Tablets, 32 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Atacand Tablets, 32 mg of AstraZeneca Pharmaceuticals LP. Candesartan Cilexetil Tablets are indicated for treatment of hypertension in adults and children and treatment of heart failure (NYHA class II-IV).
According to IMS, Candesartan Cilexetil Tablets, 32mg have an estimated market size of $27 million for twelve months ending December 2016. Alembic now has a total of 57 ANDA approvals (51 final approvals and 6 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.
