Alembic Pharma receives USFDA approval for Candesartan Cilexetil tablets

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Candesartan Cilexetil tablets USP, 4 mg, 8 mg, and 16 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Atacand Tablets, 4 mg, 8 mg, and 16 mg, of ANI Pharmaceuticals, Inc. Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to less than 17 years of age, to lower blood pressure. Candesartan cilexetil tablets also indicated for the treatment of heart failure.

Candesartan Cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg, have an estimated market size of $22 million for twelve months ending December 2017 according to IQVIA. The company has a cumulative total of 82 ANDA approvals (69 final approvals and 13 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.