Alembic Pharmaceuticals has received final approvals from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Applications (ANDAs) for Olmesartan Medoxomil Tablets, 5 mg, 20mg and 40mg and Olmesartan Medoxomil with Hydrochlorothiazide Tablets 20/12.5mg, 40/12.5mg and 40/25mg.
The approved ANDAs are therapeutically equivalent to the reference listed drug products (RLDs) Benicar Tablets 5mg, 20mg and 40mg and Benicar HCT Tablets, 20/12.5mg, 40/12.5mg and 40/25mg, of Daiichi Sankyo Inc. The approved ANDAs are indicated for the treatment of hypertension.
According to IMS, Benicar and Benicar HCT have an estimated market size of $1.8 billion for twelve months ending December 2016. Alembic now has a total of 55 ANDA approvals (49 final approvals and 6 tentative approvals) from the 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.