Granules India Limited, a vertically integrated fast growing Indian pharmaceutical company, announced that the US Food & Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Hyzaar tablets of Organon LLC.
Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension to lower blood pressure and to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.
Granules now has a total of 60 ANDA approvals from US FDA (58 Final approvals and 2 tentative approvals).
Granules India Limited, incorporated in 1991 is a vertically integrated fast growing Indian pharmaceutical company headquartered at Hyderabad with best in class facilities and commitment to operational excellence, quality, and customer service.
