Granules India gains FDA approval for Losartan-Hydrochlorothiazide Tablets

Granules India Limited proudly announced today that the United States Food & Drug Administration (US FDA) has granted its Abbreviated New Drug Application (ANDA) for Losartan Potassium and Hydrochlorothiazide Tablets USP. These tablets, available in 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg variants, have been deemed bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Hyzaar Tablets by Organon LLC.

These Losartan potassium and hydrochlorothiazide tablets serve as a vital treatment option for hypertension, aiding in lowering blood pressure and mitigating the risk of stroke, particularly in patients with hypertension and left ventricular hypertrophy.

Notably, Granules India’s achievement extends beyond this approval, as they now possess a remarkable total of 60 ANDA approvals from the US FDA, comprising 58 Final approvals and 2 tentative approvals. This regulatory nod is poised to bolster their presence in the pharmaceutical market.

Moreover, the significance of this approval is underscored by the current annual U.S. market for Losartan and Hydrochlorothiazide Tablets, estimated to be approximately $73 million as of July 2023, according to IQVIA/IMS Health data. Granules India’s entry into this segment is poised to make a substantial impact and offer valuable healthcare solutions to a wide spectrum of patients.