Granules India Limited announced today that the US Food & Drug Administration (US 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 have a total of 60 ANDA approvals from US FDA (58 Final approvals and 2 tentative approvals).
The current annual U.S. market for Losartan and Hydrochlorothiazide Tablets is approximately $73 Million, according to MAT Jul 2023, IQVIA/IMS Health.
Shares of Granules India Limited was last trading in BSE at Rs. 354.75 as compared to the previous close of Rs. 341.60. The total number of shares traded during the day was 83529 in over 1976 trades.
The stock hit an intraday high of Rs. 356.00 and intraday low of 342.65. The net turnover during the day was Rs. 29351025.00.