Granules India bags USFDA nod for Losartan and Hydrochlorothiazide Tablets
Hyderabad: 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 has 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.
Medical Dialogues team had earlier reported that the US FDA had approved the company's ANDA for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg. Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.
Read also: Granules India bags USFDA okay for hypertension drug Losartan Potassium
Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered at Hyderabad. The Company is among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Its products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, U.S. and U.K. The Company has 7 manufacturing facilities out of which 6 are located in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.
Read also: Granules India receives approval from Brazilian Health Regulatory Agency
