Granules India bags USFDA okay for hypertension drug Losartan Potassium

Hyderabad: Granules India Limited has announced that the US Food & Drug Administration (US FDA) has approved the company's Abbreviated New Drug Application (ANDA) for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg.

It is bioequivalent to the reference listed drug product (RLD), Cozaar Tablets of Organon LLC.

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.

Granules now has a total of 54 ANDA approvals from US FDA (52 Final approvals and 2 tentative approvals). The current annual U.S. market for Losartan potassium Tablets is approximately $336 Million, according to MAT Dec 2022, IQVIA/IMS Health. 

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Medical Dialogues team had earlier reported that the US FDA had approved the ANDA filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India Limited, for Prazosin Hydrochloride Capsules, USP 1mg, 2mg & 5mg. Prazosin is an antihypertensive medicine which is used to treat high blood pressure and Benign Prostatic Hypertrophy (prostate enlargement).

Read also: Granules India secures USFDA nod for Prazosin Hydrochloride Capsules

Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. The company's products are being distributed 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.