Granules India bags USFDA okay for hypertension drug Losartan Potassium

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.