Granules India receives USFDA’s approval for Losartan Potassium Tablets

27 Feb 2023 Evaluate

Granules India has received US Food & Drug Administration (USFDA) approval for its 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. Granules now has a total of 54 ANDA approvals from US FDA (52 Final approvals and 2 tentative approvals).

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. The current annual U.S. market for Losartan potassium Tablets is approximately $336 Million, according to MAT Dec 2022, IQVIA/IMS Health.

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

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