Granules India’s wholly-owned foreign subsidiary – Granules Pharmaceuticals Inc. (GPI) has received Abbreviated New Drug Application (ANDA) approval from US Food & Drug Administration (USFDA) for Potassium Chloride for Oral Solution USP, 20 mEq.
Potassium chloride is used to prevent or to treat low blood levels of potassium (hypokalemia). It is bioequivalent to the reference listed drug product, Potassium Chloride for Oral Solution, 20 mEq, of Pharma Research Software Solution, LLC. The product would be available for the US market shortly. Granules now have a total of 49 ANDA approvals from USFDA (47 Final approvals and 2 tentative approvals). The current annual U.S. market for Potassium Chloride for Oral Solution USP, 20 mEq is approximately $44 million.
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).
