Granules India announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of Granules India 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.

Commenting on the approval Priyanka Chigurupati, Executive Director, GPI, said “We are pleased to receive the approval of the product and will surely be a valuable addition to our growing product portfolio in the US market.” Granules now have a total of 49 ANDA approvals from US FDA (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, according to MAT Nov 2021, IQVIA/IMS Health.