Granules Pharmaceuticals, Receives ANDA Approval for Potassium Chloride for Oral Solution

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Granules India Limited announced on Friday that the US Food and Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) for Potassium Chloride for Oral Solution USP, 20 mEq. filed by Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of Granules India Limited.

Potassium chloride is used to prevent or treat potassium deficiency in the blood (hypokalemia). It is bioequivalent to the reference stated medication product, Pharma Research Software Solution, LLC’s Potassium Chloride for Oral Solution, 20 mEq. The product would soon be accessible in the United States.

“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,”

said Ms. Priyanka Chigurupati, Executive Director, GPI. 

The US FDA has approved 49 ANDAs for granules so far (47 Final approvals and 2 tentative approvals). According to MAT Nov 2021, IQVIA/IMS Health, the current annual U.S. market for Potassium Chloride for Oral Solution USP, 20 mEq is around $44 million.

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