Granules India receives USFDA marketing approval for Potassium Chloride ER Tablets

Granules announced that it has received marketing approval from the US FDA for Potassium Chloride Extended Release Tablets USP, 10 mEq (750 mg) and 20 mEq (1500 mg) for the treatment of patients with hypokalemia. Granules' tablet product is bioequivalent to the reference listed drug (RLD), K-Dur.

The drug will be manufactured at the Granules manufacturing facility in Gagillapur, Hyderabad. Granules now have a total of 34 ANDA approvals from the US FDA (32 Final approvals and 2 tentative approvals).

According to IQVIA Health, Potassium Chloride Extended Release Tablets USP, 10 mEq & 20 mEq had US generic sales of approximately $204 million for the most recent twelve months ending in Aug 2020.

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