Pharmaceutical manufacturer Granules India has received marketing approval from the U.S. Food and Drug Administration (USFDA) for Potassium Chloride Extended Release Tablets USP, 10 mEq (750 mg) and 20 mEq (1,500 mg).
The product is bioequivalent to the reference listed drug (RLD) K-Dur and indicated in the treatment of patients with hypokalemia. Potassium Chloride Extended Release Tablets USP, 10 mEq and 20 mEq had U.S. generic sales of around $204 million for the twelve months ended August 2020, a release from the company said, citing IQVIA Health numbers.
Granules Pharma Executive Director Priyanka Chigurupati said the USFDA approval came within 10 months of the filing and “reiterates our strength in the development of complex generics.” The drug will be manufactured at the Granules’ manufacturing facility in Gagillapur, Hyderabad.
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