Granules India gets USFDA nod for generic hypokalemia drug

Our Bureau Hyderabad | Updated on October 22, 2020

Granules India has received marketing approval from the US Food and Drug Administration (USFDA) for potassium chloride extended release tablets for the treatment of patients with hypokalemia.

Granules’ tablet product is bioequivalent to the reference listed drug (RLD), K-Dur.

“This approval of potassium chloride extended release tablets, a complex MUPS (multi-unit pellet system) based formulation, equivalent to generic “K-Dur,” and “Klor Con M,” is a good addition to our portfolio. We will be launching this product from our Gagillapur site in Hyderabad,’’ Priyanka Chigurupati, Executive Director, Granules Pharma said in a release on Thursday.

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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 had US generic sales of approximately $204 million for the most recent 12 months ending August 2020.

Published on October 22, 2020

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