Granules India subsidiary Granules Pharmaceuticals Limited has received US Food and Drug Administration (FDA) approval for potassium chloride extended-release tablets.
The drug is bioequivalent of Klor-Con extended-release tablets of Upsher-Smith Laboratories, LLC.
Potassium chloride extended-release tablets is used for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium rich foods or diuretic dose reduction is insufficient.
According to IQVIA Health, Klor-Con brand and generic had US sales of approximately US$ 54 million MAT for the most recent twelve months ending in December 2019.
Granules has a total of 24 ANDA approvals from US FDA (22 Final approvals and 2 tentative approvals).