Granules India gets US FDA 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.

Priyanka Chigurupati, Executive Director of Granules Pharma said, “This approval from Granules India, received within 10 months of filing reiterates our strength in the development of complex generics. The approval of Potassium Chloride Extended Release Tablets USP, 10 mEq and 20 mEq, a complex MUPS (multiunit 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, India.”

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.