Hyderabad : Granules India on Thursday announced that it has received marketing approval from the US Food and Drug Administration (USFDA) for Potassium Chloride Extended Release tablets USP, 10 mEq (750 mg) and 20 mEq (1500 mg) for the treatment of patients with Hypokalemia.
Granules said that its tablet product is bioequivalent to the Reference Listed Drug (RLD), K-Dur.
“This approval from Granules India, received within 10 months of filing reiterates our strength in the development of complex generics,” said Priyanka Chigurupati, Executive Director of Granules Pharma.
“The approval of Potassium Chloride Extended Release Tablets USP, 10 mEq & 20 mEq, 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, India,” said Chigurupati.
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 two 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.