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Granules India gets USFDA nod for potassium chloride tablets used to treat hypokalemia

IBEF:  October 23, 2020

Drug firm Granules India has received marketing approval from the US health regulator for Potassium Chloride extended release tablets, used for treatment of patients with hypokalemia. Hypokalemia is a condition when the potassium level in a patient's blood is too low.

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. We will be launching this product from our Gagillapur site in Hyderabad, India." Granules now have a total of 34 abbreviated new drug application (ANDA) approvals from the USFDA (32 final approvals and 2 tentative approvals).

Citing IQVIA Health data, Granules said Potassium Chloride extended release tablets had US generic sales of approximately US$ 204 million for the most recent 12 months ending in August 2020.

Disclaimer: This information has been collected through secondary research and IBEF is not responsible for any errors in the same.