Hyderabad: Granules India has received marketing approval from the US FDA for potassium chloride extended-release tablets for the treatment of patients with hypokalemia. The company will be making the drug at its Gagillapur plant in Hyderabad.
The company’s tablet is bioequivalent to the reference listed drug K-Dur. Hypokalemia happens when blood’s potassium levels are too low.
Speaking about the development, Priyanka Chigurupati, ED, 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, 10 mEq (750 mg) and 20 mEq (1500 mg), a complex multi-unit pellet system-based formulation, equivalent to generic “K-Dur,” and “Klor Con M,” is a good addition to our portfolio,” she added.
Granules now have a total of 34 ANDA (abbreviated new drug application) approvals from the US FDA, which include 32 final approvals and two tentative approvals.
According to IQVIA Health, potassium chloride extended-release tablets had US generic sales of approximately $204 million (over Rs 1,500 crore) for the most recent twelve months ending in August 2020.
