Strides Pharma Science Limited (Strides) has announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has received approval for Potassium Chloride for Oral Solution USP, 20 mEq from the United States Food & Drug Administration (USFDA).
The product is bio-equivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Potassium Chloride for Oral Solution USP, 20 mEq, of Pharma Research Software Solution, LLC.
Potassium chloride oral solution is indicated 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 are insufficient.
According to IQVIA MAT January 2021 data, the US market for Potassium Chloride for Oral Solution USP, 20 mEq is approximately $56 million. The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market.
The company has 127 cumulative ANDA filings with USFDA of which 100 ANDAs have been approved and 27 are pending approval.