Strides Pharma Science Limited announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Potassium Chloride Oral Solution USP, 40 mEq/15mL (20%) from the United States Food & Drug Administration (USFDA).The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Potassium Chloride Oral Solution USP, 40 mEq/15 mL (20%) of Genus Lifesciences Inc.
The approval further strengthens the Potassium Chloride franchise for the company which now comprises of Extended-Release Capsules, Extended-Release Tablets, Powder for Oral Solutions and Oral Solutions. The Company also has a pipeline of other Potassium Chloride products which are expected to be approved and launched in FY24. The entire Potassium Chloride range of products for the company has a cumulative market opportunity of ~ 330 Mn USD as per IQVIA. The products will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
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.
The company has 280 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA of which 261 ANDAs have been approved and 19 are pending approval. The company has set a target to launch ~ 20 new products every year in the US.
