Strides Pharma Science Ltd. on Friday said its Singapore-based arm has received approval from the U.S. health regulator for generic potassium chloride oral solution, used to treat or prevent low amounts of potassium in the blood.
The approval granted by the U.S. Food & Drug Administration to Strides Pharma Global Pte. Ltd., Singapore, is for potassium chloride oral solution of strength 40 mEq/15mL (20%), Strides Pharma Science (Strides) said in a regulatory filing.
The product is bioequivalent and therapeutically equivalent to the reference listed drug, potassium chloride oral solution USP, 40 mEq/15 mL (20%) of Genus Lifesciences Inc., it added.
"The approval further strengthens the potassium chloride franchise for the company which now comprises extended-release capsules, extended-release tablets, powder for oral solutions and oral solutions," Strides said.
The company also has a pipeline of other potassium chloride products, which are expected to be approved and launched in FY24, it said, adding the entire potassium chloride range of products for the company has a cumulative market opportunity of around $330 million as per IQVIA data.
"The products will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the U.S. market," the filing said.
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