Last Updated on December 24, 2023 by The Health Master
New Delhi: Strides Pharma Science Ltd. said that its Singapore-based arm has received approval from the US health regulator for a generic potassium chloride oral solution, used to treat or prevent low amounts of potassium in the blood.
The approval granted by the US Food & Drug Administration (USFDA) to Strides Pharma Global Pte Ltd, Singapore, is for potassium chloride oral solution of strength 40 mEq/15mL (20 percent), Strides Pharma Science (Strides) said in a regulatory filing.
The product is bioequivalent and therapeutically equivalent to Genus Lifesciences Inc.’s reference listed drug (RLD), potassium chloride oral solution USP, 40 mEq/15 mL (20 percent), according to the company.
“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 that the entire potassium chloride range of products for the company has a cumulative market opportunity of around USD 330 million as per IQVIA data.
“The products will be manufactured at the company’s facility in Bengaluru and will be marketed by Strides Pharma Inc. in the US market,” the filing said.
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