Strides Pharma Science Ltd on Friday said its Singapore-based arm has received approval from the US 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 US Food & Drug Administration (USFDA) to Strides Pharma Global Pte Ltd, Singapore, is for potassium chloride oral solution of strength 40 mEq/15mL (20 per cent), Strides Pharma Science (Strides) said in a regulatory filing.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), potassium chloride oral solution USP, 40 mEq/15 mL (20 per cent) 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 USD 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 US market," the filing said.