Strides Pharma subsidiary gets USFDA nod for Potassium Chloride Oral Solution

Strides Pharma Science informed the exchanges today that its wholly-owned subsidiary, Strides Pharma Global Private Limited, Singapore, received approval for Potassium Chloride Oral Solution USP, 20 mEq from United States Food & Drug Administration (USFDA). 

Potassium Chloride Oral Solution is used for the treatment of Hypokalaemia with or without metabolic alkalosis in patients for whom, dietary management with potassium-rich foods or diuretic dose reduction is insufficient. 

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Potassium Chloride Oral Solution USP, 20 milliequivalent (mEq) of Pharma Research Software Solutions, LLC. It will be manufactured at Strides’ facility in Bengaluru and further commercialised in the US market. 

The total market for Potassium Chloride oral solution USP, 20 mEq was around US$ 56 million, according to January 2021 MAT data from IMS Health (IQVIA) 

On Monday, the shares of Strides Pharma Science Limited closed at Rs 840.10, up by 0.30 per cent or Rs 2.50 per share, against a 0.78 per cent decline in the benchmark index. The 52-week high of the company is recorded at Rs 1,000 while its 52-week low is Rs 271 on BSE.