Strides gets USFDA nod for potassium chloride for oral solution
March 15, 2021
× Strides Pharma Science Limited (Strides) has announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has received approval for Potassium Chloride for Oral Solution USP, 20 mEq from the United States Food & Drug Administration (USFDA).
The product is bio-equivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Potassium Chloride for Oral Solution USP, 20 mEq, of Pharma Research Software Solution, LLC.
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 approved product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Deltasone tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co.
New Delhi, Feb 12: Drug firm Strides Pharma Science on Friday said its subsidiary, Strides Pharma Global Pte Ltd, has received approval from the US health
Strides Pharma Global Pte Ltd receives approval for Oxybutynin Chloride tablets USP
Bengaluru, Dec 18 (UNI) Strides Pharma Science Limited (Strides) s a wholly-owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has received approval for Oxybutynin Chloride Tablets USP, 5 mg from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Ditropan Tablets, 5 mg, of Janssen Pharmaceuticals, Inc.
According to IQVIA MAT October 2020 data, the US market for Oxybutynin Chloride Tablets USP, 5 mg is approximately USD 29 Mn. The product will be manufactured at the company’s flagship facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market.