Pharmaceutical Strides Pharma Science Ltd said wholly owned subsidiary Vensun Pharmaceuticals and partner Pharmaceutics International received approval from the United States Food and Drug Administration to launch a generic equivalent of Merck’s potassium chloride extended-release tablets.
The drug will be launched in the doses of 750 mg, 1,125 mg and 1,500 mg.
Strides Pharma already has approval for the sales of the potassium chloride extended release tablets, the generic version of Klor-Con extended release tablets manufactured by Upsher-Smith in doses of 600 mg and 750 mg.
The two approvals will help company address a total sales of $300 mn per annum in the US market, said Strides Pharma. This number represents about 90% of the market for potassium chloride extended release tablets in the US, the company said.
Potassium Chloride Extended-Release Tablet is an electrolyte replenisher and is used in treatment of patients with hypokalemia, or the deficiency of potassium levels in the bloodstream.
According to IQVIA MAT data, the tablets had sales of $240 million in the US market.
The new product will be manufactured by Pharmaceutics International and marketed by Strides in the US market.
Headquartered in Bengaluru, Strides has a global manufacturing footprint with seven manufacturing facilities spread across three continents.
Apart from its two manufacturing facilities in Bengaluru, Strides also has manufacturing sites in Pondicherry, Chennai, Milan and Singapore.