Strides Pharma receives USFDA approval for Potassium Chloride ER Tablets USP 750mg, 1125 mg and 1500 mg

Strides Pharma Science announced that its step-down wholly owned subsidiary, Vensun Pharmaceuticals, Inc., USA and it's partner Pharmaceutics International, Inc. (Pii) have received approval for jointly developed Potassium Chloride Extended-Release Tablets USP, 10 mEq (750 mg), 15 mEq (1,125 mg), and 20 mEq (1,500 mg) product from the United States Food & Drug Administration (US FDA). The product is an immediately dispersing extended-release oral dosage form of potassium chloride and is a generic version of Potassium Chloride Extended-Release Tablets of Merck, Inc.

According to IQVIA MAT data, the US market for Potassium Chloride Extended Release Tablets with the current reference product is approximately US$ 240 Mn. The product will be manufactured by Pii and will be marketed by Strides in the US market. Strides already has an approval for Potassium Chloride Extended Release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg) which is a generic version of Klor-Con Extended Release Tablets of Upsher-Smith. The two approvals taken together will help company address a combined opportunity of US$ 300 Mn per annum, representing ~ 90% of the Potassium Chloride Extended Release tablet market in the US.

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