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Strides Pharma receives USFDA approval for Potassium Chloride Oral Solution
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Strides Pharma receives USFDA approval for Potassium Chloride Oral Solution
Nov 18, 2022 11:48 PM

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Strides Pharma Science Ltd.’s Singapore-based step-down wholly-owned subsidiary, Strides Pharma Global Ltd. has received approval from the United States Food and Drug Administration (USFDA) for the sale of its Potassium Chloride Oral Solution USP, 40 mEq/15mL (20 percent).

The company’s oral solution is the therapeutic equivalent to the Potassium Chloride Oral Solution USP, 40 mEq/15 mL (20 percent), which is being developed and sold by Genus Lifesciences Inc. in the United States.

The products will be manufactured at Strides Pharma’s Bengaluru facility and will be marketed by Strides Pharma Inc in the US market.

Potassium Chloride oral solution is administered to patients who have a low potassium presence in their blood. The company’s range of these solutions includes Extended-Release Capsules, Extended-Release Tablets, Powder for Oral Solutions, and Oral Solutions along with a pipeline of other Potassium Chloride products that are expected to be approved and launched in financial year 2024.

Strides' entire range of Potassium Chloride products has a cumulative market opportunity of $330 million in the United States, according to IQVIA data.

Nearly 52 percent of Strides' revenue came from the US market during the September quarter.

The company has 280 cumulative ANDA filings, including 19 pending approvals, with the USFDA. The pharma major targets to launch 20 new products every year in the US market.

Shares of Strides Pharma ended 2.2 percent higher at Rs 338.

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