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Strides Pharma receives USFDA approval for potassium chloride for oral solution

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Last Updated : Mar 15 2021 | 12:04 PM IST

The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

Strides Pharma Science (Strides) on Monday (15 March) announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for potassium chloride for oral solution USP, 20 mEq from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Potassium Chloride for Oral Solution USP, 20 mEq, of Pharma Research Software Solution.

According to IQVIA MAT January 2021 data, the US market for Potassium Chloride for Oral Solution USP, 20 mEq is approximately $56 million.

The company has 127 cumulative ANDA filings with USFDA of which 100 ANDAs have been approved and 27 are pending approval.

Strides Pharma Science is a global pharmaceutical company. It focuses on "difficult to manufacture" products that are sold in over 100 countries. The company has 127 cumulative ANDA filings with USFDA of which 99 ANDAs have been approved and 28 are pending approval.

On a consolidated basis, the pharma company posted a 61.9% fall in net profit to Rs 35.16 crore on a 13.6% rise in net sales to Rs 832 crore in Q3 FY21 over Q3 FY20.

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First Published: Mar 15 2021 | 10:55 AM IST

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