Strides Pharma Science Limited (Strides) announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Ethacrynic Acid Tablets USP, 25 mg from the United States Food & Drug Administration (USFDA). The product is a generic version of Edecrin® Tablets, 25 mg, of Bausch Health Americas, Inc.
According to IQVIA MAT August 2020 data, the US market for Ethacrynic Acid Tablets USP, 25 mg is approximately US$ 14 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.
The company has 126 cumulative ANDA filings with USFDA of which 92 ANDAs have been approved and 34 are pending approval.
