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Strides Pharma’s arm gets USFDA’s nod for Ethacrynic Acid Tablets

20 Oct 2020 Evaluate

Strides Pharma Science’s step?down wholly?owned subsidiary -- Strides Pharma Global, 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. The US market for Ethacrynic Acid Tablets USP, 25 mg is approximately $14million. 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.

Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.

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