Lupin's Pirfenidone Tablets are given FDA approval in the United States

26 Aug 2023 , 12:19 PM

To market a generic version of Esbriet® Tablets, 267 mg and 801 mg of Hoffmann La Roche Inc., the leading global pharmaceutical company Lupin Limited (Lupin) announced today that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application for pirfenidone tablets, 267 mg and 801 mg. 

This item will be produced at the Lupin plant in Pithampur, India.

According to IQVIA MAT June 2023, Pirfenidone Tablets (RLD Esbriet®) had expected annual sales of USD 218 million in the U.S.

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