Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Pirfenidone Capsules, 267 mg, to market a generic equivalent of Esbriet® Capsules, 267 mg of Hoffmann La Roche Inc. This product will be manufactured at Lupin's Pithampur facility in India.

Pirfenidone Capsules (RLD Esbriet) had estimated annual sales of USD 95 million in the US (IQVIA MAT June 2023).