Global pharma major Lupin Limited on Thursday 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.
The approval is granted 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 U.S. (IQVIA MAT June 2023).
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