Lupin Receives Approval From USFDA For Pirfenidone Tablets
Indian pharma major Lupin on Friday informed the exchanges 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, to market a generic equivalent of Esbriet Tablets, 267 mg and 801 mg of Hoffmann La Roche Inc.
The drug is indicated to treat a certain lung disease called idiopathic pulmonary fibrosis (IPF). As per the company's statement, this product will be manufactured at Lupin’s Pithampur facility in India.
According to data from IQVIA MAT June 2023, the Pirfenidone Tablets (RLD Esbriet) had estimated annual sales of USD 218 million in the U.S.
Lupin's stock was trading 0.67 per cent lower at Rs 1081.35 per scrip as of 14:15 IST on the Bombay Stock Exchange (BSE).
