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Pharma major Lupin Ltd on Tuesday said it received approval from the US health regulator to market its generic Pirfenidone capsules used for the treatment of lung disease known as idiopathic pulmonary fibrosis.
The approval granted by the US Food and Drug Administration (USFDA) is for the
abbreviated new drug application for Pirfenidone capsules of 267 mg strength, Lupin said in a regulatory filing.
abbreviated new drug application for Pirfenidone capsules of 267 mg strength, Lupin said in a regulatory filing.
The drug is the generic equivalent of Esbriet Capsules, 267 mg of Hoffmann La Roche Inc.
This product will be manufactured at Lupin's Pithampur facility in India, it added.
Pirfenidone capsules had estimated annual sales of USD 95 million in the US, Lupin said citing IQVIA MAT June 2023 data.
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