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Lupin gets USFDA’s nod for Pirfenidone Capsules

29 Aug 2023 Evaluate

Lupin has received approval from the United States Food and Drug Administration (USFDA) 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 $95 million in the U.S. (IQVIA MAT June 2023).  

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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