Lupin Receives Approval From U.S. FDA For Pirfenidone Capsules

Global pharma major Lupin Limited (Lupin) on Tuesday 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., the company announced through an exchange filing.

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).

About Lupin

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9 percent of its revenue in research and development in FY23.

Lupin shares

The shares of Lupin on Tuesday at 1:02 pm IST were at Rs 1,104.50, down by 0.32 percent.