Lupin receives US FDA approval for generic Esbriet tablets

August 25, 2023

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (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. This product will be manufactured at Lupin’s Pithampur facility in India.

Pirfenidone tablets (Esbriet) had estimated annual sales of USD 218 million in the US (IQVIA MAT June 2023).

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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

PHARMABIZ.com