Lupin's Nagpur injectable facility gets favorable US FDA report

Global pharmaceutical major Lupin Limited today confirmed the receipt of an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its injectable facility in Nagpur, India. The report, issued following an inspection conducted from September 8 to September 16, 2025, classified the facility with a satisfactory Voluntary Action Indicated (VAI) status.

Nilesh Gupta, managing director of Lupin, expressed satisfaction with the EIR and reaffirmed the company's commitment to maintaining the highest standards of quality and compliance across its operations. This positive outcome underscores Lupin's focus on continuous enhancements to its quality systems and operational excellence.

Lupin, headquartered in Mumbai, India, operates 15 manufacturing sites and 7 research centers worldwide, employing over 24,000 professionals. The company specializes in various pharmaceutical products, including branded and generic formulations, and maintains a strong market position in India and the U.S. across multiple therapy areas.