Global pharmaceutical major Lupin Limited (Lupin) has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its injectable manufacturing facility located in Nagpur, India. The facility has been classified as Voluntary Action Indicated (VAI), reflecting a satisfactory inspection outcome.

The EIR follows a routine US FDA inspection conducted at the Nagpur facility from September 8 to September 16, 2025. A VAI classification indicates that while certain observations may have been noted during the inspection, they do not warrant any regulatory enforcement action, and the facility remains compliant with US FDA standards.

The Nagpur injectable facility plays a key role in Lupin’s global injectable portfolio, catering to regulated markets including the United States. The successful receipt of the EIR further reinforces Lupin’s commitment to maintaining robust quality systems and ensuring compliance with global regulatory requirements.

Commenting on the development, Nilesh Gupta, Managing Director, Lupin, said, “We are pleased to have received the EIR from the US FDA with a VAI classification for our Nagpur injectable facility. We remain committed to upholding the highest standards of quality and compliance across all our manufacturing sites. Our continued focus on strengthening quality systems and driving operational excellence will support our long-term growth objectives.”

Lupin has consistently invested in upgrading its manufacturing infrastructure and quality processes across its global network. The positive inspection outcome at the Nagpur facility underscores the company’s sustained efforts to meet stringent regulatory expectations and deliver high-quality products to patients worldwide.

The company added that it will continue to work proactively with regulatory authorities and focus on continuous improvement initiatives to further enhance compliance, reliability, and operational performance across its manufacturing operations.