Lupin Limited on Tuesday 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, Maharashtra. The inspection concluded with a satisfactory Voluntary Action Indicated (VAI) classification, reinforcing the company’s focus on regulatory compliance and quality standards.
The EIR was issued following a US FDA inspection conducted at the Nagpur injectable facility between September 8 and September 16, 2025. A VAI classification indicates that while certain observations may have been noted, they do not warrant regulatory enforcement action and can be addressed voluntarily by the company.
Commenting on the development, Nilesh Gupta, Managing Director of Lupin, said that the company is pleased to receive the EIR with a VAI status for the Nagpur facility. He added that Lupin remains committed to maintaining high standards of quality and compliance across all its manufacturing locations, with continuous improvements in quality systems and operational excellence.
