Lupin announced its Nagpur injectable facility received an Establishment Inspection Report (EIR) from the U.S. FDA with a satisfactory Voluntary Action Indicated (VAI) classification. The inspection, which took place between September 8 and September 16, 2025, resulted in a positive outcome for the company’s injectable manufacturing capabilities. This is a crucial step for Lupin as it strengthens its presence in the US market.
Positive Inspection Outcome
Lupin has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its injectable facility located in Nagpur, India. This follows an inspection conducted between September 8, 2025, and September 16, 2025.
VAI Classification Awarded
The US FDA has classified the inspection outcome as Voluntary Action Indicated (VAI), indicating a satisfactory level of compliance. This VAI classification demonstrates Lupin’s commitment to maintaining high standards at its manufacturing facilities.
Management Statement
Nilesh Gupta, Managing Director, Lupin, stated the company is pleased to have received the EIR with a VAI classification. He also reinforced Lupin’s commitment to quality and compliance across all its facilities and continuous improvement in its systems.
Source: BSE
