The inspection of the facility was held from September 16 to 27, 2024

Lupin has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Pithampur Unit-1 manufacturing facility that manufactures both APIs and finished products. The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection of the facility from September 16 to September 27, 2024.

Nilesh Gupta, MD, Lupin said, “We are pleased to receive the EIR from the US FDA for our Pithampur Unit-1 facility with a satisfactory VAI classification. This reflects our commitment to the highest standards of quality and compliance.”