Lupin receives EIR from USFDA for Pithampur Unit-1 Facility with VAI Classification
Drug Approval

Lupin receives EIR from USFDA for Pithampur Unit-1 Facility with VAI Classification

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

  • By IPP Bureau | January 09, 2025

Lupin Limited has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) 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, Managing Director, 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.”

Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

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