Lupin’s Gujarat Facility Clears US FDA Inspection with Establishment Inspection Report

Lupin received the Establishment Inspection Report from the U.S. FDA for its manufacturing facility located in Dabhasa, Gujarat.

Global pharma major Lupin Limited (Lupin) announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its manufacturing facility located in Dabhasa, Gujarat. The EIR was issued post the last inspection of the facility conducted from April 8 to April 12, 2024. The inspection concluded with no observations and the facility receiving an inspection classification of “No Action Indicated” (NAI). The facility is a part of Lupin Manufacturing Solutions (LMS), which is engaged in the development, manufacture and sale of Active Pharmaceutical Ingredients and Contract Development and Manufacturing Operations.

“We are pleased to receive the EIR for Dabhasa from the U.S. FDA,” said Nilesh Gupta, Managing Director, Lupin. “This achievement is in line with our continued focus and commitment to maintaining the highest standards of quality and compliance in all aspects of our operations. This reaffirms our pursuit of delivering high-quality, affordable healthcare solutions to our patients globally.”