Lupin Limited announces satisfactory FDA inspection results for Mandideep facility

Global pharmaceutical major, Lupin Limited (Lupin), has announced receiving the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Mandideep Unit-2 manufacturing facility. This report, indicating a significant milestone, was issued following the facility’s recent inspection, held from August 7 to August 11, 2023. Remarkably, the inspection concluded with the commendable classification of “No Action Indicated” (NAI), reflecting the facility’s adherence to high-quality standards.

Positive Outcome for Lupin in Recent U.S. FDA Inspection

The EIR, a critical document in pharmaceutical manufacturing and compliance, showcases the facility’s conformance with stringent regulatory standards. The “No Action Indicated” status is particularly noteworthy, implying that the U.S. FDA found the practices and processes at the Mandideep Unit-2 facility to be in full compliance with its regulations. This status is essential for Lupin, enhancing its reputation in the global pharmaceutical industry and underlining its commitment to providing quality healthcare solutions.

Lupin’s Dedication to Quality and Compliance

Commenting on this achievement, Nilesh Gupta, Managing Director at Lupin, expressed satisfaction and reaffirmed the company’s commitment to top-tier quality and compliance standards. “We are pleased to receive the EIR with a satisfactory inspection status from the U.S. FDA for the recent inspection of our Mandideep Unit-2 facility. This accomplishment is in line with our continued focus and commitment to becoming best-in-class in quality and compliance, and enables us to continue delivering quality affordable healthcare solutions globally,” said Gupta. His statement highlights Lupin’s enduring dedication to not only meeting but exceeding regulatory expectations, thus reinforcing its position as a leading provider in the global pharmaceutical market.