Lupin announced the successful completion of the United States Food and Drug Administration (US FDA) inspection at its Lupin Bioresearch Centre (LBC) without any observations. This is the fifth successive inspection without any 483 observations, indicating superior quality compliance maintained at this global bioresearch facility.
Lupin Bioresearch Centre (LBC) conducts the in-vivo and in-vitro bioequivalence studies for Lupin in Pune. This inspection also included review of studies done at the center’s new site at Lupin Research Park, Pune.
Commenting on the successful inspection, Nilesh Gupta, MD, Lupin expressed satisfaction about the quality management system maintained in LBC and said “Such a high level of compliance reiterates Lupin’s commitment to high-quality standards across its world class research centres.”