USFDA inspection of Lupin's New Jersey facility concludes with 13 observations

1 Apr 2022 , 09:46 AM

The U.S. Food and Drug Administration (USFDA) has concluded an inspection at Lupin Limited’s wholly owned subsidiary Novel Laboratories, Inc .. based in Somerset, NJ. The inspection commenced on March 7, 2022 and concluded on March 30, 2022. The inspection closed with thirteen observations.

“We are confident of addressing these observations and will work closely with the Agency to address their concerns. We uphold quality and compliance with utmost importance and are committed to be compliant with Good Manufacturing Practice standards across all our facilities.

The Company does not believe that this will have an impact on disruption of supplies or the existing revenues from operations of this facility. The facility contributes less than 5% of the Company’s global revenues,” company said in a filing on Thursday.

At around 9.50 am, Lupin Ltd was trading at Rs749.75 per share up by Rs3.7 or 0.5% from its previous closing of Rs746.05 per share on the BSE.