Lupin's New Jersey facility gets 13 US FDA observations

Mumbai-based drug major Lupin said that it's New Jersey facility has received thirteen observations from the US drug regulator. The facility accounts for less than  5 percent Lupin's global turnover. 

The observations do not, however, imply any restriction on supplies. 

"U.S. FDA inspection of the Company's Somerset, New Jersey (USA) facility. The U.S. FDA has concluded an inspection at the Company'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," Lupin said. 
 

The company further added that it is confident of addressing these issues with the regulator  

"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," it said. 

Lupin claimed that this would not have any impact on the supplies or existing revenues from operations of this facility.