USFDA issues 13 observations to Lupin’s Novel Laboratories

Pharma major Lupin Ltd on Thursday said the USFDA has issued 13 observations to its US-based wholly-owned subsidiary Novel Laboratories, Inc after an inspection.

The USFDA (US Food and Drug Administration) has concluded an inspection at the company’s wholly-owned subsidiary Novel Laboratories, Inc., based in Somerset, New Jersey. The inspection commenced on March 7, 2020 and concluded on March 30, 2022, Lupin Ltd said in a regulatory filing.

“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,” it said.

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 percent of the company’s global revenues. PTI