USFDA concludes inspection of Lupin’s Somerset facility
9th Nov 2020

United States Food and Drug Administration (USFDA) has concluded inspection at Lupin’s subsidiary Novel Laboratories Inc. based in Somerset, NJ. The inspection commenced on September 10, 2020 and concluded on November 5, 2020. The duration of the inspection was prolonged due to COVID-related delays and challenges.
The inspection at the Somerset, NJ facility closed with thirteen observations.

The company is confident of addressing these observations and will work closely with the agency to address their concerns. 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 its global revenues.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally