Lupin announced that the company's subsidiary Novel Laboratories Inc. based in Somerset, NJ has just concluded a U.S. FDA inspection. The inspection commenced on 10 September 2020 and concluded on 05 November 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.