Lupin New Jersey subsidiary gets thirteen observations
The pharma major after market hours on Thursday announced that its wholly owned subsidiary Novel Laboratories based in Somerset, New Jersey (USA) received thirteen observations from USFDA. The facility underwent a USFDA inspection from 7 March 2022 to 30 March 2022. Lupin assured of addressing these observations and said it will work closely with the agency to address their concerns. Furthermore, the company said that observations will not have an impact on disruption of supplies or the existing revenues from operations.
The facility contributes less than 5% of the company's global revenues. The drug maker assured to be compliant with good manufacturing practice standards across all its facilities. Lupin is a transnational pharmaceutical company. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
