USFDA concludes inspection at Lupin’s New Jersey facility

01 Apr 2022 Evaluate

The United States Food and Drug Administration (USFDA) has concluded an inspection at Lupin’s wholly owned subsidiary Novel Laboratories, Inc., based in Somerset, New Jersey (USA). The inspection commenced on March 7, 2022 and concluded on March 30, 2022. The inspection closed with thirteen observations. 

The company will work closely with the Agency to address their concerns. It uphold quality and compliance with utmost importance and are committed to be compliant with Good Manufacturing Practice standards across all its facilities. 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.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India.

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