Lupin Limited gets FDA warning letter for Lupin Somerset site

Indian pharma company Lupin Limited said that it has been issued a warning letter from the US Food and Drug Administration (FDA) for its manufacturing facility in Somerset, New Jersey.

The warning letter follows inspections of the Lupin Somerset site by the FDA from 10 September 2020 to 5 November 2020.

Lupin Limited said that it does not reckon that the warning letter will have an effect on disruption of supplies or the existing revenues from operations of the Lupin Somerset facility.

US FDA issues warning letter to Lupin Limited over its manufacturing facility in Somerset, New Jersey. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.

The Indian pharma company added that it will address the concerns raised by the drug regulator and will work with it and the New Jersey District to resolve the problems at the earliest.

Lupin Limited stated: “We uphold quality and compliance issues with utmost importance and are committed to be compliant with Good Manufacturing Practice standards across all our facilities.”