Lupin’s Somerset Manufacturing Plant Receives EIR from US FDA

The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI), the company stated.

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According to the company, Lutio has the potential to offer significant cost savings when available to UK patients. (File)

Global pharma major Lupin Limited (Lupin) on Thursday announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Somerset, NJ manufacturing facility, after the inspection of the facility in March 2022. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI), the company stated.

“We are very happy to have received the EIR from US FDA with satisfactory VAI classification for our Somerset facility. This is a significant milestone for our Somerset site, and an important step in our journey to build back our reputation as best in class in Quality and Compliance. We are committed to manufacture and supply products of the highest quality for the patients we serve,” said Vinita Gupta, CEO, Lupin in a statement.

“We remain committed to meet and exceed global standards of Quality and Compliance at all our manufacturing sites. We are very happy to have received the EIR for our Somerset facility with Voluntary Action Indicated status from US FDA. With this positive development, we now look forward towards building a sustainable business from our Somerset facility, and carry this momentum to positive outcomes for our other sites,” Nilesh Gupta, Managing Director, Lupin said in a statement.

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