The USFDA has determined that the facility’s inspection classification is Voluntary Action Indicated (VAI).
“Achieving USFDA certification is a major milestone for Lupin’s Somerset site, as well as a crucial step in gaining back company’s position as the best in class in Quality and Compliance. We are focused to manufacture and supply good quality products to our patients,” commented, Lupin CEO Vinita Gupta.
“We are very happy to announced that we have received the EIR for Somerset facility with Voluntary Action Indicated status from USFDA. With this positive development, we can now build a sustainable business from our Somerset facility and extending this momentum to our other sites,” commented Nitesh Gupta, MD Lupin.
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