Lupin Nagpur facility gets two USFDA observations

Mumbai: Pharma major Lupin Limited (Lupin) today announced the completion of a PAI (Prior Approval Inspection) carried out by the United States Food and Drug Administration (U.S. FDA) at its Nagpur oral solid dosage manufacturing facility.

The inspection was carried out between January 6, 2020, and January 10, 2020.

The inspection closed with two 483 observations, Lupin said in its recent filing.

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Commenting on the outcome of the inspection, Nilesh Gupta, Managing Director, Lupin said, “We are committed to meeting the highest quality standards and are committed to full compliance with CGMP regulations at all our manufacturing facilities. The Nagpur facility is our latest oral solid dosage facility, and this was the seventh U.S. FDA inspection at the facility."

"We will address the observations raised by the agency satisfactorily and will submit our comprehensive response within the stipulated timeline," he added.

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