The U.S. FDA has officially cleared Mumbai-based Lupin’s Goa manufacturing plant of cGMP violations observed during a March 2016 inspection.
During the inspection in March, the agency had made nine observations relating to cGMP deviations.
Lupin announced that it has received an Establishment Inspection Report (EIR) from the FDA, indicating closure of all FDA inspections at the facility.
Lupin has 30 Abbreviated New Drug Applications (ANDAs) pending from this location.
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