.jpg?downsize=773:435 "Lupin’s Goa Plant Gets a Dose of Good News")
Lupin shares are up for the second day in a row after the company said that the U.S. Food and Drug Administration closed the inspection carried out at its Goa plant in July 2015.
The company has received notification that the inspection carried out by the U.S. FDA in July 2015 at its Goa facility is now closed and the agency has issued an Establishment Inspection Report (EIR).Lupin's Press Release
Responses from another inspection carried out in March 2016 are still under review, according to Lupin. The drug maker had received nine Form 483 observations from the FDA post the inspection in March. Form 483 is used by the FDA to document and communicate concerns discovered during their inspections.
The Goa plant is crucial for Lupin as most of the company's new drug applications have been filed either from the unit, or from its Indore facility.
Lupin's other key plants, Mandideep and Aurangabad, were cleared by the U.S. drug regulator in May 2016.
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