Pharma major Lupin said the inspection of the US Food and Drug Administration at its Nagpur plant has “concluded without any observation.”
Conclusion of an inspection without any observations indicates that the facility was found to be up to the standards expected by the FDA.
This inspection was a product specific pre-approval inspection, it said.
The Nagpur facility is the company’s latest site and manufactures Oral Solid Dosage products.
The site also houses Lupin’s injectable manufacturing facility.
Lupin is the eighth largest generics pharmaceutical company both in terms of market capitalization and revenues globally.
The Company is the fourth largest pharmaceutical player in the US by prescriptions and the third largest Indian pharmaceutical company by global revenues.