- Lupin announced that the U.S. FDA completed a product-specific Pre-Approval Inspection at its Nagpur Unit-1 manufacturing facility with zero 483 observations.
- The inspection took place from 10–14 November 2025.
Lupin Limited has reported the completion of a product-specific Pre-Approval Inspection by the United States Food and Drug Administration at its Unit-1 oral solid dosage manufacturing facility in Nagpur. The inspection was conducted between 10 and 14 November 2025 and concluded with no Form 483 observations.
“The successful outcome of the U.S. FDA inspection at our Nagpur Unit-1 facility exemplifies our commitment to uphold and maintain the highest standards of quality, compliance, and safety across our facilities. We remain dedicated to improving the lives of our patients globally.”
Nilesh Gupta, Managing Director at Lupin
The Nagpur Unit-1 facility manufactures oral solid dosage forms for the company’s global portfolio. A Pre-Approval Inspection assesses whether a facility is ready to manufacture products for the U.S. market under the conditions described in a drug application.
