Global pharmaceutical company Lupin Limited announced today that the United States Food and Drug Administration (U.S. FDA) has successfully completed a product-specific pre-approval inspection at its Unit-1 oral solid dosage facility in Nagpur. The four-day inspection, carried out from November 10 to November 14, concluded with zero Form 483 observations, signaling full regulatory compliance.
Lupin’s Managing Director, Nilesh Gupta, expressed his satisfaction at the result, saying, “The successful outcome … 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.”
This achievement strengthens Lupin’s position as a trusted manufacturer of oral solid dosage formulations, particularly in global markets. The Nagpur Unit-1 facility is one of Lupin’s key manufacturing sites, and clearing an FDA inspection without any observations is a noteworthy milestone.
