Lupin Limited has confirmed that the US Food and Drug Administration has completed a product-specific Pre-Approval Inspection at the company’s Unit-1 oral solid dosage facility in Nagpur. The inspection took place between November 10 and November 14, 2025, and wrapped up without a single Form 483 observation, indicating that the regulator did not flag any compliance issues during the review.
The company’s Managing Director, Nilesh Gupta, noted that the positive outcome reflects Lupin’s focus on maintaining quality, safety and regulatory standards across its manufacturing network. He also added that Lupin continues to work toward supporting patients around the world through reliable and compliant operations.
This development is significant as a zero-observation close further strengthens confidence in the plant’s readiness for product approvals tied to the inspection.
