Lupin has announced that the United States Food and Drug Administration (U.S. FDA) has completed a Pre-Approval Inspection (PAI) of Edaravone Oral Suspension, 105 mg/5 mL, at its manufacturing facility in Somerset, New Jersey.
The inspection was conducted from January 28 to February 1, 2025, and concluded with zero 483 observations.
Commenting on the development, Nilesh Gupta, Managing Director, Lupin, said, “The successful outcome of the U.S. FDA inspection at our Somerset facility is a testament to our commitment to uphold and maintain the highest standards of quality, compliance and safety across our facilities. We remain steadfast in our mission to improve the lives of our patients globally.”