Lupin’s Somerset facility clears U.S. FDA Pre-Approval Inspection for Edaravone Oral Suspension - Express Pharma

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Lupin’s Somerset facility clears U.S. FDA Pre-Approval Inspection for Edaravone Oral Suspension - Express Pharma

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. F…

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Lupin Announces Closure of Inspection by U.S. FDA at its Somerset Facility with No Observations