FDA Clears Lupin's Edaravone Facility in Somerset with No Observations

Global pharma major Lupin Limited (Lupin) announced that the United States Food and Drug Administration (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 carried out from January 28 to February 1, 2025, and concluded with zero 483 observations.
 
Nilesh Gupta, managing director, Lupin said, “The successful outcome of the US 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.
 
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients."

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