United States Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) of Edaravone Oral Suspension, 105 mg/ 5 mL at Lupin’s manufacturing facility in Somerset, New Jersey. The inspection was carried out from January 28, 2025 to February 1, 2025, and concluded with zero 483 observations.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
