USFDA completes inspection of Lupin Somerset facility with no observations
Mumbai: Global pharma major Lupin Limited 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 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 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.”
Lupin Limited is a global pharmaceutical company 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. The company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally.
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