Lupin’s Mandideep Unit-2 Facility Completes U.S. FDA Inspection with No Observations
Global pharma major Lupin Limited (Lupin) today announced that its Unit-2 manufacturing facility located in Mandideep, India, has successfully completed a GMP inspection by the United States Food and Drug Administration (U.S. FDA). The inspection was
Global pharma major Lupin Limited (Lupin) today announced that its Unit-2 manufacturing facility located in Mandideep, India, has successfully completed a GMP inspection by the United States Food and Drug Administration (U.S. FDA). The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.
“We are pleased to announce that the U.S. FDA inspection of our Mandideep Unit-2 facility concluded with no observations. This further reaffirms our commitment to superior quality and compliance standards,” said Nilesh Gupta, Managing Director, Lupin.
About Lupin
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
