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Lupin’s Mandideep Unit II Facility Receives EIR from U.S. FDA
Mumbai, India, April 15, 2020: Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) after closure of the U.S. FDA inspection of its Mandideep Unit II facility, classifying the inspection as Voluntary Action Indicated. The inspection at the facility was carried out by the U.S. FDA between November 26, 2018 and December 4, 2018.
Commenting on the receipt of the EIR, Nilesh Gupta, Managing Director, Lupin said, “We are pleased to have received the EIR for our Mandideep Unit II facility, our important cardiovascular API manufacturing facility. We remain committed to enhancing compliance and quality standards across all our manufacturing sites.”
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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women’s health areas. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions and in India by global revenues. The Company invests 9.6 % of its revenues on research and development.
Lupin has fifteen manufacturing sites, seven research centers, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.
Please visit www.lupin.com for more information.
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