Mumbai, India: Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) from the U.S. FDA for its Aurangabad, India facility. The inspection for the facility was carried out by the U.S. FDA between February 10, 2020 and February 14, 2020 and concluded with no observations.
Commenting on the receipt of the EIR, Nilesh Gupta, Managing Director, Lupin said, “We are delighted with the receipt of the EIR for Aurangabad classifying the inspection as No Action Indicated. This takes us a step forward in our efforts of enhancing our compliance and quality standards across all our manufacturing sites. We continue to work with the U.S. FDA to continuously improve our quality and compliance while providing important medicines to the U.S. market”.
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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