Lupin gets USFDA EIR for Aurangabad Facility
Mumbai: Pharma major Lupin Limited (Lupin) has 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 the Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS) and women's health areas. The Company invests 9.6 % of its revenues on research and development.