Lupin’s Vizag API facility receives EIR from US FDA

Lupin Limited, an innovation-led transnational pharmaceutical company headquartered in Mumbai, announced the receipt of the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) after closure of the inspection for its Vizag facility. The inspection for the API facility was conducted by the U.S. FDA between January 13, 2020 and January 17, 2020. 

Commenting on the receipt of the EIR, Nilesh Gupta, Managing Director, Lupin said, “We are very happy to have received the EIR for our Vizag facility. We remain committed to enhancing compliance and quality standards at the Vizag facility and across all our manufacturing sites.” 

Lupin 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 claims to be 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 15 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 and Pharmaceuticals sector.

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