Lupin receives USFDA EIR for Vizag API Facility
Mumbai: Lupin Limited has announced the receipt of the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) after the closure of the inspection for its Vizag (Vishakhapatnam), India 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 Limited is a global pharmaceutical company based in Mumbai, Maharashtra, 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.