Lupin gets USFDA EIR for Pithampur Unit-1 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) for its Pithampur Unit-1, India facility.
The inspection for the facility was conducted by the U.S. FDA between February 3, 2020, and February 11, 2020, and concluded with two observations.
Commenting on the receipt of the EIR, Nilesh Gupta, Managing Director, Lupin said, "We are very happy to have received the EIR for our Pithampur Unit-1 facility with Voluntary Action Indicated (VAI) status. Continuous improvement of our quality and compliance standards across all our manufacturing sites is a key focus area for the company and we are committed to working with the U.S. FDA to manufacture and supply products of the highest quality from 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.