Summary –
The USFDA had earlier issued seven observations after inspecting the Goa manufacturing facility in September. The Goa site is the major exporter of the products manufactured by Lupin.
Global pharma major Lupin Limited (Lupin) today announced that it has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (US FDA) for its Goa manufacturing facility, after the inspection of the facility in September 2021. The US FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).
Lupin’s Goa Manufacturing Plant Receives EIR from US FDA
“We are very happy to have received the EIR from US FDA with Voluntary Action Indicated classification for our Goa plant. This is a significant milestone as we build back our reputation of being best-in-class in Quality and Compliance. We are committed to manufacture and supply products of the highest quality from all our manufacturing sites.” said Vinita Gupta, CEO, Lupin.
Commenting on the development, Nilesh Gupta, Managing Director, Lupin said “This is a very positive development and we are delighted with the news of the change in classification of our Goa site. The Goa site has a very important place in the U.S. market with the number of affordable, quality medicines we supply, and we now look forward to new products flowing out of the site again. We remain committed to meet and exceed global standards of quality and compliance at all our manufacturing facilities globally.”
About Lupin
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. The company invested 9.6% of its revenue on research and development in FY21.
Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.