Lupin gets USFDA EIR for Mandideep Unit 2 manufacturing facility
Mumbai: Global pharma major Lupin Limited has announced that the Company has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Mandideep Unit-2 manufacturing facility.
The EIR was issued post the last inspection of the facility conducted from August 7 to August 11, 2023. The inspection closed with the facility receiving an inspection classification of "No Action Indicated" (NAI).
“We are pleased to receive the EIR with a satisfactory inspection status from the U.S. FDA for the recent inspection of our Mandideep Unit-2 facility. This accomplishment is in line with our continued focus and commitment to becoming best-in-class in quality and compliance, and enables us to continue delivering quality affordable healthcare solutions globally,” said Nilesh Gupta, Managing Director, 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 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 invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.
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