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Lupin Receives EIR from U.S. FDA for its Aurangabad Manufacturing Facility

April 23, 2024

Mumbai, Naples, April 23, 2024: Global pharma major Lupin Limited (Lupin) today announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for its Aurangabad manufacturing facility. The inspection was conducted from March 6 to March 15, 2024. The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).

” We are pleased to receive the EIR with VAI status from the U.S. FDA as an outcome of the recent inspection of our Aurangabad facility. It is a testament to our commitment to consistently upholding the highest standards of compliance and providing high-quality healthcare solutions to patients worldwide, ” said Nilesh Gupta, Managing Director, Lupin

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 the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company enjoys a leadership position 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. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.9% of its revenue in research and development in FY23.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

For further information or queries please contact –

Heena Dhedhi

Deputy General Manager – Corporate Communications

heenadhedhi@lupin.com

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