Lupin : June 14, 2024 Lupin Announces Closure of US FDA Inspection at its Injectable Facility with Zero 483 Observations

Mumbai, June 14, 2024 - Global pharma major Lupin Limited (Lupin) today announced that the United States Food and Drug Administration (U.S. FDA) has completed an inspection of its Injectable facility in Nagpur, India. The inspection of the facility was carried out from June 10 to June 13, 2024, and concluded with zero 483 observations.

Nilesh Gupta, Managing Director, Lupin said, "We are pleased to have a successful outcome of the U.S. FDA inspection at our Nagpur injectable facility with zero observations. This reflects our dedication to uphold the highest quality and compliance standards across our facilities."

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 7.8% of its revenue in research and development in FY24.

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. Please visit www.lupin.com for more information.

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Heena Dhedhi
Deputy General Manager - Corporate Communications
[e-mail]

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