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U.S. FDA Completes Inspection of Lupin’s Dabhasa Facility with No Observations

April 12, 2024

Mumbai, India, April 12, 2024: Global pharma major Lupin Limited (Lupin) today announced that the United States Food and Drug Administration (U.S. FDA) has completed a GMP Inspection of its API manufacturing facility located at Dabhasa, India. The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations.

“We are pleased to announce the successful completion of the U.S. FDA inspection of our Dabhasa facility,” said Nilesh Gupta, Managing Director, Lupin. “This accomplishment underscores our unwavering dedication to maintaining the highest standards of quality and compliance in all aspects of our operations. This reaffirms our pursuit of excellence in delivering high-quality, affordable healthcare for all.”

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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