USFDA concludes inspection of Lupin Dabhasa facility with no observations
Mumbai: Global pharma major Lupin Limited has 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."
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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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