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USFDA Completes Inspection of Lupin’s Vizag Facility with No Observations

 

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USFDA Completes Inspection of Lupin’s Vizag Facility with No Observations

Global pharma major Lupin Limited announced that the United States Food and Drug Administration (U.S. FDA) has completed a Pre-Approval and GMP Inspection of its API manufacturing facility located in Visakhapatnam (Vizag), India. The inspection was conducted from March 6 to March 10, 2023 and concluded with no observations.

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.

“We are pleased with the successful completion of the inspection at our Vizag facility,” said Nilesh Gupta, Managing Director, Lupin. “This accomplishment is a testament to our commitment to upholding global quality standards across all our manufacturing sites, and to provide quality affordable healthcare for all.”