USFDA issues zero observation to Lupin Vizag facility
Mumbai: Global pharma major Lupin Limited has 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 with no observations.
The inspection was conducted from March 6 to March 10, 2023.
“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.”
Read also: Lupin unveils schizophrenia drug Lurasidone Hydrochloride in US
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, gastrointestinal (GI), central nervous system (CNS), and women’s health areas.
The company invested 8.7% of its revenue in research and development in FY22. Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.
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