USFDA issues EIR for Lupin Vizag facility
The inspection closed with the facility receiving an inspection classification of "No Action Indicated".
Mumbai: Global pharma major Lupin Limited has announced that the company has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its API manufacturing facility located in Visakhapatnam (Vizag), India.
The EIR was issued post the last inspection of the facility conducted from March 6 to March 10, 2023.
The inspection closed with the facility receiving an inspection classification of "No Action Indicated" (NAI). NAI means no objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action).
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“We are happy to have received the EIR for our Vizag facility from the US FDA," said Nilesh Gupta, Managing Director, Lupin. “We remain committed to ensuring the high quality of our products and ensuring the safety of our manufacturing processes.”
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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. 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.
