The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022
The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway
Biocon Biologics recently acquired the global biosimilars business of its long-term partner Viatris
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
Takes over the commercialization of Biosimilars Business from Viatris in 70+ countries
The launch of HULIO in the United States is an important milestone for Biocon Biologics
This approval reflects Biocon Biologics' compliance with the highest international regulatory standards
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