State-of-the-Art Production

At Fresenius Kabi, our global expertise in complex medicine, state-of-the-art supply chain, and manufacturing allows us to consistently deliver high-quality biosimilars. This increases access to essential medicines and medical devices for patients.  

We power our operations end to end with dedicated commercial teams in markets around the world: from research and development (R&D) expertise to optimized manufacturing and integrated supply capabilities.  

  • Our R&D experts, regulatory compliance, and cutting-edge facilities apply the same high-quality standards in developing and producing biosimilars as the reference products. They are supported by our Medical Affairs and strategic marketing teams  
  • Our biologics are produced in facilities that are certified by major international regulatory agencies including the U.S. Food and Drug Administration and European Medicines Agency  

Investing more to improve drug development and supply

We are leveraging our robust supply chain and global expertise in manufacturing and biotechnology to develop biosimilars with the potential to improve patient lives. 

  • 90 science, manufacturing, and R&D centers around the globe 
  • Nearly $1 billion invested over the past 3 years in U.S. manufacturing and distribution capabilities 
  • Increased capacity to provide flexibility to respond to unforseen market situations 
  • Development of leading manufacturing technologies and innovative processes to replace slower, more expensive legacy methods
  • Delivery of >470 million injectable units per year in the U.S.
  • A biosimilar portfolio in which many products are manufactured in Europe with final packaging and labeling created in Fresenius Kabi’s U.S. facilities
  • 90 science, manufacturing, and R&D centers around the globe 
  • Nearly $1 billion invested over the past 3 years in U.S. manufacturing and distribution capabilities 
  • Increased capacity to provide flexibility to respond to unforseen market situations 
  • Development of leading manufacturing technologies and innovative processes to replace slower, more expensive legacy methods
  • Delivery of >470 million injectable units per year in the U.S.
  • A biosimilar portfolio in which many products are manufactured in Europe with final packaging and labeling created in Fresenius Kabi’s U.S. facilities
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Advanced manufacturing

Equipped with global expertise in biologic development and manufacturing, we apply the same high-quality standards to developing and producing biosimilars that are required for the development of reference products.  

Expansive supply chain

With production sites and compounding centers across the globe, we leverage a robust supply chain to secure access to medicines for more patients who suffer from debilitating diseases. 

We work hand in hand with key healthcare stakeholders to help resolve drug shortages and help prevent new ones:  

  • Committed to making our products consistently available, Fresenius Kabi is recognized by the FDA for reliable supply  
  • We are well equipped to meet high-volume demands for critical and chronic care therapies—even securing additional capacity in different geographic areas

 

    Our presence in the U.S. continues to grow:  

    • We have invested nearly $1 billion over the past few years in pharmaceutical manufacturing facilities in Illinois, New York, and North Carolina and in new distribution centers throughout the U.S.
    • We delivered more than 700 million units of injectable medicine to the U.S. in 2021  and have secured additional capacity in different geographic areas to support product availability and rapid scalability to meet market needs

    Our investments enable us to make significant progress in bringing more products, more choice, and more innovation to our customers in the U.S.  

    We continue our commitment to making affordable, high-quality health care available to more patients coping with critical and chronic diseases, and we are well-equipped to consistently meet high-volume demands for critical and chronic care therapies:  

    • Our nearly $100 million U.S. supply chain expansion in Wisconsin, Nevada, and South Carolina helps us more rapidly adapt to shifting customer needs 
    • The capacity expansion helped us to ramp up production of critical injectable medicines used by hospitals during the pandemic and enabled us to support America’s strategic national stockpile, as well as America’s vaccine developers, with vital pharmaceuticals

    To learn more about how we are building more resilience into our supply chain, including our plan to more than double the Fresenius Kabi manufacturing capacity in the U.S. in the next 5 years, visit moreinamerica.com

    Consistency of quality

    Fresenius Kabi brings years of pharmaceutical experience and technical knowledge to ensure the production of consistent, high-quality products:  

    • Our biosimilars meet the high regulatory standards required by the FDA based on the totality of evidence across analytical, pharmacokinetic/pharmacodynamic (PK/PD), clinical safety, and immunogenicity assessments against the reference product 
    Totality of evidence

    FDA standards for demonstration of biosimilarity

    Learn how the FDA ensures the safety and efficacy of biosimilars with a totality of evidence approach

    FDA, U.S. Food and Drug Administration.