Fresenius Kabi Contract Manufacturing

About Fresenius Kabi Contract Manufacturing

Fresenius Kabi Contract Manufacturing is a global leader in the contract development and filling & finishing of sterile pharmaceuticals as well as for the development and supply of medical devices. Being part of Fresenius Kabi, we offer our customers access to the expertise of more than 20 Manufacturing and Research & Development Facilities  worldwide. Unparalleled production capabilities, outstanding quality compliance, and an excellent track record in contract manufacturing have made Fresenius Kabi Contract Manufacturing the supplier of choice of an impressive number of pharmaceutical companies.

The integral concept of combining development and production for sterile medicinal products and develop additionally the respective medical devices for your application makes us a one-stop-shop for nearly every kind of project.

Fresenius Kabi Contract Manufacturing Industry Content
  • AT
  • 2015
    On CPHI since
  • 4
  • 5000+
Company types
Contract Service
Contact info
Meet us at

CPHI Frankfurt 2022

Messe Frankfurt, Frankfurt, Germany
1-3 November 2022

Fresenius Kabi Contract Manufacturing Resources (6)

  • News Fresenius Kabi invests in Pre-Filled Syringe Capacities for US and EU supply

    As a safe, effective and convenient way to administer injectable medications, pre-filled syringes (PFS) have become the injection system of choice for a growing number of drugs. PFS allow healthcare professionals to easily handle syringes, reduce waste and save time by providing a ready-to-use container, while also allowing them to precisely dose and minimize overfill.
  • Brochure Fresenius Kabi Contract Manufacturing Brochure

    Find out about our Contract Manufacturing and fill- and finishing services for sterile pharmaceuticals and medical devices. We offer different containers in various sizes like pre-filled syringes, ampoules, vials, bottles and IV-bags.
  • Brochure INSIGHT US

    In our latest INSIGHT edition we introduce our three US facilities and our new US team.
  • Brochure INSIGHT IV-bags and medical devices

    This INSIGHT edition sheds light on our production site in Halden, Norway, our IV-bag capabilities and our medical devices expertise.
  • Video Your Partner for Diluents

    As a specialist in diluent solutions Fresenius Kabi is the right partner for you. We offer solutions, that fit together with your needs. Find out more about our diluent production in this video
  • Webinar Be Prepared! Combination Products under MDR - Article 117

    This extremely topical webinar addresses the challenge that the complex European Medical Device Regulation (MDR) poses for the entire industry, with a special focus on drug combination products and the requirements of Article 117.

    Join Heinrich Martens, Vice Regulatory Affairs, Fresenius Kabi and Jonas Orf, Junior Key Account Manager, Fresenius Kabi as they shed light on the new requirements of MDR including stricter pre-market control, oversight of notified bodies, inclusion of products without medical purpose and rules on clinical data and clinical investigations.

    They also provide an introduction to the drug combination ‘world’ within the context of MDR Article 117, the role of the Notified Body, fulfilment of the General Safety and Performance Requirements (GSPRs) and responsibilities and obligations of the manufacturer(s).

    “In the MDD world that we had in the past, we had the essential requirements, which were similar to the GSPRs, but there was never anything about a Notified Body opinion, an additional approval step for the device that was required for a drug combination submission to the authority,” says Martens. “Which is totally different when you look now into Article 117.”

    By watching this webinar, you will understand:
    What is a combination product

    The meaning of Article 117

    The role and task of the Notified Body

    Manufacturer responsibilities

    Evidence and fulfilment of the GSPRs

    Notified Body opinion