MANUFACTURING
Facilities
Fresenius Kabi Product Partnering offers access to over 20 manufacturing facilities worldwide, all operating according to high quality standards. With production locations on all continents as well as the required licenses (FDA, EMEA, Japan) we can choose a manufacturing location for your product according to your plans, that optimises supply-chain costs.
For product implementation Fresenius Kabi Product Partnering works together with the plants where a project leader is appointed as the responsible person for your project. Fresenius Kabi Product Partnering arranges the contractual frame work for the project and supervises the project internally.
Capabilities
Our manufacturing capabilities cover a full range of filling and finishing of both small- and large-volume sterile solutions and emulsions, with aseptic processing or terminal sterilization. We can manufacture from pilot scale through full-size commercial scale for worldwide markets. Our expertise covers the handling of Beta-lactams, biologics and cytotoxic products.
Increasingly, the characteristics of the primary container are a critical issue in launching sterile fluids successfully and in establishing and maintaining market share throughout the entire life cycle of a product. Fresenius Kabi Product Partnering has the flexibility to incorporate your specific demands on container configuration and has the expertise to advise you on all aspects of delivery systems.
Our standard range of primary containers includes:
| 50 - 3,000 ml |
| 50 - 1,000 ml |
| 1 - 20 ml |
| 1 - 30 ml |
| 50 - 1,000 ml |
| 50 - 1,000 ml |
| 0.5 - 50 ml |
| 0.5 - 50 ml |
| 2 - 50 ml |
| 5 - 100 ml |
*single- and multi-chamber
As well as processing our standard range of containers, we can support you in developing and processing containers with customized specifications and in a product- and client-specific configuration.
Quality-compliance
All manufacturing sites apply strict quality standards and procedures, laid down in the Fresenius Corporate Guidelines, and are operated in compliance with cGMP and GLP. In addition, all international manufacturing plants are ISO 9000 certified. This provides a solid basis for safe and efficient development and manufacturing of sterile pharmaceutical fluids. Our regulatory licenses for pharmaceutical products and medical devices include FDA, PIC, and TÜV Notified Bodies, among others.
References
We contract manufacture a large range of products for all kinds of therapeutic applications, such as antibiotics, pain relief, contrast media, anaesthetics, blood volume expanders, organ transplant solutions, and many others. The common denominator of these products is that they are sterile. The common denominator of our partners is that in outsourcing manufacturing they were looking for excellence in approach and performance.