Fresenius Kabi Product Partnering

Introduction

We have more than 50 years of experience in manufacturing non-coated, film-coated and sugar-coated tablets and hard gelatine capsules. The OSD drugs manufactured by us comprise a wide variety of specific pharmaceutical presentations such as gastro-resistant forms, modified & retarded-release forms etc. We have been active as a contract manufacturer for a long time and in this role we make high quality drugs for more than 30 international companies, used in over 60 countries around the world.


Production capabilities

Our facility can handle batch sizes up to 2.500.000 units. The actual manufacturing takes place in a controlled environment, in modern and well-equipped clean rooms. The conditions in rooms where products might be exposed to the environment, i.e. where open products are handled meet the grade "D" requirements of Annex 1 to the European GMP Guidelines. The air-conditioning allows the handling of humidity-sensitive products.
Handling, mixing and transport of powders & mixtures and products are done in closed IBC containers ranging from 300L to 1200L.
In an ex-proof facility, we can do wet granulation & high-shear mixing, followed by drying in a fluid bed dryer or an oven as required. Direct mixing and dry granulation with slurries / slugs is also possible.
For tabletting, presses with types B and D punches are available.
Sugar and film coating is done in an ex-proof facility.
We can fill powders, granules or pellets into hard gelatine capsules in formats number 4, 3, 2, 1, 0 and 0L.


Packaging capabilities

Products can be packed in a highly efficient manner on 4 automated packaging lines in several different blister materials such as ALU-ALU-blisters, PVC-ALU-blisters, PVC / PVDC-ALU-blisters and PVC-Aclair-ALU-blisters. Additionally, products can be packed into glass or plastic bottles using a counting device.
Our packaging competence includes "Unidose Packaging Technology" - single dosage units where the product specifics and the variable batch data are printed on every blister. Package formats are usually tailor-made to meet our customer's needs.

Quality

Our excellent production know-how is coupled with outstanding analytical competence - beginning with the analysis of the starting materials, continuing with IPC production surveillance and finally in the release analysis of finished products. The plant has climate chambers where stability studies according to the ICH requirements can be carried out.
Quality Standards - The plant holds a manufacturing license issued by the local competent authority and is additionally certified by different bodies according to EN ISO 9001, EN ISO 14001 & OHSAS 18001. And Quality Control is certified according to NP EN ISO/IEC 17025: 2000.