OncoGenerix USA, Inc. is proud to be the exclusive distributor of all the products and services provided by the state-of-the-art sterile injectable facility located in Mudanjiang, China. The facility has been designed and implemented to meet the quality requirements of the US FDA, EMA, & CFDA.
The facility we represent provides a fully integrated suite of services including technical transfer, process development, process scale up, equipment and process validation, formulation, filling, lyophilization, inspection, integrity testing, labeling and packaging. Some of the specific services offered are:
- Clinical batch sizes from 100 units to commercial batch sizes of 100,000 units, using the same high-quality manufacturing technology and quality management system.
- 2mL to 100mL vials with a fill range from 0.5mL to 100mL.
- ISO 5 isolator-based manufacturing in an ISO 7 background.
- Single-use manufacturing technology or dedicated equipment.