Central Glass Germany is dedicated to process development, upscaling and production of active ingredients and intermediates for the pharmaceutical and cosmetics industry. It operates an FDA and EU inspected facility in Halle-Kuensebeck, which it acquired from Girindus in June 2008.
An experienced and highly skilled team of organic chemists and support functions, such as analytical specialists and QA/QC team, ensure success and high quality of our projects.
Our service offering includes:
- Process development and upscaling from grams to tons
- Custom synthesis for pre-clinical studies, Phase I-III trials and launch
- cGMP production of commercial APIs and intermediates
- In-process and finished API analytical methods development
- Validation of manufacturing processes and analytical methods
- ICH stability studies for registration
- Comprehensive support for CMC file preparation
We operate under a EU GMP certificate issued in April 2012 and successfully passed a FDA cGMP systems and pre-approval inspection in June 2009, with no 483 issued.
Hall 4 Stand A11
