Girindus produces APIs and key intermediates from laboratory scale up to commercial quantities using its chemical and biotechnological capabilities.

Our production and scale-up center is located in Kuensebeck, Germany. On this site we operate a cGMP multi-purpose chemical facility, which produces material needed for clinical phases I/II, III and commercialization. Smaller quantities (preclinical and phase I) are produced at our pilot facility in Cincinnati, USA.

For biotransformation and fermentation we operate a separate facility at Kuensebeck, which is equipped with bioreactors from 10 L up to 10,000 L. Please click here for more information on our biotechnological capabilities.

Capabilities at our cGMP chemical plant in Kuensebeck include among others:

• Over 50 reactors ranging from 100 L to 5000 L (glass-lined, stainless steel, hastelloy, zirconium and tantal)
• Production lines for sophisticated conversions:
  • Hydrogenation unit
  • Nitration unit
  • High temperature reactions up +280 °C
  • Low temperature reactions down to -80 °C
  • Solvents such as diethylether (explosion proof class T4) and halogenated hydrocarbons can be handled.
• Down Stream Processing
  • High-throughput centrifuges and separators
  • Preparative filter presses and Nutsch filters
  • Double cone dryers and spray dryers
  • Preparative rectification columns
• FDA approved