Bulk Actives
Nycomed Austria is one of the biggest API producers in Austria. Our development team carries the synthesis from gram to ton scale according to GMP guidance. Naturally, each step of our work is closely monitored by QA and QC to ensure maximum quality. We understand our customers' needs for reliable quality on time, every time.
Bulk actives manufactured by Nycomed Austria can be distributed world-wide, as our facility has been certified by the FDA and health authorities in Austria, Germany and Japan.
Core competences for active pharmaceutical ingredients are:
By Substance Groups
• Nucleosides
• Heterocycles
• Narcotics
• Carbohydrates (part of Nucleosides) |
By Development Services
• Process evaluation and optimization
• Scale-up and validation of processes
• Stability and degradation studies
• Identification and preparation of impurities and reference substances
• Analytical method development and validation
• Chemistry part of CTX, IND and NDA |
By Reactions
• Halogenation
• Grignard reactions
• Friedel-Crafts reactions
• Diazotation
• Hydrogenation |
By cGMP Manufacturing
• GMP production of bulk activities and intermediates from kg to tons
• Optimization and validation of commercial process
• Preparation of the regulatory documentation; e. g. DMF |
Pilot plant
The GMP pilot plant consists of 10 glass-lined reactors ranging from 63 to 630 liters, a heating-cooling system from -40°C to 150°C including 2 stainless steel vessels for low temperature reactions (down to temperatures of -100°C) and a high vacuum (< 1mbar) distillation equipment. In addition we dispose of an explosion-proof kilo-lab for the synthesis of quantities for formulation experiments.
Multi-purpose production plant
Altogether 30 glass-lined and stainless steel reactors ranging from 300 to 6,000 liters, 2 hydrogenation facilities, several distillation columns, centrifuges, filter- and other types of driers are found on 3,000 m² on three floors including a separate finalization area with an overall capacity up to 500 tons a year.
The plant offers a wide range of custom manufacture and we are in the position of using chlorinated and organic solvents of all classes due to our waste water and air treatment systems.