Nycomed Operations Plant Singen offers a variety of technologies for manufacturing of Drug Products as well as capability for development and manufacturing of Active Ingredients. As one of the biggest global production plants within Nycomed, the plant in Singen is competence center for sterile dosage forms, processed aseptically or terminally sterilised, and responsible for production of Pantoprazole injection besides other applications.
The benefits of dealing with plant Singen are useful synergies throughout the whole process - from development, manufacture, analytical work to registration activities.
At an overall utilization of 70 % of our pharma production we currently produce 44 mio units of sterile liquids, lyophilisates, non-sterile liquids and semi-solids, corresponding to a portfolio of approx. 170 products in more than 550 different packaging formats. Our main fields of business currently are gastrointestinal, cardiovascular and respiratory therapeutics, contrast media for imaging and OTC products.
| Our Team and Facilities: |
|
- An international team of 750 employees
- Located in Singen, Germany (close to the lake of Constance)
- State of the Art Pharmaceutical Production and API Production (incl. Pilot Plant),
covering 32,000 m² |
Production of Pharmaceuticals
Bulk Production Sterile Plant
• Ultrafiltration, Sterile Filtration, Aseptic Spraydrying
• Terminally sterilized drug products:
• Bottles for Infusion
• Vials for Injection
• Prefilled Glas and Plastic Syringes
• Ampoules
• Aseptically processed drug products:
• Ampoules
• Powder Filling
• Lyophilisates
Batch sizes in the range of 200 – 4000 l |
Bulk Production Non-Sterile Plant
• Liquids:
• Bottles
• Gels:
• Stickpacks
• Tubes
• Nasal Spray
• Ointments:
• Tubes
• Suppositories
Batch sizes in the range of 100 – 6500 kg |
Packaging of Pharmaceuticals
|
• Fully automated packaging lines with modern control device and safety modules
for bottles, ampoules, vials and nasal sprays.
• State of the Art packaging lines prefilled syringes, cartridges, stickpacks, tubes
and suppositories |
Service Portfolio
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• Efficient product transfer
• Process development and up-scaling
• Development analytics
• Packaging design
• CMC dossier management
• High flexibility in scheduling, manufacturing and order processing
• Stability testing |
Quality Standards
• More than 30 successful GMP-audits from 1997 to 2006
• Inspected by German and Brazilian Authorities as well as by FDA; and of
course by our Clients in Contract Manufacturing
• Proactive quality strategy
• Quality taskforce on constant guard for process improvements
Safety & Environment Standards (German)
• ISO 14001 certificated
• EMAS II validated