Nycomed Oranienburg, Germany – Competence for Solid Dosage Formulations

 


As the competence centre for the development, production and packaging of solid dosage formulations Nycomed Oranienburg plays an important part in the global Nycomed operations network. We supply the global pharmaceutical markets in more than 100 countries, form Europe to the US and Japan. Our products include corporate Nycomed products and contract manufacturing for third parties.

At the moment we produce 3.1 bln units with 88 mill. Packs a year of 100 different products and 700 variations ranging from OTC to high potent RXT products including HIV-treatment.


Features and Services


Our Team and Facilities

- An international team of 330 employees
- Located in the heart of Europe, 30 km northwest of Berlin, Germany
- Two state-of-the-art production modules covering 36,000 m²
- Storage area of 2,500 m² with space for 8,300 pallets



Pharmaceutical Services

Production of Pharmaceuticals

Bulk production
Mixing

• Granulation (wet, fluid bed with aqueous and organic solvents)
• Roller compaction
• Pellet production (non pairelles, extrusion, Wurster coating)
• Tabletting (cores for various tablet types, e.g. bi-layer tablets)
• Encapsulation
• Coating (aqueous and organic solvents)
• Imprinting
• Batch sizes range from 50 to 350 kg



Packaging of Pharmaceuticals

• Blister packaging with various formats (PVC, PVC/PVDC, COC, Aclar, Alu/Alu)
• Bottle packaging (glass, HDPE)
• Wallet packaging
• Stick packs



Development Services

• Product transfers
• Up-scaling and process development (from 2 kg-pilot to production scale)
• Market form design (bulk & packaging)
• Analytics
• CMC dossier management, e.g. stability studies



Supply Chain Management

• Demand management
• Supplier management for raw and packaging materials and external services



Quality standards

• Approval for supplies Europe (EMEA), the US (FDA) and experience Japan
  (bulk clinical supplies)
• More than 50 successful audits including FDA audits in 1998 and 2004
• Proactive quality strategy
• Quality taskforce on constant guard for process improvements


 Environment Protection (German)