Halden Pharma, situated at strategic crossroads in Norway, is one of the largest and most advanced sterile production facilities in Northern Europe.
The state-of-the-art capabilities include the production of IV bags, plastic ampoules and vials using blow-fill-seal technology and other pharmaceutical dosage forms.
The site was not only a cornerstone of manufacturing capabilities of the former owner Fresenius Kabi in the Nordics, but already caters to other prominent pharma customers as a contract manufacturer.
The site has recently been acquired by the German family owned Prange group who is continuing the development of the site as one of Europe‘s premier sterile contract development and manufacturing organization (CDMO).
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We offer the complete supply chain starting with transfer management, analytical services, production and packaging
Sterile liquids
Terminal sterilization
- Large Volume Parenteral (LVP) with batch sizes up to 15.000 L
- IV bags from 50 ml to 1.000ml
- Small Volume Parenteral (SVP) with batch sizes up to 5.000 L
- Blow-Fill Seal (BFS) ampoules from 5 mL to 30 mL
- Blow-Fill Seal (BFS) vials up to 100ml
Sterile liquids
Aseptic
- Various compounding products
Further aseptic capabilities under development:
- IV bags
- Pre-Filled Syringes (PFS)
- Multi Dose nasal products
- Ophthalmics
Non-Sterile
liquids & gels
- Batch sites up to 5.300 L
- Bottle filling from 125 to 1000ml
- Specialty products with high flammable concentration, i.e. disinfection (ATEX)
- Capabilities of bottle extrusion
- Cassettes filling
Services
Commercial Manufacturing and Packaging
Pharmaceutical formulation development
Regulatory services
Scale-up (from laboratory over pilot-scale into production-scale)
Analytical development & Validation
Process validation
Stability testing & storage
Manufacturing of stability batches
Quality control
Optimization of existing product composition and analytical methods
Market release
Main Certifications
EU-GMP
US-FDA
Eurasian Economic Union
Australia
Brazil-ANVISA
China
UAE
Taiwan
Japan
Turkey
ISO 13485
ISO 9001