Halden, Norway
Our recently acquired plant is one of the largest and most advanced sterile production facilities in Northern Europe. We specialise in the manufacturing of IV bags, and of plastic ampoules and vials using Blow-Fill-Seal (BFS) technology and other dosage forms.
Our Site
Adragos Halden is one of the largest and most advanced sterile production facilities in Northern Europe. It specializes in the production and distribution of IV bags, plastic ampoules and vials using blow-fill-seal technology and other pharmaceutical dosage forms.
The facility holds numerous certifications and recognitions that guarantee the quality of the production. It also offers a wide range of services for end to end production. It is one of Europe‘s premier sterile contract development and manufacturing organization (CDMO).
Our Services
Sterile Liquids
- Terminal sterilization:
- IV bags with batch sizes up to 15,000 liters
- IV bags from 100 ml to 1,000 ml
- Blow-Fill Seal ampoules and vials with batch sizes up to 5,000 liters
- Blow-Fill Seal ampoules from 5 ml to 30 ml
- Blow-Fill Seal vials 10 – 20ml, 50 ml and 100 ml
- Parenteral nutrition
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 sizes up to 5,300 liters
- Bottle filling from 125 to 1,000ml
- Intestinal gel filled into plastic cassettes, 100ml
- Specialty products with high flammable concentration, i.e. disinfection (ATEX)
- Capabilities of bottle extrusion
- Disinfection: Polyethylene (PE) bottles: 125/250/1000 ml
Other Services
- Commercial manufacturing and packaging
- Pharmaceutical formulation development
- Scale-up (pilot-scale, production-scale)
- Process validation
- Manufacturing of stability batches
- Galenic optimization of existing formulae
- Regulatory services
- Analytical development and validation
- Stability testing and storage
- Internal quality control testing capabilities
- Market release
Regulatory services
- Regulatory and registration strategy
- Scientific report writing
- Compilation and publishing of data in eCTD format
- Liaising with regulatory authorities
- Registration services and support
- Risk assessment reports
Certifications and Quality processes
- EU – GMP
- US FDA
- Norway – NOMA
- Germany- TUV – SUD
- Eurasian Economic Union
- Australia-ARGPM
- Brazil-ANVISA
- China-NMPA
- Saudi Arabia- GHC
- UAE- DHA
- Taiwan-GMP
- Japan-PMDA-
- Turkey- -TMMDA
- ISO 13485
- ISO 9001
Download Our Brochure Now!
We have prepared a brochure to help you discover our facility in Halden.
Key Information
Location: Halden, Norway
SQM: 77,000m²
Foundation Year: 1977
FTE (Employees): Above 600
Certifications and Recognitions
EU-GMP
US-FDA
Norway – NOMA
Germany – TUV SUD
Eurasian Economic Union
Australia
Brazil-ANVISA
China
Saudi Arabia- GHC
UAE
Taiwan
Japan
Turkey
ISO 13485
ISO 9001
Expertise
• Sterile liquids and non-sterile liquids and gels
• Blow fill seal technology
• 7 production lines
• GMP & GPD certified
• ISO certifications
• Export rate 95%
Meet our team in Halden
Highly skilled and experienced in their field.
