Halden, Norway
Halden Pharma is one of the largest and most advanced sterile production facilities in Northern Europe, specializing in the production and distribution of IV bags and plastic ampoules (BFS). We also provide non-sterile liquids and compounding services. The facility is, among others, EMA and FDA certified, underscoring its commitment to maintaining the highest quality standards in sterile production and shipping to all major global markets. Halden operates as a partnership with the Prange Group, the current owner and also a significant shareholder in the Adragos Group.
Our Site
Adragos Halden stands as one of the largest and most advanced sterile production facilities in Northern Europe. Specializing in the manufacturing and distribution of IV bags and plastic ampoules, the facility leverages cutting-edge Blow-Fill-Seal (BFS) technology and other pharmaceutical dosage forms to ensure precision and efficiency.
As a partner within our network, Adragos Halden holds numerous global certifications and recognitions. With a broad portfolio of end-to-end services, it offers comprehensive solutions for pharmaceutical development and manufacturing, solidifying its position as a leading sterile contract development and manufacturing organization (CDMO) in Europe.
Our Services
Sterile Liquids
- Terminal sterilization:
- IV bags with batch sizes up to 15,000 L
- IV bags from 50 ml to 1,000 ml
- Small Volume Parenteral (SVP) with batch sizes up to 5.000 L
- Blow-Fill Seal (BFS) Vials up to 100ml
- Blow-Fill Seal ampoules from 5 ml to 30 ml
- Parenteral nutrition
Non Sterile
- Liquids & Gels
- Batch sizes up to 5,300 L
- 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
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
Brazil- ANVISA
Japan- PMDA
China- NMPA
Turkey- MOH
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.
Meet our Colleague
Ian Cooper
Ian Cooper is the Chief Executive Officer of Halden Pharma, which is part of the Prange Group and our partner facility in Norway. He has previous hands-on experience as an international executive leader in Operations, Supply Chain, and Commercial Operations. His expertise spans sectors such as contract manufacturing of pharmaceuticals, food, and hygiene products.
