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). It also provides 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 ships to all major global markets. Halden operates as a partnership with the Prange Group, the owner and a significant shareholder in the Adragos group.
The Site
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, 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.
Services
Sterile Liquids & Gels
- Sterile Liquids (Terminal Sterilization)
- 3 IV bag production lines automated
- 3 BFS ampoules production lines
- 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 ampoules from 10 mL to 30 mL
- Gels:
- Production line for intestinal gel
- Parenteral nutrition compounding
- Intestinal gel filled into plastic cassettes, 100 mL
Non-Sterile Liquids
- 1 production line for disinfectants, incl. IPA ethanol and chlorhexidine (w/wo color)
- Bottle filling from 125 mL to 1,000 mL
- Own bottle manufacturing (blowing)
- Pre-formed bottles possible
- Specialty products with high flammable concentration, i.e., disinfection (ATEX)
Other Services
- Norway’s largest commercial laboratory
- In-house testing and release of raw materials and finished goods
- Logistics operation sizes 1,800 TEU (twenty-foot equivalent/30 tons) worldwide
- Cold chain distribution to the Norwegian Compounding market
- Dedicated packaging lines incl. serialization and tamper evidence protection
- Scale-up (pilot-scale, production-scale)
- Manufacturing of stability batches
- Galenic optimization of existing formulae
- 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 The Brochure Now!
We have prepared a brochure to help you discover the facility in Halden.
Key Information
Location: Halden, Norway
SQM: 77,000m²
Foundation Year: 1977
FTE (Employees): 650
Certifications and Recognitions
EU – GMP
US – FDA
Brazil – ANVISA
Japan – PMDA
China – NMPA
Turkey – MOH
Australia – ARGPM
Taiwan – TFDA
UAE
Expertise
• Sterile liquids, non-sterile liquids, and gels
• Blow fill seal technology
• 7 production lines
• GMP & GPD certified
• ISO certifications
• Export rate 95%
Meet the team in Halden
Highly skilled and experienced in their field.
CEO of Halden
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.
