Norway Europe
FDF / DRUG PRODUCTS in Europe
We specialize in the manufacturing of IV bags, plastic ampoules and vials using Blow-Fill-Seal (BFS) technology and other dosage forms.
About the plant
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.
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 and registration 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
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- World Health Organization (GMP / HACCP)
- NMPA (China GMP)
- ANVISA (Brazil B-GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
- MHRA (UK GMP)
- UAE Ministry of Health & Prevention
- NSF
Activity
- Topical, mucosal and transdermal, Injectables, Liquid forms, Terminal sterilization, BFS (Blow Fill Seal) ampolues, Flexible bags / Infusion systems, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
- DEA: Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
- BSL:
- Therapeutic areas: (A) Digestive tract and metabolism, (D) Dermatologicals, (V06) Nutrients
- Markets: FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), SFDA (Saudi Arabia)
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Formulation / Galenic design, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission
Other plants of this company
FDF / DRUG PRODUCTS in Europe Semi-solid and non-sterile liquid pharmaceuticals. With over 100 years of experience, we have a track record of providing first class service and customer focused manufacturing.
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FDF / DRUG PRODUCTS in APAC Our facility provides best-in-class manufacturing of tablets and ampoules, English and Japanese outstanding customer service, and has more than 330 high skilled employees. It stands out as one of Japan largest cold storage warehouses.
