Adragos Pharma | Halden

Adragos Pharma | Halden

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 EMA and FDA certified, underscoring its commitment to maintaining the highest quality standards in sterile production, and ships to all major global markets.

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Sterile Liquids & Gels

• Sterile Liquids (Terminal Sterilization)
• 3 IV bag production lines (automated)
• 3 BFS ampoule 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

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Non-Sterile Liquids

• 1 production line for disinfectants, incl. IPA ethanol and chlorhexidine (with/without color)
• Bottle filling from 125 mL to 1,000 mL
• Own bottle manufacturing (blowing)
• Pre-formed bottles possible
• Specialty products with high flammable concentration (ATEX), e.g., disinfectants

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Other Services

• Norway’s largest commercial laboratory
• In-house testing and release of raw materials and finished goods
• Worldwide logistics operations, 1,800 TEU (30 tons)
• Cold chain distribution to the Norwegian compounding market
• Dedicated packaging lines including serialization and tamper-evidence protection
• Scale-up (pilot-scale to production-scale)
• Manufacturing of stability batches
• Galenic optimization of existing formulations
• Stability testing and storage
• Internal quality control testing capabilities
• Market release

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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

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• World Health Organization (GMP / HACCP)
• NMPA (China GMP)
• TGA (Australia GMP)
• ANVISA (Brazil B-GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• MHRA (UK GMP)
• UAE Ministry of Health & Prevention
• NSF
• TITCK (Turkish Health Authorities)

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Activity

• Sterile forms (ophtalmic, nasal, otic), Injectables, Terminal sterilization, BFS (Blow Fill Seal) ampolues, Flexible bags / Infusion systems, FDF / DRUG PRODUCTS manufacturing

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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: N/A
• Therapeutic areas: (A) Digestive tract and metabolism, (D) Dermatologicals, (V06) Nutrients
• Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), MFDS (South Korea), SFDA (Saudi Arabia), Turkish Health Authorities

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Batch Size / Reactor

• Small, Medium, Large

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Services

• Regulatory services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Formulation mixing, Engineering batches, Scale-up, 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

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