FDF / DRUG PRODUCTS in Europe
Sterile liquids and suppositories manufacturing. We handle more than 100 molecules and provide stability studies, narcotics handling and analytical testing...
About the plant
With over 100 years of experience, our facility focuses on sterile liquids and suppositories manufacturing. We handle more than 100 molecules and provide stability studies, narcotics handling and analytical testing services.
Ampoules – Imprinted or Labelled
4 production lines: 2 aseptic with RABS technology and 2 non-aseptic
Aseptic filling or terminal sterilization process by heat
30 to 1,500 liters / 120 million units
Packaging of 1,3,4,5,6,10,20,25 or 50 ampoules
3 fully automatic visual inspection lines (optical-cosmetic-pinhole detection-labelling), 2 semi-automatic inspection lines & manual inspection workshop
Suppositories
2 filling machines and packaging line PVC-PE and PVC/PVDC/PE.
1 filling machine and packaging line PVC-PE ALU-ALU.
1 Batch from 500 to 2,000 kg / 1 automated workshop
2 Batches from 100 to 600 kg / 1 standard workshop
90 million units
Suppositories or ovules from 0,9 g to 4,6 g
2 blisters packaging lines
Platelets to 4,5,6 suppositories
Boxes to 5,8,10,12,30 suppositories
Certifications
- EMA (EU GMP)
- MFDS/KFDA (Republic of Korea GMP)
Activity
- Topical, mucosal and transdermal, Injectables, Suppositories and vaginal ovules, tablets, capsules, rings, Terminal sterilization, Fill&Finish, Glass ampoules, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- 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), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- DEA: Schedule I (high potential for abuse / no medical use), 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: N/A
- 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, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Formulation mixing, Research batches, Engineering batches, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Storage
Other plants of this company
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.
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.
FDF / DRUG PRODUCTS in Europe We specialize in aseptic manufacturing of lyophilized or liquid sterile (bio)pharmaceutical drug products through fill and finish.
