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.
About the plant
Our manufacturing facility in Leipzig specialises in 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.
Semi-solids
Dosage Form: Creams, gels, ointments, healing paste
Batch size: 15l – 1,250l
Aluminum tubes: 2g – 150g; Plastic tubes: 25g – 200g
2 production lines: Marchesini and Norden
Non-Sterile Liquids
Dosage Form: Solutions, drops, suspension, emulsion
Batch size: up to 4,000 liters
Plastic and glass bottles: 20ml – 700ml
3 production lines: Dovema, Groninger and Würschum
Certifications
- EMA (EU GMP)
Activity
- Oral liquids and semisolids, Topical, mucosal and transdermal, Semisolid forms, Liquid forms, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Commercial (Phase IV), 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)
- Controlled substance: High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
- BSL: N/A
- Therapeutic areas: N/A
- Markets: EMA (EU), PMDA (Japan), MHRA (UK), NMPA (China), MFDS (South Korea)
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution
Other plants of this company
FDF / DRUG PRODUCTS BIOLOGICS in Europe We specialize in aseptic manufacturing of lyophilized or liquid sterile (bio)pharmaceutical drug products through fill and finish.
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 services.
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.
