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...
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
- Topical, mucosal and transdermal, Semisolid forms, Liquid forms, 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)
- 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: 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, 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, 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, Storage
Other plants of this company
FDF / DRUG PRODUCTS SERVICES in Europe Specializes in the development of Value Added Medicines and has been recently upgraded with HPAPI capabilities.
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.
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.
