FDF / DRUG PRODUCTS in Europe
We specialize in aseptic manufacturing of lyophilized or liquid sterile (bio)pharmaceutical drug products through fill and finish.
About the plant
We specialize in the aseptic production of lyophilized or liquid sterile (bio)pharmaceutical products through fill and finish. Our facility is ideal for the production of small clinical and commercial batches and is GMP and FDA certified.
Clinical Manufacturing – Phase I, II, & III
Commercial Manufacturing – Fill and Finish
We are specialized in two distinct dosage forms: liquid products aseptically filled and lyophilized products, both filled in vials. Capacities: Aseptic Filling, Liquid Filling, Complex Formulation, Peptides, Biological Products, Controlled Substances, Small Molecules, Sterile Suspensions, Ophthalmic Products, Placebos/Diluents, Vials, Lyophilizer Size (3.5 m²).
No minimum batch size is imposed. Specialized in the manufacturing of clinical batches from very small quantities of bulk solution (eg: 200-300ml).
We manufacture batches for the different phases of pharmaceutical development, from manufacturing under GMP and FDA conditions (first stage of scale-up under industrial conditions, preparation of material for preclinical studies, stability studies, etc.) to GMP/FDA manufacturing for clinical needs.
Development Services
Freeze-Drying Cycle Development
Manufacturing Process Development and Transfer
Formulation Development Support
Filter/Material Compatibility
Analytical Services
Primary & Secondary Packaging
Quality Control
GMP Batch Certification
Certifications
- EMA (EU GMP)
Activity
- Sterile forms (ophtalmic, nasal, otic), Injectables, Fill&Finish, Dropper bottles, Ophtalmic dispensers, Fill&Finish, Small volume vials, 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: N/A
- 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
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Formulation mixing, Lyophilization, 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, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Storage, Distribution, CMC regulatory support
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 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 Sterile liquids and suppositories manufacturing. We handle more than 100 molecules and provide stability studies, narcotics handling and analytical testing services.
