FDF / DRUG PRODUCTS in Europe
Specialized CDMO for development and production of small molecules injectables.
About the plant
Tailored CDMO Solutions for Small Molecule Injectables
With over 60 years of experience in sterile production, this company combines innovative expertise with cutting-edge manufacturing technology. They produce high-quality complex injectables – including high-potency and controlled substances, crystalline suspensions, and oily solutions – across vials, pre-filled syringes, cartridges, implants, and ampoules. These productions serve both the company´s global portfolio and third-party clients.
Founded in 1950, the site has seen extensive investments over the years. Significant resources have been dedicated to state-of-the-art manufacturing facilities, which were recently commissioned to meet modern production standards.
Expertise includes technology transfer, formulation development, and scalable manufacturing. The advanced facilities guarantee quality and efficiency, supporting your product from development to market launch. Let us help you bring your innovations to life.
Compliance
- ISO
- EMA (EU GMP)
- NMPA (China GMP)
- ANVISA (Brazil B-GMP)
- Roszdravnadzor (Russia GMP)
- MFDS/KFDA (Republic of Korea GMP)
- PMDA/MHLW (Japan GMP)
- TITCK (Turkish Health Authorities)
- 14001
Activity
- Implants, Injectables, Terminal sterilization, Fill&Finish, Small volume vials, Large volume vials / Bottles, Glass ampoules, PFS (Prefilled Syringes), Cartridges, FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Commercial (Phase IV), 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), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- Controlled substance: High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse, Lowest potential for abuse
- BSL: 1, 2
- Therapeutic areas: (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system
- Markets: DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), 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), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Registration batches, Batch records
