Italy Europe
FDF / DRUG PRODUCTS SERVICES in Europe
Sterile fill-finish manufacturing site for injectable drug products (vials, ampoules, lyophilized), offering clinical-to-commercial supply with integrated quality, packaging, and analytical services.
About the plant
Former Pfizer sterile manufacturing facility specialized in aseptic fill-finish and terminal sterilization. The site supports clinical to commercial production of sterile liquid vials, ampoules, and lyophilized products, with integrated analytical labs, packaging, and warehousing.
Key capabilities include lyophilization, liquid filling, ampoule filling, visual inspection, and serialization-ready packaging. The facility serves over 70 global markets and operates under a robust quality management system aligned with international GMP standards.
Compliance
Activity
- Sterile forms (ophtalmic, nasal, otic), Injectables, Terminal sterilization, Fill&Finish, BFS (Blow Fill Seal) ampoules, Sprays, Small volume vials, Glass ampoules, FDF / DRUG PRODUCTS, SERVICES manufacturing
Features
- Uses: Human
- Toxicity (OEB classification): 2 (PDE = 1,000 - 5,000 µg/day)
- Controlled substance: High potential for abuse & medical use, Lowest potential for abuse
- BSL: 1, 2, 3
- Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system
- Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), ANVISA (Brazil), MFDS (South Korea), Russian Health Authorities
Batch Size / Reactor
- Small, Medium, Large
Services
- Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
