FDF / DRUG PRODUCTS in Europe
CMO/CDMO cytostatics and high potency products
About the plant
DESCRIPTION
Prasfarma is a Pharmaceutical Company that operates as a CMO and CDMO with experience in cytostatics, high potency products and biologics. Our flexibility & state of the art technologies, make us the ideal partner for small productions or R&D projects (pilot plant) and commercial supply (factory).
PRODUCTS AND SERVICES
Products: Cytostatics, High potency products, Biologics
Services: Formulation, analytic validation, stability testing, quality control, regulatory, clinical development, production and regulatory.
Technology: State of the art technology (Adapted to Annex 1)
PHARMACEUTICAL FORMS
INJECTABLE FORMS:
- Ampoules
- Vials (liquid and/or freeze-dryed)
- Pre-filled syringes
ORAL SOLID FORMS:
- Tablets
- Capsules
- Sachets
Compliance
- ICH
- ISO
- EMA (EU GMP)
- NMPA (China GMP)
- ANVISA (Brazil B-GMP)
- SFDA (Saudi Food & Drug Authority)
- TITCK (Turkish Health Authorities)
Activity
- Oral liquids and semisolids, Oral solids / OSD, Injectables, Ampoules, Oral solutions, Tablets, Hard capsules, Powders, Lyophilizates, Lozenges, Terminal sterilization, Fill&Finish, Small volume vials, Glass ampoules, PFS (Prefilled Syringes), FDF / DRUG PRODUCTS manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Phase I, Phase II, Phase III, Human
- Toxicity (OEB classification): 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
- Controlled substance: High potential for abuse & medical use
- BSL: 3, 4
- Therapeutic areas: (L) Antineoplastic and immunomodulating agents
- Markets: EMA (EU), MHRA (UK), NMPA (China), ANVISA (Brazil), 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, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, 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, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission, Extractables & Leachables, Stability tests, Identity, Content, Purity / Potency, Impurities, Physicochemical characterization, Water content (KF), Particle size (LD), Crystal form, Residual solvents (GC-MS), Elemental impurities / Metals (ICP-MS), Nitrosamines (HPLC-MS/MS), Endotoxins (LAL), Microbiology, Drug Product – Liquid, Drug Product – Solid
