FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC COSMETICS NUTRACEUTICALS SERVICES PARTICLE ENGINEERING in Europe
Chemical-Pharmaceutical Plant
About the plant
A Spanish chemical-pharmaceutical company specialized in vinca-derived alkaloids, manufacturing high-quality NCF (GMP) certified APIs (Vinpocetine, Vincamine and Vinburnine) for the global pharmaceutical industry. Its ingredients are derived from African Voacanga and are processed using high-tech equipment compliant with ICH standards, supported by a GMP-certified manufacturing site and GMP-certified laboratory, with EU authorization as a drug manufacturer/importer certified by AEMPS.
As a CMO/CDMO partner, the company provides end-to-end support combining manufacturing, packaging, analytical control and regulatory traceability. Since 2020, its pharmaceutical plant is fully operational for finished dosage forms and nutraceuticals, offering tablet compression (uncoated), primary packaging (Alu/PVC and Alu/Alu blisters, thermo-sealed bottles with labeling), secondary packaging (cartoning/re-cartoning/labeling), and serialization connected to EMVO via TraceLink®.
The company also delivers a broad third-party services portfolio: a state-of-the-art QC laboratory (physico-chemical testing, method development/validation/transfer, dose uniformity, dissolution, related substances, water testing, and ICH/on-going stability studies), manufacturing services (pharmaceutical and chemical), and a full import service to support projects from development through market supply.
Compliance
- World Health Organization (GMP / HACCP)
Activity
- Oral solids / OSD, Tablets, Powders, Lozenges, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, COSMETICS, NUTRACEUTICALS, SERVICES, PARTICLE ENGINEERING, Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Skin products, Hair and scalp care products, Blister packs, Bottles: Plastic, Bottles: Glass manufacturing
Features
- Uses: Investigational, 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)
- Controlled substance: N/A
- BSL: N/A
- Therapeutic areas: (C) Cardiovascular system, (N) Nervous system
- Markets: EMA (EU), NMPA (China)
Batch Size / Reactor
- Small, Medium, Large, 1 - 10 L, 100 - 1,000 L, 1,000 - 2,000 L, 2,000 - 5,000 L, 5,000 - 10,000 L
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Clean room rental, Process development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Tech transfer, Pilot plant, Formulation mixing, 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, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, DMF (Drug Master File) preparation and submission, Samples manufacturing
