CHEMICAL-SYNTHETIC COSMETICS NUTRACEUTICALS SERVICES in Europe
Contract development and manufacturing partner located in Spain for APIs, Intermediates and fine chemicals specialized in transferring R&D projects into fully...
About the plant
Founded in 1970, MENADIONA is an independent privately-owned company.
Ever since, the company specializes in manufacturing active ingredients (APIs) and key intermediates for the Pharmaceutical, Veterinary, Plant Health, Cosmetics and Nutraceutical industries.
In addition, Aziridine and its derivatives is one of the most outstanding business units for MENADIONA.
We offer custom and contract manufacturing services through our Fine Chemical Division.
With a highly qualified team and two manufacturing plants in Spain, MENADIONA is characterized by its strong worldwide export volume, which accounts for more than 80% of its sales.
Certifications
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- ECOVADIS
- World Health Organization (GMP / HACCP)
- ANVISA (Brazil B-GMP)
- PMDA/MHLW (Japan GMP)
- Halal Research Council
Activity
- CHEMICAL-SYNTHETIC, COSMETICS, NUTRACEUTICALS, SERVICES, RSM (Raw Starting Materials), Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients) manufacturing
Features
- Uses: Commercial (Phase IV), Human, Veterinary
- 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: Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
- BSL:
- Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V09-10) Radiopharmaceuticals, (V06) Nutrients, (V04) Diagnostic agents, (V01) Allergens
- 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
- Medium, Large, 100 - 1,000 L, 1,000 - 2,000 L, 2,000 - 5,000 L, 5,000 - 10,000 L, > 10,000 L
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, R&D, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, Tech transfer, Pilot plant, 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, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, 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, Crystallization screening, Milling, Safety studies, Solid form selection, Crystal engineering, PGI assessment (Genotoxic Impurities), Nitrosamine risk assessment, Customized block synthesis
