CARBOGEN AMCIS | Veenendaal

CARBOGEN AMCIS | Veenendaal

Large scale manufacturing of Cholesterol and Vitamin D analogs.

About the plant

Veenendaal

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Certifications

• ISO
• EMA (EU GMP)
• FDA (cGMP)
• Health Canada (Canada GMP)
• French Service-Public (CIR)
• ECOVADIS
• World Health Organization (GMP / HACCP)
• NMPA (China GMP)
• TGA (Australia GMP)
• ANVISA (Brazil B-GMP)
• Roszdravnadzor (Russia GMP)
• ANMAT (Argentina nueva GMP)
• MFDS/KFDA (Republic of Korea GMP)
• PMDA/MHLW (Japan GMP)
• ISP (Chile BPM)
• INVIMA
• MSPAS
• COFEPRIS
• DIGEMID
• MHRA (UK GMP)
• SQF (Safe Quality Food)
• IFS
• BRCGS
• Halal Research Council
• UAE Ministry of Health & Prevention
• SFDA (Saudi Food & Drug Authority)
• NSF
• TITCK (Turkish Health Authorities)

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Activity

• CHEMICAL-SYNTHETIC, SERVICES, RSM (Raw Starting Materials), Intermediates, API (Active Pharmaceutical Ingredients), Excipients, Radiopharmaceuticals, Building Blocks manufacturing

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Features

• Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, 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), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
• DEA: N/A
• BSL: 1
• 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

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Batch Size / Reactor

• Small, 1 - 10 L, 10-100 L

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, R&D, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, 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, Storage, Distribution, GDP, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission 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, Orphan Drug Designation Support, Solid form selection, Nitrosamine risk assessment, Customized block synthesis, Impurity synthesis

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