CHEMICAL-SYNTHETIC SERVICES in Europe

Netherlands Europe

CHEMICAL-SYNTHETIC SERVICES in Europe

Large scale manufacturing of Cholesterol and Vitamin D analogs

About the plant

Veenendaal

Large scale manufacturing of Cholesterol and Vitamin D analogs

CARBOGEN AMCIS B.V. is active in the manufacturing, marketing/sales and distribution of Vitamin D analogs, Vitamin D2, Cholesterol and Lanolin derivatives. These products are used in pharmaceuticals, cosmetics, (shrimp) feed, and industrial applications. Through our history of Dishman Netherlands, Philips, Roxane, Duphar, and Solvay Pharmaceuticals we have more than 70 years of experience in the development, production, sales and distribution of these products.

Activities

Large scale dedicated Cholesterol production facility
Vitamin D analog manufacturing
Contract Research and Manufacturing Services

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)

Activity

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

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

Batch Size / Reactor

Small, 1 - 10 L, 10-100 L

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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