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MARCHÉS: EMA (EU)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
COMPLIANCE: ISO, EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP)
TAILLE DU LOT: Grandes dimensions, Moyen
USAGE: Humain
BSL (niveau de sécurité biologique): 1, 2
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (J) Antiinfectives for systemic use, (R) Respiratory system, (G) Genito urinary system and sex hormones
CATÉGORIE / PRODUIT: BIOLOGIE, FDF / DRUG PRODUCTS
Espagne
CZ Vaccines | Investigational and Medicinal Products Plant
CZ Vaccines
Installation d'essais cliniques
MARCHÉS: EMA (EU), ANVISA (Brazil), CDSCO (India)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
COMPLIANCE: ISO, ANVISA (Brazil B-GMP), EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP)
USAGE: Humain
BSL (niveau de sécurité biologique): 1, 2
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
TAILLE DU LOT: Petit
CATÉGORIE / PRODUIT: BIOLOGIE, FDF / DRUG PRODUCTS
MARCHÉS: EMA (EU)
SERVICES: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
COMPLIANCE: ISO, EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP)
TAILLE DU LOT: Grandes dimensions, Moyen
USAGE: Humain
BSL (niveau de sécurité biologique): 1, 2
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
CATÉGORIE / PRODUIT: BIOLOGIE, FDF / DRUG PRODUCTS
France
CARBOGEN AMCIS | Saint-Beauzire
CARBOGEN AMCIS
Développement de formulations personnalisées et fabrication stérile GMP de produits médicamenteux liquides et lyophilisés.
OEB (bandes d´exposition professionnelle): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)
SUBSTANCES CONTRÔLÉES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse
MARCHÉS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), Service public français (CIR), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
Italie
Aenova Group - Location Latina, Italy
Aenova
Centre de compétences produits de santé animale et technologies stériles.
MARCHÉS: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (BPF DE L'UE)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain, Vétérinaire
BSL (niveau de sécurité biologique): 1, 2
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
SUBSTANCES CONTRÔLÉES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)
RÉGION: Europe
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (A) Digestive tract and metabolism
COMPLIANCE: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (BPF DE L'UE), Santé Canada (Canada GMP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP)
OEB (bandes d´exposition professionnelle): 4 / HPAPI (PDE = 10 - 100 µg/jour), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)
CATÉGORIE / PRODUIT: SERVICES, FDF / DRUG PRODUCTS
BSL (niveau de sécurité biologique): 3, 1, 2
MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ISO, SFDA (Saudi Food & Drug Authority), Service public français (CIR), EMA (BPF DE L'UE)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain, Vétérinaire
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
CATÉGORIE / PRODUIT: BIOLOGIE, SERVICES, FDF / DRUG PRODUCTS
OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)
France
Adragos Pharma | Maisons-Alfort
Adragos Pharma
Spécialisée dans les seringues préremplies, les flacons liquides et lyophilisés, elle combine des systèmes avancés de remplissage aseptique, de lyophilisation e
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (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, (V01) Allergens, (V06) Nutrients, (A) Digestive tract and metabolism
MARCHÉS: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities
RÉGION: Europe
TAILLE DU LOT: Grandes dimensions
USAGE: Humain
BSL (niveau de sécurité biologique): 1
SERVICES: Manufacturing services, Analytical / QC services, Regulatory services, Packaging
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse
COMPLIANCE: ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (BPF de Chine), EMA (BPF DE L'UE), MFDS/KFDA (République de Corée GMP)
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)
États-Unis
Northway Biotech Waltham (MA)
Northway Biotech
CDMO mondial de bout en bout pour les produits biologiques
BSL (niveau de sécurité biologique): 3, 1, 2
MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), Service public français (CIR), EMA (BPF DE L'UE)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain, Vétérinaire
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
RÉGION: North America
CATÉGORIE / PRODUIT: BIOLOGIE, SERVICES, FDF / DRUG PRODUCTS
OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)
Norvège
Adragos Pharma | Halden
Adragos Pharma
Nous sommes spécialisés dans la fabrication de poches IV, d'ampoules et de flacons en plastique utilisant la technologie Blow-Fill-Seal (BFS) et d'autres formes
SUBSTANCES CONTRÔLÉES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MARCHÉS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), TGA (Australia)
SERVICES: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, NMPA (BPF de Chine), EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP), NSF
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (D) Dermatologicals, (V06) Nutrients, (A) Digestive tract and metabolism
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
Grèce
Adragos Pharma | Athens
Adragos Pharma
Spécialisé dans le développement de médicaments à valeur ajoutée et a été récemment mis à niveau avec les capacités HPAPI.
OEB (bandes d´exposition professionnelle): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)
SUBSTANCES CONTRÔLÉES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MARCHÉS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), UAE Ministry of Health & Prevention, NMPA (BPF de Chine), EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP), NSF
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain
CATÉGORIE / PRODUIT: SERVICES, FDF / DRUG PRODUCTS
Japon
Adragos Pharma | Kawagoe
Adragos Pharma
Notre usine offre la meilleure fabrication de comprimés et d’ampoules.
SUBSTANCES CONTRÔLÉES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MARCHÉS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)
SERVICES: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: APAC
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), EMA (BPF DE L'UE)
TAILLE DU LOT: Grandes dimensions
USAGE: Humain
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day)
CATÉGORIE / PRODUIT: SERVICES, FDF / DRUG PRODUCTS
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