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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)
Allemagne
Adragos Pharma | Leipzig
Adragos Pharma
Produits pharmaceutiques semi-solides et liquides non stériles.
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), MHRA (UK), MFDS (South Korea)
SERVICES: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain, Vétérinaire
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)
COMPLIANCE: EMA (BPF DE L'UE)
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
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
Suisse
Adragos Pharma | Jura
Adragos Pharma
Nous sommes spécialisés dans la fabrication aseptique de produits pharmaceutiques (bio)pharmaceutiques lyophilisés ou liquides stériles jusqu'au remplissage et
MARCHÉS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
COMPLIANCE: FDA (cGMP), EMA (BPF DE L'UE)
USAGE: Humain
SUBSTANCES CONTRÔLÉES: High potential for abuse & no medical use
TAILLE DU LOT: Petit, Moyen
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
France
Adragos Pharma | Livron
Adragos Pharma
Fabrication de liquides stériles et de suppositoires. Nous traitons plus de 100 molécules, la gestion des stupéfiants et les services d'analyse et de stabilité.
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), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)
SERVICES: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain
COMPLIANCE: EMA (BPF DE L'UE), MFDS/KFDA (République de Corée GMP)
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
Allemagne
Glatt Pharmaceutical Services GmbH Co. & KG
Glatt Pharmaceutical Services GmbH Co. & KG
Votre CDMO conforme aux bonnes pratiques de fabrication (cGMP) pour des services de bout en bout dans le domaine des formes pharmaceutiques orales solides compl
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), FDA (USA)
RÉGION: Europe
COMPLIANCE: FDA (cGMP), EMA (BPF DE L'UE)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain, Vétérinaire
BSL (niveau de sécurité biologique): 1
SERVICES: Development services, Manufacturing services, Analytical / QC services
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (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, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism
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: FDF / DRUG PRODUCTS
États-Unis
Adare Pharma | US
Adare Pharma Solutions
Adare Pharma est un CDMO mondial avec installations en EE.UU. et l'UE, qui ofrece desarrollo de productos lave en mano mediante experiencia en fabricación comer
MARCHÉS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Conseil de recherche sur le halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, Service public français (CIR), NMPA (BPF de Chine), 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, Vétérinaire
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism
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)
RÉGION: North America
CATÉGORIE / PRODUIT: SERVICES, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
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