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Aenova Group - Location Kirchberg, Switzerland
Aenova
Centre de compétences Capsules de gélatine molle.
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)
MARCHÉS: EMA (EU), FDA (USA), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP), MFDS/KFDA (République de Corée GMP)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
CATÉGORIE / PRODUIT: COSMETICS, NUTRACEUTICALS, FDF / PRODUITS MÉDICAMENTEUX
USAGE: Humain, Vétérinaire
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V06) Nutrients, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

Aenova Group - Location Killorglin, Ireland
Aenova
Centre de compétence pour le séchage par pulvérisation et les pellets à libération modifiée.
MARCHÉS: EMA (EU), PMDA (Japan), SFDA (Saudi Arabia), MFDS (South Korea)
RÉGION: Europe
COMPLIANCE: ISO, PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), EMA (BPF DE L'UE), MFDS/KFDA (République de Corée GMP)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
CATÉGORIE / PRODUIT: NUTRACEUTICALS, FDF / PRODUITS MÉDICAMENTEUX, INGÉNIERIE DES PARTICULES
USAGE: Humain, Vétérinaire
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
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)

Aenova Group - Location Gronau, Germany
Aenova
Centre de compétences pour les solides conventionnels et les services cliniques.
MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, EDE (UAE)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), UAE Ministry of Health & Prevention, EMA (BPF DE L'UE)
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)
CATÉGORIE / PRODUIT: FDF / PRODUITS MÉDICAMENTEUX

Aenova Group - Location Feldkirchen, Germany
Aenova
Centre de Compétence Semisolides et Liquides.
MARCHÉS: EMA (EU), FDA (USA), Russian Health Authorities
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
CATÉGORIE / PRODUIT: COSMETICS, FDF / PRODUITS MÉDICAMENTEUX
USAGE: Humain, Vétérinaire
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system
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)

Aenova Group - Location Cornu, Romania
Aenova
Centre de compétences et guichet unique pour les capsules de gélatine molle et les VegaGels®.
RÉGION: Europe
MARCHÉS: FDA (USA), Health Canada (Canada), TGA (Australia)
COMPLIANCE: FDA (cGMP), ISO, Conseil de recherche sur le halal, TGA (Australia GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
CATÉGORIE / PRODUIT: NUTRACEUTICALS, FDF / PRODUITS MÉDICAMENTEUX
USAGE: Humain
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
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)

Aenova Group - Location Bad Aibling, Germany
Aenova
Centre de Compétence Emballage Blister Emballage tiers Installation à grand volume pour effervescents.
MARCHÉS: EMA (EU), FDA (USA)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ISO, IFS, EMA (BPF DE L'UE)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
CATÉGORIE / PRODUIT: COSMETICS, NUTRACEUTICALS, FDF / PRODUITS MÉDICAMENTEUX
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)

Aenova Group - Location Carugate, Italy
Aenova
Centre de compétence Semi-solides et liquides non stériles.
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)
MARCHÉS: EMA (EU), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia)
RÉGION: Europe
COMPLIANCE: ISO, Roszdravnadzor (Russia GMP), SFDA (Saudi Food & Drug Authority), EMA (BPF DE L'UE)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
CATÉGORIE / PRODUIT: COSMETICS, FDF / PRODUITS MÉDICAMENTEUX
USAGE: Humain, Vétérinaire
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

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), MHRA (UK)
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ISO, EMA (BPF DE L'UE)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain, Vétérinaire
SERVICES: Development services, Manufacturing services, Analytical / QC services
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (N) Nervous system
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 / PRODUITS MÉDICAMENTEUX

TRADICHEM INDUSTRIAL SERVICES
TRADICHEM INDUSTRIAL SERVICES S.L.
TECHNOLOGIE HIPING® - LA PASSERELLE POUR LE LEAN MANUFACTURING
MARCHÉS: EMA (EU), FDA (USA)
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ISO, EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
CATÉGORIE / PRODUIT: NUTRACEUTICALS, SERVICES, INGÉNIERIE DES PARTICULES
USAGE: Humain, Vétérinaire
BSL (niveau de sécurité biologique): 1, 2
SERVICES: Development services, Manufacturing services
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)
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 / PRODUITS MÉDICAMENTEUX

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 / PRODUITS MÉDICAMENTEUX
OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)

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 / PRODUITS MÉDICAMENTEUX
OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)
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