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Showing 18 facilities
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Allemagne
BAG Health Care
BAG Health Care GmbH
Fournisseur parentéral de F&F pour flacons en lots de petite à moyenne taille.
TAILLE DU LOT: Petit, Moyen
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI)
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
BSL (niveau de sécurité biologique): 1
MARCHÉS: EMA (EU), TGA (Australia), MHRA (UK)
Allemagne
Cellex Cell Professionals
Cellex Cell Professionals
Usine de fabrication de cellules CGT CDMO et centre de collecte de matières premières
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGIE
COMPLIANCE: EMA (BPF DE L'UE), FDA (cGMP)
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
MARCHÉS: FDA (USA), EMA (EU)
BSL (niveau de sécurité biologique): 1, 2
Allemagne
Aenova Group - Location Tittmoning, Germany
Aenova
Centre de compétence usine conventionnelle de solides à haut volume.
TAILLE DU LOT: Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, NUTRACEUTICALS
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), Santé Canada (Canada GMP)
RÉGION: Europe
MARCHÉS: ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU), TGA (Australia), Health Canada (Canada)
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
Allemagne
Aenova Group - Location Regensburg, Germany
Aenova
Centre de compétences solides hautement puissants (oncologie) solides conventionnels - semi-solides et liquides spécialisés.
MARCHÉS: Turkish Health Authorities, ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, COSMETICS, PARTICLE ENGINEERING, NUTRACEUTICALS
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), SFDA (Saudi Food & Drug Authority), TITCK (Turkish Health Authorities), MFDS/KFDA (République de Corée GMP)
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
Allemagne
Aenova Group - Location Münster, Germany
Aenova
Centre de compétence solides à faible dose et haute puissance (hormones, hormon-like), capsules à faible dose.
MARCHÉS: Turkish Health Authorities, ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), ANVISA (Brazil B-GMP), FDA (cGMP), TITCK (Turkish Health Authorities), MFDS/KFDA (République de Corée GMP)
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
Allemagne
Aenova Group - Location Marburg, Germany
Aenova
Centre de compétences complexe pour les solides conventionnels et les stupéfiants.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, NUTRACEUTICALS
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), ANVISA (Brazil B-GMP), FDA (cGMP)
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
RÉGION: Europe
MARCHÉS: ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU)
USAGE: Humain
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
Allemagne
Aenova Group - Location Gronau, Germany
Aenova
Centre de compétences pour les solides conventionnels et les services cliniques.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), FDA (cGMP)
MARCHÉS: EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU)
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
Allemagne
Aenova Group - Location Feldkirchen, Germany
Aenova
Centre de Compétence Semisolides et Liquides.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, COSMETICS
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), FDA (cGMP), ISO
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Manufacturing services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
MARCHÉS: FDA (USA), Russian Health Authorities, EMA (EU)
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (M) Musculoskeletal system, (J) Antiinfectives for systemic use, (D) Dermatologicals
Allemagne
Aenova Group - Location Bad Aibling, Germany
Aenova
Centre de Compétence Emballage Blister Emballage tiers Installation à grand volume pour effervescents.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, COSMETICS, NUTRACEUTICALS
COMPLIANCE: EMA (BPF DE L'UE), IFS, FDA (cGMP), ISO
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
MARCHÉS: FDA (USA), EMA (EU)
RÉGION: Europe
Allemagne
Adragos Pharma | Leipzig
Adragos Pharma
Produits pharmaceutiques semi-solides et liquides non stériles.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (BPF DE L'UE)
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
MARCHÉS: PMDA (Japan), EMA (EU), MFDS (South Korea), NMPA (China), MHRA (UK)
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
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
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs, (V06) Nutrients
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (BPF DE L'UE), FDA (cGMP)
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Manufacturing services, Development services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
MARCHÉS: FDA (USA), EMA (EU)
BSL (niveau de sécurité biologique): 1
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