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Portugal
Sidefarma
Sidefarma SA
CMO est spécialisé dans la fabrication de lots de petite et moyenne taille pour les sociétés pharmaceutiques du monde entier sur les marchés réglementés.
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), Health Canada (Canada), DIGEMID (Peru), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), TGA (Australia)
RÉGION: Europe
COMPLIANCE: ISO, UAE Ministry of Health & Prevention, EMA (BPF DE L'UE)
USAGE: Humain
SERVICES: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
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
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), MFDS (South Korea), EDE (UAE), TGA (Australia)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), Service public français (CIR), NMPA (BPF de Chine), 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
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)
Allemagne
Aenova Group - Location Tittmoning, Germany
Aenova
Centre de compétence usine conventionnelle de solides à haut volume.
MARCHÉS: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, TGA (Australia)
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP)
TAILLE DU LOT: Grandes dimensions, Moyen
CATÉGORIE / PRODUIT: NUTRACEUTICALS, FDF / DRUG PRODUCTS
USAGE: Humain, Vétérinaire
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory 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)
Suisse
Aenova Group - Location Sisseln, Switzerland
Aenova
Centre de compétences solides conventionnels complexes.
RÉGION: Europe
MARCHÉS: FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), Organisation mondiale de la santé (BPF / HACCP), MFDS/KFDA (République de Corée GMP)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
CATÉGORIE / PRODUIT: NUTRACEUTICALS, FDF / DRUG PRODUCTS
USAGE: Humain
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory 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)
Allemagne
Aenova Group - Location Regensburg, Germany
Aenova
Centre de compétences solides hautement puissants (oncologie) solides conventionnels - semi-solides et liquides spécialisés.
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), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities
RÉGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), 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: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
USAGE: Humain, Vétérinaire
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Allemagne
Aenova Group - Location Münster, Germany
Aenova
Centre de compétence solides à faible dose et haute puissance (hormones, hormon-like), capsules à faible dose.
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), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (BPF DE L'UE), MFDS/KFDA (République de Corée GMP)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain, Vétérinaire
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
Allemagne
Aenova Group - Location Marburg, Germany
Aenova
Centre de compétences complexe pour les solides conventionnels et les stupéfiants.
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), ANVISA (Brazil), Russian Health Authorities
RÉGION: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
CATÉGORIE / PRODUIT: NUTRACEUTICALS, FDF / DRUG PRODUCTS
USAGE: Humain
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory 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)
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
Suisse
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 / DRUG PRODUCTS
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
Irlande
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 / DRUG PRODUCTS, PARTICLE ENGINEERING
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)
Allemagne
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 / DRUG PRODUCTS
Roumanie
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 / DRUG PRODUCTS
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)
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