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FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Une installation de fabrication API et intermédiaire approuvée par l'USFDA.
Location available after registration
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Installation Chimique-Pharmaceutique
Location available after registration
These facilities match your main criteria but not all optional filters.
SENN India | Non-GMP Plant | Hyderabad, India
Senn Chemicals
Site de fabrication non BPF à grande échelle pour les intermédiaires peptidiques, la synthèse organique, les opérations LPPS et l'augmentation de la production.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: COSMETICS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
SERVICES: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
RÉGION: APAC
SENN India | R&D Lab | Hyderabad, India
Senn Chemicals
Centre de R&D pour la chimie peptidique et organique avec support SPPS, purification, lyophilisation, analyse et ingénierie des particules.
TAILLE DU LOT: Petit
SERVICES: Analytical / QC services, Logistics, Development services, Packaging, Quality Assurance services
RÉGION: APAC
CATÉGORIE / PRODUIT: PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
Avara Pharmaceutical Services | Arecibo Site
AVARA
Installation de fabrication de doses solides orales (OSD) à l'échelle commerciale avec une forte expertise dans les substances contrôlées (DEA II V).
TAILLE DU LOT: 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, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), Santé Canada (Canada GMP), MFDS/KFDA (République de Corée GMP), ICH
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
MARCHÉS: ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada)
USAGE: Humain
SERVICES: Analytical / QC services, Manufacturing 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)
RÉGION: North America
Avara Pharmaceutical Services | Norman Site
AVARA
Installation de fabrication sous contrat spécialisée dans le dosage oral solide (OSD) pour l'approvisionnement clinique et commercial.
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, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MHRA (BPF AU ROYAUME-UNI), TGA (Australia GMP), FDA (cGMP), Santé Canada (Canada GMP), MFDS/KFDA (République de Corée GMP), ICH
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
MARCHÉS: ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), MHRA (UK)
USAGE: Humain
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), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
RÉGION: North America
CARBOGEN AMCIS | Manchester, UK
CARBOGEN AMCIS
Découvrez nos capacités de fabrication d'ingrédients cosmétiques, de chimie fine et de synthèse personnalisée d'intermédiaires pharmaceutiques.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
RÉGION: Europe
SERVICES: Analytical / QC services, Manufacturing services, Development services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
COMPLIANCE: ECOVADIS, ISO, Conseil de recherche sur le halal
CARBOGEN AMCIS | Aarau
CARBOGEN AMCIS
Développement et fabrication cGMP à moyenne échelle, y compris la chromatographie.
TAILLE DU LOT: Petit, Moyen
COMPLIANCE: PMDA/MHLW (Japan GMP), Organisation mondiale de la santé (BPF / HACCP), FDA (cGMP), ISO
CATÉGORIE / PRODUIT: SERVICES, PARTICLE ENGINEERING, BIOLOGIE, CHEMICAL-SYNTHETIC
RÉGION: Europe
MARCHÉS: ANVISA (Brazil), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Manufacturing services, Development services, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CARBOGEN AMCIS | Bubendorf
CARBOGEN AMCIS
Développement et fabrication cGMP d'API hautement puissants, y compris des conjugués anticorps-médicament (ADC).
MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
TAILLE DU LOT: Petit, Moyen
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs
COMPLIANCE: EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), FDA (cGMP), ISO
CATÉGORIE / PRODUIT: SERVICES, PARTICLE ENGINEERING, BIOLOGIE, CHEMICAL-SYNTHETIC
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, 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)
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)
Aenova Group - Location Killorglin, Ireland
Aenova
Centre de compétence pour le séchage par pulvérisation et les pellets à libération modifiée.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING, NUTRACEUTICALS
COMPLIANCE: EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), ISO, MFDS/KFDA (République de Corée GMP)
RÉGION: Europe
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Manufacturing services, Development services, Packaging, Quality Assurance services
MARCHÉS: PMDA (Japan), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia)
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)
TRADICHEM INDUSTRIAL SERVICES
TRADICHEM INDUSTRIAL SERVICES S.L.
TECHNOLOGIE HIPING® - LA PASSERELLE POUR LE LEAN MANUFACTURING
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
COMPLIANCE: EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP), FDA (cGMP), ISO
CATÉGORIE / PRODUIT: SERVICES, PARTICLE ENGINEERING, NUTRACEUTICALS
RÉGION: Europe
USAGE: Humain, Vétérinaire
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)
SERVICES: Manufacturing services, Development services
MARCHÉS: FDA (USA), EMA (EU)
BSL (niveau de sécurité biologique): 1, 2