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États-Unis
Lifecore Injectables CDMO
Lifecore Biomedical
CDMO qui fabrique des produits pharmaceutiques injectables stériles cliniques et commerciaux.
MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (BPF DE L'UE), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, Santé Canada (Canada GMP), MFDS/KFDA (République de Corée GMP)
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse
BSL (niveau de sécurité biologique): 3, 1, 2
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), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
RÉGION: North America
États-Unis
Pharmaron API Commercial Synthesis Coventry (US)
Pharmaron
Synthèse de petites molécules API commerciales.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (B) Blood and blood forming organs, (V06) Nutrients
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
USAGE: Humain, Vétérinaire
MARCHÉS: PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), MHRA (UK)
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)
SERVICES: Manufacturing services, Development services
RÉGION: North America
COMPLIANCE: FDA (cGMP), ECOVADIS, ISO
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC
États-Unis
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
États-Unis
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
États-Unis
Aenova Group - Location Greensboro, USA
Aenova
Centre de compétences pour les solides d'emballage.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
USAGE: Humain
SERVICES: Logistics, Manufacturing services, Packaging
RÉGION: North America
MARCHÉS: FDA (USA), Health Canada (Canada)
COMPLIANCE: FDA (cGMP), NSF, Conseil de recherche sur le halal, Santé Canada (Canada GMP)
CATÉGORIE / PRODUIT: NUTRACEUTICALS
États-Unis
Northway Biotech Waltham (MA)
Northway Biotech
CDMO mondial de bout en bout pour les produits biologiques
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGIE
MARCHÉS: EDE (UAE), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), Health Canada (Canada), MHRA (UK)
COMPLIANCE: EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), Service public français (CIR), FDA (cGMP), SFDA (Saudi Food & Drug Authority), ISO
BSL (niveau de sécurité biologique): 3, 1, 2
USAGE: Humain, Vétérinaire
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Quality Assurance services
RÉGION: North America
OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)
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: DIGEMID (Peru), ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING
COMPLIANCE: EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), Service public français (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (BPF de Chine), ECOVADIS, ISO, Conseil de recherche sur le halal, Santé Canada (Canada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (République de Corée GMP)
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), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
RÉGION: North America
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Organisation de développement et de fabrication sous contrat (CDMO) spécialisée dans les protéines recombinantes et les anticorps monoclonaux (mAb).
Location available after registration
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Services de R&D et d'analyse, transfert de technologie et introduction de nouveaux produits, et fabrication de formes posologiques orales solides et liquides.
Location available after registration
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Laboratoire de recherche et développement sous contrat (CRDO) basé aux États-Unis qui fournit des services de développement de produits pharmaceutiques.
Location available after registration
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