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Pharmaron API Commercial Synthesis Shaoxing (China)
Pharmaron
Synthèse commerciale de petites molécules/peptides API.
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (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, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
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: NMPA (China), FDA (USA)
RÉGION: APAC
COMPLIANCE: FDA (cGMP), ISO, NMPA (BPF de Chine)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain, Vétérinaire
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
Pharmaron API Commercial Synthesis Cramlington (UK)
Pharmaron
Synthèse de petites molécules API commerciales.
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
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), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), TGA (Australia)
RÉGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain, Vétérinaire
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
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)
Pharmaron API Commercial Synthesis Coventry (US)
Pharmaron
Synthèse de petites molécules API commerciales.
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
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), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea), TGA (Australia)
COMPLIANCE: FDA (cGMP), ISO, ECOVADIS
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain, Vétérinaire
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC
SERVICES: Development services, Manufacturing services
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)
RÉGION: North America
Cultiply
Cultiply
CDMO espagnol qui développe des procédés de production et de purification de protéines recombinantes, d'enzymes, d'ADN et d'autres produits biodérivés.
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), CDSCO (India), TGA (Australia)
RÉGION: Europe
COMPLIANCE: ISO
BSL (niveau de sécurité biologique): 1, 2
SERVICES: Development services, Manufacturing services
SUBSTANCES CONTRÔLÉES: Lowest potential for abuse
TAILLE DU LOT: Petit, Moyen
CATÉGORIE / PRODUIT: BIOLOGIE
OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)
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).
SUBSTANCES CONTRÔLÉES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
COMPLIANCE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP), MFDS/KFDA (République de Corée GMP)
MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), TGA (Australia)
TAILLE DU LOT: Grandes dimensions, Moyen
USAGE: Humain
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC, SERVICES, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
SERVICES: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
RÉGION: North America
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)
Avara Pharmaceutical Services | Norman Site
AVARA
Installation de fabrication sous contrat spécialisée dans le dosage oral solide (OSD) pour l'approvisionnement clinique et commercial.
SUBSTANCES CONTRÔLÉES: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
COMPLIANCE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (BPF DE L'UE), Santé Canada (Canada GMP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP)
MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea), TGA (Australia)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC, SERVICES, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
RÉGION: North America
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)
Bilthoven Biologicals Drug Substance and Drug Product Facilities
Bilthoven Biologicals
Installations BPF multi-produits pour les substances médicamenteuses et les produits médicamenteux.
MARCHÉS: EMA (EU), MHRA (UK)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain
BSL (niveau de sécurité biologique): 1, 2
COMPLIANCE: EMA (BPF DE L'UE)
CATÉGORIE / PRODUIT: BIOLOGIE, SERVICES, FDF / DRUG PRODUCTS
Rodon Biologics
Rodon Biologics - RDN Serviços de Biotecnologia
Rodon Biologics offre l'excellence dans le développement de produits biopharmaceutiques pour des tiers.
RÉGION: Europe
CATÉGORIE / PRODUIT: NUTRACEUTICALS, BIOLOGIE, SERVICES
BSL (niveau de sécurité biologique): 1, 2
SERVICES: Development services, Analytical / QC services
TAILLE DU LOT: Petit
Indena Settala
Indena
Installation conforme aux BPF et inspectée par la FDA, spécialisée dans les API complexes et les composés très puissants jusqu'à OEB 6.
MARCHÉS: TGA (Australia), Rest of World, 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), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India)
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
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), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour)
COMPLIANCE: NMPA (BPF de Chine), EMA (BPF DE L'UE), MFDS/KFDA (République de Corée GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP)
SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
RÉGION: Europe
USAGE: Humain, Vétérinaire
CATÉGORIE / PRODUIT: CHEMICAL-SYNTHETIC
HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes
HISTOCELL
Histocell est une CDMO espagnole qui développe et fabrique des thérapies cellulaires, des sécrétomes et des exosomes, ainsi que des dispositifs médicaux.
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism
MARCHÉS: MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), CDSCO (India), TGA (Australia), EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities
TAILLE DU LOT: Petit, Moyen
COMPLIANCE: EMA (BPF DE L'UE), ISO
CATÉGORIE / PRODUIT: BIOLOGIE, SERVICES, FDF / DRUG PRODUCTS, COSMETICS
RÉGION: Europe
USAGE: Humain, Vétérinaire
BSL (niveau de sécurité biologique): 1, 2
SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services
Hikal Ltd | Bangalore, India
Hikal Ltd.
Développement de processus cGMP, mise à l'échelle et fabrication d'API, de NME et d'intermédiaires à petites molécules, des grammes aux tonnes.
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), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World
RÉGION: APAC
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), COFEPRIS, Conseil de recherche sur le halal, ECOVADIS, TGA (Australia GMP), EMA (BPF DE L'UE)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
CATÉGORIE / PRODUIT: COSMETICS, NUTRACEUTICALS, CHEMICAL-SYNTHETIC, SERVICES
USAGE: Humain, Vétérinaire
SERVICES: Development services, Manufacturing services
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (V06) Nutrients
HIPRA BIOTECH SERVICES | Aiguaviva
HIPRA Biotech Services
Capacités internes de bout en bout, du développement de lignées cellulaires à la fabrication commerciale.
MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)
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, INVIMA, ISP (Chile BPM), 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)
TAILLE DU LOT: Grandes dimensions, Petit, Moyen
USAGE: Humain
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: BIOLOGIE
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