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CZ Vaccines | Investigational and Medicinal Products Plant
Espagne

CZ Vaccines | Investigational and Medicinal Products Plant

CZ Vaccines

Installation d'essais cliniques

MARCHÉS: EMA (EU), ANVISA (Brazil), CDSCO (India)

SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

RÉGION: Europe

COMPLIANCE: ISO, ANVISA (Brazil B-GMP), EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP)

USAGE: Humain

BSL (niveau de sécurité biologique): 1, 2

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

TAILLE DU LOT: Petit

CATÉGORIE / PRODUIT: BIOLOGIE, FDF / DRUG PRODUCTS

CZ Vaccines | Large Scale Plant Spain
Espagne

CZ Vaccines | Large Scale Plant Spain

CZ Vaccines

Installation commerciale à usage unique

MARCHÉS: EMA (EU)

SERVICES: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

RÉGION: Europe

COMPLIANCE: ISO, EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP)

TAILLE DU LOT: Grandes dimensions, Moyen

USAGE: Humain

BSL (niveau de sécurité biologique): 1, 2

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones

CATÉGORIE / PRODUIT: BIOLOGIE, FDF / DRUG PRODUCTS

CARBOGEN AMCIS | Saint-Beauzire
France

CARBOGEN AMCIS | Saint-Beauzire

CARBOGEN AMCIS

Développement de formulations personnalisées et fabrication stérile GMP de produits médicamenteux liquides et lyophilisés.

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)

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), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), 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: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), Service public français (CIR), 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

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS

Aenova Group - Location Latina, Italy
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

GENSENTA ILAC SANAYI AS
Turquie

GENSENTA ILAC SANAYI AS

GENSENTA

FABRICANT CMO & CDMO & FDF

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), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)

RÉGION: Europe

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (A) Digestive tract and metabolism

COMPLIANCE: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (BPF DE L'UE), Santé Canada (Canada GMP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP)

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)

CATÉGORIE / PRODUIT: SERVICES, FDF / DRUG PRODUCTS

Northway Biotech Vilnius
Lituanie

Northway Biotech Vilnius

Northway Biotech

CDMO global de services intégraux en biologie

BSL (niveau de sécurité biologique): 3, 1, 2

MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)

RÉGION: Europe

COMPLIANCE: FDA (cGMP), ISO, SFDA (Saudi Food & Drug Authority), Service public français (CIR), EMA (BPF DE L'UE)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain, Vétérinaire

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

CATÉGORIE / PRODUIT: BIOLOGIE, SERVICES, FDF / DRUG PRODUCTS

OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)

Adragos Pharma | Maisons-Alfort
France

Adragos Pharma | Maisons-Alfort

Adragos Pharma

Spécialisée dans les seringues préremplies, les flacons liquides et lyophilisés, elle combine des systèmes avancés de remplissage aseptique, de lyophilisation e

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (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, (A) Digestive tract and metabolism

MARCHÉS: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities

RÉGION: Europe

TAILLE DU LOT: Grandes dimensions

USAGE: Humain

BSL (niveau de sécurité biologique): 1

SERVICES: Manufacturing services, Analytical / QC services, Regulatory services, Packaging

SUBSTANCES CONTRÔLÉES: Lowest potential for abuse

COMPLIANCE: ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (BPF de Chine), EMA (BPF DE L'UE), MFDS/KFDA (République de Corée GMP)

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS

OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)

Northway Biotech Waltham (MA)
États-Unis

Northway Biotech Waltham (MA)

Northway Biotech

CDMO mondial de bout en bout pour les produits biologiques

BSL (niveau de sécurité biologique): 3, 1, 2

MARCHÉS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), Service public français (CIR), EMA (BPF DE L'UE)

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain, Vétérinaire

SERVICES: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

RÉGION: North America

CATÉGORIE / PRODUIT: BIOLOGIE, SERVICES, FDF / DRUG PRODUCTS

OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day)

Adragos Pharma |  Athens
Grèce

Adragos Pharma | Athens

Adragos Pharma

Spécialisé dans le développement de médicaments à valeur ajoutée et a été récemment mis à niveau avec les capacités HPAPI.

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)

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), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)

SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

RÉGION: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), UAE Ministry of Health & Prevention, NMPA (BPF de Chine), EMA (BPF DE L'UE), Organisation mondiale de la santé (BPF / HACCP), MHRA (BPF AU ROYAUME-UNI), MFDS/KFDA (République de Corée GMP), NSF

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

CATÉGORIE / PRODUIT: SERVICES, FDF / DRUG PRODUCTS

Adragos Pharma | Jura
Suisse

Adragos Pharma | Jura

Adragos Pharma

Nous sommes spécialisés dans la fabrication aseptique de produits pharmaceutiques (bio)pharmaceutiques lyophilisés ou liquides stériles jusqu'au remplissage et

MARCHÉS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea)

SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

RÉGION: Europe

COMPLIANCE: FDA (cGMP), EMA (BPF DE L'UE)

USAGE: Humain

SUBSTANCES CONTRÔLÉES: High potential for abuse & no medical use

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

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
Chine

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site

Seacross Pharmaceutical Co Ltd

Le centre de R&D joue un rôle fondamental en soutenant le développement d’API et de formes posologiques finies.

COMPLIANCE: MFDS/KFDA (République de Corée GMP), SQF (Safe Quality Food), NSF, DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Conseil de recherche sur le halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), 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)

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC

OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 10,000 µg/day), 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)

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

BSL (niveau de sécurité biologique): 3, 4, 1, 2

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), 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), TGA (Australia), Rest of World

SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

RÉGION: APAC

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
Chine

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site

Seacross Pharmaceutical Co Ltd

Le site de fabrication de formulations est dédié au développement et à la production de formes galéniques complexes et de grande valeur.

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

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)

BSL (niveau de sécurité biologique): 3, 4, 1, 2

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), 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), TGA (Australia), Rest of World

SERVICES: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

RÉGION: APAC

COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Conseil de recherche sur le halal, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), 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), SQF (Safe Quality Food), NSF

TAILLE DU LOT: Grandes dimensions, Petit, Moyen

USAGE: Humain

CATÉGORIE / PRODUIT: SERVICES, FDF / DRUG PRODUCTS

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