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Upperton Pharma Solutions
Royaume-Uni

Upperton Pharma Solutions

Upperton Pharma Solutions

Développement et fabrication de produits pharmaceutiques sous forme de poudres et de liquides secs et stériles à dose orale solide (OSD), nasale, pour inhalatio

TAILLE DU LOT: Petit, Moyen

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (C) Cardiovascular system, (N) Nervous system

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

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

RÉGION: Europe

USAGE: Humain

COMPLIANCE: MHRA (BPF AU ROYAUME-UNI)

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)

MARCHÉS: FDA (USA), EMA (EU), TGA (Australia), Health Canada (Canada), MHRA (UK)

BSL (niveau de sécurité biologique): 1

FAES FARMA | DERIO facility
Espagne

FAES FARMA | DERIO facility

FAES FARMA

Développeur et fabricant de médicaments à usage humain.

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), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

TAILLE DU LOT: Petit, Moyen, Grandes dimensions

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (M) Musculoskeletal system, (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

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS

COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), DIGEMID, 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, INVIMA, Santé Canada (Canada GMP), MSPAS, MFDS/KFDA (République de Corée GMP), COFEPRIS

RÉGION: Europe

USAGE: Humain

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

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

Aenova Group - Location Latina, Italy
Italie

Aenova Group - Location Latina, Italy

Aenova

Centre de compétences produits de santé animale et technologies stériles.

MARCHÉS: Turkish Health Authorities, ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU), SFDA (Saudi Arabia)

TAILLE DU LOT: Petit, Moyen, Grandes dimensions

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS

COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), ANVISA (Brazil B-GMP), FDA (cGMP), SFDA (Saudi Food & Drug Authority), TITCK (Turkish Health Authorities)

RÉGION: Europe

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), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)

BSL (niveau de sécurité biologique): 1, 2

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.

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

TAILLE DU LOT: Petit, Moyen, Grandes dimensions

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, SERVICES

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), FDA (cGMP), NSF, NMPA (BPF de Chine), ISO, MFDS/KFDA (République de Corée GMP)

SUBSTANCES CONTRÔLÉES: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse

RÉGION: Europe

USAGE: Humain

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), 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)

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.

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

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (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

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

COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), IFS, DIGEMID, 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), NSF, NMPA (BPF de Chine), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Conseil de recherche sur le halal, INVIMA, Santé Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (République de Corée GMP), COFEPRIS

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

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

USAGE: Humain

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

RÉGION: APAC

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)

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.

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

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

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, SERVICES

COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentine nouveau GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), IFS, DIGEMID, 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), NSF, NMPA (BPF de Chine), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Conseil de recherche sur le halal, INVIMA, Santé Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (République de Corée GMP), COFEPRIS

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

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

USAGE: Humain

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

RÉGION: APAC

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)

PHARMALOOP S.L. - a Salvat Company
Espagne

PHARMALOOP S.L. - a Salvat Company

Laboratorios Salvat

Solutions CDMO entièrement intégrées pour Blow-Fill-Seal (BFS), multidoses stériles, multidoses non stériles, sachets, gélules et comprimés.

TAILLE DU LOT: Petit, Moyen, Grandes dimensions

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING

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

RÉGION: Europe

USAGE: Humain

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

MARCHÉS: FDA (USA), EMA (EU)

DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (V01) Allergens, (S) Sensory organs

BSL (niveau de sécurité biologique): 1

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

Ophtapharm, a Sentiss Company
Suisse

Ophtapharm, a Sentiss Company

Ophtapharm, a Sentiss Company

Ophtalmique et otique - Solutions, suspensions, émulsions, pommades et gels - Installation approuvée par la FDA.

TAILLE DU LOT: Petit, Moyen, Grandes dimensions

CATÉGORIE / PRODUIT: FDF / DRUG PRODUCTS

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

RÉGION: Europe

USAGE: Humain, Vétérinaire

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

MARCHÉS: FDA (USA), EMA (EU)

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Solutions pour les programmes de distribution non virale

Location available after registration

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

Solutions CDMO à guichet unique pour les APL et les intermédiaires clés.

Location available after registration

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

CDMO israélien spécialisé dans le développement et la fabrication GMP de produits pharmaceutiques synthétiques complexes et de dispositifs médicaux basés sur la

Location available after registration

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