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Allemagne
Glatt Pharmaceutical Services GmbH Co. & KG
Glatt Pharmaceutical Services GmbH Co. & KG
Your cGMP-compliant CDMO for end-to-end services in the complex oral solids dosage forms field, based in Binzen Germany.
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, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs, (V06) Nutrients
CATÉGORIE / PRODUIT: FDF / PRODUITS PHARMACEUTIQUES, SERVICES, OLIGONUCLÉOTIDES, INGÉNIERIE DES PARTICULES, CHIMIQUE-SYNTHÉTIQUE
COMPLIANCE: EMA (BPF DE L'UE), FDA (cGMP)
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, Vétérinaire
SERVICES: Analytical / QC services, Manufacturing services, Development services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1 000 - 5 000 µg/jour), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
MARCHÉS: FDA (USA), EMA (EU)
BSL (niveau de sécurité biologique): 1
Italie
Adare Pharma | US
Adare Pharma Solutions
Adare Pharma es un CDMO global con instalaciones en EE.UU. y la UE, que ofrece desarrollo de productos llave en mano mediante experiencia en fabricación comerci
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 / PRODUITS PHARMACEUTIQUES, SERVICES, CHIMIQUE-SYNTHÉTIQUE
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)
RÉGION: Europe, North America
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 - 5 000 µg/jour), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals
Italie
Adare Pharma | EU
Adare Pharma Solutions
Global CDMO offering turnkey product development through commercial manufacturing expertise, focused on oral dosage forms.
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
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (R) Respiratory system, (V01) Allergens, (M) Musculoskeletal system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system
CATÉGORIE / PRODUIT: FDF / PRODUITS PHARMACEUTIQUES, SERVICES, INGÉNIERIE DES PARTICULES, CHIMIQUE-SYNTHÉTIQUE
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)
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 - 5 000 µg/jour), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
Royaume-Uni
Seda Pharma Development Services
Seda Pharma Development Services Ltd
Seda Pharmaceutical Development Services specialises in integrated Pharmaceutical Development and Clinical Pharmacology.
MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), 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
CATÉGORIE / PRODUIT: FDF / PRODUITS PHARMACEUTIQUES, SERVICES, CHIMIQUE-SYNTHÉTIQUE
RÉGION: Europe
USAGE: Humain
COMPLIANCE: MHRA (BPF AU ROYAUME-UNI), ECOVADIS
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1 000 - 5 000 µg/jour), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs
Chine
Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
Seacross Pharmaceutical Co Ltd
The R&D Center plays a fundamental role in supporting the development of both APIs and finished dosage forms.
MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), 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 / PRODUITS PHARMACEUTIQUES, OLIGONUCLÉOTIDES, INGÉNIERIE DES PARTICULES, CHIMIQUE-SYNTHÉTIQUE
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 - 5 000 µg/jour), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
Chine
Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
Seacross Pharmaceutical Co Ltd
The Formulation Manufacturing Site is dedicated to the development and production of complex, high-value dosage forms.
MARCHÉS: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), 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 / PRODUITS PHARMACEUTIQUES, SERVICES, INGÉNIERIE DES PARTICULES, CHIMIQUE-SYNTHÉTIQUE
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 - 5 000 µg/jour), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
Espagne
PHARMALOOP S.L. - a Salvat Company
Laboratorios Salvat
Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, capsules and tablets.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / PRODUITS PHARMACEUTIQUES, SERVICES, INGÉNIERIE DES PARTICULES, CHIMIQUE-SYNTHÉTIQUE
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, (A) Digestive tract and metabolism
BSL (niveau de sécurité biologique): 1
OEB (bandes d´exposition professionnelle): 1 / low-hazard (PDE > 5,000 µg/day)
France
Cenexi SAS
Cenexi
Accueil Sites Osny. Acquired in 2011, the Osny site specializes in the development and production of highly active solid pharmaceutical forms.
TAILLE DU LOT: Petit, Moyen
CATÉGORIE / PRODUIT: FDF / PRODUITS PHARMACEUTIQUES, SERVICES, CHIMIQUE-SYNTHÉTIQUE
COMPLIANCE: EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), MFDS/KFDA (République de Corée GMP)
RÉGION: Europe
MARCHÉS: ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), NMPA (China), MHRA (UK)
USAGE: Humain
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (G) Genito urinary system and sex hormones
OEB (bandes d´exposition professionnelle): 2 (PDE = 1 000 - 5 000 µg/jour), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/jour), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
Porto Rico
Sidefarma
Sidefarma SA
Sidefarma es un CMO especializado en la fabricación de lotes peque os y medianos para compa ías farmacéuticas de todo el mundo, en mercados regulados y siguiend
MARCHÉS: DIGEMID (Peru), Turkish Health Authorities, EDE (UAE), PMDA (Japan), EMA (EU), SFDA (Saudi Arabia), TGA (Australia), Health Canada (Canada), MHRA (UK)
TAILLE DU LOT: Petit, Moyen
CATÉGORIE / PRODUIT: FDF / PRODUITS PHARMACEUTIQUES, SERVICES, CHIMIQUE-SYNTHÉTIQUE
COMPLIANCE: EMA (BPF DE L'UE), UAE Ministry of Health & Prevention, ISO
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, Manufacturing services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1 000 - 5 000 µg/jour), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
Allemagne
Aenova Group - Location Gronau, Germany
Aenova
Centro de competencia para sólidos convencionales y servicios clínicos.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / PRODUITS PHARMACEUTIQUES, SERVICES, BIOLOGIE, CHIMIQUE-SYNTHÉTIQUE
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), FDA (cGMP)
MARCHÉS: EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU)
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 - 5 000 µg/jour), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
DOMAINES THÉRAPEUTIQUES D´EXPERTISE (ATC): (L) Antineoplastic and immunomodulating agents
Allemagne
Aenova Group - Location Killorglin, Ireland
Aenova
Centro de Competencia para secado por atomización (spray drying) y pellets de liberación modificada.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / PRODUITS PHARMACEUTIQUES, INGÉNIERIE DES PARTICULES, NUTRACEUTICALS, CHIMIQUE-SYNTHÉTIQUE
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 - 5 000 µg/jour), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
Allemagne
Aenova Group - Location Marburg, Germany
Aenova
Centro de competencia sólidos convencionales complejos y estupefacientes.
TAILLE DU LOT: Petit, Moyen, Grandes dimensions
CATÉGORIE / PRODUIT: FDF / PRODUITS PHARMACEUTIQUES, INGÉNIERIE DES PARTICULES, NUTRACEUTICALS, CHIMIQUE-SYNTHÉTIQUE
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (BPF DE L'UE), ANVISA (Brazil B-GMP), FDA (cGMP)
RÉGION: Europe
MARCHÉS: ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU)
USAGE: Humain
SERVICES: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (bandes d´exposition professionnelle): 2 (PDE = 1 000 - 5 000 µg/jour), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1 000 µg/jour)
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