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FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
CMO certificato EU-GMP con sede a Martin, Slovacchia. L'azienda fornisce servizi di produzione e confezionamento di prodotti farmaceutici sterili. prodotti e fo
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Upperton Pharma Solutions
Upperton Pharma Solutions
Sviluppo e produzione di prodotti farmaceutici liquidi a dose solida orale (OSD), nasali, per inalazione e sterili in polvere secca e liquida.
DIMENSIONE DEL LOTTO: Piccolo, Medio
AREE TERAPEUTICHE DI COMPETENZA (ATC): (R) Respiratory system, (C) Cardiovascular system, (N) Nervous system
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, SERVICES, OLIGONUCLEOTIDI, BIOLOGIA
SOSTANZE CONTROLLATE: 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
REGIONE: Europe
USO: Umano
COMPLIANCE: MHRA (UK GMP)
SERVIZI: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
MERCATI: FDA (USA), EMA (EU), TGA (Australia), Health Canada (Canada), MHRA (UK)
BSL (Livello di sicurezza biologica): 1

Pharmaron API Commercial Synthesis Cramlington (UK)
Pharmaron
Sintesi di piccole molecole API commerciali.
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
AREE TERAPEUTICHE DI COMPETENZA (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
COMPLIANCE: EMA (GMP UE), PMDA/MHLW (Japan GMP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), Health Canada (Canada GMP), MFDS/KFDA (Repubblica di Corea GMP)
SOSTANZE CONTROLLATE: 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
REGIONE: Europe
MERCATI: ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
USO: Umano, Veterinario
SERVIZI: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC

Pharmaron API Commercial Synthesis Coventry (US)
Pharmaron
Sintesi di piccole molecole API commerciali.
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
AREE TERAPEUTICHE DI COMPETENZA (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
SOSTANZE CONTROLLATE: 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
USO: Umano, Veterinario
MERCATI: PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), MHRA (UK)
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
SERVIZI: Manufacturing services, Development services
REGIONE: North America
COMPLIANCE: FDA (cGMP), ECOVADIS, ISO
CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC

CARBOGEN AMCIS | Saint-Beauzire
CARBOGEN AMCIS
Sviluppo di formulazioni personalizzate e produzione sterile GMP di prodotti farmaceutici liquidi e liofilizzati.
MERCATI: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
AREE TERAPEUTICHE DI COMPETENZA (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (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, (D) Dermatologicals, (N) Nervous system
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
COMPLIANCE: ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), Servizio pubblico francese (CIR), TGA (Australia GMP), FDA (cGMP), SFDA (Saudi Food & Drug Authority), ISO, Health Canada (Canada GMP), MFDS/KFDA (Repubblica di Corea GMP)
SOSTANZE CONTROLLATE: 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
REGIONE: Europe
USO: Umano
SERVIZI: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)

Aenova Group - Location Marburg, Germany
Aenova
Centro di competenza solidi convenzionali complessi e narcotici.
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, NUTRACEUTICI
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (GMP UE), ANVISA (Brazil B-GMP), FDA (cGMP)
SOSTANZE CONTROLLATE: 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
REGIONE: Europe
MERCATI: ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU)
USO: Umano
SERVIZI: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)

Adragos Pharma | Jura
Adragos Pharma
Siamo specializzati nella produzione asettica di prodotti farmaceutici (bio)farmaceutici sterili liofilizzati o liquidi attraverso il riempimento e la finitura.
DIMENSIONE DEL LOTTO: Piccolo, Medio
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (GMP UE), FDA (cGMP)
REGIONE: Europe
USO: Umano
SERVIZI: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
MERCATI: PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), NMPA (China), Health Canada (Canada), MHRA (UK)
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
SOSTANZE CONTROLLATE: High potential for abuse & no medical use

Adragos Pharma | Livron
Adragos Pharma
Produzione di liquidi sterili e supposte. Gestiamo più di 100 molecole, gestione dei narcotici e servizi di analisi e stabilità.
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (GMP UE), MFDS/KFDA (Repubblica di Corea GMP)
SOSTANZE CONTROLLATE: 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
REGIONE: Europe
USO: Umano
SERVIZI: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
MERCATI: PMDA (Japan), CDSCO (India), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), MHRA (UK)
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)

Glatt Pharmaceutical Services GmbH Co. & KG
Glatt Pharmaceutical Services GmbH Co. & KG
Il vostro CDMO conforme a cGMP per servizi end-to-end nel campo delle forme di dosaggio complesse dei solidi orali, con sede a Binzen in Germania.
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
AREE TERAPEUTICHE DI COMPETENZA (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
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (GMP UE), FDA (cGMP)
SOSTANZE CONTROLLATE: 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
REGIONE: Europe
USO: Umano, Veterinario
SERVIZI: Analytical / QC services, Manufacturing services, Development services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
MERCATI: FDA (USA), EMA (EU)
BSL (Livello di sicurezza biologica): 1

Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site
Seacross Pharmaceutical Co Ltd
Essendo uno dei tre siti principali, insieme al centro di ricerca e sviluppo e all'impianto di formulazione, il nostro impianto di produzione di API svolge un r
MERCATI: 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)
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
AREE TERAPEUTICHE DI COMPETENZA (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
COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), Servizio pubblico francese (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (Cina GMP), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Consiglio di ricerca halal, INVIMA, Health Canada (Canada GMP), SQF (alimenti di qualità sicuri), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (Repubblica di Corea GMP), COFEPRIS
SOSTANZE CONTROLLATE: 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 (Livello di sicurezza biologica): 3, 4, 1, 2
USO: Umano
SERVIZI: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
REGIONE: APAC
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
Seacross Pharmaceutical Co Ltd
Il Centro R&D svolge un ruolo fondamentale nel supportare lo sviluppo sia degli API che delle forme di dosaggio finite.
MERCATI: 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)
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
AREE TERAPEUTICHE DI COMPETENZA (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
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC
COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), Servizio pubblico francese (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (Cina GMP), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Consiglio di ricerca halal, INVIMA, Health Canada (Canada GMP), SQF (alimenti di qualità sicuri), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (Repubblica di Corea GMP), COFEPRIS
SOSTANZE CONTROLLATE: 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 (Livello di sicurezza biologica): 3, 4, 1, 2
USO: Umano
SERVIZI: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
REGIONE: APAC
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)

Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
Seacross Pharmaceutical Co Ltd
Il sito di produzione della formulazione è dedicato allo sviluppo e alla produzione di forme di dosaggio complesse e di alto valore.
MERCATI: 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)
DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande
AREE TERAPEUTICHE DI COMPETENZA (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
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, SERVICES
COMPLIANCE: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), Servizio pubblico francese (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (Cina GMP), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Consiglio di ricerca halal, INVIMA, Health Canada (Canada GMP), SQF (alimenti di qualità sicuri), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (Repubblica di Corea GMP), COFEPRIS
SOSTANZE CONTROLLATE: 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 (Livello di sicurezza biologica): 3, 4, 1, 2
USO: Umano
SERVIZI: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
REGIONE: APAC
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno)
