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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
Regno Unito

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)
Regno Unito

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)
Stati Uniti

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
Francia

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
Germania

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
Svizzera

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
Francia

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
Germania

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
Cina

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
Cina

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
Cina

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)