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Cenexi Hérouville Saint Clair
Francia

Cenexi Hérouville Saint Clair

Cenexi

Il sito di Hérouville-Saint-Clair, situato vicino a Caen, in Normandia, è specializzato nella produzione e nel riempimento di liquidi sterili iniettabili e non

SOSTANZE CONTROLLATE: 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

MERCATI: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea), TGA (Australia)

REGIONE: Europe

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (Cina GMP), EMA (GMP UE), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)

USO: Umano

SERVIZI: Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (N) Nervous system, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

DIMENSIONE DEL LOTTO: Piccolo, Medio

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

Cenexi Laboratoires Thissen
Belgio

Cenexi Laboratoires Thissen

Cenexi

Questo stabilimento di 8.000 m2, con edifici sparsi su un sito di quasi sette ettari, si trova a 20 km a sud di Bruxelles e conta 340 dipendenti*.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

BSL (Livello di sicurezza biologica): 3, 4, 1, 2

SOSTANZE CONTROLLATE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MERCATI: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), TGA (Australia)

REGIONE: Europe

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), NMPA (Cina GMP), EMA (GMP UE), Health Canada (Canada GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano, Veterinario

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

STE PRASFARMA
Spagna

STE PRASFARMA

STE PRASFARMA

Citostatici CMO/CDMO e prodotti ad alta potenza.

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno)

BSL (Livello di sicurezza biologica): 3, 4

SOSTANZE CONTROLLATE: High potential for abuse & medical use

COMPLIANCE: ICH, ISO, ANVISA (Brazil B-GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (Cina GMP), EMA (GMP UE)

MERCATI: EMA (EU), NMPA (China), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities

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

REGIONE: Europe

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano

AREE TERAPEUTICHE DI COMPETENZA (ATC): (L) Antineoplastic and immunomodulating agents

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

Limited view

CHEMICAL-SYNTHETIC manufacturing site

MAI network supplier

Soluzioni per programmi di distribuzione non virale

Location available after registration

Limited view

FDF / DRUG PRODUCTS manufacturing site

MAI network supplier

CDMO farmaceutico end-to-end

Location available after registration

Limited view

SERVICES manufacturing site

MAI network supplier

Fiale liquide e liofilizzate: due suite per camere bianche conformi all'Allegato I BSL-2.

Location available after registration

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Laboratorios Grifols | Murcia Plant
Spagna

Laboratorios Grifols | Murcia Plant

Grifols International

Soluzioni di produzione sterili (piccole molecole) in sacchetti flessibili.

MERCATI: ANMAT (Argentina), ANVISA (Brazil), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia)

DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

COMPLIANCE: ISP (Chile BPM), ANMAT (nuove BPF dell'Argentina), EMA (GMP UE), ANVISA (Brazil B-GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, INVIMA, Health Canada (Canada GMP), MFDS/KFDA (Repubblica di Corea GMP)

SOSTANZE CONTROLLATE: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse

REGIONE: Europe

USO: Umano, Veterinario

SERVIZI: Analytical / QC services, Logistics, Manufacturing 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)

AREE TERAPEUTICHE DI COMPETENZA (ATC): (M) Musculoskeletal system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system

Adragos Pharma | Halden
Norvegia

Adragos Pharma | Halden

Adragos Pharma

Siamo specializzati nella produzione di sacche per flebo, fiale e fiale di plastica utilizzando la tecnologia Blow-Fill-Seal (BFS) e altre forme di dosaggio.

MERCATI: Turkish Health Authorities, EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), MHRA (UK)

DIMENSIONE DEL LOTTO: Piccolo, Medio, Grande

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

COMPLIANCE: 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), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (Cina GMP), ISO, TITCK (Turkish Health Authorities), MFDS/KFDA (Repubblica di Corea GMP)

SOSTANZE CONTROLLATE: Lowest potential for abuse, 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

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)

AREE TERAPEUTICHE DI COMPETENZA (ATC): (A) Digestive tract and metabolism, (D) Dermatologicals, (V06) Nutrients

Adragos Pharma | Kawagoe
Giappone

Adragos Pharma | Kawagoe

Adragos Pharma

La nostra struttura fornisce la migliore produzione di compresse e fiale.

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, SERVICES

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

COMPLIANCE: EMA (GMP UE), PMDA/MHLW (Japan GMP), FDA (cGMP)

DIMENSIONE DEL LOTTO: Grande

SOSTANZE CONTROLLATE: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse

USO: Umano

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

REGIONE: APAC

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 | 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)

Green Phoenix Labs GmbH
Germania

Green Phoenix Labs GmbH

Green Phoenix Labs GmbH

Azienda di terapia cellulare con capacità di camere bianche in eccesso.

DIMENSIONE DEL LOTTO: Piccolo, Medio

AREE TERAPEUTICHE DI COMPETENZA (ATC): (R) Respiratory system, (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

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS, SERVICES, BIOLOGIA

COMPLIANCE: EMA (GMP UE)

SOSTANZE CONTROLLATE: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse

REGIONE: Europe

USO: Umano

SERVIZI: Logistics, 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)

BSL (Livello di sicurezza biologica): 1

MERCATI: EMA (EU)

Seda Pharma Development Services
Regno Unito

Seda Pharma Development Services

Seda Pharma Development Services Ltd

Seda Pharmaceutical Development Services è specializzata nello sviluppo farmaceutico integrato e nella farmacologia clinica.

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

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

REGIONE: Europe

USO: Umano

COMPLIANCE: MHRA (UK GMP), ECOVADIS

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)

AREE TERAPEUTICHE DI COMPETENZA (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

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