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Showing 52 facilities
Laboratorio REIG JOFRE, SA (TOLEDO PLANT)
Spagna

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)

LABORATORIO REIG JOFRE SA

Impianti all'avanguardia per lo sviluppo e la produzione di antibiotici betalattamici (FDF).

Batch Size: Large, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1

Compliance: DIGEMID, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ECOVADIS, ISP (Chile BPM), World Health Organization (GMP / HACCP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP)

Markets: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, SFDA (Saudi Arabia), INVIMA (Colombia), TGA (Australia)

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

Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use

Controlled Substances: Lowest potential for abuse

Category / Product: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Region: Europe

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.

Batch Size: Large, Small, Medium

Use: Human

BSL (Biological Safety Level): 1, 2, 3, 4

Compliance: ISO, FDA (cGMP), DIGEMID, BRCGS, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), World Health Organization (GMP / HACCP), EMA (EU GMP), NMPA (China GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food)

Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia), Resto del mondo

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

Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (D) Dermatologicals, (J) Antiinfectives for systemic use, (B) Blood and blood forming organs, (N) Nervous system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens, (R) Respiratory system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

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

Category / Product: SERVICES, FDF / DRUG PRODUCTS

Region: APAC

Lifecore Injectables CDMO
Stati Uniti

Lifecore Injectables CDMO

Lifecore Biomedical

CDMO che produce prodotti farmaceutici iniettabili sterili clinici e commerciali.

Batch Size: Large, Small, Medium

Use: Human, Veterinary

BSL (Biological Safety Level): 1, 2, 3

Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), ECOVADIS, EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)

Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia), Resto del mondo

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

Controlled Substances: Lowest potential for abuse

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

Category / Product: FDF / DRUG PRODUCTS

Region: North America

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

Use: Human

Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), NMPA (China GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

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

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

Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (C) Cardiovascular system, (A) Digestive tract and metabolism

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use

Batch Size: Small, Medium

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

Category / Product: FDF / DRUG PRODUCTS

Region: Europe

CZ Vaccines | Large Scale Plant Portugal
Portogallo

CZ Vaccines | Large Scale Plant Portugal

CZ Vaccines

Impianto su scala commerciale

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

Markets: EMA (EU)

Compliance: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)

BSL (Biological Safety Level): 1, 2

Use: Human

Batch Size: Large, Medium

Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use, (R) Respiratory system, (G) Genito urinary system and sex hormones

Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS

Region: Europe

Cenexi
Francia

Cenexi

Cenexi

Lo stabilimento GMP su un sito di quattro ettari si trova a 9 km a est di Parigi. È un centro di eccellenza per le fiale iniettabili.

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

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

Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

Use: Human, Veterinary

Batch Size: Large, Small, Medium

Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Low potential for abuse

Therapeutic Areas of Expertise (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (D) Dermatologicals, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism

Category / Product: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)

Region: Europe

HIPRA BIOTECH SERVICES | Amer
Spagna

HIPRA BIOTECH SERVICES | Amer

HIPRA Biotech Services

Capacità interne end-to-end dallo sviluppo della linea cellulare alla produzione commerciale.

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

Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)

Compliance: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

BSL (Biological Safety Level): 1, 2

Use: Human, Veterinary

Batch Size: Large, Small, Medium

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS

Region: Europe

Bilthoven Biologicals Drug Substance and Drug Product Facilities
Paesi Bassi

Bilthoven Biologicals Drug Substance and Drug Product Facilities

Bilthoven Biologicals BV

Impianti GMP multiprodotto per sostanze farmaceutiche e prodotti farmaceutici.

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

Markets: EMA (EU), MHRA (UK)

BSL (Biological Safety Level): 1, 2

Use: Human

Batch Size: Large, Small, Medium

Compliance: EMA (EU GMP)

Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS

Region: Europe

HBM Pharma
Slovacchia

HBM Pharma

Hbm Pharma

CMO certificato EU-GMP con sede a Martin, Slovacchia. L'azienda fornisce servizi di produzione e confezionamento di prodotti farmaceutici sterili. prodotti e forme di dosaggio solide orali

Markets: EMA (EU), NMPA (China), Health Canada (Canada), ANVISA (Brazil), COFEPRIS (Mexico), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, TGA (Australia)

Compliance: ISO, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), ANVISA (Brazil)

Use: Human

Batch Size: Large, Small, Medium

Services: Analytical / QC services, Packaging, Quality Assurance services, Manufacturing services

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)

Controlled Substances: High potential for abuse & medical use

Category / Product: FDF / DRUG PRODUCTS, SERVICES

Region: Europe

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
Spagna

Laboratorio REIG JOFRE, SA (BARCELONA PLANT)

LABORATORIO REIG JOFRE SA

Impianti di produzione di prodotti iniettabili (liofilizzati e liquidi) e liquidi.

BSL (Biological Safety Level): 3, 1, 2

Markets: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)

Region: Europe

Batch Size: Large, Medium

Use: Human, Veterinary

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

Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism

Controlled Substances: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

Compliance: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ECOVADIS, INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)

Category / Product: FDF / DRUG PRODUCTS

EVER Pharma Jena GmbH
Germania

EVER Pharma Jena GmbH

EVER Neuro Pharma GmbH

CDMO specializzato nello sviluppo e nella produzione di piccole molecole iniettabili.

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

Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Resto del mondo

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

Region: Europe

Compliance: ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

Batch Size: Large, Small, Medium

Use: Human

BSL (Biological Safety Level): 1, 2

Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system

Category / Product: FDF / DRUG PRODUCTS

CZ Vaccines | Investigational and Medicinal Products Plant
Spagna

CZ Vaccines | Investigational and Medicinal Products Plant

CZ Vaccines

Struttura per sperimentazioni cliniche

Markets: EMA (EU), ANVISA (Brazil), CDSCO (India)

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

Region: Europe

Compliance: ISO, ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

Use: Human

BSL (Biological Safety Level): 1, 2

Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

Batch Size: Small

Category / Product: BIOLOGICS, FDF / DRUG PRODUCTS

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Siete un´azienda farmaceutica alla ricerca di un partner CMO o CDMO affidabile per accelerare il processo di sviluppo dei vostri farmaci? Non cercate oltre MAI CDMO Network. La nostra piattaforma di ricerca avanzata vi mette in contatto con una vasta rete di produttori a contratto e organizzazioni di sviluppo qualificate in tutto il mondo.

Perché scegliere MAI CDMO Network?

  • Elenco completo di fornitori: Scoprite una vasta gamma di CMO e CDMO specializzati in vari servizi, tra cui produzione di API, forniture per studi clinici, fill-finish, confezionamento e altro ancora.
  • Capacità di ricerca su misura: I nostri filtri di ricerca avanzati vi permettono di affinare la ricerca in base a criteri specifici come la posizione, le capacità, la capacità e la conformità normativa.
  • Portata globale: Collegatevi con CMO e CDMO di tutto il mondo per trovare il partner perfetto per i vostri progetti globali.
  • Risparmio di tempo e costi: Semplificate il vostro processo di sourcing e riducete il time-to-market trovando il partner giusto sulla nostra piattaforma.
  • Miglioramento del processo decisionale: Accesso a profili aziendali dettagliati, casi di studio e recensioni per prendere decisioni informate.

Come funziona MAI CDMO Network

  • Creare un account gratuito: Registrate un account gratuito per accedere al nostro ampio database di CMO e CDMO.
  • Affina la tua ricerca: Utilizzate i nostri filtri di ricerca avanzati per identificare i fornitori che soddisfano esattamente i vostri requisiti.
  • Richiesta di preventivi: Contattate direttamente i fornitori selezionati per richiedere preventivi e saperne di più sui loro servizi.
  • Prendete decisioni informate: Confrontate i preventivi, esaminate i profili delle aziende e scegliete il partner migliore per il vostro progetto.

Vantaggi principali della collaborazione con un CMO/CDMO

  • Accelerazione del time-to-market: Sfruttare l´esperienza e le risorse di una CMO/CDMO per accelerare il processo di sviluppo del farmaco.
  • Costi ridotti: Beneficiare di economie di scala e di attrezzature specializzate per ridurre i costi di produzione.
  • Miglioramento della qualità: Garantire la qualità del prodotto e la conformità agli standard normativi grazie a rigorosi sistemi di gestione della qualità.
  • Maggiore flessibilità: Aumentare o ridurre la produzione in base alle necessità per soddisfare le mutevoli richieste del mercato.
  • Concentrazione sulle competenze principali: Esternalizzare le attività non essenziali per liberare le risorse interne per l´innovazione e le iniziative strategiche.

Servizi in primo piano

  • Produzione di API: Procuratevi ingredienti farmaceutici attivi di alta qualità da produttori esperti.
  • Forniture per studi clinici: Assicuratevi forniture affidabili e conformi per i vostri studi clinici.
  • Riempimento e confezionamento: Collaborate con esperti di riempimento sterile, liofilizzazione e confezionamento per garantire la stabilità del prodotto e la sicurezza del paziente.
  • Test analitici: Accesso a un´ampia gamma di servizi analitici per supportare il vostro programma di sviluppo dei farmaci.

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