These facilities match your main criteria but not all optional filters.

CARBOGEN AMCIS
Sviluppo e produzione cGMP su media scala inclusa la cromatografia.
Batch Size: Small, Medium
Compliance: PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
Category / Product: SERVICES, PARTICLE ENGINEERING, BIOLOGICS, CHEMICAL-SYNTHETIC
Region: Europe
Markets: ANVISA (Brazil), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
Use: Human, Veterinary
Services: Analytical / QC services, Manufacturing services, Development services, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)

CARBOGEN AMCIS
Sviluppo e produzione cGMP di API altamente potenti, inclusi coniugati di farmaci anticorpali (ADC).
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
Category / Product: SERVICES, PARTICLE ENGINEERING, BIOLOGICS, CHEMICAL-SYNTHETIC
Region: Europe
Use: Human, Veterinary
Services: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)

Bilthoven Biologicals BV
Impianti GMP multiprodotto per sostanze farmaceutiche e prodotti farmaceutici.
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Compliance: EMA (EU GMP)
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
Markets: EMA (EU), MHRA (UK)

Green Phoenix Labs GmbH
Sito ATMP con licenza in Germania. Produzione GMP e rilascio di lotti QP per terapie cellulari e tissutali.
Batch Size: Small, Medium
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (M) Musculoskeletal system, (S) Sensory organs, (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
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Compliance: EMA (EU GMP)
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
Region: Europe
Use: Human
Services: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
BSL (Biological Safety Level): 1, 2
Markets: EMA (EU)

VIVEbiotech
Il vostro CDMO leader certificato GMP dedicato esclusivamente alla produzione di vettori lentivirali.
Batch Size: Small, Medium, Large
Compliance: EMA (EU GMP), MHRA (UK GMP), French Service-Public (CIR), FDA (cGMP)
Region: Europe
Use: Human
Services: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Markets: FDA (USA), EMA (EU), MHRA (UK)
Category / Product: BIOLOGICS
BSL (Biological Safety Level): 1, 2
Probio
GCT globale e CDMO biologico, accelerano la pipeline dal gene al mercato commerciale.
Batch Size: Small, Medium, Large
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), FDA (cGMP), ISO
Use: Human
Region: APAC
Category / Product: BIOLOGICS

Cellex Cell Professionals
Impianto di produzione di celle CGT CDMO e centro di raccolta dei materiali di partenza
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Compliance: EMA (EU GMP), FDA (cGMP)
Region: Europe
Use: Human, Veterinary
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Markets: FDA (USA), EMA (EU)
BSL (Biological Safety Level): 1, 2
MAI network supplier
Finitura del riempimento sterile della fase iniziale
Location available after registration
MAI network supplier
Struttura clinica non sterile (dosi solide orali)
Location available after registration
MAI network supplier
Possiamo portare i vostri prodotti farmaceutici dalla scala di laboratorio alla fase clinica iniziale e oltre.
Location available after registration
MAI network supplier
Il tuo partner CDMO di fiducia con esperienza nello sviluppo e nella produzione di prodotti biofarmaceutici, vettori virali e vaccini.
Location available after registration
MAI network supplier
Produzione di mRNA e LNP e riempimento e finitura.
Location available after registration
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