Exibir 33 facilidades
Espanha
mAbxience Garín
mAbxience CDMO
24,000 L single-use capacity for antibody-like molecule GMP manufacturing
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Resto do mundo, ANVISA (Brazil), ISP (Chile), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), SFDA (Saudi Arabia), INVIMA (Colombia)
Batch Size: Medium, Large
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (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
Compliance: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Food & Drug Authority), ISO, TITCK (Turkish Health Authorities), COFEPRIS, ICH
Region: Europe
Use: Human
Services: Analytical / QC services, Manufacturing services
Category / Product: BIOLOGICS
Espanha
mAbxience Genhelix
mAbxience CDMO
24,000 L single-use capacity for antibody-like molecule development and GMP manufacturing, from cell line development to commercial drug substance
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Resto do mundo, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium, Large
Compliance: Health Canada, ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), PMDA (Japan), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), ANVISA (Brazil), TGA (Australia GMP), MHRA (UK), FDA (cGMP), SFDA (Saudi Food & Drug Authority), TGA (Australia), ECOVADIS, ISO, Health Canada (Canada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (Republic of Korea GMP), COFEPRIS, ICH
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (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, (B) Blood and blood forming organs
Region: Europe
Use: Human, Veterinary
Services: Analytical / QC services, Manufacturing services, Development services, Quality Assurance services
Category / Product: BIOLOGICS
Espanha
CZ Vaccines | Investigational and Medicinal Products Plant
CZ Vaccines
Instalação de ensaios clínicos
Batch Size: Small
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (G) Genito urinary system and sex hormones, (A) Digestive tract and metabolism
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Compliance: EMA (EU GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), ISO
Region: Europe
Markets: ANVISA (Brazil), CDSCO (India), EMA (EU)
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
Espanha
HIPRA BIOTECH SERVICES | Aiguaviva
HIPRA Biotech Services
Capacidades internas completas, desde o desenvolvimento de linhas celulares até a fabricação comercial.
Markets: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium, Large
Compliance: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), ISO, INVIMA, Health Canada (Canada GMP), MSPAS, COFEPRIS
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, 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)
Category / Product: BIOLOGICS
BSL (Biological Safety Level): 1, 2
Batch Size: Medium, Large
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Compliance: EMA (EU GMP), World Health Organization (GMP / HACCP), ISO
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)
Espanha
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
Capacidades internas completas, desde o desenvolvimento de linhas celulares até a fabricação comercial.
Markets: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Compliance: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), ISO, INVIMA, Health Canada (Canada GMP), MSPAS, COFEPRIS
Region: Europe
Use: Human, Veterinary
Services: Analytical / QC services, Logistics, 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
Espanha
53Biologics Production Plant
53Biologics
53Biologics é uma CDMO espanhola especializada na decodificação da produção de produtos biológicos, do DNA às proteínas.
Markets: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium, Large
Compliance: EMA (EU GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
Region: Europe
Use: Human, Veterinary
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Quality Assurance services
Category / Product: BIOLOGICS
BSL (Biological Safety Level): 1, 2
Espanha
BDI biotech Production Plant
BDI biotech
Trabalhamos como um departamento de P&D especializado em desenvolvimento de cepas e bioprocessos, aumento de escala e produção em lotes.
Markets: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium
Region: Europe
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services
Category / Product: BIOLOGICS
BSL (Biological Safety Level): 1
Compliance: ISO
Espanha
Cultiply
Cultiply
CDMO espanhola que desenvolve processos de produção e purificação de proteínas recombinantes, enzimas, DNA e outros produtos bioderivados.
Markets: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium
Controlled Substances: Lowest potential for abuse
Region: Europe
Services: Manufacturing services, Development services
Category / Product: BIOLOGICS
BSL (Biological Safety Level): 1, 2
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
Compliance: ISO
Batch Size: Medium, Large
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (N) Nervous system
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Compliance: EMA (EU GMP), World Health Organization (GMP / HACCP), ISO
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
Markets: EMA (EU)
Visualização limitada
BIOLOGICS manufacturing site
MAI network supplier
Embio is a leading pharmaceutical CDMO and the world’s largest fully integrated manufacturer of APIs and advanced intermediates.
Localização disponível após o registo
Visualização limitada
COSMETICS manufacturing site
MAI network supplier
Embio is a leading player in the domain of controlled substances. It is world's largest fully integrated manufacturers of API and its advanced intermediates.
Localização disponível após o registo
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