Exibir 55 facilidades
Compliance: ANMAT (Argentina nueva GMP)
Markets: ANMAT (Argentina), Resto do mundo
Services: Development services, Manufacturing services
Region: Europe
Category / Product: BIOLOGICS
Espanha
mAbxience Garín
mAbxience CDMO
Capacidade de uso único de 24.000 L para fabricação de moléculas semelhantes a anticorpos GMP
Batch Size: Large, Medium
Compliance: ISO, TITCK (Turkish Health Authorities), ANVISA (Brazil B-GMP), COFEPRIS, ICH, MHRA (UK GMP), ANMAT (Argentina nueva GMP), ISP (Chile BPM), World Health Organization (GMP / HACCP), EMA (EU GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), ANVISA (Brazil), MHRA (UK)
Markets: ANMAT (Argentina), Resto do mundo, COFEPRIS (Mexico), Russian Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Turkish Health Authorities, EMA (EU), SFDA (Saudi Arabia), INVIMA (Colombia)
Use: Human
Services: Analytical / QC services, Manufacturing services
Therapeutic Areas of Expertise (ATC): (B) Blood and blood forming organs, (D) Dermatologicals, (N) Nervous system, (J) Antiinfectives for systemic use, (R) Respiratory system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Region: Europe
Category / Product: BIOLOGICS
Espanha
mAbxience Genhelix
mAbxience CDMO
Capacidade de uso único de 24.000 L para desenvolvimento de moléculas semelhantes a anticorpos e fabricação de GMP, desde o desenvolvimento de linhagens celulares até substâncias medicamentosas…
Batch Size: Large, Small, Medium
Compliance: ISO, TITCK (Turkish Health Authorities), ANVISA (Brazil B-GMP), COFEPRIS, ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), World Health Organization (GMP / HACCP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), PMDA (Japan), ANVISA (Brazil), Health Canada, MHRA (UK), TGA (Australia)
Markets: FDA (USA), PMDA (Japan), Health Canada (Canada), ANMAT (Argentina), Resto do mundo, COFEPRIS (Mexico), Russian Health Authorities, EDE (UAE), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Turkish Health Authorities, EMA (EU), MHRA (UK), MFDS (South Korea), MSPAS (Guatemala), SFDA (Saudi Arabia), INVIMA (Colombia), TGA (Australia)
Use: Human, Veterinary
Services: Development services, Analytical / QC services, Manufacturing services, Quality Assurance services
Therapeutic Areas of Expertise (ATC): (B) Blood and blood forming organs, (D) Dermatologicals, (N) Nervous system, (J) Antiinfectives for systemic use, (R) Respiratory system, (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
Region: Europe
Category / Product: BIOLOGICS
Países Baixos
Bilthoven Biologicals Drug Substance and Drug Product Facilities
Bilthoven Biologicals BV
Instalações GMP de vários produtos para substâncias medicamentosas e produtos farmacêuticos.
Markets: EMA (EU), MHRA (UK)
Batch Size: Large, Small, Medium
BSL (Biological Safety Level): 1, 2
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Use: Human
Compliance: EMA (EU GMP)
Category / Product: FDF / DRUG PRODUCTS, CRO ANALÍTICO, BIOLOGICS
Region: Europe
Espanha
CZ Vaccines | Investigational and Medicinal Products Plant
CZ Vaccines
Instalação de ensaios clínicos
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Markets: EMA (EU), ANVISA (Brazil), CDSCO (India)
Use: Human
BSL (Biological Safety Level): 1, 2
Compliance: ISO, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), EMA (EU GMP)
Batch Size: Small
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (G) Genito urinary system and sex hormones, (A) Digestive tract and metabolism
Region: Europe
Suíça
CARBOGEN AMCIS | Bubendorf
CARBOGEN AMCIS
Desenvolvimento e fabricação de cGMP de API altamente potente, incluindo conjugados de anticorpos e drogas (ADC).
Services: Development services, Analytical / QC services, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)
Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)
Use: Human, Veterinary
Therapeutic Areas of Expertise (ATC): (V09-10) Radiopharmaceuticals, (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism
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: PARTICLE ENGINEERING, CRO ANALÍTICO, BIOLOGICS, CHEMICAL-SYNTHETIC
Region: Europe
Suíça
CARBOGEN AMCIS | Aarau
CARBOGEN AMCIS
Desenvolvimento e fabricação de cGMP em média escala, incluindo cromatografia.
Use: Human, Veterinary
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), CDSCO (India), MFDS (South Korea), TGA (Australia)
Services: Development services, Analytical / QC services, Manufacturing services, Quality Assurance services
Compliance: ISO, FDA (cGMP), PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP)
Batch Size: Small, Medium
Category / Product: CRO ANALÍTICO, PARTICLE ENGINEERING, BIOLOGICS, CHEMICAL-SYNTHETIC
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Region: Europe
Espanha
HIPRA BIOTECH SERVICES | Aiguaviva
HIPRA Biotech Services
Capacidades internas completas, desde o desenvolvimento de linhas celulares até a fabricação comercial.
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
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)
Region: Europe
Category / Product: BIOLOGICS
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
Alemanha
Nexora Cell and Tissue Therapy Manufacturing Site
Green Phoenix Labs GmbH
Site ATMP licenciado na Alemanha. Fabricação de GMP e liberação de lote QP para terapias celulares e teciduais.
Services: Development services, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU)
BSL (Biological Safety Level): 1, 2
Use: Human
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
Therapeutic Areas of Expertise (ATC): (S) Sensory organs, (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Batch Size: 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)
Compliance: EMA (EU GMP)
Category / Product: FDF / DRUG PRODUCTS, CRO ANALÍTICO, BIOLOGICS
Region: Europe
Espanha
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
Capacidades internas completas, desde o desenvolvimento de linhas celulares até a fabricação comercial.
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
Espanha
VIVEbiotech
VIVEbiotech
Seu CDMO líder com certificação GMP, dedicado exclusivamente à produção de vetores lentivirais.
Markets: EMA (EU), FDA (USA), MHRA (UK)
Region: Europe
Compliance: FDA (cGMP), French Service-Public (CIR), EMA (EU GMP), MHRA (UK GMP)
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1, 2
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Category / Product: BIOLOGICS
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