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Países Baixos
CARBOGEN AMCIS | Veenendaal
CARBOGEN AMCIS
Fabricação em larga escala de análogos de colesterol e vitamina D.
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Resto do mundo, 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)
Batch Size: Small
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (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, (V06) Nutrients
Compliance: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (China GMP), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Halal Research Council, INVIMA, Health Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (Republic of Korea GMP), COFEPRIS
Category / Product: CRO ANALÍTICO, CHEMICAL-SYNTHETIC
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), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
BSL (Biological Safety Level): 1
Países Baixos
Bilthoven Biologicals Drug Substance and Drug Product Facilities
Bilthoven Biologicals BV
Instalações GMP de vários produtos para substâncias medicamentosas e produtos farmacêuticos.
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, CRO ANALÍTICO, 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)
Visualização limitada
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Podemos levar seus produtos farmacêuticos desde a escala de laboratório até a fase clínica inicial e além.
Localização disponível após o registo
Resultados Sugeridos
Estas instalações correspondem aos seus critérios principais, mas nem todos os filtros opcionais.
Espanha
mAbxience Garín
mAbxience CDMO
24,000 L single-use capacity for antibody-like molecule GMP manufacturing
Compliance: ISO, ICH, ANVISA (Brazil B-GMP), COFEPRIS, ISP (Chile BPM), TITCK (Turkish Health Authorities), World Health Organization (GMP / HACCP), EMA (EU GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), ANVISA (Brazil), MHRA (UK)
Batch Size: Large, Medium
Markets: EMA (EU), Russian Health Authorities, Resto do mundo, EDE (UAE), SFDA (Saudi Arabia), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Turkish Health Authorities, ANMAT (Argentina), COFEPRIS (Mexico), INVIMA (Colombia)
Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (B) Blood and blood forming organs, (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
Services: Analytical / QC services, Manufacturing services
Use: Human
Region: Europe
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
Compliance: ISO, ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), COFEPRIS, Roszdravnadzor (Russia GMP), TGA (Australia GMP), ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), TITCK (Turkish Health Authorities), World Health Organization (GMP / HACCP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva 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: PMDA (Japan), Health Canada (Canada), FDA (USA), EMA (EU), MHRA (UK), Russian Health Authorities, MFDS (South Korea), Resto do mundo, EDE (UAE), SFDA (Saudi Arabia), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Turkish Health Authorities, ANMAT (Argentina), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), TGA (Australia)
Batch Size: Large, Small, Medium
Services: Development services, Analytical / QC services, Manufacturing services, Quality Assurance services
Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (B) Blood and blood forming organs, (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
Use: Human, Veterinary
Region: Europe
Category / Product: BIOLOGICS
Polônia
Polpharma API | CDMO
Polpharma API
Integrated CDMO solutions for HP APIs (OEB 6), ADC payload-linkers and oligonucleotides from development to GMP supply.
Compliance: BRCGS, ISO, ICH, FDA (cGMP), DIGEMID, ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, PMDA/MHLW (Japan GMP), TGA (Australia GMP), INVIMA, ECOVADIS, ISP (Chile BPM), TITCK (Turkish Health Authorities), French Service-Public (CIR), ANMAT (Argentina nueva GMP), EMA (EU GMP), NMPA (China GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP), SQF (Safe Quality Food), NSF, UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), NMPA (China GMP), PMDA (Japan), ANVISA (Brazil), Health Canada, MHRA (UK), TGA (Australia)
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), MHRA (UK), MFDS (South Korea)
Batch Size: Large, Small, Medium
Services: Development services, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services
Therapeutic Areas of Expertise (ATC): (N) Nervous system, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Category / Product: PARTICLE ENGINEERING, SERVICES, CHEMICAL-SYNTHETIC, OLIGONUCLEOTIDES
Use: Human
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)
Region: Europe
Reino Unido
Arcinova Ltd. – Alnwick, UK
Arcinova - A Quotient Sciences Company
A Arcinova acelera o desenvolvimento de medicamentos desde a descoberta precoce até a prova de conceito e além.
Compliance: FDA (cGMP), ICH, MHRA (UK GMP), EMA (EU GMP), MHRA (UK)
Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK)
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Use: Human
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, Narcotic, High potential for abuse & medical use
Batch Size: Small
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, CRO ANALÍTICO, CHEMICAL-SYNTHETIC
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
Alemanha
Aenova Group - Location Münster, Germany
Aenova
Centro de Competência Sólidos de baixa dosagem e alta potência (hormônios, semelhantes a hormônios), cápsulas de baixa dosagem.
Use: Human, Veterinary
Markets: FDA (USA), EMA (EU), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
Services: Development services, Analytical / QC services, Regulatory services, Packaging, Manufacturing services, Quality Assurance services
Batch Size: Large, Small, Medium
Compliance: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
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: FDF / DRUG PRODUCTS
Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins
Region: Europe
Itália
Aenova Group - Location Latina, Italy
Aenova
Centro de Competência em produtos de saúde animal e tecnologias estéreis.
Markets: ANVISA (Brazil), FDA (USA), EMA (EU), Russian Health Authorities, Turkish Health Authorities, SFDA (Saudi Arabia)
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2
Compliance: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (EU GMP), SFDA (Saudi Food & Drug Authority)
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
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
Region: Europe
Grécia
Adragos Pharma | Athens
Adragos Pharma
É especializada no desenvolvimento de medicamentos de valor agregado e foi recentemente atualizada com recursos HPAPI.
Markets: Health Canada (Canada), ANVISA (Brazil), FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), CDSCO (India), EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)
Batch Size: Large, Small, Medium
Use: Human
Compliance: ISO, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), NMPA (China GMP), MHRA (UK GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, UAE Ministry of Health & Prevention
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, 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: FDF / DRUG PRODUCTS, CRO ANALÍTICO
Region: Europe
Suíça
CARBOGEN AMCIS | Vionnaz
CARBOGEN AMCIS
Desenvolvimento de APIs altamente potentes e produção de cGMP em pequena escala, incluindo cromatografia e liofilização.
Services: Development services, Analytical / QC 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), 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
Batch Size: Small
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)
Region: Europe
Category / Product: CHEMICAL-SYNTHETIC
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