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Resultados Sugeridos
Estas instalações correspondem aos seus critérios principais, mas nem todos os filtros opcionais.
Espanha
Laboratorios Grifols | Murcia Plant
Grifols International
Soluções de fabricação estéreis (moléculas pequenas) em sacos flexíveis.
Markets: EMA (EU), FDA (USA), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)
Compliance: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
Use: Human, Veterinary
Batch Size: Large, Small, Medium
Services: Logistics, Analytical / QC services, Packaging, Quality Assurance services, Manufacturing services
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
Therapeutic Areas of Expertise (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism
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
França
Cenexi
Cenexi
A fábrica da GMP em um terreno de quatro hectares está localizada 9 km a leste de Paris. É um centro de excelência em ampolas injetáveis.
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
Japão
Adragos Pharma | Kawagoe
Adragos Pharma
Nossas instalações oferecem a melhor fabricação de comprimidos e ampolas.
Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), EMA (EU GMP)
Use: Human
Batch Size: Large
Services: Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & medical use, Low potential for abuse
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, CRO ANALÍTICO
Region: APAC
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
Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
LABORATORIO REIG JOFRE SA
Instalações de fabricação de injetáveis (lio e líquidos) e líquidos.
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
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)
Markets: EMA (EU), FDA (USA)
Region: Europe
Batch Size: Large, Small, Medium
Use: Human
Services: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
Therapeutic Areas of Expertise (ATC): (L) Antineoplastic and immunomodulating agents
Compliance: EMA (EU GMP)
Category / Product: FDF / DRUG PRODUCTS
Markets: EMA (EU)
Services: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
Batch Size: Large, Medium
Use: Human
BSL (Biological Safety Level): 1, 2
Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
Category / Product: BIOLOGICS, FDF / DRUG PRODUCTS
França
Adragos Pharma | Maisons-Alfort
Adragos Pharma
Especializado em seringas pré-cheias, frascos líquidos e liofilizados, combina sistemas avançados de enchimento asséptico, liofilização e inspeção.
Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (A) Digestive tract and metabolism
Markets: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities
Region: Europe
Batch Size: Large
Use: Human
BSL (Biological Safety Level): 1
Services: Manufacturing services, Analytical / QC services, Regulatory services, Packaging
Controlled Substances: Lowest potential for abuse
Compliance: ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
Category / Product: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
Reino Unido
Seda Pharma Development Services
Seda Pharma Development Services Ltd
A Seda Pharmaceutical Development Services é especializada em Desenvolvimento Farmacêutico integrado e Farmacologia Clínica.
Therapeutic Areas of Expertise (ATC): (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (B) Blood and blood forming organs
Markets: TGA (Australia), Resto do mundo, 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)
Batch Size: Small, Medium
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), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
Compliance: MHRA (UK GMP), ECOVADIS
Category / Product: FDF / DRUG PRODUCTS
Region: Europe
Use: Human
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
BSL (Biological Safety Level): 3, 4
Controlled Substances: High potential for abuse & medical use
Compliance: ICH, ISO, ANVISA (Brazil B-GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (China GMP), EMA (EU GMP)
Markets: EMA (EU), NMPA (China), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Batch Size: Large, Small, Medium
Use: Human
Therapeutic Areas of Expertise (ATC): (L) Antineoplastic and immunomodulating agents
Category / Product: FDF / DRUG PRODUCTS
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PARTICLE ENGINEERING manufacturing site
MAI network supplier
Soluções para programas de distribuição não viral
Localização disponível após o registo
Visualização limitada
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Parceiro CDMO confiável para fabricação asséptica e liofilização de produtos biológicos e medicamentos injetáveis.
Localização disponível após o registo
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