Exibir 13 facilidades
Grécia
Adragos Pharma | Athens
Adragos Pharma
É especializada no desenvolvimento de medicamentos de valor agregado e foi recentemente atualizada com recursos HPAPI.
Markets: ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, CRO ANALÍTICO
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), NSF, NMPA (China GMP), ISO, MFDS/KFDA (Republic of Korea GMP)
Controlled Substances: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
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), 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)
França
Cenexi Hérouville Saint Clair
Cenexi
A unidade de Hérouville-Saint-Clair, situada perto de Caen, na Normandia, é especializada no fabrico e envase de líquidos estéreis injetáveis e não injetáveis
Batch Size: Small, Medium
Category / Product: FDF / DRUG PRODUCTS
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MHRA (UK GMP), FDA (cGMP), NMPA (China GMP), MFDS/KFDA (Republic of Korea GMP)
Controlled Substances: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
Region: Europe
Markets: ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), MHRA (UK)
Use: Human
Services: Analytical / QC services, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system
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)
Itália
Content Group | Pomezia Plant
CONTENT GROUP
Tubilux Pharma: sede social; instalação de fabricação.
Batch Size: Medium, Large
Category / Product: FDF / DRUG PRODUCTS, CRO ANALÍTICO
Compliance: Roszdravnadzor (Russia GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), TITCK (Turkish Health Authorities)
Region: Europe
Markets: ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU), TGA (Australia)
Use: Human, Veterinary
Therapeutic Areas of Expertise (ATC): (S) Sensory organs
Itália
Content Group | Rovereto s/S Plant
CONTENT GROUP
COC Farmaceutici srl: sede comercial e administrativa; instalação de fabricação.
Batch Size: Medium, Large
Category / Product: FDF / DRUG PRODUCTS, COSMETICS, CRO ANALÍTICO
Markets: EDE (UAE), EMA (EU), SFDA (Saudi Arabia), MHRA (UK)
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Compliance: ISO
Visualização limitada
FDF / DRUG PRODUCTS 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
A CDMO israelense especializou-se no desenvolvimento e fabricação de GMP de medicamentos sintéticos complexos e dispositivos médicos baseados em produtos químic
Localização disponível após o registo
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.
Estados Unidos
Lifecore Injectables CDMO
Lifecore Biomedical
CDMO que fabrica medicamentos injetáveis estéreis clínicos e comerciais.
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2, 3
Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), ECOVADIS, EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia), Resto do mundo
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Controlled Substances: Lowest potential for abuse
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
Region: North America
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
Eslováquia
HBM Pharma
Hbm Pharma
CMO com certificação EU-GMP com sede em Martin, Eslováquia. A empresa fornece serviços de fabricação e embalagem para produtos farmacêuticos estéreis. produtos e formas farmacêuticas orais sólidas
Markets: EMA (EU), NMPA (China), Health Canada (Canada), ANVISA (Brazil), COFEPRIS (Mexico), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, TGA (Australia)
Compliance: ISO, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), ANVISA (Brazil)
Use: Human
Batch Size: Large, Small, Medium
Services: Analytical / QC services, Packaging, Quality Assurance services, Manufacturing services
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)
Controlled Substances: High potential for abuse & medical use
Category / Product: FDF / DRUG PRODUCTS, CRO ANALÍTICO
Region: Europe
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
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
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