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Alemanha
Aenova Group - Location Marburg, Germany
Aenova
Centro de Competência complexo de sólidos convencionais e entorpecentes.
Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse
Markets: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities
Region: Europe
Compliance: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP)
Batch Size: Large, Small, Medium
Category / Product: NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Human
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
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)
Alemanha
Aenova Group - Location Gronau, Germany
Aenova
Centro de competência em sólidos convencionais e serviços clínicos.
Markets: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, EDE (UAE)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), UAE Ministry of Health & Prevention, EMA (EU GMP)
Batch Size: Large, Small, Medium
Use: Human, Veterinary
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
Alemanha
Aenova Group - Location Bad Aibling, Germany
Aenova
Centro de Competência Embalagem blister Embalagem de terceiros Planta de alto volume para efervescentes.
Markets: EMA (EU), FDA (USA)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
Region: Europe
Compliance: FDA (cGMP), ISO, IFS, EMA (EU GMP)
Batch Size: Large, Small, Medium
Category / Product: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Human, Veterinary
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)
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
Espanha
PHARMALOOP S.L. - a Salvat Company
Laboratorios Salvat
Soluções CDMO totalmente integradas para Blow-Fill-Seal (BFS), multidose estéril, multidose não estéril, sachês, cápsulas e comprimidos.
Markets: EMA (EU), FDA (USA)
Region: Europe
Compliance: FDA (cGMP), ISO, EMA (EU GMP)
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (S) Sensory organs, (V01) Allergens
Category / Product: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
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
Visualização limitada
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
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Localização disponível após o registo
Visualização limitada
COSMETICS manufacturing site
MAI network supplier
Soluções CDMO completas para intermediários APl e Key.
Localização disponível após o registo
Visualização limitada
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Desenvolvimento e fabricação de medicamentos para dose sólida oral (OSD), nasal, para inalação e pós secos estéreis e líquidos.
Localização disponível após o registo
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