
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

Adare Pharma Solutions
CDMO global que oferece desenvolvimento de produtos prontos para uso por meio de experiência em fabricação comercial, com foco em formas farmacêuticas orais.
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), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), TGA (Australia)
Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, French Service-Public (CIR), NMPA (China 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
Therapeutic Areas of Expertise (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (V01) Allergens, (R) Respiratory system, (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), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING, CRO ANALÍTICO
Region: Europe

CONTENT GROUP
Tubilux Pharma: sede social; instalação de fabricação.
Markets: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, TGA (Australia)
Compliance: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), EMA (EU GMP)
Use: Human, Veterinary
Batch Size: Large, Medium
Therapeutic Areas of Expertise (ATC): (S) Sensory organs
Category / Product: FDF / DRUG PRODUCTS, CRO ANALÍTICO
Region: Europe

Aenova
Centro de Competência Semissólidos e líquidos não estéreis.
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), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia)
Region: Europe
Compliance: ISO, Roszdravnadzor (Russia GMP), SFDA (Saudi Food & Drug Authority), EMA (EU GMP)
Batch Size: Large, Small, Medium
Category / Product: COSMETICS, FDF / DRUG PRODUCTS
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

CONTENT GROUP
COC Farmaceutici srl: sede comercial e administrativa; instalação de fabricação.
Markets: EMA (EU), MHRA (UK), SFDA (Saudi Arabia), EDE (UAE)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: ISO
Batch Size: Large, Medium
Category / Product: COSMETICS, CRO ANALÍTICO, FDF / DRUG PRODUCTS
Use: Human

CONTENT GROUP
COC Farmaceutici srl: sede social; instalação de fabricação.
Markets: EMA (EU)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: ISO, EMA (EU GMP)
Batch Size: Large, Medium
Category / Product: COSMETICS, CHEMICAL-SYNTHETIC, CRO ANALÍTICO, FDF / DRUG PRODUCTS
Use: Human, Veterinary
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (S) Sensory organs
MAI network supplier
Local de desenvolvimento e fabricação de substâncias medicamentosas de pequenas moléculas.
Localização disponível após o registo
MAI network supplier
Como CDMO, a HMC apoia seus parceiros durante todo o processo, desde o desenvolvimento do produto até os dispositivos embalados e esterilizados.
Localização disponível após o registo
MAI network supplier
CDMO europeu especializado em esteróides, hormônios e HPAPI.
Localização disponível após o registo
Estas instalações correspondem aos seus critérios principais, mas nem todos os filtros opcionais.

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

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

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
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