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Pharmaron API Commercial Synthesis Cramlington (UK)
Pharmaron
Síntese comercial de pequenas moléculas de API.
ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
SUBSTÂNCIAS CONTROLADAS: 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
MERCADOS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), TGA (Australia)
REGIÃO: Europa
CONFORMIDADE: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
TAMANHO DO LOTE: Large, Small, Medium
USAR: Human, Veterinary
CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO
SERVIÇOS: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
OEB (Faixas de Exposição Ocupacional): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
Pharmaron API Commercial Synthesis Coventry (US)
Pharmaron
Síntese comercial de pequenas moléculas de API.
ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
SUBSTÂNCIAS CONTROLADAS: 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
MERCADOS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea), TGA (Australia)
CONFORMIDADE: FDA (cGMP), ISO, ECOVADIS
TAMANHO DO LOTE: Large, Small, Medium
USAR: Human, Veterinary
CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO
SERVIÇOS: Development services, Manufacturing services
OEB (Faixas de Exposição Ocupacional): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
REGIÃO: América do Norte
EVER Pharma Jena GmbH
EVER Neuro Pharma GmbH
CDMO especializada para desenvolvimento e produção de injetáveis de pequenas moléculas.
OEB (Faixas de Exposição Ocupacional): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
SUBSTÂNCIAS CONTROLADAS: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MERCADOS: 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), TGA (Australia), Rest of World
SERVIÇOS: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIÃO: Europa
CONFORMIDADE: ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
TAMANHO DO LOTE: Large, Small, Medium
USAR: Human
BSL (Nível de Segurança Biológica): 1, 2
ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system
CATEGORIA / PRODUTO: FDF / MEDICAMENTOS
Avara Pharmaceutical Services | Arecibo Site
AVARA
Instalação de fabricação de dosagem oral sólida (OSD) em escala comercial com forte experiência em substâncias controladas (DEA II V).
SUBSTÂNCIAS CONTROLADAS: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
CONFORMIDADE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
MERCADOS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), TGA (Australia)
TAMANHO DO LOTE: Large, Medium
USAR: Human
CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO, SERVIÇOS, FDF / MEDICAMENTOS, ENGENHARIA DE PARTÍCULAS
SERVIÇOS: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (C) Cardiovascular system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
REGIÃO: América do Norte
OEB (Faixas de Exposição Ocupacional): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
Avara Pharmaceutical Services | Liscate Site (Italy)
AVARA
Local de fabricação estéril de preenchimento e acabamento de medicamentos injetáveis (frascos, ampolas, liofilizados).
BSL (Nível de Segurança Biológica): 3, 1, 2
SUBSTÂNCIAS CONTROLADAS: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MERCADOS: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea)
REGIÃO: Europa
TAMANHO DO LOTE: Large, Small, Medium
USAR: Human
SERVIÇOS: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (C) Cardiovascular system, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
OEB (Faixas de Exposição Ocupacional): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORIA / PRODUTO: SERVIÇOS, FDF / MEDICAMENTOS
Avara Pharmaceutical Services | Norman Site
AVARA
Instalação de fabricação contratada especializada em Dosagem Oral Sólida (OSD) para fornecimento clínico e comercial.
SUBSTÂNCIAS CONTROLADAS: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
CONFORMIDADE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
MERCADOS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea), TGA (Australia)
TAMANHO DO LOTE: Large, Small, Medium
USAR: Human
CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO, SERVIÇOS, FDF / MEDICAMENTOS, ENGENHARIA DE PARTÍCULAS
SERVIÇOS: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (C) Cardiovascular system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
REGIÃO: América do Norte
OEB (Faixas de Exposição Ocupacional): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
Sidefarma
Sidefarma SA
A CMO especializou-se na fabricação de lotes de pequeno e médio porte para empresas farmacêuticas de todo o mundo em mercados regulamentados.
SUBSTÂNCIAS CONTROLADAS: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MERCADOS: EMA (EU), PMDA (Japan), Health Canada (Canada), DIGEMID (Peru), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), TGA (Australia)
REGIÃO: Europa
CONFORMIDADE: ISO, UAE Ministry of Health & Prevention, EMA (EU GMP)
USAR: Human
SERVIÇOS: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
TAMANHO DO LOTE: Small, Medium
OEB (Faixas de Exposição Ocupacional): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORIA / PRODUTO: FDF / MEDICAMENTOS
CARBOGEN AMCIS | Saint-Beauzire
CARBOGEN AMCIS
Desenvolvimento de formulações personalizadas e fabricação estéril GMP de medicamentos líquidos e liofilizados.
OEB (Faixas de Exposição Ocupacional): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
SUBSTÂNCIAS CONTROLADAS: 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
MERCADOS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World
REGIÃO: Europa
CONFORMIDADE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), French Service-Public (CIR), 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)
TAMANHO DO LOTE: Large, Small, Medium
USAR: Human
SERVIÇOS: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
CATEGORIA / PRODUTO: FDF / MEDICAMENTOS
Aenova Group - Location Marburg, Germany
Aenova
Centro de Competência complexo de sólidos convencionais e entorpecentes.
SUBSTÂNCIAS CONTROLADAS: 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
MERCADOS: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities
REGIÃO: Europa
CONFORMIDADE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP)
TAMANHO DO LOTE: Large, Small, Medium
CATEGORIA / PRODUTO: NUTRACÊUTICOS, FDF / MEDICAMENTOS
USAR: Human
SERVIÇOS: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
OEB (Faixas de Exposição Ocupacional): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
SUBSTÂNCIAS CONTROLADAS: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MERCADOS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK)
REGIÃO: Europa
CONFORMIDADE: FDA (cGMP), ISO, EMA (EU GMP)
TAMANHO DO LOTE: Large, Small, Medium
USAR: Human, Veterinary
SERVIÇOS: Development services, Manufacturing services, Analytical / QC services
ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (N) Nervous system
OEB (Faixas de Exposição Ocupacional): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORIA / PRODUTO: FDF / MEDICAMENTOS
SUBSTÂNCIAS CONTROLADAS: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MERCADOS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)
REGIÃO: Europa
TAMANHO DO LOTE: Large, Small, Medium
USAR: Human
SERVIÇOS: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (A) Digestive tract and metabolism
CONFORMIDADE: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
OEB (Faixas de Exposição Ocupacional): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORIA / PRODUTO: SERVIÇOS, FDF / MEDICAMENTOS
Adragos Pharma | Leipzig
Adragos Pharma
Produtos farmacêuticos não estéreis, semissólidos e líquidos.
SUBSTÂNCIAS CONTROLADAS: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MERCADOS: EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), MFDS (South Korea)
SERVIÇOS: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIÃO: Europa
TAMANHO DO LOTE: Large, Small, Medium
USAR: Human, Veterinary
OEB (Faixas de Exposição Ocupacional): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CONFORMIDADE: EMA (EU GMP)
CATEGORIA / PRODUTO: FDF / MEDICAMENTOS
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