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White Raven - Legiapark
Bélgica

White Raven - Legiapark

White Raven

Site de preenchimento e acabamento dedicado à formulação GMP e ao envase asséptico de injetáveis ​​líquidos estéreis.

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)

MERCADOS: EMA (EU)

REGIÃO: Europa

USAR: Human

BSL (Nível de Segurança Biológica): 1, 2

SERVIÇOS: Manufacturing services, Packaging

TAMANHO DO LOTE: Small, Medium

CONFORMIDADE: EMA (EU GMP)

CATEGORIA / PRODUTO: BIOLÓGICA, FDF / MEDICAMENTOS

Sylentis
Espanha

Sylentis

Sylentis

Fabricante de oligonucleotídeos.

CONFORMIDADE: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)

MERCADOS: EMA (EU), FDA (USA)

REGIÃO: Europa

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human, Veterinary

CATEGORIA / PRODUTO: OLIGONUCLEOTÍDEOS

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 Shaoxing (China)
China

Pharmaron API Commercial Synthesis Shaoxing (China)

Pharmaron

Síntese comercial de pequenas moléculas/peptídeos 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, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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)

MERCADOS: NMPA (China), FDA (USA)

REGIÃO: APAC

CONFORMIDADE: FDA (cGMP), ISO, NMPA (China 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

Pharmaron API Commercial Synthesis Cramlington (UK)
Reino Unido

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)
Estados Unidos

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

BAG Health Care
Alemanha

BAG Health Care

BAG Health Care GmbH

Fornecedor de F&F parenteral para frascos em lotes pequenos e médios.

MERCADOS: EMA (EU), MHRA (UK), TGA (Australia)

REGIÃO: Europa

USAR: Human, Veterinary

BSL (Nível de Segurança Biológica): 1

SERVIÇOS: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

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)

TAMANHO DO LOTE: Small, Medium

CONFORMIDADE: EMA (EU GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

CATEGORIA / PRODUTO: FDF / MEDICAMENTOS

Lifecore Injectables CDMO
Estados Unidos

Lifecore Injectables CDMO

Lifecore Biomedical

CDMO que fabrica medicamentos injetáveis ​​estéreis clínicos e comerciais.

BSL (Nível de Segurança Biológica): 3, 1, 2

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

CONFORMIDADE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human, Veterinary

SUBSTÂNCIAS CONTROLADAS: Lowest potential for abuse

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

CATEGORIA / PRODUTO: FDF / MEDICAMENTOS

EVER Pharma Jena GmbH
Alemanha

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

Indena Settala
Itália

Indena Settala

Indena

Instalação em conformidade com GMP e inspecionada pela FDA, especializada em APIs complexos e compostos de alta potência até OEB 6.

MERCADOS: TGA (Australia), Rest of World, 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)

TAMANHO DO LOTE: Small, Medium, Large

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), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)

CONFORMIDADE: NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP)

SERVIÇOS: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGIÃO: Europa

USAR: Human, Veterinary

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO

Hikal Ltd | Bangalore, India
Índia

Hikal Ltd | Bangalore, India

Hikal Ltd.

Desenvolvimento de processos cGMP, aumento de escala e fabricação de APIs de pequenas moléculas, NMEs e intermediários de gramas a toneladas.

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)

MERCADOS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), 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

REGIÃO: APAC

CONFORMIDADE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), COFEPRIS, Halal Research Council, ECOVADIS, TGA (Australia GMP), EMA (EU GMP)

TAMANHO DO LOTE: Large, Small, Medium

CATEGORIA / PRODUTO: COSMÉTICOS, NUTRACÊUTICOS, QUÍMICO-SINTÉTICO, SERVIÇOS

USAR: Human, Veterinary

SERVIÇOS: Development services, Manufacturing services

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (V06) Nutrients

CARBOGEN AMCIS | Vionnaz
Suíça

CARBOGEN AMCIS | Vionnaz

CARBOGEN AMCIS

Desenvolvimento de APIs altamente potentes e produção de cGMP em pequena escala, incluindo cromatografia e liofilização.

MERCADOS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)

REGIÃO: Europa

CONFORMIDADE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

USAR: Human, Veterinary

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO

SERVIÇOS: Development services, Manufacturing services, Analytical / QC services, Quality Assurance 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)

TAMANHO DO LOTE: Small

CARBOGEN AMCIS | Veenendaal
Países Baixos

CARBOGEN AMCIS | Veenendaal

CARBOGEN AMCIS

Fabricação em larga escala de análogos de colesterol e vitamina D.

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, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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)

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: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), 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), SQF (Safe Quality Food), NSF

USAR: Human, Veterinary

BSL (Nível de Segurança Biológica): 1

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO, SERVIÇOS

TAMANHO DO LOTE: Small

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