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Cellex Cell Professionals
Alemanha

Cellex Cell Professionals

Cellex Cell Professionals

Planta de fabricação de células CGT CDMO e centro de coleta de materiais iniciais

MERCADOS: EMA (EU), FDA (USA)

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

REGIÃO: Europa

CONFORMIDADE: FDA (cGMP), EMA (EU GMP)

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human, Veterinary

BSL (Nível de Segurança Biológica): 1, 2

CATEGORIA / PRODUTO: BIOLÓGICA, SERVIÇOS, FDF / MEDICAMENTOS

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

CARBOGEN AMCIS | Shanghai, China
China

CARBOGEN AMCIS | Shanghai, China

CARBOGEN AMCIS

Fabricação em grande escala.

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

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

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

REGIÃO: APAC

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human

CATEGORIA / PRODUTO: OLIGONUCLEOTÍDEOS, QUÍMICO-SINTÉTICO, SERVIÇOS

CONFORMIDADE: ANVISA (Brazil B-GMP), NMPA (China 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)

CARBOGEN AMCIS | Neuland
Suíça

CARBOGEN AMCIS | Neuland

CARBOGEN AMCIS

Desenvolvimento e fabricação em média escala.

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

REGIÃO: Europa

CONFORMIDADE: FDA (cGMP), PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP)

USAR: Human, Veterinary

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO, SERVIÇOS

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

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)

CARBOGEN AMCIS | Manchester, UK
Reino Unido

CARBOGEN AMCIS | Manchester, UK

CARBOGEN AMCIS

Descubra nossos recursos de fabricação de ingredientes cosméticos, química fina e síntese personalizada de intermediários farmacêuticos.

REGIÃO: Europa

CONFORMIDADE: ISO, Halal Research Council, ECOVADIS

TAMANHO DO LOTE: Large, Small, Medium

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO, SERVIÇOS, ENGENHARIA DE PARTÍCULAS

SERVIÇOS: Development services, Manufacturing services, Analytical / QC services

OEB (Faixas de Exposição Ocupacional): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

CARBOGEN AMCIS | Aarau
Suíça

CARBOGEN AMCIS | Aarau

CARBOGEN AMCIS

Desenvolvimento e fabricação de cGMP em média escala, incluindo cromatografia.

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), World Health Organization (GMP / HACCP)

USAR: Human, Veterinary

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO, BIOLÓGICA, SERVIÇOS, ENGENHARIA DE PARTÍCULAS

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

TAMANHO DO LOTE: Small, Medium

OEB (Faixas de Exposição Ocupacional): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

CARBOGEN AMCIS | Bubendorf
Suíça

CARBOGEN AMCIS | Bubendorf

CARBOGEN AMCIS

Desenvolvimento e fabricação de cGMP de API altamente potente, incluindo conjugados de anticorpos e drogas (ADC).

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), MFDS (South Korea), Turkish Health Authorities, 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, BIOLÓGICA, SERVIÇOS, ENGENHARIA DE PARTÍCULAS

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

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

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

Apeloa Pharmaceutical Co., Ltd.
China

Apeloa Pharmaceutical Co., Ltd.

Apeloa Pharmaceutical Co., Ltd

Apeloa CDMO fornece serviços de descoberta, desenvolvimento e fabricação de classe mundial para APIs, intermediários e RSMs.

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)

REGIÃO: APAC

CONFORMIDADE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ECOVADIS, NMPA (China GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human, Veterinary

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO

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

Green Phoenix Labs GmbH
Alemanha

Green Phoenix Labs GmbH

Green Phoenix Labs GmbH

Empresa de terapia celular com excesso de capacidade de sala limpa.

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (R) Respiratory system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system

SUBSTÂNCIAS CONTROLADAS: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

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)

CONFORMIDADE: EMA (EU GMP)

CATEGORIA / PRODUTO: BIOLÓGICA, SERVIÇOS, FDF / MEDICAMENTOS

MERCADOS: EMA (EU)

SERVIÇOS: Logistics, Development services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging

REGIÃO: Europa

USAR: Human

BSL (Nível de Segurança Biológica): 1

Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site
China

Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site

Seacross Pharmaceutical Co Ltd

Como um dos três locais principais, juntamente com o centro de P&D e a fábrica de formulação, nossa unidade de fabricação de API desempenha um papel vital na ca

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), 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: APAC

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

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human

BSL (Nível de Segurança Biológica): 1, 2, 3, 4

CATEGORIA / PRODUTO: QUÍMICO-SINTÉTICO

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, (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, (V04) Diagnostic agents

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), 5 / HPAPI (PDE < 10 µg/day)

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
China

Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site

Seacross Pharmaceutical Co Ltd

O Centro de P&D desempenha um papel fundamental no apoio ao desenvolvimento tanto de APIs quanto de formas farmacêuticas acabadas.

CONFORMIDADE: MFDS/KFDA (Republic of Korea GMP), SQF (Safe Quality Food), NSF, 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)

CATEGORIA / PRODUTO: FDF / MEDICAMENTOS, QUÍMICO-SINTÉTICO

OEB (Faixas de Exposição Ocupacional): 1 / low-hazard (PDE > 10,000 µg/day), 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)

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

BSL (Nível de Segurança Biológica): 3, 4, 1, 2

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), 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: APAC

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human

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