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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

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

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

Seacross Pharmaceutical Co Ltd

O Centro de Fabricação de Formulações é dedicado ao desenvolvimento e produção de formas farmacêuticas complexas e de alto valor.

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

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)

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

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

CATEGORIA / PRODUTO: SERVIÇOS, FDF / MEDICAMENTOS

PHARMALOOP S.L. - a Salvat Company
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.

MERCADOS: EMA (EU), FDA (USA)

REGIÃO: Europa

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

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human

BSL (Nível de Segurança Biológica): 1

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

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (S) Sensory organs, (V01) Allergens

CATEGORIA / PRODUTO: FDF / MEDICAMENTOS, ENGENHARIA DE PARTÍCULAS

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

Ophtapharm, a Sentiss Company
Suíça

Ophtapharm, a Sentiss Company

Ophtapharm, a Sentiss Company

Oftalmológica e Ótica - Soluções, suspensões, emulsões, pomadas e géis - Instalação aprovada pela FDA.

MERCADOS: EMA (EU), FDA (USA)

REGIÃO: Europa

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

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human, Veterinary

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

CATEGORIA / PRODUTO: FDF / MEDICAMENTOS

Cenexi SAS
França

Cenexi SAS

Cenexi

Acesse Sites Osny. Adquirida em 2011, a unidade de Osny é especializada no desenvolvimento e produção de formas farmacêuticas sólidas altamente ativas.

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), ANVISA (Brazil), MHRA (UK), MFDS (South Korea)

REGIÃO: Europa

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

USAR: Human

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

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (G) Genito urinary system and sex hormones

TAMANHO DO LOTE: Small, Medium

CATEGORIA / PRODUTO: FDF / MEDICAMENTOS

Cenexi
França

Cenexi

Cenexi

A fábrica da GMP em um terreno de quatro hectares está localizada 9 km a leste de Paris. É um centro de excelência em ampolas injetáveis.

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), EDE (UAE), TGA (Australia)

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

REGIÃO: Europa

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

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human, Veterinary

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (A) Digestive tract and metabolism

CATEGORIA / PRODUTO: FDF / MEDICAMENTOS

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

Cenexi Hérouville Saint Clair
França

Cenexi Hérouville Saint Clair

Cenexi

A unidade de Hérouville-Saint-Clair, situada perto de Caen, na Normandia, é especializada no fabrico e envase de líquidos estéreis injetáveis ​​e não injetáveis

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), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea), TGA (Australia)

REGIÃO: Europa

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

USAR: Human

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

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (N) Nervous system, (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

CATEGORIA / PRODUTO: FDF / MEDICAMENTOS

Cenexi Laboratoires Thissen
Bélgica

Cenexi Laboratoires Thissen

Cenexi

Esta fábrica de 8.000 m2, com edifícios espalhados por um terreno de quase sete hectares, está localizada 20 km ao sul de Bruxelas e emprega 340 funcionários*.

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)

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, 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), ANVISA (Brazil B-GMP), TGA (Australia GMP), NMPA (China 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, Veterinary

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

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones

CATEGORIA / PRODUTO: FDF / MEDICAMENTOS

Korott - EVP Iberia
Espanha

Korott - EVP Iberia

Korott - EVP Iberia

Somos especialistas no desenvolvimento e fabricação de suplementos alimentares: cápsulas, sticks, doypacks, pós e frascos.

MERCADOS: EMA (EU), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), ANMAT (Argentina), INVIMA (Colombia)

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

REGIÃO: Europa

CONFORMIDADE: BRCGS, ISO, IFS, World Health Organization (GMP / HACCP)

TAMANHO DO LOTE: Large, Small, Medium

CATEGORIA / PRODUTO: COSMÉTICOS, NUTRACÊUTICOS

USAR: Human

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (V06) Nutrients

STE PRASFARMA
Espanha

STE PRASFARMA

STE PRASFARMA

Citostáticos CMO/CDMO e produtos de alta potência.

OEB (Faixas de Exposição Ocupacional): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)

BSL (Nível de Segurança Biológica): 3, 4

SUBSTÂNCIAS CONTROLADAS: High potential for abuse & medical use

CONFORMIDADE: ICH, ISO, ANVISA (Brazil B-GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (China GMP), EMA (EU GMP)

MERCADOS: EMA (EU), NMPA (China), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities

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

REGIÃO: Europa

TAMANHO DO LOTE: Large, Small, Medium

USAR: Human

ÁREAS DE EXPERIÊNCIA TERAPÊUTICA (ATC): (L) Antineoplastic and immunomodulating agents

CATEGORIA / PRODUTO: FDF / MEDICAMENTOS

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