
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.
Compliance: 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)
Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC
OEB (Occupational Exposure Banding): 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), 3 (PDE = 100 - 1,000 µg/day)
Therapeutic Areas of Expertise (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 (Biological Safety Level): 3, 4, 1, 2
Controlled Substances: 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
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), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Resto do mundo
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: APAC
Batch Size: Large, Small, Medium
Use: Human

Laboratorios Salvat
Soluções CDMO totalmente integradas para Blow-Fill-Seal (BFS), multidose estéril, multidose não estéril, sachês, cápsulas e comprimidos.
Markets: EMA (EU), FDA (USA)
Region: Europe
Compliance: FDA (cGMP), ISO, EMA (EU GMP)
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (S) Sensory organs, (V01) Allergens
Category / Product: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
MAI network supplier
Tubilux Pharma: sede social; instalação de fabricação.
Localização disponível após o registo
MAI network supplier
Desenvolvedor e fabricante de novos medicamentos com tecnologias de liberação de controle.
Localização disponível após o registo
MAI network supplier
A CDMO israelense especializou-se no desenvolvimento e fabricação de GMP de medicamentos sintéticos complexos e dispositivos médicos baseados em produtos químic
Localização disponível após o registo
Estas instalações correspondem aos seus critérios principais, mas nem todos os filtros opcionais.

Lifecore Biomedical
CDMO que fabrica medicamentos injetáveis estéreis clínicos e comerciais.
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2, 3
Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), ECOVADIS, EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia), Resto do mundo
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Controlled Substances: Lowest potential for abuse
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
Region: North America

Hbm Pharma
CMO com certificação EU-GMP com sede em Martin, Eslováquia. A empresa fornece serviços de fabricação e embalagem para produtos farmacêuticos estéreis. produtos e formas farmacêuticas orais sólidas
Markets: EMA (EU), NMPA (China), Health Canada (Canada), ANVISA (Brazil), COFEPRIS (Mexico), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, TGA (Australia)
Compliance: ISO, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), ANVISA (Brazil)
Use: Human
Batch Size: Large, Small, Medium
Services: Analytical / QC services, Packaging, Quality Assurance services, Manufacturing services
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)
Controlled Substances: High potential for abuse & medical use
Category / Product: FDF / DRUG PRODUCTS, SERVICES
Region: Europe

Aenova
Centro de Competência em produtos de saúde animal e tecnologias estéreis.
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2
Markets: FDA (USA), EMA (EU), ANVISA (Brazil), Russian Health Authorities, Turkish Health Authorities, SFDA (Saudi Arabia)
Services: Development services, Logistics, Analytical / QC services, Regulatory services, Packaging, Manufacturing services, Quality Assurance services
Compliance: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (EU GMP), SFDA (Saudi Food & Drug Authority)
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

Seacross Pharmaceutical Co Ltd
O Centro de Fabricação de Formulações é dedicado ao desenvolvimento e produção de formas farmacêuticas complexas e de alto valor.
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1, 2, 3, 4
Compliance: ISO, FDA (cGMP), DIGEMID, BRCGS, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), World Health Organization (GMP / HACCP), EMA (EU GMP), NMPA (China GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food)
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia), Resto do mundo
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (D) Dermatologicals, (J) Antiinfectives for systemic use, (B) Blood and blood forming organs, (N) Nervous system, (S) Sensory organs, (V06) Nutrients, (V01) Allergens, (R) Respiratory system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (H) Systemic hormonal preparations excl. sex hormones and insulins, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use
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)
Category / Product: SERVICES, FDF / DRUG PRODUCTS
Region: APAC

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
Use: Human
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), NMPA (China GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), ANVISA (Brazil), MHRA (UK), Russian Health Authorities, MFDS (South Korea), TGA (Australia)
Services: Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (C) Cardiovascular system, (A) Digestive tract and metabolism
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, High potential for abuse & medical use
Batch Size: Small, Medium
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
Region: Europe

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), MFDS (South Korea), EDE (UAE), TGA (Australia)
Compliance: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), 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)
Use: Human
Batch Size: Large, Small, Medium
Therapeutic Areas of Expertise (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (D) Dermatologicals, (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Category / Product: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
Region: Europe

JAFRAL
Instalação integrada de biotecnologia que fornece P&D, fabricação não-GMP e GMP, testes de controle de qualidade e serviços de preenchimento e acabamento para produtos biológicos avançados.
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Compliance: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP), SQF (Safe Quality Food)
Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)
BSL (Biological Safety Level): 1, 2
Category / Product: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Use: Human, Veterinary
Batch Size: Large, Small, Medium
Controlled Substances: Lowest potential for abuse
Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use, (D) Dermatologicals, (V06) Nutrients, (R) Respiratory system, (A) Digestive tract and metabolism
Region: Europe
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