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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.
Markets: ISP (Chile), MSPAS (Guatemala), FDA (USA), COFEPRIS (Mexico), DIGEMID (Peru), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), Russian Health Authorities, SFDA (Saudi Arabia), ANMAT (Argentina), CDSCO (India), MFDS (South Korea), INVIMA (Colombia), Turkish Health Authorities, EDE (UAE), TGA (Australia), Resto do mundo
Batch Size: Large, Small, Medium
Compliance: FDA (cGMP), DIGEMID, BRCGS, ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, INVIMA, TGA (Australia GMP), TITCK (Turkish Health Authorities), ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), World Health Organization (GMP / HACCP), EMA (EU GMP), NMPA (China GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Use: Human
BSL (Biological Safety Level): 1, 2, 3, 4
Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (N) Nervous system, (S) Sensory organs, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (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: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC
Region: APAC
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.
Markets: Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), TGA (Australia), Resto do mundo
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), INVIMA, ECOVADIS, ISP (Chile BPM), French Service-Public (CIR), World Health Organization (GMP / HACCP), NMPA (China GMP), Health Canada (Canada GMP), MHRA (UK GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), NSF, SQF (Safe Quality Food), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority)
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (V04) Diagnostic agents, (B) Blood and blood forming organs, (D) Dermatologicals, (J) Antiinfectives for systemic use, (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: FDF / DRUG PRODUCTS, CRO ANALÍTICO
Region: APAC
Itália
Aenova Group - Location Latina, Italy
Aenova
Centro de Competência em produtos de saúde animal e tecnologias estéreis.
Markets: ANVISA (Brazil), FDA (USA), EMA (EU), Russian Health Authorities, Turkish Health Authorities, SFDA (Saudi Arabia)
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2
Compliance: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (EU GMP), SFDA (Saudi Food & Drug Authority)
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
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
Batch Size: Large, Small, Medium
Use: Human
Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities, SFDA (Saudi Arabia), TGA (Australia)
Services: Development services, Analytical / QC services, Packaging, Manufacturing services, Quality Assurance services
Compliance: ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), PMDA/MHLW (Japan GMP), TITCK (Turkish Health Authorities), TGA (Australia GMP), Health Canada (Canada GMP), MHRA (UK GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), SFDA (Saudi Food & Drug Authority)
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse, High potential for abuse & medical use
Therapeutic Areas of Expertise (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism
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, CRO ANALÍTICO
Region: Europe
Estados Unidos
Lifecore Injectables CDMO
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
Alemanha
EVER Pharma Jena GmbH
EVER Neuro Pharma GmbH
CDMO especializada para desenvolvimento e produção de injetáveis de pequenas moléculas.
OEB (Occupational Exposure Banding): 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), 1 / low-hazard (PDE > 5,000 µg/day)
Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, 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: Europe
Compliance: 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)
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1, 2
Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system
Category / Product: FDF / DRUG PRODUCTS
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 (Occupational Exposure Banding): 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), 1 / low-hazard (PDE > 5,000 µg/day)
BSL (Biological Safety Level): 3, 4, 1, 2
Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), TGA (Australia)
Region: Europe
Compliance: 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)
Batch Size: Large, Small, Medium
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (G) Genito urinary system and sex hormones
Category / Product: FDF / DRUG PRODUCTS
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FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Acabamento de preenchimento estéril de fase inicial
Localização disponível após o registo
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COSMETICS manufacturing site
MAI network supplier
Soluções CDMO completas para intermediários APl e Key.
Localização disponível após o registo
Visualização limitada
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Desenvolvimento e fabricação de medicamentos para dose sólida oral (OSD), nasal, para inalação e pós secos estéreis e líquidos.
Localização disponível após o registo
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