
Cenexi
موقع Hérouville-Saint-Clair، الواقع بالقرب من كاين، في نورماندي، متخصص في تصنيع وتعبئة السوائل المعقمة القابلة للحقن وغير القابلة للحقن.
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)
Compliance: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
BSL (Biological Safety Level): 1, 2
Use: Human
Batch Size: Large, Medium
Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use, (R) Respiratory system, (G) Genito urinary system and sex hormones
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Region: Europe

HIPRA Biotech Services
القدرات الداخلية الشاملة بدءًا من تطوير خط الخلايا وحتى التصنيع التجاري.
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)
Compliance: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
BSL (Biological Safety Level): 1, 2
Use: Human, Veterinary
Batch Size: Large, Small, Medium
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, BIOLOGICS
Region: Europe

LABORATORIO REIG JOFRE SA
مرافق التصنيع القابلة للحقن (الليو والسائل) والسائلة.
BSL (Biological Safety Level): 3, 1, 2
Markets: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)
Region: Europe
Batch Size: Large, Medium
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism
Controlled Substances: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Compliance: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ECOVADIS, INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
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)
Markets: EMA (EU), FDA (USA)
Region: Europe
Batch Size: Large, Small, Medium
Use: Human
Services: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
Therapeutic Areas of Expertise (ATC): (L) Antineoplastic and immunomodulating agents
Compliance: EMA (EU GMP)
Category / Product: FDF / DRUG PRODUCTS

EVER Neuro Pharma GmbH
CDMO متخصص لتطوير وإنتاج الجزيئات الصغيرة القابلة للحقن.
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), بقية العالم
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

Markets: EMA (EU), ANVISA (Brazil), CDSCO (India)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: ISO, ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)
Use: Human
BSL (Biological Safety Level): 1, 2
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
Batch Size: Small
Category / Product: BIOLOGICS, FDF / DRUG PRODUCTS

Markets: EMA (EU)
Services: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
Batch Size: Large, Medium
Use: Human
BSL (Biological Safety Level): 1, 2
Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
Category / Product: BIOLOGICS, FDF / DRUG PRODUCTS

Adragos Pharma
وهي متخصصة في المحاقن المعبأة مسبقًا، والقوارير السائلة والمجففة بالتجميد، وهي تجمع بين أنظمة التعبئة المعقمة المتقدمة، والتجفيف بالتجميد، والفحص.
Therapeutic Areas of Expertise (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, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (A) Digestive tract and metabolism
Markets: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities
Region: Europe
Batch Size: Large
Use: Human
BSL (Biological Safety Level): 1
Services: Manufacturing services, Analytical / QC services, Regulatory services, Packaging
Controlled Substances: Lowest potential for abuse
Compliance: ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
Category / Product: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)

Cenexi
يقع هذا المصنع الذي تبلغ مساحته 8000 متر مربع، والمباني المنتشرة حول موقع تبلغ مساحته حوالي سبعة هكتارات، على بعد 20 كيلومترًا جنوب بروكسل ويعمل به 340 موظفًا*.
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
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
BSL (Biological Safety Level): 3, 4
Controlled Substances: High potential for abuse & medical use
Compliance: ICH, ISO, ANVISA (Brazil B-GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (China GMP), EMA (EU GMP)
Markets: EMA (EU), NMPA (China), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Batch Size: Large, Small, Medium
Use: Human
Therapeutic Areas of Expertise (ATC): (L) Antineoplastic and immunomodulating agents
Category / Product: FDF / DRUG PRODUCTS
MAI network supplier
المرحلة المبكرة من التعبئة المعقمة
الموقع متاح بعد التسجيل
سجل لفتح الكتالوج الكامل مع تفاصيل الاتصال والمواقع.
+26 المزيد من المرافق
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