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MÄRKTE: EMA (EU)
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: ISO, EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP)
BATCH-GRÖSSE: Groß, Mittel
VERWENDUNG: Menschlich
BSL (Biologische Sicherheitsstufe): 1, 2
THERAPEUTISCHE FACHGEBIETE (ATC): (J) Antiinfectives for systemic use, (R) Respiratory system, (G) Genito urinary system and sex hormones
KATEGORIE/PRODUKT: BIOLOGIEN, FDF / DRUG PRODUCTS
CZ Vaccines | Investigational and Medicinal Products Plant
CZ Vaccines
Einrichtung für klinische Studien
MÄRKTE: EMA (EU), ANVISA (Brazil), CDSCO (India)
DIENSTLEISTUNGEN: 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), Weltgesundheitsorganisation (GMP / HACCP)
VERWENDUNG: Menschlich
BSL (Biologische Sicherheitsstufe): 1, 2
THERAPEUTISCHE FACHGEBIETE (ATC): (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
BATCH-GRÖSSE: Klein
KATEGORIE/PRODUKT: BIOLOGIEN, FDF / DRUG PRODUCTS
MÄRKTE: EMA (EU)
DIENSTLEISTUNGEN: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: ISO, EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP)
BATCH-GRÖSSE: Groß, Mittel
VERWENDUNG: Menschlich
BSL (Biologische Sicherheitsstufe): 1, 2
THERAPEUTISCHE FACHGEBIETE (ATC): (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
KATEGORIE/PRODUKT: BIOLOGIEN, FDF / DRUG PRODUCTS
CARBOGEN AMCIS | Saint-Beauzire
CARBOGEN AMCIS
Entwicklung kundenspezifischer Formulierungen und sterile GMP-Herstellung von flüssigen und lyophilisierten Arzneimitteln.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
KONTROLLIERTE SUBSTANZEN: 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
MÄRKTE: 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
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), Französischer Dienst - öffentlich (CIR), ANMAT (Argentinien neue GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
THERAPEUTISCHE FACHGEBIETE (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, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
Aenova Group - Location Latina, Italy
Aenova
Kompetenzzentrum Tiergesundheitsprodukte und Steriltechnik.
MÄRKTE: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU-GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich, Veterinär
BSL (Biologische Sicherheitsstufe): 1, 2
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)
REGION: Europe
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (A) Digestive tract and metabolism
COMPLIANCE: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP)
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/Tag), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
KATEGORIE/PRODUKT: SERVICES, FDF / DRUG PRODUCTS
Northway Biotech Vilnius
Northway Biotech
CDMO Global für ganzheitliche biologische Dienstleistungen
BSL (Biologische Sicherheitsstufe): 3, 1, 2
MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, SFDA (Saudi Food & Drug Authority), Französischer Dienst - öffentlich (CIR), EMA (EU-GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
KATEGORIE/PRODUKT: BIOLOGIEN, SERVICES, FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
Adragos Pharma | Maisons-Alfort
Adragos Pharma
Das Unternehmen ist auf vorgefüllte Spritzen, flüssige und lyophilisierte Fläschchen spezialisiert und kombiniert fortschrittliche aseptische Abfüll-, Gefriertr
THERAPEUTISCHE FACHGEBIETE (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
MÄRKTE: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities
REGION: Europe
BATCH-GRÖSSE: Groß
VERWENDUNG: Menschlich
BSL (Biologische Sicherheitsstufe): 1
DIENSTLEISTUNGEN: Manufacturing services, Analytical / QC services, Regulatory services, Packaging
KONTROLLIERTE SUBSTANZEN: 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 (Republik Korea GMP)
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
Northway Biotech Waltham (MA)
Northway Biotech
Globaler End-to-End-CDMO für Biologika
BSL (Biologische Sicherheitsstufe): 3, 1, 2
MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), Französischer Dienst - öffentlich (CIR), EMA (EU-GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
REGION: North America
KATEGORIE/PRODUKT: BIOLOGIEN, SERVICES, FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
Adragos Pharma | Halden
Adragos Pharma
Wir sind auf die Herstellung von Infusionsbeuteln, Kunststoffampullen und Fläschchen mit Blow-Fill-Seal (BFS)-Technologie und anderen Darreichungsformen spezial
KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), TGA (Australia)
DIENSTLEISTUNGEN: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP), NSF
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich
THERAPEUTISCHE FACHGEBIETE (ATC): (D) Dermatologicals, (V06) Nutrients, (A) Digestive tract and metabolism
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
Adragos Pharma | Athens
Adragos Pharma
Spezialisiert auf die Entwicklung von Arzneimitteln mit Mehrwert und wurde kürzlich mit HPAPI-Funktionen aufgerüstet.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP), NSF
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich
KATEGORIE/PRODUKT: SERVICES, FDF / DRUG PRODUCTS
Adragos Pharma | Kawagoe
Adragos Pharma
Unsere Anlage bietet erstklassige Herstellung von Tabletten und Ampullen.
KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)
DIENSTLEISTUNGEN: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: APAC
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), EMA (EU-GMP)
BATCH-GRÖSSE: Groß
VERWENDUNG: Menschlich
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
KATEGORIE/PRODUKT: SERVICES, FDF / DRUG PRODUCTS
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