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HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes
HISTOCELL
Histocell ist ein spanisches CDMO, das Zelltherapien, Sekretome und Exosomen sowie medizinische Geräte entwickelt und herstellt.
THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism
MÄRKTE: MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), CDSCO (India), TGA (Australia), EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities
BATCH-GRÖSSE: Klein, Mittel
COMPLIANCE: EMA (EU-GMP), ISO
KATEGORIE/PRODUKT: BIOLOGIEN, SERVICES, FDF / DRUG PRODUCTS, KOSMETIK
REGION: Europe
VERWENDUNG: Menschlich, Veterinär
BSL (Biologische Sicherheitsstufe): 1, 2
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services
Hikal Ltd | Bangalore, India
Hikal Ltd.
cGMP-Prozessentwicklung, Scale-up und Herstellung kleiner Molekül-APIs, NMEs und Zwischenprodukte von Gramm bis Tonnen.
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)
MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), 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
REGION: APAC
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), COFEPRIS, Halal-Forschungsrat, ECOVADIS, TGA (Australia GMP), EMA (EU-GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
KATEGORIE/PRODUKT: KOSMETIK, NUTRAZEUTIKA, CHEMICAL-SYNTHETIC, SERVICES
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Development services, Manufacturing services
THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (V06) Nutrients
HIPRA BIOTECH SERVICES | Aiguaviva
HIPRA Biotech Services
Interne End-to-End-Fähigkeiten von der Zelllinienentwicklung bis zur kommerziellen Fertigung.
MÄRKTE: 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)
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentinien neue GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich
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: BIOLOGIEN
MÄRKTE: 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)
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
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), Französischer Dienst - öffentlich (CIR), NMPA (China GMP), 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
THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
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
Cellex Cell Professionals
Cellex Cell Professionals
CGT CDMO Zellfertigungsanlage und Sammelzentrum für Ausgangsmaterialien
MÄRKTE: EMA (EU), FDA (USA)
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), EMA (EU-GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich, Veterinär
BSL (Biologische Sicherheitsstufe): 1, 2
KATEGORIE/PRODUKT: BIOLOGIEN, SERVICES, FDF / DRUG PRODUCTS
CARBOGEN AMCIS | Vionnaz
CARBOGEN AMCIS
Entwicklung hochwirksamer APIs und cGMP-Produktion im kleinen Maßstab, einschließlich Chromatographie und Lyophilisierung.
MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP)
VERWENDUNG: Menschlich, Veterinär
KATEGORIE/PRODUKT: CHEMICAL-SYNTHETIC
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services
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)
BATCH-GRÖSSE: Klein
CARBOGEN AMCIS | Veenendaal
CARBOGEN AMCIS
Großserienfertigung von Cholesterin- und Vitamin-D-Analoga.
THERAPEUTISCHE FACHGEBIETE (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
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)
MÄRKTE: 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
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal-Forschungsrat, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), Französischer Dienst - öffentlich (CIR), NMPA (China GMP), ANMAT (Argentinien neue GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP), SQF (Sichere Lebensmittelqualität), NSF
VERWENDUNG: Menschlich, Veterinär
BSL (Biologische Sicherheitsstufe): 1
KATEGORIE/PRODUKT: CHEMICAL-SYNTHETIC, SERVICES
BATCH-GRÖSSE: Klein
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, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism
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
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: APAC
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich
KATEGORIE/PRODUKT: OLIGONUKLEOTIDE, CHEMICAL-SYNTHETIC, SERVICES
COMPLIANCE: ANVISA (Brazil B-GMP), NMPA (China 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)
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
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