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Svizzera
CARBOGEN AMCIS | Aarau
CARBOGEN AMCIS
Sviluppo e produzione cGMP su media scala inclusa la cromatografia.
MERCATI: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), Organizzazione Mondiale della Sanità (GMP / HACCP)
USO: Umano, Veterinario
CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC, BIOLOGIA, SERVICES, PARTICLE ENGINEERING
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services
DIMENSIONE DEL LOTTO: Piccolo, Medio
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
Svizzera
CARBOGEN AMCIS | Bubendorf
CARBOGEN AMCIS
Sviluppo e produzione cGMP di API altamente potenti, inclusi coniugati di farmaci anticorpali (ADC).
MERCATI: 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), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)
USO: Umano, Veterinario
CATEGORIA / PRODOTTO: CHEMICAL-SYNTHETIC, BIOLOGIA, SERVICES, PARTICLE ENGINEERING
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
DIMENSIONE DEL LOTTO: Piccolo, Medio
Spagna
AMSbiopharma
AMSbiopharma
Forniamo servizi analitici per supportare le industrie farmaceutiche, biofarmaceutiche e chimiche in ogni fase dello sviluppo dei farmaci.
COMPLIANCE: ICH, ISO, Organizzazione Mondiale della Sanità (GMP / HACCP)
MERCATI: EMA (EU)
REGIONE: Europe
USO: Umano, Veterinario
SERVIZI: Development services, Analytical / QC services
CATEGORIA / PRODOTTO: SERVICES
Germania
Aenova Group - Location Tittmoning, Germany
Aenova
Centro di competenza Impianto per solidi convenzionali ad alto volume.
MERCATI: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, TGA (Australia)
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (GMP UE), Health Canada (Canada GMP)
DIMENSIONE DEL LOTTO: Grande, Medio
CATEGORIA / PRODOTTO: NUTRACEUTICI, FDF / DRUG PRODUCTS
USO: Umano, Veterinario
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
Svizzera
Aenova Group - Location Sisseln, Switzerland
Aenova
Centro di competenza solidi convenzionali complessi.
REGIONE: Europe
MERCATI: FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), Organizzazione Mondiale della Sanità (GMP / HACCP), MFDS/KFDA (Repubblica di Corea GMP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
CATEGORIA / PRODOTTO: NUTRACEUTICI, FDF / DRUG PRODUCTS
USO: Umano
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
Germania
Aenova Group - Location Regensburg, Germany
Aenova
Centro di competenza solidi ad alta potenza (oncologia) solidi convenzionali - semisolidi e liquidi speciali.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
MERCATI: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities
REGIONE: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (GMP UE), MFDS/KFDA (Repubblica di Corea GMP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
CATEGORIA / PRODOTTO: COSMETICI, NUTRACEUTICI, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
USO: Umano, Veterinario
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Germania
Aenova Group - Location Münster, Germany
Aenova
Competence Center solidi potenti a basso dosaggio (ormoni, simili agli ormoni), capsule a basso dosaggio.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
MERCATI: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (GMP UE), MFDS/KFDA (Repubblica di Corea GMP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
AREE TERAPEUTICHE DI COMPETENZA (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
Germania
Aenova Group - Location Marburg, Germany
Aenova
Centro di competenza solidi convenzionali complessi e narcotici.
SOSTANZE CONTROLLATE: 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
MERCATI: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (GMP UE)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
CATEGORIA / PRODOTTO: NUTRACEUTICI, FDF / DRUG PRODUCTS
USO: Umano
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
Italia
Aenova Group - Location Latina, Italy
Aenova
Centro di Competenza prodotti per la sanità animale e tecnologie sterili.
MERCATI: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (GMP UE)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
BSL (Livello di sicurezza biologica): 1, 2
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
Svizzera
Aenova Group - Location Kirchberg, Switzerland
Aenova
Centro di competenza Capsule di gelatina morbida.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
MERCATI: EMA (EU), FDA (USA), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP), MFDS/KFDA (Repubblica di Corea GMP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
CATEGORIA / PRODOTTO: COSMETICI, NUTRACEUTICI, FDF / DRUG PRODUCTS
USO: Umano, Veterinario
AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V06) Nutrients, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
Germania
Aenova Group - Location Gronau, Germany
Aenova
Centro di competenza per solidi convenzionali e servizi clinici.
MERCATI: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, EDE (UAE)
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGIONE: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), UAE Ministry of Health & Prevention, EMA (GMP UE)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
USO: Umano, Veterinario
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)
CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS
Germania
Aenova Group - Location Feldkirchen, Germany
Aenova
Centro di Competenza Semisolidi e Liquidi.
MERCATI: EMA (EU), FDA (USA), Russian Health Authorities
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), EMA (GMP UE)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
CATEGORIA / PRODOTTO: COSMETICI, FDF / DRUG PRODUCTS
USO: Umano, Veterinario
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
AREE TERAPEUTICHE DI COMPETENZA (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)