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)
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)
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
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
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)
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
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
Aenova Group - Location Killorglin, Ireland
Aenova
Centro di competenza per l'essiccazione a spruzzo e pellet a rilascio modificato.
MERCATI: EMA (EU), PMDA (Japan), SFDA (Saudi Arabia), MFDS (South Korea)
REGIONE: Europe
COMPLIANCE: ISO, PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), EMA (GMP UE), MFDS/KFDA (Repubblica di Corea GMP)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
CATEGORIA / PRODOTTO: NUTRACEUTICI, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
USO: Umano, Veterinario
SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance 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)
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
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)
Aenova Group - Location Cornu, Romania
Aenova
Centro di competenza e sportello unico per capsule di gelatina morbida e VegaGel®.
REGIONE: Europe
MERCATI: FDA (USA), Health Canada (Canada), TGA (Australia)
COMPLIANCE: FDA (cGMP), ISO, Consiglio di ricerca halal, TGA (Australia GMP), EMA (GMP UE), Health Canada (Canada 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, 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)
Aenova Group - Location Bad Aibling, Germany
Aenova
Centro di Competenza Confezionamento in blister Confezionamento conto terzi Impianto ad alto volume per effervescenti.
MERCATI: EMA (EU), FDA (USA)
SERVIZI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
REGIONE: Europe
COMPLIANCE: FDA (cGMP), ISO, IFS, EMA (GMP UE)
DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio
CATEGORIA / PRODOTTO: COSMETICI, NUTRACEUTICI, FDF / DRUG PRODUCTS
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)
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