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Schweiz
Aenova Group - Location Sisseln, Switzerland
Aenova
Kompetenzzentrum komplexe konventionelle Feststoffe.
REGION: Europe
MÄRKTE: FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), Weltgesundheitsorganisation (GMP / HACCP), MFDS/KFDA (Republik Korea GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
KATEGORIE/PRODUKT: NUTRAZEUTIKA, FDF / DRUG PRODUCTS
VERWENDUNG: Menschlich
DIENSTLEISTUNGEN: 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/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
Deutschland
Aenova Group - Location Regensburg, Germany
Aenova
Kompetenzzentrum hochwirksame Feststoffe (Onkologie), konventionelle Feststoffe – spezielle Halbfeststoffe und Flüssigkeiten.
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), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities
REGION: 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 (EU-GMP), MFDS/KFDA (Republik Korea GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
KATEGORIE/PRODUKT: KOSMETIK, NUTRAZEUTIKA, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Deutschland
Aenova Group - Location Münster, Germany
Aenova
Kompetenzzentrum niedrig dosierte hochwirksame Feststoffe (Hormone, hormonähnlich), niedrig dosierte Kapseln.
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), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
REGION: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (EU-GMP), MFDS/KFDA (Republik Korea GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
THERAPEUTISCHE FACHGEBIETE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
Deutschland
Aenova Group - Location Marburg, Germany
Aenova
Kompetenzzentrum Komplex konventionelle Feststoffe und Betäubungsmittel.
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), FDA (USA), ANVISA (Brazil), Russian Health Authorities
REGION: Europe
COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU-GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
KATEGORIE/PRODUKT: NUTRAZEUTIKA, FDF / DRUG PRODUCTS
VERWENDUNG: Menschlich
DIENSTLEISTUNGEN: 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/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
Italien
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
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), FDA (USA), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP), MFDS/KFDA (Republik Korea GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
KATEGORIE/PRODUKT: KOSMETIK, NUTRAZEUTIKA, FDF / DRUG PRODUCTS
VERWENDUNG: Menschlich, Veterinär
THERAPEUTISCHE FACHGEBIETE (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
Irland
Aenova Group - Location Killorglin, Ireland
Aenova
Kompetenzzentrum für Sprühtrocknung und Pellets mit modifizierter Freisetzung.
MÄRKTE: EMA (EU), PMDA (Japan), SFDA (Saudi Arabia), MFDS (South Korea)
REGION: Europe
COMPLIANCE: ISO, PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), EMA (EU-GMP), MFDS/KFDA (Republik Korea GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
KATEGORIE/PRODUKT: NUTRAZEUTIKA, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: 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/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
Deutschland
Aenova Group - Location Gronau, Germany
Aenova
Kompetenzzentrum für konventionelle Feststoffe und klinische Dienstleistungen.
MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, EDE (UAE)
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), UAE Ministry of Health & Prevention, EMA (EU-GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich, Veterinär
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
Vereinigte Staaten
Aenova Group - Location Greensboro, USA
Aenova
Kompetenzzentrum Verpackung Feststoffe.
DIENSTLEISTUNGEN: Logistics, Manufacturing services, Packaging
MÄRKTE: FDA (USA), Health Canada (Canada)
COMPLIANCE: FDA (cGMP), Halal-Forschungsrat, Gesundheit Kanada (Kanada GMP), NSF
BATCH-GRÖSSE: Groß, Klein, Mittel
KATEGORIE/PRODUKT: NUTRAZEUTIKA
VERWENDUNG: Menschlich
REGION: North America
Deutschland
Aenova Group - Location Feldkirchen, Germany
Aenova
Kompetenzzentrum Halbfeste und Flüssigkeiten.
MÄRKTE: EMA (EU), FDA (USA), Russian Health Authorities
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), EMA (EU-GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
KATEGORIE/PRODUKT: KOSMETIK, FDF / DRUG PRODUCTS
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
THERAPEUTISCHE FACHGEBIETE (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system
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)
Rumänien
Aenova Group - Location Cornu, Romania
Aenova
Kompetenzzentrum und One-Stop-Shop für Weichgelatinekapseln und VegaGels®.
REGION: Europe
MÄRKTE: FDA (USA), Health Canada (Canada), TGA (Australia)
COMPLIANCE: FDA (cGMP), ISO, Halal-Forschungsrat, TGA (Australia GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
KATEGORIE/PRODUKT: NUTRAZEUTIKA, FDF / DRUG PRODUCTS
VERWENDUNG: Menschlich
DIENSTLEISTUNGEN: 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/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
Deutschland
Aenova Group - Location Bad Aibling, Germany
Aenova
Kompetenzzentrum Blisterverpackung Fremdverpackung Großserienanlage für Brausemittel.
MÄRKTE: EMA (EU), FDA (USA)
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, IFS, EMA (EU-GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
KATEGORIE/PRODUKT: KOSMETIK, NUTRAZEUTIKA, FDF / DRUG PRODUCTS
VERWENDUNG: Menschlich, Veterinär
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)
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