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Aenova Group - Location Sisseln, Switzerland
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)

Aenova Group - Location Regensburg, Germany
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

Aenova Group - Location Münster, Germany
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

Aenova Group - Location Marburg, Germany
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)

Aenova Group - Location Latina, Italy
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

Aenova Group - Location Kirchberg, Switzerland
Schweiz

Aenova Group - Location Kirchberg, Switzerland

Aenova

Kompetenzzentrum Weichgelatinekapseln.

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

Aenova Group - Location Killorglin, Ireland
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)

Aenova Group - Location Gronau, Germany
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

Aenova Group - Location Greensboro, USA
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

Aenova Group - Location Feldkirchen, Germany
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)

Aenova Group - Location Cornu, Romania
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)

Aenova Group - Location Bad Aibling, Germany
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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