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Deutschland
BAG Health Care
BAG Health Care GmbH
Anbieter von parenteralem F&F für Fläschchen in kleinen bis mittelgroßen Chargen.
BATCH-GRÖSSE: Klein, Mittel
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP)
REGION: Europe
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
BSL (Biologische Sicherheitsstufe): 1
MÄRKTE: EMA (EU), TGA (Australia), MHRA (UK)
Deutschland
Cellex Cell Professionals
Cellex Cell Professionals
CGT CDMO Zellfertigungsanlage und Sammelzentrum für Ausgangsmaterialien
BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGIEN
COMPLIANCE: EMA (EU-GMP), FDA (cGMP)
REGION: Europe
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
MÄRKTE: FDA (USA), EMA (EU)
BSL (Biologische Sicherheitsstufe): 1, 2
Deutschland
Aenova Group - Location Tittmoning, Germany
Aenova
Kompetenzzentrum für konventionelle Feststoff-Großmengenanlagen.
BATCH-GRÖSSE: Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS, NUTRAZEUTIKA
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU-GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), Gesundheit Kanada (Kanada GMP)
REGION: Europe
MÄRKTE: ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU), TGA (Australia), Health Canada (Canada)
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
Deutschland
Aenova Group - Location Regensburg, Germany
Aenova
Kompetenzzentrum hochwirksame Feststoffe (Onkologie), konventionelle Feststoffe – spezielle Halbfeststoffe und Flüssigkeiten.
MÄRKTE: Turkish Health Authorities, ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia)
BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS, KOSMETIK, PARTICLE ENGINEERING, NUTRAZEUTIKA
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU-GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), SFDA (Saudi Food & Drug Authority), TITCK (Turkish Health Authorities), MFDS/KFDA (Republik Korea GMP)
REGION: Europe
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
Deutschland
Aenova Group - Location Münster, Germany
Aenova
Kompetenzzentrum niedrig dosierte hochwirksame Feststoffe (Hormone, hormonähnlich), niedrig dosierte Kapseln.
MÄRKTE: Turkish Health Authorities, ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea)
BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU-GMP), ANVISA (Brazil B-GMP), FDA (cGMP), TITCK (Turkish Health Authorities), MFDS/KFDA (Republik Korea GMP)
REGION: Europe
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
THERAPEUTISCHE FACHGEBIETE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
Deutschland
Aenova Group - Location Marburg, Germany
Aenova
Kompetenzzentrum Komplex konventionelle Feststoffe und Betäubungsmittel.
BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS, NUTRAZEUTIKA
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU-GMP), ANVISA (Brazil B-GMP), FDA (cGMP)
KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
REGION: Europe
MÄRKTE: ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU)
VERWENDUNG: Menschlich
DIENSTLEISTUNGEN: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
Deutschland
Aenova Group - Location Gronau, Germany
Aenova
Kompetenzzentrum für konventionelle Feststoffe und klinische Dienstleistungen.
BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU-GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), FDA (cGMP)
MÄRKTE: EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU)
REGION: Europe
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
Deutschland
Aenova Group - Location Feldkirchen, Germany
Aenova
Kompetenzzentrum Halbfeste und Flüssigkeiten.
BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS, KOSMETIK
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU-GMP), FDA (cGMP), ISO
REGION: Europe
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Analytical / QC services, Manufacturing services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
MÄRKTE: FDA (USA), Russian Health Authorities, EMA (EU)
THERAPEUTISCHE FACHGEBIETE (ATC): (M) Musculoskeletal system, (J) Antiinfectives for systemic use, (D) Dermatologicals
Deutschland
Aenova Group - Location Bad Aibling, Germany
Aenova
Kompetenzzentrum Blisterverpackung Fremdverpackung Großserienanlage für Brausemittel.
BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS, KOSMETIK, NUTRAZEUTIKA
COMPLIANCE: EMA (EU-GMP), IFS, FDA (cGMP), ISO
REGION: Europe
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Analytical / QC services, Logistics, Manufacturing services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
MÄRKTE: FDA (USA), EMA (EU)
REGION: Europe
Deutschland
Adragos Pharma | Leipzig
Adragos Pharma
Nicht sterile halbfeste und flüssige pharmazeutische Produkte.
BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (EU-GMP)
KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
REGION: Europe
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
MÄRKTE: PMDA (Japan), EMA (EU), MFDS (South Korea), NMPA (China), MHRA (UK)
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
Deutschland
Glatt Pharmaceutical Services GmbH Co. & KG
Glatt Pharmaceutical Services GmbH Co. & KG
Ihr cGMP-konformes CDMO für End-to-End-Dienstleistungen im Bereich komplexer oraler fester Darreichungsformen mit Sitz in Binzen, Deutschland.
BATCH-GRÖSSE: Klein, Mittel, Groß
THERAPEUTISCHE FACHGEBIETE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs, (V06) Nutrients
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (EU-GMP), FDA (cGMP)
KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
REGION: Europe
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Analytical / QC services, Manufacturing services, Development services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
MÄRKTE: FDA (USA), EMA (EU)
BSL (Biologische Sicherheitsstufe): 1
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