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Aenova Group - Location Carugate, Italy
Italien

Aenova Group - Location Carugate, Italy

Aenova

Kompetenzzentrum Halbfeste und unsterile 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), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia)

REGION: Europe

COMPLIANCE: ISO, Roszdravnadzor (Russia GMP), SFDA (Saudi Food & Drug Authority), 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

Aenova Group
Deutschland

Aenova Group

Aenova

Hauptsitz - Standort Starnberg

REGION: Europe

AdhexPharma SAS
Frankreich

AdhexPharma SAS

AdhexPharma

CDMO für transdermale Pflaster und oromuköse Filme.

KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK)

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, EMA (EU-GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich, Veterinär

DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services

THERAPEUTISCHE FACHGEBIETE (ATC): (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (N) Nervous system

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

TRADICHEM INDUSTRIAL SERVICES
Spanien

TRADICHEM INDUSTRIAL SERVICES

TRADICHEM INDUSTRIAL SERVICES S.L.

HIPERING® TECHNOLOGY – DAS TOR FÜR LEAN MANUFACTURING

MÄRKTE: EMA (EU), FDA (USA)

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP)

BATCH-GRÖSSE: Groß, Klein, Mittel

KATEGORIE/PRODUKT: NUTRAZEUTIKA, SERVICES, PARTICLE ENGINEERING

VERWENDUNG: Menschlich, Veterinär

BSL (Biologische Sicherheitsstufe): 1, 2

DIENSTLEISTUNGEN: Development services, Manufacturing services

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)

GENSENTA ILAC SANAYI AS
Türkei

GENSENTA ILAC SANAYI AS

GENSENTA

CMO & CDMO & FDF-HERSTELLER

KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)

REGION: Europe

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (A) Digestive tract and metabolism

COMPLIANCE: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP)

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)

KATEGORIE/PRODUKT: SERVICES, FDF / DRUG PRODUCTS

Northway Biotech Vilnius
Litauen

Northway Biotech Vilnius

Northway Biotech

CDMO Global für ganzheitliche biologische Dienstleistungen

BSL (Biologische Sicherheitsstufe): 3, 1, 2

MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, SFDA (Saudi Food & Drug Authority), Französischer Dienst - öffentlich (CIR), EMA (EU-GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich, Veterinär

DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

KATEGORIE/PRODUKT: BIOLOGIEN, SERVICES, FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

Adragos Pharma | Maisons-Alfort
Frankreich

Adragos Pharma | Maisons-Alfort

Adragos Pharma

Das Unternehmen ist auf vorgefüllte Spritzen, flüssige und lyophilisierte Fläschchen spezialisiert und kombiniert fortschrittliche aseptische Abfüll-, Gefriertr

THERAPEUTISCHE FACHGEBIETE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (A) Digestive tract and metabolism

MÄRKTE: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities

REGION: Europe

BATCH-GRÖSSE: Groß

VERWENDUNG: Menschlich

BSL (Biologische Sicherheitsstufe): 1

DIENSTLEISTUNGEN: Manufacturing services, Analytical / QC services, Regulatory services, Packaging

KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse

COMPLIANCE: ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (China GMP), EMA (EU-GMP), MFDS/KFDA (Republik Korea GMP)

KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

Northway Biotech Waltham (MA)
Vereinigte Staaten

Northway Biotech Waltham (MA)

Northway Biotech

Globaler End-to-End-CDMO für Biologika

BSL (Biologische Sicherheitsstufe): 3, 1, 2

MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), Französischer Dienst - öffentlich (CIR), EMA (EU-GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich, Veterinär

DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

REGION: North America

KATEGORIE/PRODUKT: BIOLOGIEN, SERVICES, FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

Adragos Pharma | Leipzig
Deutschland

Adragos Pharma | Leipzig

Adragos Pharma

Nicht sterile halbfeste und flüssige pharmazeutische Produkte.

KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), MFDS (South Korea)

DIENSTLEISTUNGEN: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: Europe

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)

COMPLIANCE: EMA (EU-GMP)

KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS

Adragos Pharma | Halden
Norwegen

Adragos Pharma | Halden

Adragos Pharma

Wir sind auf die Herstellung von Infusionsbeuteln, Kunststoffampullen und Fläschchen mit Blow-Fill-Seal (BFS)-Technologie und anderen Darreichungsformen spezial

KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), TGA (Australia)

DIENSTLEISTUNGEN: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP), NSF

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

THERAPEUTISCHE FACHGEBIETE (ATC): (D) Dermatologicals, (V06) Nutrients, (A) Digestive tract and metabolism

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

Adragos Pharma |  Athens
Griechenland

Adragos Pharma | Athens

Adragos Pharma

Spezialisiert auf die Entwicklung von Arzneimitteln mit Mehrwert und wurde kürzlich mit HPAPI-Funktionen aufgerüstet.

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)

KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)

DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: Europe

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP), NSF

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

KATEGORIE/PRODUKT: SERVICES, FDF / DRUG PRODUCTS

Adragos Pharma | Kawagoe
Japan

Adragos Pharma | Kawagoe

Adragos Pharma

Unsere Anlage bietet erstklassige Herstellung von Tabletten und Ampullen.

KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)

DIENSTLEISTUNGEN: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: APAC

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), EMA (EU-GMP)

BATCH-GRÖSSE: Groß

VERWENDUNG: Menschlich

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: SERVICES, FDF / DRUG PRODUCTS

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