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CARBOGEN AMCIS | Veenendaal
Niederlande

CARBOGEN AMCIS | Veenendaal

CARBOGEN AMCIS

Großserienfertigung von Cholesterin- und Vitamin-D-Analoga.

THERAPEUTISCHE FACHGEBIETE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (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, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

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

REGION: Europa

COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal-Forschungsrat, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), Französischer Dienst - öffentlich (CIR), NMPA (China GMP), ANMAT (Argentinien neue GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP), SQF (Sichere Lebensmittelqualität), NSF

VERWENDUNG: Menschlich, Veterinär

BSL (Biologische Sicherheitsstufe): 1

KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH, DIENSTLEISTUNGEN

BATCH-GRÖSSE: Klein

CARBOGEN AMCIS | Shanghai, China
China

CARBOGEN AMCIS | Shanghai, China

CARBOGEN AMCIS

Großserienfertigung.

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, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

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

REGION: APAC

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

KATEGORIE/PRODUKT: OLIGONUKLEOTIDE, CHEMISCH-SYNTHETISCH, DIENSTLEISTUNGEN

COMPLIANCE: ANVISA (Brazil B-GMP), NMPA (China 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)

CARBOGEN AMCIS | Saint-Beauzire
Frankreich

CARBOGEN AMCIS | Saint-Beauzire

CARBOGEN AMCIS

Entwicklung kundenspezifischer Formulierungen und sterile GMP-Herstellung von flüssigen und lyophilisierten Arzneimitteln.

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, High potential for abuse & no medical use, Lower potential for abuse

MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World

REGION: Europa

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), Französischer Dienst - öffentlich (CIR), ANMAT (Argentinien neue GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

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

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

KATEGORIE/PRODUKT: FDF / Arzneimittelprodukte

CARBOGEN AMCIS | Bubendorf
Schweiz

CARBOGEN AMCIS | Bubendorf

CARBOGEN AMCIS

Entwicklung und cGMP-Herstellung hochwirksamer Wirkstoffe, einschließlich Antikörper-Wirkstoff-Konjugaten (ADC).

MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)

REGION: Europa

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP)

VERWENDUNG: Menschlich, Veterinär

KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH, BIOLOGIEN, DIENSTLEISTUNGEN, PARTIKELTECHNIK

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

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

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)

BATCH-GRÖSSE: Klein, Mittel

Apeloa Pharmaceutical Co., Ltd.
China

Apeloa Pharmaceutical Co., Ltd.

Apeloa Pharmaceutical Co., Ltd

Apeloa CDMO bietet erstklassige Entdeckungs-, Entwicklungs- und Herstellungsdienstleistungen für APIs, Zwischenprodukte und RSMs.

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), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)

REGION: APAC

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ECOVADIS, NMPA (China GMP), EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP)

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich, Veterinär

KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH

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

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: Europa

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 / Arzneimittelprodukte, PARTIKELTECHNIK

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: Europa

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 / Arzneimittelprodukte

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: Europa

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 / Arzneimittelprodukte

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 Feldkirchen, Germany
Deutschland

Aenova Group - Location Feldkirchen, Germany

Aenova

Kompetenzzentrum Halbfeste und Flüssigkeiten.

MÄRKTE: EMA (EU), FDA (USA), Russian Health Authorities

REGION: Europa

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

BATCH-GRÖSSE: Groß, Klein, Mittel

KATEGORIE/PRODUKT: KOSMETIK, FDF / Arzneimittelprodukte

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 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: Europa

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

BATCH-GRÖSSE: Groß, Klein, Mittel

KATEGORIE/PRODUKT: KOSMETIK, FDF / Arzneimittelprodukte

VERWENDUNG: Menschlich, Veterinär

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

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: Europa

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: DIENSTLEISTUNGEN, FDF / Arzneimittelprodukte

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: Europa

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: DIENSTLEISTUNGEN, FDF / Arzneimittelprodukte

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