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Pharmaron API Commercial Synthesis Cramlington (UK)
Vereinigtes Königreich

Pharmaron API Commercial Synthesis Cramlington (UK)

Pharmaron

Kommerzielle API-Synthese kleiner Moleküle.

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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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), MHRA (UK), MFDS (South Korea), TGA (Australia)

REGION: Europa

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich, Veterinär

KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH

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

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)

Pharmaron API Commercial Synthesis Coventry (US)
Vereinigte Staaten

Pharmaron API Commercial Synthesis Coventry (US)

Pharmaron

Kommerzielle API-Synthese kleiner Moleküle.

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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

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), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea), TGA (Australia)

COMPLIANCE: FDA (cGMP), ISO, ECOVADIS

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich, Veterinär

KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH

DIENSTLEISTUNGEN: Development services, Manufacturing services

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)

REGION: Nordamerika

EVER Pharma Jena GmbH
Deutschland

EVER Pharma Jena GmbH

EVER Neuro Pharma GmbH

Spezialisiertes CDMO für die Entwicklung und Produktion von Injektionspräparaten mit kleinen Molekülen.

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), 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: ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), NMPA (China GMP), EMA (EU-GMP), MFDS/KFDA (Republik Korea GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

BSL (Biologische Sicherheitsstufe): 1, 2

THERAPEUTISCHE FACHGEBIETE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system

KATEGORIE/PRODUKT: FDF / Arzneimittelprodukte

Avara Pharmaceutical Services | Arecibo Site
Vereinigte Staaten

Avara Pharmaceutical Services | Arecibo Site

AVARA

Kommerzielle Produktionsanlage für orale feste Dosierungen (OSD) mit ausgeprägter Expertise im Bereich kontrollierter Substanzen (DEA II V).

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

COMPLIANCE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), MFDS/KFDA (Republik Korea GMP)

MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), TGA (Australia)

BATCH-GRÖSSE: Groß, Mittel

VERWENDUNG: Menschlich

KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH, DIENSTLEISTUNGEN, FDF / Arzneimittelprodukte, PARTIKELTECHNIK

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

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (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, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

REGION: Nordamerika

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)

Avara Pharmaceutical Services | Liscate Site (Italy)
Italien

Avara Pharmaceutical Services | Liscate Site (Italy)

AVARA

Sterile Abfüll- und Endproduktionsstätte für injizierbare Arzneimittel (Fläschchen, Ampullen, lyophilisiert).

BSL (Biologische Sicherheitsstufe): 3, 1, 2

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), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea)

REGION: Europa

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

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

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

KATEGORIE/PRODUKT: DIENSTLEISTUNGEN, FDF / Arzneimittelprodukte

Avara Pharmaceutical Services | Norman Site
Vereinigte Staaten

Avara Pharmaceutical Services | Norman Site

AVARA

Auftragsfertigungsanlage, spezialisiert auf orale feste Dosierung (OSD) für die klinische und kommerzielle Versorgung.

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

COMPLIANCE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP)

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

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

KATEGORIE/PRODUKT: CHEMISCH-SYNTHETISCH, DIENSTLEISTUNGEN, FDF / Arzneimittelprodukte, PARTIKELTECHNIK

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

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (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, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

REGION: Nordamerika

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)

Sidefarma
Portugal

Sidefarma

Sidefarma SA

CMO hat sich auf die Herstellung kleiner und mittlerer Chargen für Pharmaunternehmen auf der ganzen Welt in regulierten Märkten spezialisiert.

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), Health Canada (Canada), DIGEMID (Peru), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), TGA (Australia)

REGION: Europa

COMPLIANCE: ISO, UAE Ministry of Health & Prevention, EMA (EU-GMP)

VERWENDUNG: Menschlich

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

BATCH-GRÖSSE: Klein, Mittel

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 / Arzneimittelprodukte

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

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: Europa

COMPLIANCE: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU-GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

KATEGORIE/PRODUKT: NUTRAZEUTIKA, FDF / Arzneimittelprodukte

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)

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: Europa

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 / Arzneimittelprodukte

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 | 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: Europa

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 / Arzneimittelprodukte

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