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Laboratorio REIG JOFRE, SA (TOLEDO PLANT)
Spanien

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)

LABORATORIO REIG JOFRE SA

Entwicklung und Herstellung von Betalactam-Antibiotika (FDF) in hochmodernen Anlagen.

MÄRKTE: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), INVIMA (Colombia), SFDA (Saudi Arabia), TGA (Australia)

REGION: APAC, MENA, LATAM, Europa, Nordamerika

COMPLIANCE: DIGEMID, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP)

BATCH-GRÖSSE: Groß, Mittel

VERWENDUNG: Menschlich, Veterinär

BSL (Biologische Sicherheitsstufe): 1

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

THERAPEUTISCHE FACHGEBIETE (ATC): (J) Antiinfectives for systemic use

KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse

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

KATEGORIE/PRODUKT: FDF / Arzneimittelprodukte

Upperton Pharma Solutions
Vereinigtes Königreich

Upperton Pharma Solutions

Upperton Pharma Solutions

Entwicklung und Herstellung oraler fester Dosen (OSD), nasaler, inhalativer und steriler Trockenpulver und flüssiger Arzneimittel.

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), FDA (USA), Health Canada (Canada), MHRA (UK), TGA (Australia)

REGION: Europa

VERWENDUNG: Menschlich

KATEGORIE/PRODUKT: OLIGONUKLEOTIDE, BIOLOGIEN, DIENSTLEISTUNGEN, FDF / Arzneimittelprodukte

BSL (Biologische Sicherheitsstufe): 1

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

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (N) Nervous system, (R) Respiratory system

BATCH-GRÖSSE: Klein, Mittel

COMPLIANCE: MHRA (UK GMP)

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 | 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

FAES FARMA | DERIO facility
Spanien

FAES FARMA | DERIO facility

FAES FARMA

Entwickler und Hersteller von Humanarzneimitteln.

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), MFDS (South Korea), EDE (UAE), TGA (Australia)

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

REGION: Europa

COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), 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)

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

KATEGORIE/PRODUKT: FDF / Arzneimittelprodukte

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

Aenova Group - Location Tittmoning, Germany
Deutschland

Aenova Group - Location Tittmoning, Germany

Aenova

Kompetenzzentrum für konventionelle Feststoff-Großmengenanlagen.

MÄRKTE: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, TGA (Australia)

REGION: Europa

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

BATCH-GRÖSSE: Groß, Mittel

KATEGORIE/PRODUKT: NUTRAZEUTIKA, FDF / Arzneimittelprodukte

VERWENDUNG: Menschlich, Veterinär

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 Sisseln, Switzerland
Schweiz

Aenova Group - Location Sisseln, Switzerland

Aenova

Kompetenzzentrum komplexe konventionelle Feststoffe.

REGION: Europa

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 / 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)

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 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)

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: Europa

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 / Arzneimittelprodukte

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