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Vereinigte Staaten
Lifecore Injectables CDMO
Lifecore Biomedical
CDMO, das klinische und kommerzielle sterile injizierbare Arzneimittelprodukte herstellt.
MÄRKTE: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
COMPLIANCE: EMA (EU-GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, Gesundheit Kanada (Kanada GMP), MFDS/KFDA (Republik Korea GMP)
KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse
BSL (Biologische Sicherheitsstufe): 3, 1, 2
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), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
REGION: North America
Vereinigte Staaten
Pharmaron API Commercial Synthesis Coventry (US)
Pharmaron
Kommerzielle API-Synthese kleiner Moleküle.
BATCH-GRÖSSE: Klein, Mittel, Groß
THERAPEUTISCHE FACHGEBIETE (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (V01) Allergens, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (V04) Diagnostic agents, (S) Sensory organs, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (B) Blood and blood forming organs, (V06) Nutrients
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
VERWENDUNG: Menschlich, Veterinär
MÄRKTE: PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), MHRA (UK)
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)
DIENSTLEISTUNGEN: Manufacturing services, Development services
REGION: North America
COMPLIANCE: FDA (cGMP), ECOVADIS, ISO
KATEGORIE/PRODUKT: CHEMICAL-SYNTHETIC
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).
BATCH-GRÖSSE: 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, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU-GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), Gesundheit Kanada (Kanada GMP), MFDS/KFDA (Republik Korea GMP), ICH
KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
MÄRKTE: ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada)
VERWENDUNG: Menschlich
DIENSTLEISTUNGEN: Analytical / QC services, Manufacturing 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)
REGION: North America
Vereinigte Staaten
Avara Pharmaceutical Services | Norman Site
AVARA
Auftragsfertigungsanlage, spezialisiert auf orale feste Dosierung (OSD) für die klinische und kommerzielle Versorgung.
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, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING, CHEMICAL-SYNTHETIC
COMPLIANCE: Roszdravnadzor (Russia GMP), EMA (EU-GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), Gesundheit Kanada (Kanada GMP), MFDS/KFDA (Republik Korea GMP), ICH
KONTROLLIERTE SUBSTANZEN: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
MÄRKTE: ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), MHRA (UK)
VERWENDUNG: Menschlich
DIENSTLEISTUNGEN: Analytical / QC services, 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)
REGION: North America
Vereinigte Staaten
Aenova Group - Location Greensboro, USA
Aenova
Kompetenzzentrum Verpackung Feststoffe.
BATCH-GRÖSSE: Klein, Mittel, Groß
VERWENDUNG: Menschlich
DIENSTLEISTUNGEN: Logistics, Manufacturing services, Packaging
REGION: North America
MÄRKTE: FDA (USA), Health Canada (Canada)
COMPLIANCE: FDA (cGMP), NSF, Halal-Forschungsrat, Gesundheit Kanada (Kanada GMP)
KATEGORIE/PRODUKT: NUTRAZEUTIKA
Vereinigte Staaten
Northway Biotech Waltham (MA)
Northway Biotech
Globaler End-to-End-CDMO für Biologika
BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGIEN
MÄRKTE: EDE (UAE), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), Health Canada (Canada), MHRA (UK)
COMPLIANCE: EMA (EU-GMP), PMDA/MHLW (Japan GMP), Französischer Dienst - öffentlich (CIR), FDA (cGMP), SFDA (Saudi Food & Drug Authority), ISO
BSL (Biologische Sicherheitsstufe): 3, 1, 2
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Quality Assurance services
REGION: North America
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
Vereinigte Staaten
Adare Pharma | US
Adare Pharma Solutions
Adare Pharma ist ein weltweit tätiges CDMO mit Installationen in EE.UU. In der EU haben wir viele Produkte entwickelt, die viel Erfahrung bei der Herstellung im
MÄRKTE: DIGEMID (Peru), ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
BATCH-GRÖSSE: Klein, Mittel, Groß
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING
COMPLIANCE: EMA (EU-GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), Französischer Dienst - öffentlich (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), ECOVADIS, ISO, Halal-Forschungsrat, Gesundheit Kanada (Kanada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (Republik Korea GMP)
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), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag)
REGION: North America
THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Contract Development and Manufacturing Organization (CDMO) mit Schwerpunkt auf rekombinanten Proteinen und monoklonalen Antikörpern (mAbs).
Location available after registration
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
F&E und analytische Dienstleistungen, Technologietransfer und Einführung neuer Produkte sowie Herstellung fester und flüssiger oraler Darreichungsformen.
Location available after registration
Limited view
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Auftragsforschungs- und Entwicklungslabor (CRDO) mit Sitz in den USA, das Dienstleistungen in der Entwicklung pharmazeutischer Produkte anbietet.
Location available after registration
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