Seans 13 udogodnienia
Grecja
Adragos Pharma | Athens
Adragos Pharma
Specjalizuje się w opracowywaniu leków o wartości dodanej i został niedawno wzbogacony o możliwości HPAPI.
Markets: ANMAT (Argentina), EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, ANALITYCZNE CRO
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), NSF, NMPA (China GMP), ISO, MFDS/KFDA (Republic of Korea GMP)
Controlled Substances: Lowest potential for abuse, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Francja
Cenexi Hérouville Saint Clair
Cenexi
Zakład w Hérouville-Saint-Clair, zlokalizowany w pobliżu Caen w Normandii, specjalizuje się w produkcji i rozlewaniu sterylnych płynów do iniekcji i nie do inie
Batch Size: Small, Medium
Category / Product: FDF / DRUG PRODUCTS
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MHRA (UK GMP), FDA (cGMP), NMPA (China GMP), MFDS/KFDA (Republic of Korea GMP)
Controlled Substances: 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
Region: Europe
Markets: ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), MHRA (UK)
Use: Human
Services: Analytical / QC services, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Batch Size: Medium, Large
Category / Product: FDF / DRUG PRODUCTS, ANALITYCZNE CRO
Compliance: Roszdravnadzor (Russia GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), TITCK (Turkish Health Authorities)
Region: Europe
Markets: ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU), TGA (Australia)
Use: Human, Veterinary
Therapeutic Areas of Expertise (ATC): (S) Sensory organs
Włochy
Content Group | Rovereto s/S Plant
CONTENT GROUP
COC Farmaceutici srl: siedziba handlowa i administracyjna; zakład produkcyjny.
Batch Size: Medium, Large
Category / Product: FDF / DRUG PRODUCTS, COSMETICS, ANALITYCZNE CRO
Markets: EDE (UAE), EMA (EU), SFDA (Saudi Arabia), MHRA (UK)
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Compliance: ISO
Ograniczony widok
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Rozwiązania dla programów dostarczania innych niż wirusowe
Lokalizacja dostępna po rejestracji
Ograniczony widok
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Izraelskie CDMO specjalizowało się w opracowywaniu i wytwarzaniu zgodnie z GMP złożonych syntetycznych produktów leczniczych i wyrobów medycznych opartych na ch
Lokalizacja dostępna po rejestracji
Ograniczony widok
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Możemy przenieść Twoje produkty farmaceutyczne ze skali laboratoryjnej do wczesnej fazy klinicznej i dalej.
Lokalizacja dostępna po rejestracji
Sugerowane wyniki
Obiekty te spełniają Twoje główne kryteria, ale nie wszystkie opcjonalne filtry.
Stany Zjednoczone
Lifecore Injectables CDMO
Lifecore Biomedical
CDMO produkująca sterylne produkty lecznicze do wstrzykiwań do użytku klinicznego i komercyjnego.
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2, 3
Compliance: ISO, FDA (cGMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), ECOVADIS, EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), Russian Health Authorities, CDSCO (India), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), SFDA (Saudi Arabia), ANMAT (Argentina), INVIMA (Colombia), TGA (Australia), Reszta świata
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Controlled Substances: Lowest potential for abuse
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
Region: North America
Hiszpania
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
Kompleksowe możliwości wewnętrzne, od rozwoju linii komórkowych po produkcję komercyjną.
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)
Compliance: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)
BSL (Biological Safety Level): 1, 2
Use: Human, Veterinary
Batch Size: Large, Small, Medium
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Region: Europe
Słowacja
HBM Pharma
Hbm Pharma
CMO z certyfikatem GMP UE z siedzibą w Martinie na Słowacji. Firma świadczy usługi produkcyjne i konfekcjonowania sterylnych produktów farmaceutycznych. produkty i stałe doustne postacie dawkowania
Markets: EMA (EU), NMPA (China), Health Canada (Canada), ANVISA (Brazil), COFEPRIS (Mexico), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, TGA (Australia)
Compliance: ISO, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), ANVISA (Brazil)
Use: Human
Batch Size: Large, Small, Medium
Services: Analytical / QC services, Packaging, Quality Assurance services, Manufacturing services
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Controlled Substances: High potential for abuse & medical use
Category / Product: FDF / DRUG PRODUCTS, ANALITYCZNE CRO
Region: Europe
Holandia
Bilthoven Biologicals Drug Substance and Drug Product Facilities
Bilthoven Biologicals BV
Wieloproduktowe obiekty GMP dla substancji i produktów leczniczych.
Markets: EMA (EU), MHRA (UK)
Batch Size: Large, Small, Medium
BSL (Biological Safety Level): 1, 2
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Use: Human
Compliance: EMA (EU GMP)
Category / Product: FDF / DRUG PRODUCTS, ANALITYCZNE CRO, BIOLOGICS
Region: Europe
Wielka Brytania
Arcinova Ltd. – Alnwick, UK
Arcinova - A Quotient Sciences Company
Arcinova przyspiesza opracowywanie leków od wczesnego odkrycia po weryfikację koncepcji i nie tylko.
Compliance: FDA (cGMP), ICH, MHRA (UK GMP), EMA (EU GMP), MHRA (UK)
Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK)
Services: Development services, Logistics, Analytical / QC services, Manufacturing services, Quality Assurance services, Regulatory services, Packaging
Use: Human
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, Low potential for abuse, Narcotic, High potential for abuse & medical use
Batch Size: Small
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, ANALITYCZNE CRO, CHEMICAL-SYNTHETIC
Region: Europe
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