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Laboratorios Grifols | Barcelona Plant
Grifols International
Sterylne roztwory produkcyjne (małe cząsteczki) w elastycznych workach i fiolkach.
RYNKI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)
USŁUGI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europa
ZGODNOŚĆ: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
ROZMIAR PARTII: Large, Small, Medium
UŻYWAĆ: Human, Veterinary
TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (C) Cardiovascular system, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism
SUBSTANCJE KONTROLOWANE: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE
Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
LABORATORIO REIG JOFRE SA
Zakłady produkujące produkty do wstrzykiwania (lyo i płyn) oraz płynne.
BSL (poziom bezpieczeństwa biologicznego): 3, 1, 2
RYNKI: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)
REGION: Europa
ROZMIAR PARTII: Large, Medium
UŻYWAĆ: Human, Veterinary
USŁUGI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism
SUBSTANCJE KONTROLOWANE: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
ZGODNOŚĆ: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ECOVADIS, INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE
Pharmaron API Commercial Synthesis Cramlington (UK)
Pharmaron
Komercyjna synteza małych cząsteczek API.
TERAPEUTYCZNE OBSZARY WIEDZY (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
SUBSTANCJE KONTROLOWANE: 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
RYNKI: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), TGA (Australia)
REGION: Europa
ZGODNOŚĆ: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
ROZMIAR PARTII: Large, Small, Medium
UŻYWAĆ: Human, Veterinary
KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY
USŁUGI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
OEB (pasmo narażenia zawodowego): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
Lifecore Injectables CDMO
Lifecore Biomedical
CDMO produkująca sterylne produkty lecznicze do wstrzykiwań do użytku klinicznego i komercyjnego.
BSL (poziom bezpieczeństwa biologicznego): 3, 1, 2
RYNKI: 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
USŁUGI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
ZGODNOŚĆ: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
ROZMIAR PARTII: Large, Small, Medium
UŻYWAĆ: Human, Veterinary
SUBSTANCJE KONTROLOWANE: Lowest potential for abuse
OEB (pasmo narażenia zawodowego): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
REGION: Ameryka Północna
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE
Laboratorios Grifols | Murcia Plant
Grifols International
Sterylne roztwory produkcyjne (małe cząsteczki) w elastycznych workach.
RYNKI: EMA (EU), FDA (USA), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)
USŁUGI: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
REGION: Europa
ZGODNOŚĆ: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
ROZMIAR PARTII: Large, Small, Medium
UŻYWAĆ: Human, Veterinary
TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (C) Cardiovascular system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism
SUBSTANCJE KONTROLOWANE: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE
EVER Pharma Jena GmbH
EVER Neuro Pharma GmbH
Specjalistyczne CDMO do opracowywania i produkcji małocząsteczkowych preparatów do wstrzykiwań.
OEB (pasmo narażenia zawodowego): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
SUBSTANCJE KONTROLOWANE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
RYNKI: 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
USŁUGI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europa
ZGODNOŚĆ: ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
ROZMIAR PARTII: Large, Small, Medium
UŻYWAĆ: Human
BSL (poziom bezpieczeństwa biologicznego): 1, 2
TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE
Avara Pharmaceutical Services | Arecibo Site
AVARA
Zakład produkujący doustne dawki stałe (OSD) na skalę komercyjną, posiadający dużą wiedzę specjalistyczną w zakresie substancji kontrolowanych (DEA II V).
SUBSTANCJE KONTROLOWANE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
ZGODNOŚĆ: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
RYNKI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), TGA (Australia)
ROZMIAR PARTII: Large, Medium
UŻYWAĆ: Human
KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY, USŁUGI, FDF / PRODUKTY LEKOWE, INŻYNIERIA CZĄSTEK
USŁUGI: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
TERAPEUTYCZNE OBSZARY WIEDZY (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: Ameryka Północna
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
Avara Pharmaceutical Services | Norman Site
AVARA
Zakład produkcyjny kontraktowy specjalizujący się w doustnym dozowaniu substancji stałych (OSD) na potrzeby dostaw klinicznych i komercyjnych.
SUBSTANCJE KONTROLOWANE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
ZGODNOŚĆ: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
RYNKI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea), TGA (Australia)
ROZMIAR PARTII: Large, Small, Medium
UŻYWAĆ: Human
KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY, USŁUGI, FDF / PRODUKTY LEKOWE, INŻYNIERIA CZĄSTEK
USŁUGI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
TERAPEUTYCZNE OBSZARY WIEDZY (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: Ameryka Północna
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
Indena Settala
Indena
Placówka zgodna z GMP i kontrolowana przez FDA, specjalizująca się w złożonych API i związkach o silnym działaniu do OEB 6.
RYNKI: TGA (Australia), Rest of World, 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)
ROZMIAR PARTII: Small, Medium, Large
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day)
ZGODNOŚĆ: NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP), FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP)
USŁUGI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europa
UŻYWAĆ: Human, Veterinary
KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY
RYNKI: 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)
USŁUGI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europa
ZGODNOŚĆ: 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), French Service-Public (CIR), NMPA (China GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
ROZMIAR PARTII: Large, Small, Medium
UŻYWAĆ: Human
TERAPEUTYCZNE OBSZARY WIEDZY (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
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE
OEB (pasmo narażenia zawodowego): 1 / low-hazard (PDE > 10,000 µg/day)
CARBOGEN AMCIS | Veenendaal
CARBOGEN AMCIS
Produkcja na dużą skalę analogów cholesterolu i witaminy D.
TERAPEUTYCZNE OBSZARY WIEDZY (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 (pasmo narażenia zawodowego): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
RYNKI: 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
USŁUGI: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europa
ZGODNOŚĆ: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP), SQF (Safe Quality Food), NSF
UŻYWAĆ: Human, Veterinary
BSL (poziom bezpieczeństwa biologicznego): 1
KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY, USŁUGI
ROZMIAR PARTII: Small
CARBOGEN AMCIS | Saint-Beauzire
CARBOGEN AMCIS
Opracowywanie niestandardowych receptur i sterylna produkcja płynnych i liofilizowanych produktów leczniczych w sposób sterylny GMP.
OEB (pasmo narażenia zawodowego): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
SUBSTANCJE KONTROLOWANE: 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
RYNKI: 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
ZGODNOŚĆ: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), French Service-Public (CIR), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)
ROZMIAR PARTII: Large, Small, Medium
UŻYWAĆ: Human
USŁUGI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
TERAPEUTYCZNE OBSZARY WIEDZY (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
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE
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