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Pharmaron API Commercial Synthesis Cramlington (UK)
Pharmaron
Komercyjna synteza małych cząsteczek API.
ROZMIAR PARTII: Small, Medium, Large
TERAPEUTYCZNE OBSZARY WIEDZY (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
ZGODNOŚĆ: EMA (EU GMP), PMDA/MHLW (Japan GMP), MHRA (UK GMP), TGA (Australia GMP), FDA (cGMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
SUBSTANCJE KONTROLOWANE: 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: Europa
RYNKI: ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
UŻYWAĆ: Human, Veterinary
USŁUGI: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Quality Assurance services
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY
Pharmaron API Commercial Synthesis Coventry (US)
Pharmaron
Komercyjna synteza małych cząsteczek API.
ROZMIAR PARTII: Small, Medium, Large
TERAPEUTYCZNE OBSZARY WIEDZY (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
SUBSTANCJE KONTROLOWANE: 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
UŻYWAĆ: Human, Veterinary
RYNKI: PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), Health Canada (Canada), MHRA (UK)
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
USŁUGI: Manufacturing services, Development services
REGION: Ameryka Północna
ZGODNOŚĆ: FDA (cGMP), ECOVADIS, ISO
KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY
CARBOGEN AMCIS | Saint-Beauzire
CARBOGEN AMCIS
Opracowywanie niestandardowych receptur i sterylna produkcja płynnych i liofilizowanych produktów leczniczych w sposób sterylny GMP.
RYNKI: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Rest of World, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
ROZMIAR PARTII: Small, Medium, Large
TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (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, (D) Dermatologicals, (N) Nervous system
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE
ZGODNOŚĆ: ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), SFDA (Saudi Food & Drug Authority), ISO, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
SUBSTANCJE KONTROLOWANE: 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: Europa
UŻYWAĆ: Human
USŁUGI: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Quality Assurance services
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Aenova Group - Location Marburg, Germany
Aenova
Centrum Kompetencji kompleks konwencjonalnych substancji stałych i narkotyków.
ROZMIAR PARTII: Small, Medium, Large
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE, NUTRACEUTYKI
ZGODNOŚĆ: Roszdravnadzor (Russia GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), FDA (cGMP)
SUBSTANCJE KONTROLOWANE: 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: Europa
RYNKI: ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU)
UŻYWAĆ: Human
USŁUGI: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Adragos Pharma | Jura
Adragos Pharma
Specjalizujemy się w aseptycznej produkcji liofilizowanych lub płynnych sterylnych (bio)farmaceutycznych produktów leczniczych, poprzez napełnienie i wykończeni
ROZMIAR PARTII: Small, Medium
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE
ZGODNOŚĆ: EMA (EU GMP), FDA (cGMP)
REGION: Europa
UŻYWAĆ: Human
USŁUGI: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
RYNKI: PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), NMPA (China), Health Canada (Canada), MHRA (UK)
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
SUBSTANCJE KONTROLOWANE: High potential for abuse & no medical use
Adragos Pharma | Livron
Adragos Pharma
Produkcja sterylnych płynów i czopków. Zajmujemy się ponad 100 molekułami, zarządzaniem narkotykami oraz usługami analitycznymi i stabilnościowymi.
ROZMIAR PARTII: Small, Medium, Large
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE
ZGODNOŚĆ: EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
SUBSTANCJE KONTROLOWANE: 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: Europa
UŻYWAĆ: Human
USŁUGI: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
RYNKI: PMDA (Japan), CDSCO (India), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), MHRA (UK)
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Glatt Pharmaceutical Services GmbH Co. & KG
Glatt Pharmaceutical Services GmbH Co. & KG
Twoje CDMO zgodne z cGMP, zapewniające kompleksowe usługi w dziedzinie złożonych postaci doustnych substancji stałych, z siedzibą w Binzen w Niemczech.
ROZMIAR PARTII: Small, Medium, Large
TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (R) Respiratory system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (S) Sensory organs, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system, (B) Blood and blood forming organs, (V06) Nutrients
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE
ZGODNOŚĆ: EMA (EU GMP), FDA (cGMP)
SUBSTANCJE KONTROLOWANE: 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: Europa
UŻYWAĆ: Human, Veterinary
USŁUGI: Analytical / QC services, Manufacturing services, Development services
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
RYNKI: FDA (USA), EMA (EU)
BSL (poziom bezpieczeństwa biologicznego): 1
Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site
Seacross Pharmaceutical Co Ltd
Jako jeden z trzech głównych zakładów, obok centrum badawczo-rozwojowego i zakładu formułowania, nasz zakład produkcyjny API odgrywa kluczową rolę w zintegrowan
RYNKI: 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)
ROZMIAR PARTII: Small, Medium, Large
TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (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
ZGODNOŚĆ: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (China GMP), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Halal Research Council, INVIMA, Health Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (Republic of Korea GMP), COFEPRIS
SUBSTANCJE KONTROLOWANE: 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
BSL (poziom bezpieczeństwa biologicznego): 3, 4, 1, 2
UŻYWAĆ: Human
USŁUGI: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
REGION: APAC
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY
Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
Seacross Pharmaceutical Co Ltd
Centrum Badawczo-Rozwojowe odgrywa zasadniczą rolę we wspieraniu rozwoju zarówno API, jak i gotowych postaci dawkowania.
RYNKI: 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)
ROZMIAR PARTII: Small, Medium, Large
TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (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
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE, CHEMICZNO-SYNTETYCZNY
ZGODNOŚĆ: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (China GMP), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Halal Research Council, INVIMA, Health Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (Republic of Korea GMP), COFEPRIS
SUBSTANCJE KONTROLOWANE: 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
BSL (poziom bezpieczeństwa biologicznego): 3, 4, 1, 2
UŻYWAĆ: Human
USŁUGI: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
REGION: APAC
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
Seacross Pharmaceutical Co Ltd
Zakład produkcyjny receptur zajmuje się opracowywaniem i produkcją złożonych postaci dawkowania o wysokiej wartości.
RYNKI: 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)
ROZMIAR PARTII: Small, Medium, Large
TERAPEUTYCZNE OBSZARY WIEDZY (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
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE, USŁUGI
ZGODNOŚĆ: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), IFS, DIGEMID, UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NSF, NMPA (China GMP), SFDA (Saudi Food & Drug Authority), BRCGS, ECOVADIS, ISO, Halal Research Council, INVIMA, Health Canada (Canada GMP), SQF (Safe Quality Food), TITCK (Turkish Health Authorities), MSPAS, MFDS/KFDA (Republic of Korea GMP), COFEPRIS
SUBSTANCJE KONTROLOWANE: 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
BSL (poziom bezpieczeństwa biologicznego): 3, 4, 1, 2
UŻYWAĆ: Human
USŁUGI: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
REGION: APAC
OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Cenexi
Cenexi
Zakład GMP na czterohektarowym terenie położony jest 9 km na wschód od Paryża. Jest to centrum doskonałości w zakresie ampułek do wstrzykiwań.
ROZMIAR PARTII: Small, Medium, Large
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE
RYNKI: EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
ZGODNOŚĆ: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), NMPA (China GMP), MFDS/KFDA (Republic of Korea GMP)
SUBSTANCJE KONTROLOWANE: 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: Europa
UŻYWAĆ: Human, Veterinary
USŁUGI: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents
OEB (pasmo narażenia zawodowego): 1 / low-hazard (PDE > 10,000 µg/day)
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
ROZMIAR PARTII: Small, Medium
KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE
ZGODNOŚĆ: 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)
SUBSTANCJE KONTROLOWANE: 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: Europa
RYNKI: ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), MHRA (UK)
UŻYWAĆ: Human
USŁUGI: Analytical / QC services, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
TERAPEUTYCZNE OBSZARY WIEDZY (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 (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
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