Seans 36 udogodnienia
Wielka Brytania
Arcinova Ltd. – Alnwick, UK
Arcinova - A Quotient Sciences Company
Arcinova przyspiesza opracowywanie leków od wczesnego odkrycia po weryfikację koncepcji i nie tylko.
Batch Size: Small
Category / Product: FDF / DRUG PRODUCTS, ANALITYCZNE CRO, CHEMICAL-SYNTHETIC
Compliance: EMA (EU GMP), MHRA (UK GMP), MHRA (UK), FDA (cGMP), ICH
Controlled Substances: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Narcotic, Low potential for abuse
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Markets: PMDA (Japan), FDA (USA), EMA (EU), Health Canada (Canada), MHRA (UK)
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)
Chiny
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.
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Reszta świata, 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 Size: Small, Medium, Large
Therapeutic Areas of Expertise (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
Category / Product: FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC
Compliance: 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
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
BSL (Biological Safety Level): 3, 4, 1, 2
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Region: APAC
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)
Chiny
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.
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Reszta świata, 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 Size: Small, Medium, Large
Therapeutic Areas of Expertise (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
Category / Product: FDF / DRUG PRODUCTS, ANALITYCZNE CRO
Compliance: 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
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
BSL (Biological Safety Level): 3, 4, 1, 2
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Region: APAC
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)
Indie
HIKAL | Mumbai
Hikal Ltd.
Hikal jest wiodącym farmaceutycznym CDMO specjalizującym się w małych cząsteczkach, HPAPI, rozwoju procesów, syntezie na zamówienie i produkcji komercyjnej.
Markets: ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Reszta świata, 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
Compliance: Health Canada, EMA (EU GMP), PMDA/MHLW (Japan GMP), PMDA (Japan), World Health Organization (GMP / HACCP), MHRA (UK GMP), ANVISA (Brazil), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP), ICH
Therapeutic Areas of Expertise (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
Category / Product: ANALITYCZNE CRO, CHEMICAL-SYNTHETIC
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
BSL (Biological Safety Level): 3, 4, 1, 2
Use: Human, Veterinary
Region: APAC
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
CARBOGEN AMCIS | Saint-Beauzire
CARBOGEN AMCIS
Opracowywanie niestandardowych receptur i sterylna produkcja płynnych i liofilizowanych produktów leczniczych w sposób sterylny GMP.
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), Reszta świata, 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)
Batch Size: Small, Medium, Large
Therapeutic Areas of Expertise (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
Category / Product: FDF / DRUG PRODUCTS
Compliance: 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)
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
Use: Human
Services: Analytical / QC services, Manufacturing services, Regulatory services, Development services, 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)
Niemcy
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.
Batch Size: Small, Medium, Large
Therapeutic Areas of Expertise (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
Category / Product: FDF / DRUG PRODUCTS
Compliance: EMA (EU GMP), FDA (cGMP)
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
Use: Human, Veterinary
Services: Analytical / QC services, Manufacturing services, Development services
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)
Markets: FDA (USA), EMA (EU)
BSL (Biological Safety Level): 1
Szwajcaria
Adragos Pharma | Jura
Adragos Pharma
Specjalizujemy się w aseptycznej produkcji liofilizowanych lub płynnych sterylnych (bio)farmaceutycznych produktów leczniczych, poprzez napełnienie i wykończeni
Batch Size: Small, Medium
Category / Product: FDF / DRUG PRODUCTS
Compliance: EMA (EU GMP), FDA (cGMP)
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Markets: PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), NMPA (China), Health Canada (Canada), MHRA (UK)
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Controlled Substances: High potential for abuse & no medical use
Francja
Adragos Pharma | Livron
Adragos Pharma
Produkcja sterylnych płynów i czopków. Zajmujemy się ponad 100 molekułami, zarządzaniem narkotykami oraz usługami analitycznymi i stabilnościowymi.
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS
Compliance: EMA (EU 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
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Packaging, Quality Assurance services
Markets: PMDA (Japan), CDSCO (India), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), MHRA (UK)
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)
Francja
Cenexi
Cenexi
Zakład GMP na czterohektarowym terenie położony jest 9 km na wschód od Paryża. Jest to centrum doskonałości w zakresie ampułek do wstrzykiwań.
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS
Markets: EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-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
Use: Human, Veterinary
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
Therapeutic Areas of Expertise (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 (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
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: Turkish Health Authorities, ANVISA (Brazil), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), 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: Roszdravnadzor (Russia GMP), EMA (EU GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil), TGA (Australia GMP), NMPA (China GMP), ECOVADIS, ISO, Health Canada (Canada GMP)
Region: Europe
Use: Human
Services: Analytical / QC services, Manufacturing services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Controlled Substances: High potential for abuse & medical use
Niemcy
Aenova Group - Location Marburg, Germany
Aenova
Centrum Kompetencji kompleks konwencjonalnych substancji stałych i narkotyków.
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, NUTRACEUTICALS
Compliance: Roszdravnadzor (Russia GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), FDA (cGMP)
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), FDA (USA), Russian Health Authorities, EMA (EU)
Use: Human
Services: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
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