显示中 28 设施
中国
Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
Seacross Pharmaceutical Co Ltd
制剂生产基地致力于复杂、高价值剂型的开发和生产。
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), 世界其他地区, 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, SERVICES
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)
中国
Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
Seacross Pharmaceutical Co Ltd
研发中心在支持原料药和成品剂型的开发方面发挥着基础性作用。
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), 世界其他地区, 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)
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, SERVICES
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)
德国
Glatt Pharmaceutical Services GmbH Co. & KG
Glatt Pharmaceutical Services GmbH Co. & KG
位于德国 Binzen 的符合 cGMP 的 CDMO，为复杂口服固体剂型领域提供端到端服务。
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
Markets: 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 Size: Small, Medium, Large
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (V01) Allergens, (M) Musculoskeletal system, (J) Antiinfectives for systemic use, (C) Cardiovascular system, (A) Digestive tract and metabolism, (N) Nervous system
Category / Product: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING
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), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), ECOVADIS, ISO, Halal Research Council, Health Canada (Canada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (Republic of Korea GMP)
Region: Europe
Use: Human, Veterinary
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), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Markets: 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 Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, SERVICES, PARTICLE ENGINEERING
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), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), ECOVADIS, ISO, Halal Research Council, Health Canada (Canada GMP), TITCK (Turkish Health Authorities), MFDS/KFDA (Republic of Korea GMP)
Use: Human, Veterinary
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), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Region: North America
Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism
Markets: 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), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium, Large
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (M) Musculoskeletal system, (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: ISP (Chile BPM), Roszdravnadzor (Russia GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), French Service-Public (CIR), TGA (Australia GMP), FDA (cGMP), NMPA (China GMP), ECOVADIS, ISO, INVIMA, Health Canada (Canada GMP), MSPAS, MFDS/KFDA (Republic of Korea GMP), COFEPRIS
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
Markets: Turkish Health Authorities, ANVISA (Brazil), FDA (USA), Russian Health Authorities, MFDS (South Korea)
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, NUTRACEUTICALS
Compliance: Roszdravnadzor (Russia GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO, MFDS/KFDA (Republic of Korea GMP)
Region: Europe
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)
Markets: Turkish Health Authorities, ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia)
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, COSMETICS, PARTICLE ENGINEERING, NUTRACEUTICALS
Compliance: Roszdravnadzor (Russia GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), FDA (cGMP), SFDA (Saudi Food & Drug Authority), TITCK (Turkish Health Authorities), MFDS/KFDA (Republic of Korea GMP)
Region: Europe
Use: Human, Veterinary
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), 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)
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)
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING, NUTRACEUTICALS
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), ISO, MFDS/KFDA (Republic of Korea GMP)
Region: Europe
Use: Human, Veterinary
Services: Analytical / QC services, Manufacturing services, Development services, Packaging, Quality Assurance services
Markets: PMDA (Japan), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia)
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)
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS
Compliance: Roszdravnadzor (Russia GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil B-GMP), FDA (cGMP)
Markets: EDE (UAE), ANVISA (Brazil), PMDA (Japan), FDA (USA), Russian Health Authorities, EMA (EU)
Region: Europe
Use: Human, Veterinary
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), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
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