显示中 115 设施
Markets: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), EMA (EU GMP)
Use: Human
Batch Size: Large
Services: Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & medical use, Low potential for abuse
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, SERVICES
Region: APAC
德国
Nexora Cell and Tissue Therapy Manufacturing Site
Green Phoenix Labs GmbH
德国获得许可的 ATMP 站点。细胞和组织疗法的 GMP 制造和 QP 批次放行。
Services: Development services, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU)
BSL (Biological Safety Level): 1, 2
Use: Human
Controlled Substances: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse
Therapeutic Areas of Expertise (ATC): (S) Sensory organs, (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism
Batch Size: 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)
Compliance: EMA (EU GMP)
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Region: Europe
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
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Compliance: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP), SQF (Safe Quality Food)
Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)
BSL (Biological Safety Level): 1, 2
Category / Product: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Use: Human, Veterinary
Batch Size: Large, Small, Medium
Controlled Substances: Lowest potential for abuse
Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use, (D) Dermatologicals, (V06) Nutrients, (R) Respiratory system, (A) Digestive tract and metabolism
Region: Europe
荷兰
Bilthoven Biologicals Drug Substance and Drug Product Facilities
Bilthoven Biologicals BV
用于原料药和药品的多产品 GMP 设施。
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: EMA (EU), MHRA (UK)
BSL (Biological Safety Level): 1, 2
Use: Human
Batch Size: Large, Small, Medium
Compliance: EMA (EU GMP)
Category / Product: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Region: Europe
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, SERVICES
Region: Europe
Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: 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)
Batch Size: Large, Small, Medium
Use: Human, Veterinary
Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism
Controlled Substances: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
BSL (Biological Safety Level): 3, 1, 2
Markets: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)
Region: Europe
Batch Size: Large, Medium
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism
Controlled Substances: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Compliance: 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 (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Markets: 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), 世界其他地区
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: 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)
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1, 2
Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system
Category / Product: FDF / DRUG PRODUCTS
匈牙利
ALPHAVET Zrt.- Bábolna Manufacturing Plant
Alphavet Zrt.
该工厂已获得欧盟 GMP 认证，为 18 个欧盟成员国和欧盟以外的其他 7 个欧洲国家生产兽药产品。
Markets: EMA (EU)
Region: Europe
Compliance: ISO, EMA (EU GMP)
Batch Size: Large, Medium
Category / Product: NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Veterinary
Services: Manufacturing services, Analytical / QC services, Regulatory services, Packaging
Controlled Substances: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Markets: EMA (EU), PMDA (Japan), Health Canada (Canada), DIGEMID (Peru), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), TGA (Australia)
Region: Europe
Compliance: ISO, UAE Ministry of Health & Prevention, EMA (EU GMP)
Use: Human
Services: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging
Batch Size: Small, Medium
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
Markets: EMA (EU), ANVISA (Brazil), CDSCO (India)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: ISO, ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)
Use: Human
BSL (Biological Safety Level): 1, 2
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
Batch Size: Small
Category / Product: BIOLOGICS, FDF / DRUG PRODUCTS
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