Показаны 115 удобства
Словакия
HBM Pharma
Hbm Pharma
Директор по маркетингу, сертифицированный EU-GMP, находится в Мартине, Словакия. Компания предоставляет услуги по производству и упаковке стерильных фармацевтических препаратов. продукты и твердые…
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
Испания
Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
LABORATORIO REIG JOFRE SA
Производственные мощности для инъекций (лиофилизированных и жидких) и жидкостей.
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
Германия
EVER Pharma Jena GmbH
EVER Neuro Pharma GmbH
Специализированный CDMO для разработки и производства инъекционных препаратов с малыми молекулами.
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), Остальной мир
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
Венгрия
ALPHAVET Zrt.- Bábolna Manufacturing Plant
Alphavet Zrt.
Завод сертифицирован ЕС GMP и производит ветеринарные лекарственные препараты для 18 государств-членов ЕС и 7 других европейских стран за пределами ЕС.
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
Португалия
Sidefarma
Sidefarma SA
CMO специализируется на производстве малых и средних партий для фармацевтических компаний по всему миру на регулируемых рынках.
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
Испания
CZ Vaccines | Investigational and Medicinal Products Plant
CZ Vaccines
Центр клинических исследований
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
Markets: EMA (EU)
Services: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)
Batch Size: Large, Medium
Use: Human
BSL (Biological Safety Level): 1, 2
Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
Category / Product: BIOLOGICS, FDF / DRUG PRODUCTS
Германия
Cellex Cell Professionals
Cellex Cell Professionals
Завод по производству клеток CGT CDMO и центр сбора исходных материалов
Markets: EMA (EU), FDA (USA)
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Compliance: FDA (cGMP), EMA (EU GMP)
Batch Size: Large, Small, Medium
Use: Human, Veterinary
BSL (Biological Safety Level): 1, 2
Category / Product: BIOLOGICS, SERVICES, FDF / DRUG PRODUCTS
Германия
Aenova Group - Location Tittmoning, Germany
Aenova
Центр компетенции для крупнообъемной установки по производству традиционных твердых материалов.
Markets: EMA (EU), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, TGA (Australia)
Region: Europe
Compliance: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP)
Batch Size: Large, Medium
Category / Product: NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
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)
Швейцария
Aenova Group - Location Sisseln, Switzerland
Aenova
Центр компетенции по сложным традиционным твердым телам.
Region: Europe
Markets: FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
Compliance: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), World Health Organization (GMP / HACCP), MFDS/KFDA (Republic of Korea GMP)
Batch Size: Large, Small, Medium
Category / Product: NUTRACEUTICALS, FDF / DRUG PRODUCTS
Use: Human
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
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)
Германия
Aenova Group - Location Regensburg, Germany
Aenova
Центр компетенции сильнодействующие твердые вещества (онкология) обычные твердые вещества – специальные полутвердые вещества и жидкости.
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)
Markets: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities
Region: Europe
Compliance: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
Batch Size: Large, Small, Medium
Category / Product: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Германия
Aenova Group - Location Münster, Germany
Aenova
Центр компетенции низкодозированные сильнодействующие твердые вещества (гормоны, гормоноподобные), низкодозированные капсулы.
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)
Markets: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities
Region: Europe
Compliance: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
Batch Size: Large, Small, Medium
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins
Category / Product: FDF / DRUG PRODUCTS
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