Batch Size: Small, Medium
Region: North America
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
Category / Product: FDF / DRUG PRODUCTS
Compliance: EMA (EU GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), ECOVADIS, ISO, Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)
Controlled Substances: Lowest potential for abuse
BSL (Biological Safety Level): 3, 1, 2
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

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
Batch Size: Small, Medium, Large
Use: Human
Services: Logistics, Manufacturing services, Packaging
Region: North America
Markets: FDA (USA), Health Canada (Canada)
Compliance: FDA (cGMP), NSF, Halal Research Council, Health Canada (Canada GMP)
Category / Product: NUTRACEUTICALS
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合同开发和制造组织 (CDMO),专注于重组蛋白和单克隆抗体 (mAb)。
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您值得信赖的 GMP CDMO,适用于先进的无菌和非无菌药品制造、配方开发和分析测试。
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商业 API 小分子合成。
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这些设施符合您的主要标准,但不符合所有可选过滤器。
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制药 CRO/CMO
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用于高度复杂小分子 API 的先进 CDMO 平台,波多黎各瓜亚马。概述 Skalar Pharma 经营着最成熟的 API 制造商之一
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卓越的质量和监管 • 符合 FDA cGMP(21 CFR 第 210 和 211 部分) • 操作符合 ICH Q7 • 全面的质量管理体系 • CAPA 和 C
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