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生产制造

服务领域和我们的优势

设施

工厂面积:20,000平方英尺

每日废水处理量:50吨

设施:盐水冷冻、压缩空气、去离子水等装置

蒸汽:工业园集中提供

Non-GMP公斤级实验室:17个反应釜(50-100L)

cGMP公斤级实验室:5个反应釜(100-200L)

Non-GMP中试工厂:20个反应釜(300-5000L)

我们的优势

健全的质量管理体系

桑迪亚的质量保证部门已经建立了一套符合中、美FDA cGMP质量体系,从原材料到产品,实验室到中试工厂,操作工到首席执行官,我们都建立了近百条标准操作规程以确保我们提供的服务和产品的质量。我们的员工在每次独立完成客户项目之前都会在包括操作、安全性、数据完整性、保密性等各方面经过严格培训合格后参与工作。桑迪亚已经成功通过了数百个来自全球制药公司和药监局的审计以及现场核查

质量保证

我们建立了标准的操作规程、培训管理、良好的文档实践、存档管理、材料管理、规范管理、供应商资质和合同制造商资质,校准、维护,质量意外管理包括服务偏差、服务中断、客户投诉、产品召回以及变更控制、验证和资质管理、包装和标签管理、内部审计和例行检查

完善的EHS体系

EHS方针

严格遵守所有适用的国家法律、法规和标准

建立并实施良好的公司内部的各项EHS制度与管理程序

EHS职责

EHS部门负责提供安全指导,对所有危险反应进行专业培训,负责作业现场的安全,负责常规安全评估报告以及其他安全相关事务

可持续发展目标

严格控制废气废液排放,提高废弃物处理能力以尽量减少对环境的影响

我们的优势

通过多家国际大型制药公司EHS, GMP查核:

Clients Indications Sundia Support
Amount Status Description
US Rare Disease 2kg (2013) , 8 kg (2014) Phase III Providing GMP starting material
US Oncology 15kg (2013~2014)
20kg (2015~2016)
Phase II/III API production
US Oncology 5kg (2015~2016) PCD API production
US Oncology 150kg (2015~2016) PCD Providing GMP starting material
Canada Breast cancer 30kg (2015~2016) Phase I API production
Korea Inflammatory disease 4kg (2014), 10kg (2015~2016) Phase II API production
Korea Oncology 20kg (2015~2016) PCD Providing GMP starting material
Korea Antibiotics 5 kg (2014) PCD Providing GMP starting material
Korea Lung cancer 1500kg (2013~2014)
1500kg (2015~2016)
Phase III Providing GMP starting material
EU Chemotherapy-induced Neuropathic Pain 1 kg (2015) Phase I API process develop
7 kg (2015) Providing GMP starting material
Australia N/A 10kg (2015~2016) PCD API/GMP starting material
EU Rare Disease 100kg (2015~2016) Phase III Providing GMP starting material
UK N/A 100kg (2015)
200kg (2016)
Phase I Provide Material for GMP production
China Anti-HIV 20kg (2015~2016) Phase I API production
China Oncology 30kg (2016) Phase I Providing GMP starting material
China Oncology 100kg (2015~2016) PCD Providing GMP starting material
China Antilipemic 10kg (2015~2016) Phase I API production
China Lung cancer 5kg (2014)
10kg (2015~2016)
Phase I API production
China Oncology 5kg (2015) Phase I API production
Taiwan Periodic Paralysis 2kg (2015) PCD API production
Japan N/A 100kg(2015), 500kg (2016) N/A Provide Material for GMP production
Japan N/A 1kg (2015), 40kg (2016) N/A Provide Material for GMP production

IND中报项目:

Classification Pharmacology Indications
Chemical Drug 1.1 RR inhibitor Cancer
Chemical Drug 1.1 Multi targeted RTK inhibitor Cancer
Macular degeneration
Herbal Medicine 5 Non hormones Endometriosis
Chemical Drug 1.5 Prescription Common cold
Chemical Drug 1.1 NP inhibitor Cancer
Chemical Drug 1.1 Neuroprotectant Stroke
Chemical Drug 1.1 ALK/MET inhibitor Cancer
Chemical Drug 1.1 LDLR regulator Hyperlipoidemia
Chemical Drug 1.1 Multi targeted RTK inhibitor Cancer
Chemical Drug 1.1 b-RAF inhibitor Cancer
Chemical Drug 1.1 Protease inhibitor Cancer
Chemical Drug 1.1 mTOR inhibitor Cancer
Chemical Drug 1.1 NS3-4A Protease inhibitor HCV
Chemical Drug 1.1 Multi targeted RTK inhibitor Cancer
Chemical Drug 1.1 MEK inhibitor Cancer
Chemical Drug 1.1 Pro drug Leukemia
Chemical Drug 1.1 Multi targeted drug Senile dementia
Chemical Drug 1.1 PARP inhibitor Cancer
Chemical Drug 1.1 Peptide Pro drug Cancer
Chemical Drug 1.1 Confidential Diabetes
Chemical Drug 1.1 Confidential Cancer
Chemical Drug 1.1 Antivirus Confidential
Chemical Drug 1.1 Confidential Cancer