CMO业务

Non-cGMP / cGMP 中试放大、注册验证和商业化生产:

国药江苏威奇达十余年致力于专攻原料药生产及服务,持续完善全面的技术创新能力,为客户提供医药定制研发、注册验证及生产服务,涵盖了从小试、中试及小规模生产到商业化大规模的生产能力,能够为客户提供全面的原料药、中间体生产定制服务。

工厂顺利通过了 NMPA , FDA , EMA 等管理机构的官方现场检查和认证,具有国际标准的质量体系、合规配套的 EHS 体系、以及大规模商业化 GMP 产品的生产经验。

国药江苏威奇达能给客户提供成本最优、质量最好的商业化 API 和 GMP 中间体产品及服务,同时依托中国医药集团研究院的强大资源,能够为客户提供二次工艺开发和优化等一系列附加服务。

 

●中国医药集团、上海现代制药股份有限供公司全资子公司背景;

●位于长三角核心区(江苏省南通市海门区临江工业园区),毗邻上海(1.5h车程),交通便捷;

●占地面积260,000平方米(390亩);

●已建成四个大车间8条生产线,独立的氢化车间、溶媒回收车间,设备配套齐全,先进的DCS自控,配套完善的分析检测、安全环保设备设施;

●设置了2个独立且功能强大的分析部门,能够有效支持non-GMP/cGMP产品生产的过程检测和终产品放行;

 

擅长:
常温常压精细化全流程化工单元操作控制;叠氮化、卤化反应(溴化、氯化等);高压催化加氢(6MPa, GL / ss ,100-1000L);低温(-80℃,300L-1000L)、高温(350℃,300L-1000L)反应;高真空(-50Pa)蒸馏、精馏;中压柱层析分离;离子交换树脂、电渗析、膜分离等等……

 

  • Non-cGMP / cGMP Pilot Scale-up, Registration Validation and Commercialization:

  • Sinopharm Jiangsu Weiqida has been dedicated to the production and service of featured APIs for more than ten years, and kept on improving its comprehensive technical innovation capability, providing customers with pharmaceutical custom R&D, registration validation and production services, covering all stages from small pilot, pilot and small scale production to commercial large scale production capacity, providing customers with comprehensive custom services for APIs and intermediates.
  • Our company has successfully passed the on-site inspections and received certifications from NMPA, FDA, EMA and other pharmaceutical regulatory authorities. The facility has been designed with international standard quality system, compliant EHS system, and experience in large-scale commercial production of GMP products.
  • We can provide the best cost-efficient commercial APIs and intermediate products as well as services, with the best quality and GMP-compliant to our customers, and also provide a series of additional choices such as secondary process development and optimization by relying on the strong resources of China Pharmaceutical Group Research Institute.
  • Background of China National Pharmaceutical Group Co., Ltd. (Sinopharm) and wholly-owned subsidiary of Shanghai Shyndec Pharmaceutical Co., Ltd.
  • Located at the core area of Yangtze River Delta (Linjiang Industrial Park, Haimen District, Nantong City, Jiangsu Province) with convenient transportation near Shanghai (1.5h drive).
  • Covering an area of 260,000 square meters (390 mu).
  • Four large workshops with 8 production lines have been built, independent hydrogenation workshop and solvent recovery workshop with complete equipment, advanced DCS automatic control, supporting perfect analysis and testing, safety and environmental protection equipment and facilities.
  • Two independent and powerful analytical departments are set up to effectively support the process testing and final product release of non-GMP/cGMP product manufacturing.
  • We are good at:
  • Operation control of the whole process chemical unit at room temperature and pressure refinement; Azide and Halogenation reaction (bromination, chlorination, etc.); High pressure catalytic hydrogenation (6MPa, GL/ss ,100-1000L); Low temperature (-80℃,300L-1000L); High temperature (350℃,300L-1000L) reaction; High vacuum (-50Pa) distillation; Distillation; Medium pressure column chromatographic separation; Ion exchange resin; Electrodialysis; Membrane separation, etc.
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