Non-cGMP / cGMP 中試放大、注冊驗證和商業化生產：
國藥江蘇威奇達十余年致力于專攻原料藥生產及服務，持續完善全面的技術創新能力，為客戶提供醫藥定制研發、注冊驗證及生產服務，涵蓋了從小試、中試及小規模生產到商業化大規模的生產能力，能夠為客戶提供全面的原料藥、中間體生產定制服務。
工廠順利通過了 NMPA , FDA , EMA 等管理機構的官方現場檢查和認證，具有國際標準的質量體系、合規配套的 EHS 體系、以及大規模商業化 GMP 產品的生產經驗。
國藥江蘇威奇達能給客戶提供成本最優、質量最好的商業化 API 和 GMP 中間體產品及服務，同時依托中國醫藥集團研究院的強大資源，能夠為客戶提供二次工藝開發和優化等一系列附加服務。
●中國醫藥集團、上海現代制藥股份有限供公司全資子公司背景；
●位于長三角核心區（江蘇省南通市海門區臨江工業園區），毗鄰上海（1.5h車程），交通便捷；
●占地面積260,000平方米（390畝）；
●已建成四個大車間8條生產線，獨立的氫化車間、溶媒回收車間，設備配套齊全，先進的DCS自控，配套完善的分析檢測、安全環保設備設施；
●設置了2個獨立且功能強大的分析部門，能夠有效支持non-GMP/cGMP產品生產的過程檢測和終產品放行；
擅長：
常溫常壓精細化全流程化工單元操作控制；疊氮化、鹵化反應（溴化、氯化等）；高壓催化加氫（6MPa, GL / ss ,100-1000L)；低溫（-80℃,300L-1000L)、高溫（350℃,300L-1000L)反應；高真空（-50Pa)蒸餾、精餾；中壓柱層析分離；離子交換樹脂、電滲析、膜分離等等……
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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.