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R&D &MAH

CDMO&MAH

Process development
The company development process can be used for clinical and non-clinical, commercial production using advanced intermediates and apis.Our development team in the pharmaceutical industry, for the development of the synthesis process route and industrialization have years of experience.We based on your quality design products and services, and strive to exceed your expectations.
Our core competence is to:
•Route selection: based on the safety, quality and cost to choose the best route.
Technology development: high quality, low cost and good stability of process
• Impurity research: according to the ICH guidelines, impurity profile
• Amplification, process and technology transfer: kg to t products produced steadily
• The industry's leading asymmetric catalysis and enzyme catalysis technology
• In-depth analysis of the service
Scale-up and transfer of technology including: the establishment of the range of acceptable process parameters, the determination of key process parameters, production process and analysis method of authentication.According to customer needs, our quality assurance and registration team can provide you chemical production and control applications provide data support and service.

co-production
Our production team of experts can provide a wide range of service technology and analysis, in order to achieve excellent quality and yield.
We offer a variety of production services, including up to commercial scale of GMP/ISO intermediates production, as well as in the GMP workshop kg to commercial scale production of active pharmaceutical ingredients and intermediates.
• Kg to dozens of tons of production capacity
• Reliable quality system and successful batch records to track
• In support of registration, chemical production and can provide comprehensive control documents
• Strict quality, occupational health and safety standards
• With our business cooperation in the development and production, you can focus on more rapid development product, and simplify the supply chain management.

MAH Service
Companies actively implement drug marketing authorisation holder system, acceptable MAH services, sincerely welcome all kinds of raw materials for new drugs project joint declaration with our company
• Reliable production quality system and successful batch records to track
• Perfect EHS system
• A strict system of intellectual property, and technical secrecy
• According to customer demand, provide research and development, the success of the listed products registration, production, sales through-train service

 

Contact Us

  • Sales Department I:
    Contact:Kirsten Jiang
    TEL:+86-025-84351604/13057662806
    QQ:在线联系
  • Sales Department II
    Contact:Dannie Lee
    TEL:+86-025-84352267/15150674956
    QQ:在线联系
  • Sales Department III
    Contact:Ms.zhu
    TEL:+86-025-84351676/13809032362
    QQ:在线联系
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