Company Profile

公司概況
  • Sinotherapeutics Inc. (SinoT) is a specialty pharmaceutical company based in China, focusing on developing generic products that are of high commercial value and possesses high technological barriers. The company is integrated with R&D, regulatory affairs for product registration with FDA and CFDA agencies, clinical supply and commercial manufacture, and sales and marketing capabilities. The company’s R & D Center is located in Pudong Zhangjiang disctrict, and manufacture facility, Haimen Pharma Inc., a wholly owned subsidiary, is located in Jiangxu province, Haimen City, which is about 2 hour drive from Shanghai.

    SinoT's R & D management team has an average of more than 15 years of experience with either large multinational pharmaceutical companies and or generic companies. Key members have led and participated in development of a variety of pharmaceutical products and advance them successfully to regulatory filings and approvals. In particular, the team has rich practical experience in formulation innovation product development and the product life cycle management (LCM), project management and enterprise management.

  • The company has established strong formulation platforms and infrastructures in supporting its business goals: (1) the R&D center is innovation and technology driven, capable of producing prototypes for feasibility testing as well as making pilot scale clinical supplies and developmental batches. The lab is well-equipped with a variety of modern pharmaceutical instruments and equipment. R & D personnel is well trained and qualified for challenging R&D tasks. (2) The quality system is conforming to international standards, and meet quality standards/expectations from US FDA, Chinese NMPA, and other regulatory bodies. (3) The regulatory department is capable of product filing with eCTD documentation and has direct connection with FDA via electronic gateways.

     

    The company has submitted successfully a number of products to the United States FDA and Chinese NMPA regulatory agencies for approval, of which 5 ANDA were approved by FDA and 2 by Chinese NMPA. The company is distributing several products in US via US partners as well as in China.

     

    The company foster good working environment and career growth opportunities for its staff, and will continue to enhance a culture that attracts talents from universities and research institutions from China and US.

     

    The company will also promote collaborations with potential partners on a global basis, and strive for achieving win-win results vial the collaborations.


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  • 12013.09

  • 1 2014

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