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    Tel: Tel:+86-531-88729285

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  • Tel:Tel:+86-531-88729285
  • Fax::+86-531-88729257
  • Province/state:Shandong
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  • Street:8169Jingshidong Rd linuo hi-tech zone Jinan
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    About us
  • Welcome To Our Site!

  • Shandong Keyuan Pharmaceutical Co., Ltd is a high technology enterprise mainly focused on the development, manufacture and marketing of Active Pharmaceutical ingredients (APIs). As a result of the strategic cooperation between Linuo Group and Shandong Pharmaceutical Industrial Research institute (SDPIRI), Keyuan Pharm heritages the innovative spirit from its parent company. When it was founded in July 1992, it was only a medium trial base under SDPIRI while the new GMP plant with total investment of millions of US dollars in Shanghe County marks the new stage of its development. In May 2004, we received the GMP certificates for the 15 APIs manufactured in the new plant. In 2005, we received the GMP certificates for the 4 new products.

    With years of experience in API field, Keyuan Pharm has become a pioneer with the support from its key products: Gliclazide、Isosorbide Mononitrate、Isoflurane、Xanthinol Nicotinate、3-Amino-3-Azabicyclo[3.3.0]Octane、Clarithromycin Lactobionate、Metformin Hydrochloride、Ropivacaine Hydrochloride、Amlexanox、Esmolol Hydrochloride,etc.

    With the goal of becoming a leading player in the manufacturing of anti-diabetes, cardiovascular and inhalent anesthetics APIs, Keyuan Pharm will contribute more to the development of national pharmaceutical industry.

    Chinese GMP Certificate
    EDQM COS Certificate
    Korean FDA Certificate
    Japanese Ministry of Health Certificate
    South African Department of Health Certificate
    Indian CDSCO Certificate
    Israel Ministry of Health Certificate
    Pakistan Ministry of Health Certificate
    Passed the supplier auditing of Sanofi Aventis
    Passed the supplier auditing of Actavis
    Passde the supplier auditing of RatioPharm
    Passde the supplier auditing of Teva
    Applying for US FDA Certificate
    Applying for Australia TGA Certificate

  • Process Capability :    Quality management department consisting of QC and QA is an effective system for managing quality under the authorization of General Manager. All parts of quality management department are adequately resourced with competent personnel who could fulfill both quality assurance and quality control responsibilities. We have established an effective quality managing system, covering the whole process from the coming of raw materials and the releasing of final products. Our laboratory is equipped with advanced testing instruments and all the production related raw materials, packing materials, intermediates could not be released until approved by QA. The 960 SOPs, records, management documents we have established could cover the whole process of production to minimize the happening

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