Shandong Binzhou Zhiyuan Biotechnology Co.,Ltd
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    Shandong Binzhou Zhiyuan Biotechnology Co.,Ltd

    Tel: +86-543-2616568

    Fax: +86-543-2605568

    Email: info@cydextrin.com

    Add: Boxing Economic Development Zone, Binzhou, Shandong, China

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Our Company Hydroxypropyl Beta Cyclodextrin And Sulfobutyl Ether Beta Cyclodextrin Sodium Salt Obtained United States Food And Drug Administration (FDA) DMF Record Certificate

In January 22, 2016, the two products of Shandong Binzhou Zhiyuan Biotechnology Co. Ltd. passed the DMF audit record.


Approved by the US Food and Drug Administration (abbreviated FDA) lasted six month review, verification and certification, the company developed products Hydroxypropyl Beta Cyclodextrin and Sulfobutyl Ether Beta Cyclodextrin Sodium Salt are in line with the US food and Drug Administration (FDA) standard requirements, so they are approved for registration.The record number of Hydroxypropyl Beta Cyclodextrin is 030168,and Sulfobutyl Ether Beta Cyclodextrin Sodium Salt record number is 030167.


The U.S. Food and Drug Administration (FDA) is an international medical audit authority and authorized by the Congress of the United States that the federal government, specializing in the food and drug administration, the executive body of the highest organ of that in the world, FDA has been recognized for is one of the world's largest food and drug administration. According to the United States federal management law and drugs into the United States must be to the United States FDA approval for registration and submit the relevant documents, chemical raw material medicine according to the requirements submitted a drug master file (DMF), so that the FDA of the products of this factory have a comprehensive understanding, including production, processing, packaging and storage of a drug with specific facilities and monitoring data to determine the production of drugs is through the GMP and guaranteed.


Our company’s implementation of the "Quality by Design" concept of the production, will be closely integrated R & D and production quality, the new GMP concept throughout the development, production, circulation and always make sure our products quality are consistent and persistent. The US Food and Drug Administration registration to open a new milestone for us to better serve the world's pharmaceutical industry.

Contact Us
Address: Boxing Economic Development Zone, Binzhou, Shandong, China
Tel: +86-0543-2616568
 Fax:+86-543-2605568
 E-mail:info@cydextrin.com
Shandong Binzhou Zhiyuan Biotechnology Co.,Ltd
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