Changzhou Yinsheng Pharmaceutical Co., Ltd.

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Engineering Center
Introduction

Jiangsu Blood and Infectious Disease Pharmaceutical Engineering Technology Research Center (hereinafter referred to as "center") was founded in 2015 based on Changzhou Yinsheng Pharmacy Co., Ltd. The center is specialized in laboratory scale test, pilot scale test and industrialization study of bulk drug and preparations as well as carries out registration and declaration research and clinical test research management of products. The center has many bulk drug and preparation test equipment such as high performance liquid chromatographs, gas chromatographs, infra-red spectrophotometers and atomic absorption spectrometers, 500㎡ bulk drug GMP production workshop and 1500㎡ preparation production site.


The research by the center covers the whole process of registration and declaration of drugs, including technical study of bulk drug, technical study of preparations, research and establishment of drug quality standard, registration and declaration of drugs, clinical trials of drugs, production process validation, GMP certification and FDA certification, etc. 


Based on technology and talent advantage of national key laboratory for biotherapy of Sichuan University, the center widely carries out industry-university- research cooperation as well as implements several industry-university- research cooperation development projects with Sichuan University, WuXiAppTec Group, China Pharmaceutical University, Changzhou University and Nanjing Tech University. The center introduces one "innovative and entrepreneurial talent" in Jiangsu Province, one creative cloud plan talent in Changzhou City and one "innovative and entrepreneurial doctor" in Jiangsu Province. As one research-based engineering center, the center has declared 3 approved documents regarding clinical trials of drugs and gotten 2 approved documents as well as pushed drugs to Phase I and Phase II clinical application with one reviewed. The center is also carrying out generic drug consistency evaluation or bioequivalence research. When the center helps Changzhou Yinsheng Pharmacy Co., Ltd. development, it also provides services to Yinsheng Pharmacy Co., Ltd. such as technical service or practical training of talent cultivation as well as establishes the training base of bachelor or doctor talents together with Sichuan University and Changzhou University.

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