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GMP management system
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Innovation strength
Innovation strength
Adhering to the concept of treating product quality as enterprise life, the company enhances risk management and sets up and completes the quality management system as per the requirements of GMP.
1. The company has 20,000 m2 cyclodextrin production base and clean production workshop conforming to GMP;
2. It has advanced quality control instruments worth of over RMB 13 million;
3. Its quality management system passes ISO9001 Quality Management System Certification;
4. Its quality management system is accepted by well-known domestic and foreign pharmaceutical enterprises such as Teva, Mylan, Yangtze River Pharmaceutical Group, Hengrui Medicine, Qilu Pharmaceutical and Poly Pharm. The company has become their stable supplier.
Product quality meets several standards such as ChP, USP and EP.
It launches “conformity” evaluation of excipient. Functional and safety indexes of its products are not inferior to and even superior than the reference listed drug.
With reference to ICH research principle, the company strives to enhance integrity of pharmaceutical excipient data and guarantee safe and effective excipient through process control.
Creativity
China Cyclodextrin Application Research Center (co-built with China Pharmaceutical University) Zibo Cyclodextrin Center, State Key Laboratory of Food Science and Technology (co-built with Jiangnan University) |
China's First Cyclodextrin Academic Summit Forum The 2nd China Cyclodextrin Academic Summit Forum |
3 national invention patents were approved Enter 8 items in the final section of the trial Approved 18 utility model patents |
Zibo Enterprise Technology Center Zibo Cyclodextrin Engineering Laboratory Zibo Cyclodextrin Engineering Technology Research Center |
In2021
● Shandong Provincial central guide local science and technology development fund project
In 2020
● Key Special Project of “Technology Drives Economy 2020” of Ministry of Science and Technology
In 2019
●“Ten Innovative Enterprise Talents and Ten Innovative Project Talents” Plan Project of Zibo High-tech Innovation
In 2018
● Major Special Scientific Sub-topic of “Major New Drug Creation” of National Health Commission
In 2017
● National Innovation Demonstration Zone (Zibo) Construction and Development Project on Shandong Peninsula
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