Qualification Certificate：
1.Drug Manufacturer License( No. Ha20060331, issued by HUBEI FDA )
2.GMP Certificate(No. I0322, issued by HUBEI FDA)
3.Free Sale Certificate(No. 2012-041, issued by HUBEI FDA )
4.Registration certificates of 4 foreign countries
Quality Management System：
Good quality management system is established, which applies to the whole lifecycle of the product. The quality director is responsible for supervision and maintaining the system to ensure the effective operation.
The quality department that is independent of production is established, which fulfills both quality assurance (QA) and quality control (QC) responsibilities.
The quality control system is established starting from the site audit to raw materials’ supplier’s to the products’ distribution. QA is responsible for supervision the implementation of the system.
The advanced testing instruments and equipments are equipped in labs, which is suitable for the production capacity. And the complete testing instruments are also equipped for the test of leading products - medium molecular weight Hydroxyethyl Starches, which conform the requirement of European Pharmacopoeia.
International regulatory affairs are the basis, which helps to develop the international market. The quality of Hydroxyethyl Starches product series can meet European Pharmacopoeia’s requirement. They have been filed in many countries, eg, India, Russia, Ukraine, Bangaladesh etc. Meanwhile, Hydroxyethyl Starches 130/0.4 CEP project is in progress.
Quality by Design and Focus on In-Process Control.
The advanced Quality Management Concept is going deep into enterprise’s GMP culture.
Production Facilities：
Hydroxyethyl Starches (API) manufacturing site: located in East Lake High-Tech Development Zone, Wuhan City, Hubei Province P. R. China. It has been initially founded in 2006 and already passed GMP audit conducted by SFDA China.
Polymer drug manufacturing site: located in Xingfu Industrial Park, Miaoshan Development zone, Jiangxia District, Wuhan City, Hubei Province P. R. China. The site is started to build in 2013. And a comprehensive pharmaceutical enterprise will be founded in the site, which manufactures Polymer APIs (Active Pharmaceutical Ingredients), finished products, high- technology medical equipments.