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CPRI is committed to offering our customer with broad range of reliable services including contracted R&D of generics, improved drug and innovative drug, CMC research of innovative drugs, pharmaceutical study of quality consistency evaluation for generic drugs and regulatory registration. Meanwhile, methodology development for specific analytical purpose, custom synthesis of API impurities and optimization of industrial manufacturing process are also included.
We have a professional team engaged in managing clinical research for many years and directly led by a group of experts with in-depth insight in project design, experiment organization and coordination by applying a robust quality management system. They are responsible for preparation and organization of clinical study activities and BE study of new drug product and managed to maintain long-term and good relations with many clinical trial center.
1)Manufacturing CapabilitiesChongqing RuiZhe Pharmaceutical Co., Ltd. (hereinafter referred to RuiZhe Pharmaceutical), wasfounded in Changshou District, Chongqing in 2012. As CPRI’s pilot scale-up manufacturing site, it is also well known for being one of new drug industrialization andincubation base in Chongqing. Ruizhe has been mostly engaged in process development activities for high-tec,high value-added API and advanced intermediates by adopting a patent designing-around strategy to support manufacturing process development enabling our customer to file an ANDA application with PIV certification. Key products had been regulatory approved by US FDA, CFDA, EDQM, Korea FDA, Japan PMDA andAustralia TGA, 80% of which exported overseas to US/EU market.  Ruizhe had been constructed in ...
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Tel: 86-023-62505954
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E-mail:cpri@cpri.com.cn
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