From July 25 to 28, 2016, our contract manufacturer-Chongqing Southwest No.2 Pharmaceutical Factory (hereinafter referred to as ‘SW#2’) passed the U.S. FDA GMP onsite audit with excellent performance. And this was the second time that SW#2 received the highest international standards of quality certification after the first time in 2012. It represented SW#2 became the only procaine hydrochloride manufacturer which passed the United States FDA certification.
In present times, FDA carries out increasingly strict inspections to Chinese pharmaceutical industry and data integrity problems frequently emerge, it is really difficult to reach the “0-483” conclusion. This is the inevitable result of SW#2 firm implementation of cGMP management, technological progress and internationalization strategy, it reflects the strong international competitiveness of their products and lays a solid foundation for their products accessing to the US and European high-end markets. This is also the result of working closely together with Pharmax and the long-term win-win model of inter-firm cooperation.
