Oxytocin change was approved by the EU, CEP certificate regain valid

At the end of 2015s and beginning of 2016s, our company relocated from Putuo district Shanghai to a new cGMP factory located in Qingpu district. As the GMP regulations required, manufacture position change belongs to big change, and during that time the CP upgrade from CP2010 to CP2015, which means the 6 major products(5 China GMP, 1 EU CEP) need to be changed and verified.

In 2016, on the efforts of each stuff of the company, the company obtained new GMP certificate successfully and finished changing 5 China GMP products during the first half year. During the second half year, all the stuff still working hard to submit the verification document and changing apply of Oxytocin CEP certificate.

Finally, Recently, the company has been informed by the EU office that our application of change and verification materials have passed the examination successfully, which means the Oxytocin CEP certificate regain valid.

So far, the GMP change re-verification work of the company's six main products has successfully passed the review by domestic and foreign regulatory agencies. The successfully passed of all varieties is inseparable from the hard work of all Soho-Yiming employees in their respective positions and the overall improvement of the company's new factory GMP management platform. We believe this will also have a positive impact on the company's subsequent performance.