Recently, Shandong Lixin Pharmaceutical Co., Ltd. received the CEP certificate for Nilotinib HCl issued by the European Directorate for the Quality of Medicines & HealthCare (EDQM). It indicates that the product quality, R&D and technical capability of this API has been recognized by the European regulated market.

With the obtaining of this CEP certificate, Lixin Pharmaceutical has become the first pharmaceutical company in China to obtain the CEP certificate of Nilotinib HCL, and also increased the number of CEP certificates of Lixin Pharmaceutical to eight. In June 2022, Suzhou Lixin Pharmaceutical obtained the first generics approval for its Nilotinib HCl API and its related preparations from the U.S. FDA, and in November 2022, Shandong Lixin Pharmaceutical obtained the first generics approval [Registration No. Y20210000245] for its Nilotinib HCl in China. The three “firsts” will surely become important milestones in Lixin Pharmaceutical's global layout.

Nilotinib HCl is a highly selective tyrosine kinase inhibitor anti-tumor drug used for the effective treatment of chronic myeloid leukemia patients who develop resistance or intolerance. The synthesis process of Nilotinib HCl is complex and requires high quality. The R&D team of Lixin Pharmaceutical has concentrated its advantageous resources to overcome difficulties along the way, successfully breaking through a number of technical barriers, and forming technical achievements with distinctive features and competitive advantages in many aspects, such as the green process, impurity research, and crystalline particle size. In order to better utilize and expand the significant advantages of this variety in technology, quality and service, Lixin Pharmaceuticals has synchronously carried out regulatory registration and market expansion in Russia, Canada, South America, the Middle East and Africa.

Lixin Pharmaceutical adheres to global standards and has been certified by authoritative institutions such as FDA, EDQM, EMA, and PMDA multiple times. In the future, Lixin Pharmaceutical will further accelerate the process of international registration, enhance the market share and influence of its products in the international market, and provide high-quality integrated services for global partners.