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On the evening of May 5, Kexing Biopharm (stock code: 688136) announced it had obtained a "Certificate of GMP Compliance of a Manufacturer" granted by the Norwegian Medical Products Agency in accordance with the European Medicines Agency (EMA) regulations.
The certification is a milestone for Kexing Biopharm, whose first drug for cancer therapy, Paclitaxel for Injection (Albumin Bound) , can now be registered in the EU as the company overcomes the primary obstacle and officially embarks on its journey into the EU pharmaceutical market.
Since its initial public offering, Kexing Biopharm has actualized international strategies, focusing on high clinical value, a high technical level, high international quality management and registration standards, and fast commercialization to expand its portfolio to 13 products. Paclitaxel for Injection (Albumin Bound) is Kexing Biopharm's first drug for cancer therapy. The manufacturing of the drug requires production equipment of a higher level, technical expertise of an advanced level, incredibly stringent aseptic management of the lean manufacturing process, and pharmaceutical processes of great complexity. The potential of the drug on the EU market prompted Kexing Biopharm to establish an EU cGMP-compliant brand-new production line that would enable the company to integrate research, production and marketing to capitalize more effectively on market opportunities.
Kexing Biopharm
sales@kexing.com
