Boteng Co., Ltd. (300363.SZ) subsidiary Boteng Zhituo passed the EU QP audit

According to Zhitong Finance App, Boteng Co., Ltd. (300363.SZ) issued an announcement. Shanghai Boteng Zhituo Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Boteng Zhituo”), a wholly-owned subsidiary of the company, recently obtained a declaration of compliance issued by the EU Qualified Person (QP) and successfully passed the EU QP audit.

The audit was based on EU GMP Guidelines EudraLex Volume 4, EU Clinical Trial Regulation, GMP for IMP, and ICH Q7. The scope of the audit covered quality management, production management, plant equipment and facilities, material systems, packaging and labeling systems for small molecule and new molecule API businesses. The successful completion of the QP audit indicates that Boteng Zhituo's quality management system has reached EU GMP standards and can provide global customers with customized R&D and production services for small molecules, peptides and oligonucleotides, proteins and conjugated drugs that meet international standards.