Guobang Pharmaceutical (605507.SH) subsidiary's cultured dimyristate glyceride passed the joint review and approval of the CDE and formulation

Zhitongcaijing · 2d ago

Zhitong Finance App News, Guobang Pharmaceutical (605507.SH) issued an announcement. The company recently learned from an inquiry on the “Original Auxiliary Package Registration Information” platform of the Drug Evaluation Center (CDE) of the China Drug Administration that the joint review and approval results for the “cultured dimyristate glyceride (for injection)” pharmaceutical excipient CDE and formulation submitted by Zhejiang Guobang Pharmaceutical Co., Ltd., a wholly-owned subsidiary, were A.

Cultivated glyceryl dimyristate has now passed the joint review and approval of the drug evaluation center (CDE) and the formulation. The registration status of the excipient was changed to A status, which met the supply conditions for commercial production of downstream customer formulations, and is expected to have a positive impact on the market expansion of the company's pharmaceutical excipients business.