Guobang Pharma Ltd. (SH: 605507) has announced that its wholly-owned subsidiary, Zhejiang Guobang Pharmaceutical Co., Ltd., has received an "A" status for the pharmaceutical excipient 培化二肉豆蔻酸甘油酯 (for injection) following a joint review with the Center for Drug Evaluation (CDE) of the National Medical Products Administration.
The company learned of this development through the CDE's "Registration Information for Raw Materials, Excipients, and Packaging Materials" platform. The excipient's registration status has now been upgraded to "A" after passing the joint review with drug formulations.
This regulatory milestone satisfies the supply requirements for downstream customers to begin commercial production of their formulations. Management expects this approval to have a positive impact on the market expansion of the company's pharmaceutical excipient business.