Guobang Pharma Ltd. (605507.SH) subsidiary product pegylated dimyristoyl glycerol passes CDE and formulation joint review and approval
Guobang Pharma Ltd. (605507.SH) announced that the company recently learned from the National Medical Products Administration Center for Drug Evaluation (CDE) "Raw and Auxiliary Materials and Packaging Registration Information" platform that the pharmaceutical excipient "pegylated dimyristoyl glycerol (for injection)" submitted by its wholly-owned subsidiary Zhejiang Guobang Pharmaceutical Co., Ltd. has received an "A" rating in the CDE joint review and approval with formulations.
Guobang Pharma Ltd. (605507.SH) announced that the company recently learned from the "Raw and Auxiliary Materials and Packaging Materials Registration Information" platform of the Center for Drug Evaluation (CDE) of the National Medical Products Administration that the pharmaceutical excipient "pegylated dimyristoyl glycerol (for injection)" submitted by its wholly-owned subsidiary Zhejiang Guobang Pharmaceutical Co., Ltd. has passed the CDE joint review and approval with the formulation, with a result of A.
The passing of the CDE joint review and approval with the formulation for pegylated dimyristoyl glycerol this time has changed the excipient registration status to A, meeting the supply conditions for downstream customers' commercial production of formulations, and is expected to bring a positive impact on the market expansion of the company's pharmaceutical excipient business.
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