山东步长制药股份有限公司关于全资子公司药品生产许可证变更的公告

Core Viewpoint - The announcement highlights the approval of changes to the drug production license of Baoding Tianhao Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Shandong Buchang Pharmaceutical Co., Ltd., which is expected to optimize production structure and maintain stable production capacity to meet market demand [1][4]. Summary by Sections Drug Production License Information - Baoding Tianhao Pharmaceutical Co., Ltd. has received permission from the Hebei Provincial Drug Administration to change the production scope and drug commissioning details of its drug production license [1]. - The production address is located at 128 Xinghua East Road, Dingxing County, Hebei Province, and the license is valid until July 7, 2030 [1]. Changes in Production Lines - The production line at Tianjin Hanrui Pharmaceutical Co., Ltd. has changed from "oral suspension" to "oral suspension (Oseltamivir phosphate dry suspension)" [2]. - The production line at Shandong Buchang Pharmaceutical Co., Ltd. has changed from "tablets" to "tablets (Donepezil hydrochloride tablets)" [2]. - The production line at Yangling Buchang Pharmaceutical Co., Ltd. has changed from "tablets" to "tablets (Sitagliptin and Metformin sustained-release tablets), tablets (Compound Sodium Sulfate tablets)" [2]. Commissioning Details - Baoding Tianhao Pharmaceutical Co., Ltd. has commissioned Shandong Buchang Pharmaceutical Co., Ltd. to produce Donepezil hydrochloride tablets, with the production address at 1566 Zhonghua West Road, Heze City, and the commissioning is valid until July 7, 2030 [3]. Impact on Future Operations - The changes in the drug production license are expected to positively impact the company's future operations by optimizing production structure and ensuring stable production capacity to meet market demand [4].