华润双鹤: 华润双鹤关于控股子公司浙江新赛科药业有限公司通过GMP符合性检查的公告

Core Viewpoint - The announcement highlights that China Resources Double Crane Pharmaceutical Co., Ltd.'s subsidiary, Zhejiang Xinsai Pharmaceutical Co., Ltd., has successfully passed the GMP compliance inspection for two raw materials, Fenofibrate and Azilsartan, indicating adherence to quality management standards [1][2]. Group 1: GMP Compliance Inspection - Zhejiang Xinsai received GMP compliance inspection notices for Fenofibrate and Azilsartan raw materials from the Zhejiang Provincial Drug Administration [1]. - The inspection covered production lines for Fenofibrate in workshop 201 and Azilsartan in workshop 101, confirming that both meet the requirements of the 2010 revised Good Manufacturing Practice (GMP) standards [1][2]. Group 2: Production Capacity and Market Context - The inspection is the first GMP compliance check for these raw materials prior to their market launch, utilizing existing facilities without additional capital investment [1]. - There are currently 9 registered manufacturers for Fenofibrate and 13 for Azilsartan in the CDE database, indicating a competitive market landscape [2]. Group 3: Impact on the Company - The successful GMP compliance will help the company maintain stable product quality and production capacity to meet market demand [3]. - The inspection results are not expected to have a significant impact on the company's financial performance [3].