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华润双鹤:关于控股子公司通过GMP符合性检查的公告
Zheng Quan Ri Bao· 2025-09-02 14:11
Core Viewpoint - Recently, China Resources Double Crane announced that its subsidiary, Zhejiang Xinsai Pharmaceutical Co., Ltd., received a GMP compliance inspection notice for the active pharmaceutical ingredients of Fenofibrate and Azilsartan from the Zhejiang Provincial Drug Administration [2] Group 1 - The company has received regulatory approval for two key pharmaceutical products [2] - The approval is significant for the company's production capabilities and market positioning in the pharmaceutical industry [2] - This development may enhance the company's competitive edge in the active pharmaceutical ingredient market [2]
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
Zheng Quan Zhi Xing· 2025-09-02 10:25
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].
华润双鹤:控股子公司浙江新赛科药业有限公司通过GMP符合性检查
Mei Ri Jing Ji Xin Wen· 2025-09-02 09:57
Core Viewpoint - China Resources Double Crane (华润双鹤) announced that its subsidiary, Zhejiang Xinsai Ke, received a GMP compliance inspection notice from the Zhejiang Provincial Drug Administration for the active pharmaceutical ingredients (APIs) of Fenofibrate and Azilsartan. This marks the first inspection before the market launch of these APIs, and no additional funding was required for this process [1]. Summary by Category - **Company Announcement** - China Resources Double Crane's subsidiary, Zhejiang Xinsai Ke, has received a GMP compliance inspection notice for Fenofibrate and Azilsartan APIs [1]. - This inspection is the first before the market launch of these products [1]. - The company did not incur any additional costs for this inspection [1].
华润双鹤控股子公司浙江新赛科通过GMP符合性检查
Zhi Tong Cai Jing· 2025-09-02 09:45
Core Viewpoint - China Resources Double Crane (600062.SH) announced that its subsidiary, Zhejiang Xinsai Pharmaceutical Co., Ltd., received a GMP compliance inspection notice from the Zhejiang Provincial Drug Administration for the raw materials of Fenofibrate and Azilsartan [1] Group 1 - The successful GMP compliance inspection indicates that the company's production quality management meets GMP requirements [1] - This achievement will help the company maintain stable product quality and continuous production capacity [1] - The company aims to meet the market demand for related pharmaceuticals [1]
华润双鹤(600062.SH)控股子公司浙江新赛科通过GMP符合性检查
智通财经网· 2025-09-02 09:41
Core Viewpoint - China Resources Double Crane (600062.SH) announced that its subsidiary, Zhejiang Xinsai Pharmaceutical Co., Ltd., received a GMP compliance inspection notice from the Zhejiang Provincial Drug Administration for the active pharmaceutical ingredients of Fenofibric Acid and Azilsartan [1] Group 1 - The successful GMP compliance inspection indicates that the company's product quality management meets GMP requirements [1] - This achievement will help the company maintain stable product quality and continuous production capacity [1] - The company aims to meet the market demand for related pharmaceuticals [1]
华润双鹤:子公司产品获药品补充申请批准
news flash· 2025-04-16 08:55
Core Viewpoint - China Resources Double Crane (华润双鹤) has received approval for two significant pharmaceutical products, indicating potential growth in its product portfolio and market presence [1] Group 1: Product Approvals - The wholly-owned subsidiary, China Resources Zizhu Pharmaceutical Co., Ltd., received a drug supplement approval notice for Olopatadine Hydrochloride Eye Drops from the National Medical Products Administration (NMPA) [1] - The approval notice numbers are 2025B01154 and 2025B01155, highlighting the regulatory progress for the product [1] - The eye drops are intended for treating the signs and symptoms of allergic conjunctivitis, developed in collaboration with Nanjing Hengdao Pharmaceutical Technology Co., Ltd. [1] Group 2: Raw Material Approval - The controlling subsidiary, Zhejiang Xinsai Pharmaceutical Co., Ltd., received a marketing approval notice for Fenofibrate Choline Raw Material from the NMPA [1] - The approval notice number is 2025YS00306, indicating successful regulatory compliance for the raw material [1] - Fenofibrate is used to lower triglyceride levels in patients with severe hypertriglyceridemia and for treating primary hypercholesterolemia or mixed dyslipidemia [1]