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湖南方盛制药股份有限公司关于公司通过药品GMP符合性检查的公告
Group 1 - The company, Hunan Fangsheng Pharmaceutical Co., Ltd., has received a GMP compliance inspection notice from the Hunan Provincial Drug Administration, indicating that its production lines meet the required standards [1][2]. - The inspection took place on July 8, and from July 15 to 17, 2025, focusing on the production lines for Ezetimibe and Benidipine in the raw material drug workshop [1]. - The inspection concluded that the company complies with the Drug Administration Law, the Drug Production Supervision and Administration Measures, and the Good Manufacturing Practice (GMP) standards [1][2]. Group 2 - The successful GMP compliance inspection is expected to enhance the company's ability to diversify its product offerings and maintain stable production capacity to meet market demand [2]. - The pharmaceutical industry is characterized by high technology, high risk, and high added value, which means that future sales of various products may be influenced by market conditions and industry policies, leading to significant uncertainty [2].
方盛制药(603998.SH):公司通过药品GMP符合性检查
Ge Long Hui A P P· 2025-12-16 08:56
Core Viewpoint - Fangsheng Pharmaceutical (603998.SH) has received a GMP compliance inspection notice from the Hunan Provincial Drug Administration, indicating that its production lines meet GMP requirements, which will help the company diversify its product offerings and maintain stable production capacity to meet market demand [1] Group 1 - The company received the GMP compliance inspection notice for its production facilities located in the Hunan Wangcheng Economic Development Zone [1] - The inspection covered the production lines for Ezetimibe and Benidipine in the raw material drug workshop [1] - The compliance with GMP standards is expected to enhance the company's ability to meet market needs and ensure stable production capabilities [1]
方盛制药(603998.SH)通过药品GMP符合性检查
智通财经网· 2025-12-16 08:51
Core Viewpoint - Fangsheng Pharmaceutical (603998.SH) has received a GMP compliance inspection notice from the Hunan Provincial Drug Administration, indicating regulatory approval for specific production lines [1] Group 1: Company Announcement - The company announced the receipt of the GMP compliance inspection notice [1] - The inspection covers the production lines for Ezetimibe and Benidipine in the raw material drug workshop [1] - Specific areas inspected include the B and E zones for Ezetimibe and the A and E zones for Benidipine [1]
方盛制药通过药品GMP符合性检查
Zhi Tong Cai Jing· 2025-12-16 08:50
Core Viewpoint - Fangsheng Pharmaceutical (603998.SH) has received a GMP compliance inspection notice from the Hunan Provincial Drug Administration, indicating progress in regulatory compliance for its production facilities [1] Group 1: Inspection Details - The inspection covers the production lines for Ezetimibe and Benidipine in the raw material drug workshop [1] - Specific areas inspected include Zone B and Zone E for Ezetimibe, and Zone A and Zone E for Benidipine in the raw material drug workshop [1]
湖南方盛制药股份有限公司关于公司《药品生产许可证》变更的公告
Core Points - The company has completed the change registration of its "Drug Production License" and obtained the new license from the Hunan Provincial Drug Administration [1] - The validity of the "Drug Production License" has been extended to October 16, 2030 [1][3] - The company has made several changes to its production lines and added new products to its production scope [1][3] License Change Details - The license validity has been extended from December 3, 2025, to October 16, 2030 [1] - The production address for the raw material drug (Ibandronate) has been updated to "Raw Material Drug Workshop (Workshop 101) B Area and E Area" [1] - The company has added the production of "Raw Material Drug (Benidipine Hydrochloride)" at the same production address [1] - The company has commissioned Tian Di Heng Yi Pharmaceutical Co., Ltd. to produce "Yuan Qi Bone Pain Tincture" with a validity until October 16, 2030 [1] - Additional commissioned production information has been included for two products: "Flurbiprofen Gel Patch" and "Compound Glycyrrhizin Tablets" [1] Production Scope and Impact - The production scope includes various forms of drugs such as powder injections, tablets, hard capsules, and raw materials [3] - The changes in the "Drug Production License" will not affect the company's existing production structure and will maintain stable production capacity [3] - The new license is not expected to have a significant impact on the company's current performance [3]
方盛制药:公司药品生产许可证变更
Core Viewpoint - The company has received a renewed drug production license from the Hunan Provincial Drug Administration, which includes several changes to its production capabilities and license validity [1] Summary by Relevant Sections - **License Renewal**: The drug production license has been extended until October 16, 2030 [1] - **Production Changes**: Modifications include changes to the production line for the raw material drug Ezetimibe and the addition of the raw material drug Benidipine to the production scope [1] - **Operational Stability**: The changes will not affect the company's existing production structure, ensuring stable production capacity [1] - **License Number**: The new license number is 湘20150028 [1]