证券代码：603998 证券简称：方盛制药 公告编号：2025-104 检查地址：湖南望城经济开发区铜官镇循环经济工业基地内黄龙路368号 检查时间：2025年7月8日、7月15日至17日 检查范围及相关车间、生产线：1.依折麦布，原料药车间（101车间）B区与E区依折麦布生产线；2.盐 酸贝尼地平，原料药车间（101车间）A区与E区盐酸贝尼地平生产线 检查结论：符合《药品管理法》《药品生产监督管理办法》《药品生产质量管理规范（2010年修订）》 等要求。 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 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担法律责任。 近日，湖南方盛制药股份有限公司（以下简称"公司"）收到湖南省药品监督管理局签发的《药品GMP 符合性检查告知书》，现就相关情况公告如下： 一、本次检查情况 被检查单位名称：湖南方盛制药股份有限公司 公司本次获得药品GMP符合性检查结果，表明公司相关生产线符合GMP要求，有利于公司进一步丰富 生产品种，保持稳定的生产能力，满足市场需求。 由于医药产品具有高科技、高 ...

被检查单位名称：湖南方盛制药股份有限公司,检查地址：湖南望城经济开发区铜官镇循环经济工业基 地内黄龙路368号检查范围及相关车间、生产线：1.依折麦布,原料药车间(101车间)B区与E区依折麦布生 产线；2.盐酸贝尼地平,原料药车间(101车间)A区与E区盐酸贝尼地平生产线 公司本次获得药品GMP符合性检查结果,表明公司相关生产线符合GMP要求,有利于公司进一步丰富生产 品种,保持稳定的生产能力,满足市场需求。 格隆汇12月16日丨方盛制药(603998.SH)公布,近日,公司收到湖南省药品监督管理局签发的《药品GMP符 合性检查告知书》。 ...

智通财经APP讯，方盛制药(603998.SH)发布公告，近日，公司收到湖南省药品监督管理局签发的《药 品GMP符合性检查告知书》，检查范围及相关车间、生产线：1.依折麦布，原料药车间(101车间)B区与 E区依折麦布生产线;2.盐酸贝尼地平，原料药车间(101车间)A区与E区盐酸贝尼地平生产线。 ...

方盛制药（603998）(603998.SH)发布公告，近日，公司收到湖南省药品监督管理局签发的《药品GMP 符合性检查告知书》，检查范围及相关车间、生产线：1.依折麦布，原料药车间(101车间)B区与E区依 折麦布生产线;2.盐酸贝尼地平，原料药车间(101车间)A区与E区盐酸贝尼地平生产线。 ...

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]

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]