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国药现代(600420.SH):全资子公司通过药品GMP符合性检查
Ge Long Hui A P P· 2026-02-09 08:34
注射用盐酸瑞芬太尼用于全麻诱导和全麻维持过程中的镇静和镇痛。国内其他生产企业还有宜昌人福药 业有限责任公司和江苏恩华药业股份有限公司。 本次国药工业廊坊分公司的冻干粉针剂相关生产线通过药品GMP符合性检查,表明该新建生产线符合 《药品生产质量管理规范(2010年修订)》的要求,有利于公司稳定增加麻醉阵痛板块产品产能,以满 足相关药品的市场需求。上述事项对公司目前经营业绩不会产生重大影响。 格隆汇2月9日丨国药现代(600420.SH)公布,公司全资子公司国药集团工业有限公司(以下简称国药工 业)下属的廊坊分公司收到药品GMP符合性检查告知书,国药工业廊坊分公司的制剂2车间相关生产线 通过GMP符合性检查。 本次GMP符合性检查范围为国药工业廊坊分公司的冻干粉针剂(制剂2车间冻干粉针剂2生产线),系 冻干粉针剂增加"生产地址、生产线"的药品GMP符合性检查。该生产车间及生产线均为新建,建设总 投入约人民币9,282.77万元(未经审计)。 ...
江苏诺泰澳赛诺生物制药股份有限公司 关于自愿披露通过药品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。 二、对公司的影响 公司始终坚持"时间领先、技术领先"的经营理念。本次建德工厂原料药生产线通过GMP符合性检查, 再次印证公司具备领先的生产及质量管理体系,对建德工厂创新药CDMO业务从高级中间体向原料药价 值延伸具有里程碑意义,对公司持续开拓创新药原料药客户具有积极意义。 三、风险提示 江苏诺泰澳赛诺生物制药股份有限公司(以下简称"公司")全资子公司杭州澳赛诺生物科技有限公司 (以下简称"澳赛诺"或"建德工厂")于近日收到浙江省药品监督管理局签发的《药品GMP符合性检查告 知书》(编号:浙2026第0013号),澳赛诺奥格特韦钠原料药正式通过GMP符合性检查。 一、本次GMP符合性检查的相关情况 1、企业名称:杭州澳赛诺生物科技有限公司 2、检查地址:浙江省杭州市建德市下涯镇丰和路18号 3、检查范围及相关车间、生产线:原料药(奥格特韦钠):一车间、六车间、九车间,B原料药生产 线 4、检查时间:2026年1月14日至2026年1月16日 5、结论:该公司原料药(奥格特韦钠):一 ...
2月2日重要公告一览
Xi Niu Cai Jing· 2026-02-02 02:32
Group 1 - Quzhou Dongfeng's controlling shareholder proposed to repurchase shares worth between 50 million to 100 million yuan for employee stock ownership plans or equity incentives [1] - Fushi Holdings' actual controller and chairman Chen Yongliang has been placed under detention by a national supervisory committee [2] - Chipone Technology's shareholder plans to reduce its stake by up to 1.95%, amounting to a maximum of 10.25 million shares due to personal funding needs [3] Group 2 - Leshan Electric reported a revenue of 3.395 billion yuan for 2025, a year-on-year increase of 6.24%, with a net profit of 23.4023 million yuan, up 3.68% [4] - Sanjia Technology plans to issue shares to its controlling shareholder to raise no more than 300 million yuan, with proceeds aimed at replenishing working capital and repaying bank loans [5] - GoerTek increased its share repurchase fund from a minimum of 500 million yuan to a range of 1 billion to 1.5 billion yuan [6] Group 3 - Hongbaoli clarified that it does not produce propylene oxide products, and its subsidiary's project is in the pre-production preparation stage [7] - Hunan Gold noted uncertainty regarding the future market price of its gold products despite recent price increases [8] - Great Wall Motors reported January sales of 90,300 vehicles, a year-on-year increase of 11.59% [9] Group 4 - Yanzhou Coal Mining announced the public transfer of 100% equity in Xintai Coal at a base price of 670 million yuan, which may significantly impact its net profit for 2026 [10] - Jerry Holdings signed a sales contract worth approximately 1.826 billion yuan with a U.S. client, representing 9.47% of its audited revenue for 2024 [11] - Fulongma pre-bid for four sanitation service projects in January, with a total first-year service fee of 83.5364 million yuan [12] Group 5 - China Unicom and China Telecom announced adjustments to the VAT applicable to their telecom services, which will affect their revenue and profits starting January 1, 2026 [13][17] - BAIC Blue Valley reported January sales of 8,073 vehicles, a year-on-year increase of 11.83% [19] - Penghui Energy submitted an application for H-share issuance and listing on the Hong Kong Stock Exchange [20] Group 6 - Haichuang Pharmaceutical passed the GMP compliance inspection for its soft capsule production line [21] - BGI Intelligent Manufacturing plans to acquire 100% equity in two companies for a total of 365.7 million yuan, aiming to integrate advanced technology platforms [22] - Jiamei Packaging's stock resumed trading after a suspension for volatility investigation [23] - Fenglong Co. also resumed trading following the completion of its stock trading suspension investigation [24]
拓新药业:原料药奥拉帕利、胞磷胆碱通过 GMP 符合性检查
Zhong Zheng Wang· 2026-01-21 07:27
公告显示,公司原料药(奥拉帕利)相关车间及生产线通过药品GMP符合性检查,原料药(胞磷胆碱)的生 产线也符合相关规范要求。 拓新药业表示,新乡制药本次原料药(奥拉帕利)(抗肿瘤药)、原料药(胞磷胆碱)相关车间及生产线通过药 品GMP符合性检查,标志着公司相应生产设施与管理体系满足药品生产质量管理规范要求。原料药(胞 磷胆碱)即可上市销售,原料药(奥拉帕利)由于涉及地址变更,待通过国家药品监督管理局备案后,即可 上市销售。本次通过药品GMP符合性检查,将助力公司持续保障产品质量稳定性与生产供应能力,更 好地满足相关药品的市场需求,将有力推动公司未来的业务拓展。(王珞) 1月20日晚,拓新药业(301089)发布公告称,公司全资子公司新乡制药股份有限公司(以下简称"新乡 制药")近日收到河南省药品监督管理局分别核发的两份《药品GMP符合性检查告知书》。 ...
拓新药业:子公司收到药品GMP符合性检查告知书
Ge Long Hui· 2026-01-20 09:34
HNGMP26015、编号:豫GMP202503049)。新乡制药本次原料药(奥拉帕利)(抗肿瘤药)、原料药 (胞磷胆碱)相关车间及生产线通过药品GMP符合性检查,标志着公司相应生产设施与管理体系满足 药品生产质量管理规范要求。原料药(胞磷胆碱)即可上市销售,原料药(奥拉帕利)由于涉及地址变 更,待通过国家药品监督管理局备案后,即可上市销售。本次通过药品GMP符合性检查,将助力公司 持续保障产品质量稳定性与生产供应能力,更好地满足相关药品的市场需求,将有力推动公司未来的业 务拓展。 格隆汇1月20日丨拓新药业(301089.SZ)公布,全资子公司新乡制药股份有限公司(简称"新乡制药")近 日收到河南省药品监督管理局分别核发的两份《药品GMP符合性检查告知书》(编号: ...
尖峰集团子公司尖峰药业通过药品GMP符合性检查
Zhi Tong Cai Jing· 2025-12-23 10:23
Core Viewpoint - Jianfeng Group's subsidiary, Zhejiang Jianfeng Pharmaceutical Co., has passed the GMP compliance inspection for its raw material production line of Tafluprost, ensuring the supply capability for Tafluprost eye drops and enriching the company's product line [1] Group 1 - Jianfeng Pharmaceutical has received the GMP compliance inspection result announcement from the Zhejiang Provincial Drug Administration [1] - The successful inspection allows the company to produce Tafluprost raw materials, which is critical for the manufacturing of Tafluprost eye drops [1] - This development enhances the company's product offerings and strengthens its position in the pharmaceutical market [1]
奥锐特药业股份有限公司 关于通过药品GMP符合性检查的公告
Group 1 - The company, Aorite Pharmaceutical Co., Ltd., has received a GMP compliance inspection notice from the Zhejiang Provincial Drug Administration, confirming that its production lines meet the required standards [1] - The inspection covered the production of active pharmaceutical ingredients, specifically mometasone furoate and betamethasone, conducted from November 12 to November 14, 2025 [1] - The inspection concluded that the company complies with the relevant laws and regulations, including the Drug Administration Law and the Good Manufacturing Practice (GMP) guidelines [1] Group 2 - The company is expected to maintain stable product quality and production capacity, which will help meet market demand for its pharmaceutical products [3] - The company acknowledges that future sales may be influenced by market conditions and industry policies, indicating potential uncertainties in the pharmaceutical sector [3]
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].
陕西省药品监督管理局关于陕西白云制药有限公司等药品生产企业药品GMP符合性检查结果的通告
Core Points - The announcement details the results of GMP compliance inspections for two pharmaceutical companies in Shaanxi Province, confirming that both companies meet the required standards [1] Group 1: Company Inspections - Shaanxi Baiyun Pharmaceutical Co., Ltd. was inspected from September 9 to September 12, 2025, and was found to be compliant with GMP requirements [1] - Shaanxi Jingyang Jinlan Skin Disease Research Institute and Shaanxi Kanghui Pharmaceutical Co., Ltd. were inspected on July 22, 2025, and from July 30 to August 1, 2025, respectively, and both were also found to be compliant with GMP requirements [1]
北京天坛生物制品股份有限公司关于下属企业获得《药品GMP符合性检查告知书》及变更《药品生产许可证》的公告
Core Viewpoint - Beijing Tiantan Biological Products Co., Ltd. announced that its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. has received the Drug GMP Compliance Inspection Notice and the updated Drug Production License, indicating the completion of the production site change for the product "Recombinant Human Coagulation Factor VIII" and the potential for expanded production capacity [1][4]. Group 1: GMP Compliance Inspection - Chengdu Rongsheng received the Drug GMP Compliance Inspection Notice from the Sichuan Provincial Drug Administration [1]. - The inspection was conducted from August 18 to August 21, 2025, and concluded that the company complies with the Drug Production Quality Management Standards (2010 revision) and related appendices [2]. Group 2: Drug Production License Changes - The production scope for Chengdu Rongsheng has been updated to include the production of "Recombinant Human Coagulation Factor VIII," limited to registered application use, following the successful GMP compliance inspection [3]. - The production address remains the same: No. 280, Jingyuan Road, Shuangliu District, Chengdu, Sichuan Province [3]. Group 3: Impact on the Company - The product "Recombinant Human Coagulation Factor VIII" was approved for market launch in September 2023, and the production site change was approved in July 2025 [4]. - The completion of the production site change allows for an increase in production scale for the product [4].