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国家药监局关于28批次不符合规定药品的通告(2025年第30号)
Core Viewpoint - The National Medical Products Administration (NMPA) announced that 28 batches of drugs produced by 17 companies do not meet regulatory standards, prompting investigations and corrective actions [3][5]. Group 1: Non-compliant Drugs - Five batches of fusidic acid cream produced by Aomei Pharmaceutical Factory failed due to particle size issues [3]. - Two batches of loratadine syrup from Want Pharmaceutical (Hainan) Co., Ltd. did not meet standards related to impurities [3]. - One batch of sodium phosphate oral solution from Shanghai Haihong Industrial Group's Chao Hu Jinchen Pharmaceutical Co., Ltd. failed due to relative density [3]. - Two batches of tocilizumab capsules from Shaanxi Xiyue Pharmaceutical Co., Ltd. did not meet dissolution rate standards [3]. - One batch of acetylcysteine effervescent tablets from Zhejiang Jinhua Kang'enbei Biopharmaceutical Co., Ltd. failed due to physical characteristics [3]. - Two batches of Twenty-five Flavor Coral Pills from Tibet Shenhui Pharmaceutical Co., Ltd. did not meet weight difference standards [3]. - Two batches of Qili San from Hubei Minkan Pharmaceutical Co., Ltd. failed due to content determination [3]. Group 2: Regulatory Actions - The NMPA has mandated that the involved companies take risk control measures such as suspending sales and conducting recalls [5]. - The NMPA requires provincial drug supervision departments to investigate potential illegal activities by the companies involved and to publicly disclose the results of these investigations [5].
国家药监局通告28批次药品不符合规定
Zhong Guo Xin Wen Wang· 2025-08-27 13:28
Core Viewpoint - The National Medical Products Administration (NMPA) announced that 28 batches of drugs produced by 17 companies do not meet regulatory standards, highlighting quality control issues in the pharmaceutical industry [1][2][3]. Summary by Categories Non-compliance Details - Five batches of fusidic acid cream produced by Aumei Pharmaceutical are non-compliant due to particle size [1] - Two batches of loratadine syrup from Wante Pharmaceutical (Hainan) are non-compliant due to related substances [1] - One batch of sodium phosphate oral solution from Shanghai Haihong Industrial Group is non-compliant due to relative density [1] - Two batches of tosylate capsules from Shaanxi Xiyue Pharmaceutical are non-compliant due to dissolution rate [1] - One batch of acetylcysteine effervescent tablets from Zhejiang Jinhua Kang'enbei Biopharmaceutical is non-compliant due to physical properties [1] - Two batches of Twenty-five Flavor Coral Pills from Tibet Shenhou Pharmaceutical are non-compliant due to weight differences [1] Additional Non-compliance Findings - Two batches of Qili Powder from Hubei Minkan Pharmaceutical are non-compliant due to content measurement [2] - Four batches of Qingqi Huatan Pills from Hubei Ruihua Pharmaceutical are non-compliant due to dosage discrepancies [2] - Two batches of red peony from Sichuan Jinke Pharmaceutical and Sichuan Yixiangkang Pharmaceutical are non-compliant due to physical properties [2] - Three batches of red ginseng (red ginseng slices) from multiple companies are non-compliant due to identification issues and pesticide residue [2] - One batch of Gentian from Jiangsu Heshengtang Pharmaceutical is non-compliant due to impurities [2] - One batch of wild chrysanthemum from Jiangxi Xinjian Pharmaceutical is non-compliant due to content measurement [2] Regulatory Actions - The NMPA has mandated that the involved companies take risk control measures such as halting sales and conducting recalls [3] - Investigations into the causes of non-compliance are required, along with corrective actions [3] - Provincial drug supervision departments are instructed to investigate potential illegal activities by the companies involved [3] Public Awareness Initiatives - The NMPA has provided educational information regarding the significance of various non-compliance indicators, such as particle size, related substances, relative density, dissolution rate, physical properties, weight differences, content measurement, identification, pesticide residues, total reducing sugars, impurities, and moisture content [4][5]
国家药监局发布通告28批次药品不符合规定
Yang Shi Wang· 2025-08-27 09:29
Summary of Key Points Core Viewpoint - The National Medical Products Administration (NMPA) has announced that 28 batches of drugs produced by 17 companies do not meet regulatory standards, prompting investigations and corrective actions from the involved companies [1][3]. Group 1: Non-compliance Details - Five batches of fusidic acid cream produced by Aumei Pharmaceutical are non-compliant due to particle size issues [1] - Two batches of loratadine syrup from Wante Pharmaceutical (Hainan) are non-compliant due to related substances [1] - One batch of sodium phosphate oral solution from Shanghai Haihong Industrial Group is non-compliant due to relative density [1] - Two batches of tocilizumab capsules from Shaanxi Xiyue Pharmaceutical are non-compliant due to dissolution rate [1] - One batch of acetylcysteine effervescent tablets from Zhejiang Jinhua Kang'enbei Biopharmaceutical is non-compliant due to physical properties [1] - Two batches of Twenty-Five Flavor Coral Pills from Tibet Shenhui Pharmaceutical are non-compliant due to weight differences [1] Group 2: Additional Non-compliance Cases - Two batches of Qili Powder from Hubei Minkan Pharmaceutical are non-compliant due to content measurement [2] - Four batches of Qingqi Huatan Pills from Hubei Ruihua Pharmaceutical are non-compliant due to dosage discrepancies [2] - Two batches of red peony from Sichuan Jinke Pharmaceutical and Sichuan Yixiangkang Pharmaceutical are non-compliant due to physical properties [2] - Three batches of red ginseng (red ginseng slices) from multiple companies are non-compliant due to identification issues and pesticide residue [2] - One batch of Gentian from Jiangsu Heshengtang Pharmaceutical is non-compliant due to impurities [2] - One batch of wild chrysanthemum from Jiangxi Xinjian Pharmaceutical is non-compliant due to content measurement [2] Group 3: Regulatory Actions - The NMPA has mandated that the involved companies take risk control measures such as suspending sales and conducting recalls [3] - Investigations into the causes of non-compliance are required, along with corrective actions [3] - Provincial drug supervision departments are instructed to investigate potential illegal activities by the companies involved [3]
国家药监局今天通告28批次药品不符合规定
Yang Shi Xin Wen· 2025-08-27 09:18
Core Viewpoint - The National Medical Products Administration (NMPA) announced that 28 batches of drugs produced by 17 companies do not meet regulatory standards, prompting investigations and corrective actions from the involved companies [1][3]. Summary by Categories Non-compliance Details - Five batches of fusidic acid cream produced by Aumei Pharmaceutical Factory failed due to particle size issues [1]. - Two batches of loratadine syrup from Wante Pharmaceutical (Hainan) Co., Ltd. did not meet standards due to related substances [1]. - One batch of sodium phosphate oral solution from Shanghai Haihong Industrial (Group) Co., Ltd. failed due to relative density [1]. - Two batches of tocilizumab capsules from Shaanxi Xiyue Pharmaceutical Co., Ltd. did not meet standards due to dissolution rate [1]. - One batch of acetylcysteine effervescent tablets from Zhejiang Jinhua Kang'enbei Biopharmaceutical Co., Ltd. failed due to physical properties [1]. - Two batches of Twenty-five Flavor Coral Pills from Tibet Shenhui Pharmaceutical Co., Ltd. did not meet standards due to weight differences [1]. Additional Non-compliance Cases - Two batches of Qili Powder from Hubei Minkan Pharmaceutical Co., Ltd. failed due to content determination [2]. - Four batches of Qingqi Huatan Pills from Hubei Ruihua Pharmaceutical Co., Ltd. did not meet standards due to dosage discrepancies [2]. - Two batches of red peony from Sichuan Jinke Pharmaceutical Co., Ltd. and Sichuan Yixiangkang Pharmaceutical Co., Ltd. failed due to physical properties [2]. - Three batches of red ginseng (red ginseng slices) from multiple companies failed due to identification issues and pesticide residue [2]. - One batch of Gentian from Jiangsu Heshengtang Pharmaceutical Co., Ltd. did not meet standards due to impurities [2]. - One batch of wild chrysanthemum from Jiangxi Xinjian Pharmaceutical Co., Ltd. failed due to content determination [2]. Regulatory Actions - The NMPA has mandated that the involved companies take risk control measures such as suspending sales and conducting recalls [3]. - Investigations into the causes of non-compliance are required, and the NMPA will pursue legal actions against any violations [3]. - The NMPA provided public education on the significance of various non-compliance indicators, including particle size, related substances, relative density, dissolution rate, physical properties, weight differences, content determination, identification, pesticide residues, total reducing sugars, impurities, and moisture content [3][4].