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陕西省药品监督管理局关于西安京西双鹤药业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 Viewpoint - The article reports on the compliance inspection results of five pharmaceutical manufacturing companies in Xi'an, China, conducted by the Shaanxi Provincial Drug Supervision Administration, confirming their adherence to drug production quality management standards [2] Group 1: Company Inspection Results - Xi'an Jingxi Shuanghe Pharmaceutical Co., Ltd. passed the inspection for large-volume injection and washing agents, with the inspection conducted from July 7 to July 11, 2025 [2] - Shaanxi Jiuzhou Pharmaceutical Co., Ltd. passed the inspection for oral solid preparations, specifically Olaparib tablets (150mg), from August 5 to August 8, 2025 [2] - Xi'an Yuanda Detian Pharmaceutical Co., Ltd. passed the inspection for lyophilized powder injections and entrusted production of injection use Yanhuning, from July 15 to July 18, 2025 [2] - Xi'an Hanfeng Pharmaceutical Co., Ltd. passed the inspection for tablets and hard capsules, with the inspection date on September 23, 2025 [2] Group 2: Inspection Scope and Compliance - The inspections covered various production lines and workshops, ensuring compliance with the Drug Production Quality Management Standards [2] - The inspections were conducted in accordance with multiple regulatory frameworks, including the Drug Administration Law and related management measures [2]