{"id":31381,"date":"2025-04-08T15:34:19","date_gmt":"2025-04-08T07:34:19","guid":{"rendered":"https:\/\/flcube.com\/?p=31381"},"modified":"2025-04-08T15:34:20","modified_gmt":"2025-04-08T07:34:20","slug":"shanxi-yanghe-medical-technology-faces-production-halt-over-gmp-violation","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=31381","title":{"rendered":"Shanxi Yanghe Medical Technology Faces Production Halt Over GMP Violation"},"content":{"rendered":"\n<p>China&#8217;s National Drug Alliance Procurement Office has imposed manufacturing suspensions on Shanxi Yanghe Pharmaceutical Technology&#8217;s peramivir, produced by Shanxi GuoRun Pharmaceutical, due to failure to comply with Good Manufacturing Practice (GMP) standards. This decision follows the identification of non-compliance issues during regulatory inspections.<\/p>\n\n\n\n<p><strong>Regulatory Action<\/strong><br>The injectable antiviral medication, which has not yet entered commercial distribution since receiving approval, will have its winning bid in the 10th National Volume-Based Procurement (VBP) round nullified. This regulatory action underscores the importance of adhering to GMP standards to ensure patient safety and product quality.<\/p>\n\n\n\n<p><strong>Impact on Companies<\/strong><br>Both Shanxi Yanghe Medical Technology and Shanxi GuoRun Pharmaceutical will face a suspension of procurement eligibility effective from April 8, 2025, through October 7, 2026. This period of ineligibility highlights the severity of the GMP violations and the necessary measures taken to address them.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>China&#8217;s National Drug Alliance Procurement Office has imposed manufacturing suspensions on Shanxi Yanghe Pharmaceutical Technology&#8217;s&#8230;<\/p>\n","protected":false},"author":1,"featured_media":31383,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[3980,82,3979],"class_list":["post-31381","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-guorun-pharmaceutical","tag-vbp-voluem-based-procurement","tag-yanghe-pharmaceutical-technology"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Shanxi Yanghe Medical Technology Faces Production Halt Over GMP Violation - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"China&#039;s National Drug Alliance Procurement Office has imposed manufacturing suspensions on Shanxi Yanghe Pharmaceutical Technology&#039;s peramivir, produced by Shanxi GuoRun Pharmaceutical, due to failure to comply with Good Manufacturing Practice (GMP) standards. 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