By Fineline Cube 
China’s National Drug Alliance Procurement Office has imposed manufacturing suspensions on Shanxi Yanghe Pharmaceutical Technology’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.
Regulatory Action
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.
Impact on Companies
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.-Fineline Info & Tech