HMZS Biopharmaceutical, a Chinese company that won a bid for its phloroglucinol in the 10th volume-based procurement (VBP) tender round, has been blacklisted by the National Drug Alliance Procurement Office. The company’s entrusted manufacturer, Taiji Group Sichuan Taiji Pharmaceutical Co. Ltd., was also blacklisted following the incident.
Reason for Blacklisting
The Marketing Authorization Holder (MAH), HMZS Bio, failed to conduct effective monitoring of the production process at the entrusted manufacturer. Some batches of the product deviated from key production processes and were not handled according to regulations, constituting a violation of Good Manufacturing Practice (GMP). As a result, the manufacturing of the product at Sichuan Taiji Pharma has been suspended, and HMZS Bio’s marketing of the product has also been halted.
Consequences and Impact
HMZS Bio’s winning status in the VBP was canceled, and both companies have been suspended from VBP filing qualifications from March 18, 2025, to September 17, 2026. The backup manufacturer will become the main supplier, providing the drug at its winning price. The results of the 10th VBP round will be implemented nationwide next month.-Fineline Info & Tech
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