Cefodizime Sodium

Daewoong can no longer take part in China's national volume-based procurement program until January 17, 2026. As with GSK before it, Daewoong Bio’s manufacturing misstep has resulted in a ban for the Korean company from China’s bulk-buy drug procurement program. On Thursday, China’s National Medical Products Administration (NMPA) said it’s suspending (Chinese) the import, sale and use of Daewoong’s cephalosporin antibiotic cefodizime sodium for injection after the company declined to participate in an inspection of its production site. As a result, the NMPA determined that Daewoong’s inspection results were “not in compliance with the requirements.” Daewoong’s decision to turn down the inspection further violated China’s Drug Administration Law and Regulations on Overseas Inspection of Drugs and Medical Devices, NMPA added. What’s more, the violation means Daewoong can no longer take part in national volume-based procurement (VBP) activities until January 17, 2026. China’s VBP was set up in 2018 to help cut the costs of off-patent drugs. The scheme requires manufacturers to go through a bidding process to supply products to public hospitals. NMPA is now advising provinces where Daewoong is the main supplier of cefodizime sodium to rely on backup suppliers for stocks of the antibiotic, which is used to treat a variety of bacterial infections and is sometimes given to patients allergic to penicillin. If the backup suppliers cannot meet demand, the provinces can begin the process of adding additional backup suppliers. Daewoong did not immediately respond to Fierce Pharma’s request for comment. The situation in many ways mirrors that faced by GSK when the sale and import of the company’s Avodart soft capsules were banned in China back in October of 2022. The product cull was triggered by an inspection of a facility in Poznan, Poland, where it was found GSK did not conduct batch-by-batch and full-item inspections of Avodart sent to China. As part of the ban for that specific product, GSK was also prohibited from taking part in VBP for 18 months. Prior to that incident, BeiGene’s chemotherapy Abraxane was banned from Chinese import in 2020 after Chinese authorities uncovered shortfalls during an inspection of a Fresenius Kabi plant in Melrose Park, Illinois.