Manufacturing Non-Compliance Leads to Daewoong Bio Ban in China

Daewoong Bio has been barred from China's bulk-buy medication procurement programme as a consequence of a manufacturing error, similar to GSK before it.

China's National Medical Products Administration (NMPA) announced on Thursday that it was stopping the import, sale, and usage of cefodizime sodium injection, a cephalosporin antibiotic manufactured by Daewoong, after the business refused to allow an examination of its manufacturing facility.Daewoong's inspection findings were thus deemed by the NMPA to be "not in compliance with the requirements."The Drug Administration Law and Regulations on Overseas Inspection of Drugs and Medical Devices in China were further broken by Daewoong's decision to refuse the inspection, according to the NMPA. 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.

Prior to GSK, 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.