The National Medical Products Administration (NMPA) in China has taken a decisive step to suspend the import, distribution, and utilization of cefodizime, an antibiotic from Daewoong Bio Inc., a South Korean pharmaceutical company. This move comes after Daewoong declined to cooperate with the NMPA’s scheduled on-site inspections, citing non-compliance with the required standards. The repercussions of this decision are significant, as Daewoong is now barred from participating in China’s national volume-based procurement (VBP) program, affecting the company’s market access from July 18, 2024, through January 17, 2026.
The suspension is particularly impactful as it relates to the 8th round of VBP, where cefodizime was included. Originally, Daewoong was among the companies, including Kelun Pharma, Livzon Pharma, Hainan Haiyao, and Yongning Pharma, that secured tenders for the drug. With the suspension, the supply of cefodizime in Daewoong’s designated regions will be managed by the four domestic manufacturers.
This development underscores the importance for pharmaceutical companies to adhere to regulatory compliance and the stringent standards set by procurement programs. The VBP program, established in 2018, aims to reduce the cost of off-patent drugs by requiring manufacturers to bid on supplying products to public hospitals. The program has been instrumental in driving down drug prices and improving access to affordable medications.
Daewoong’s exclusion from the VBP program may have broader implications for the company’s operations in China and could serve as a cautionary tale for other pharmaceutical firms operating in the country. It highlights the need for companies to maintain transparency and cooperation with regulatory bodies to ensure the safety and quality of their products.- Flcube.com
