On May 8, the National Medical Products Administration approved the marketing application for leflunomide tablets, a Class 3 generic drug submitted by Qilu Pharmaceutical, deeming it to have passed the consistency evaluation. This makes Qilu Pharmaceutical the first manufacturer in China to achieve consistency evaluation approval for this drug.
Leflunomide Tablets are clinically indicated primarily for the treatment of rheumatoid arthritis in adults. Currently, there is no relevant registration information available in China from the originator manufacturer, Sanofi. There are six manufacturers producing and marketing this product in the domestic market, including Changzhou Huasheng Pharmaceutical, Meiluo Pharmaceutical, and Suzhou Changzheng-Xinkai Pharmaceutical.
Source: PharmaCube PharmaGo - China Marketed Drug Database
Qilu Pharmaceutical is the first manufacturer to pass the consistency evaluation for this drug. In addition, Suzhou Changzheng-Xinkai Pharmaceutical and Fujian Huitian Biological Pharmaceutical have also submitted applications for consistency evaluation, which are currently under review.
