Jingxin Pharmaceutical Co., Ltd. and xinlitai entered the three in one review on the same day

Levetiracetam is a pyrrolidone derivative Because of its high therapeutic index, mild adverse reactions and good tolerance, it is the most widely used new antiepileptic drug In China, only the original research enterprise, Belgium United Chemical (Kaplan), produces one According to the data of Nanfang Institute, the sales volume of levetiracetam in domestic sample hospitals in 2012 was 78.77 million yuan, up 67% year on year
According to the functional division after the reform of the review center of the State Food and Drug Administration and the provisions of the principles and procedures for technical review of drugs, the business management department of the center is responsible for the on-site inspection report, on-site sampling inspection report and technical review report of the varieties that must be subject to on-site inspection and sample inspection after the completion of the technical review We will make a comprehensive report (referred to as "three in one") to form a comprehensive opinion of "three in one" According to CFDA, there are no domestic production enterprises of levetiracetam, but more than 10 enterprises have declared production Among them, Jingxin pharmaceutical, xinlitai pharmaceutical and Chongqing shenghuaxi pharmaceutical ranked first According to the new drug review process, after the completion of the three in one review, only the drug review center forms a report, submits CFDA for signature and other procedures According to the R & D process of other new drugs, the above three products are expected to get production approval documents in about two months.