Weigh! The first domestic preparation for export was transferred to domestic product "azithromycin for injection" and approved for listing

Source: Pharmaceutical magic cube 2017-08-08 Hainan Puli pharmaceutical announced on August 7 that azithromycin for injection of the company recently obtained the drug registration approval (approval No 2017s00327) issued by CFDA and will be officially listed in China Azithromycin for injection of Puli pharmaceutical was applied for listing on April 10, 2013 On September 14, 2016, together with Ganciclovir Sodium for injection and pantoprazole sodium for injection, it was publicized by CDE for priority review The reason is that the application for listing was submitted in the United States, the European Union and other regulated markets simultaneously or it has been listed, and it has passed FDA or EMA on-site inspection Azithromycin 500mg for injection is a dual report product registered in China and the United States by Puli Pharmaceutical Co., Ltd It has been temporarily approved by the U.S FDA in October 2015 Therefore, it was approved by the U.S FDA in September 2016 In June, it obtained the priority review and approval qualification of the drug review center, which is also the first product in China to be transferred to the domestic market for approval, marking the timely realization of the policy dividend of CFDA Although the consistency evaluation of injections has not yet started, according to the opinions of the general office of the State Council on the consistency evaluation of quality and efficacy of generic drugs (GBF [2016] No 8) issued by the State Council in March last year, the following situations can be regarded as passing the consistency evaluation: It was confirmed to Puli pharmaceutical that the product belongs to the co production line in the first time by the magic formula of medicine, which means that azithromycin for injection of Puli pharmaceutical will take the lead in the consistency evaluation It will also get significant support in medical insurance payment and bidding procurement According to the medical magic cube database, there are 309 domestic manufacturers of azithromycin preparations, including 67 injection manufacturers If Puli pharmaceutical is approved to be listed in the identity of passing the consistency evaluation, it will put pressure on other manufacturers At present, the domestic terminal market scale of azithromycin is about 1.5 billion yuan, and the use amount is at least 20-30 million Although there are many manufacturers, Pfizer and Northeast Pharmaceutical occupy most of the market share Pfizer as the original research enterprise, the bid price of azithromycin (0.5g / piece) is between 90-120 yuan Due to the separate pricing treatment obtained in the last bidding period, the bid price of Northeast Pharmaceutical was about 70 yuan after it was converted to 0.5g/pc Due to the fierce competition among other domestic enterprises, the bid price is even less than 10 yuan Azithromycin of Puli pharmaceutical is expected to obtain a quality level different from other domestic enterprises and get rid of the price competition with other enterprises.