[site view] Wang xiangxu: 4 + 7 centralized mining, India may have infiltrated into the Bureau quietly

"If the preparation is a kite, the API is the kite's line How far and how high a kite flies is determined by the line." What are the concerns of kites and lines, APIs and preparations in drug production or research and development? Some people think it's money, some people think it's talent, although both of these aspects are very important, but there is no money to earn and finance; there is no talent to train and recruit; there is no API suddenly in the process of production and research and development, which is the most worrying In particular, the current 4 + 7 trial, on the basis of quality and quantity, also shows the importance of APIs The results of 4 + 7 volume purchase were published on December 6, 2018 When ensuring the safety and effectiveness of drugs, the drug price was reduced, which forced the drug manufacturers to transform and upgrade Its significance is very positive Some pharmaceutical manufacturers feel that they have invested millions or tens of millions and failed to win the bid, which is very frustrating In fact, they do not need to be sad If they fail to pass the consistency evaluation, the drugs will be eliminated If they pass the consistency evaluation, they will not be out at least on the platform opportunity It is an opportunity for the winning bidder to obtain the market, and the stable source of raw material supply determines whether the follow-up enterprises can grasp this opportunity Some pharmaceutical enterprises, such as Hengrui, have their own raw material companies, while others may not The large-scale production of preparations, product update and iteration, and innovation are inseparable from the selection of raw materials The first batch of 4 + 7 volume procurement, 31 varieties were invited for bidding, and 25 varieties were selected finally, including 20 varieties with their own APIs, 5 varieties without their own APIs, montelukast sodium tablets of abison, fosinopril sodium tablets of Squibb, cefuroxime ester tablets of Chengdu Beite, amlodipine besylate tablets of Zhejiang Jingxin and pemetrexed disodium for injection of Sichuan Huiyu "If the preparation is a kite, the API is the kite's line How far and how high a kite flies is determined by the line." Wang xiangxu, chairman of Shanghai Huyuan Pharmaceutical Co., Ltd., shared the 2019 China Pharmaceutical Health Industry Development Conference and the fourth China Pharmaceutical R & D Innovation Summit (PDI Conference) held in Chongqing Taking amlodipine besylate as an example, which has the largest number of manufacturers applying for conformity assessment in China, there are 45 enterprises registered in CDE, 12 enterprises to be declared, and 8 enterprises have passed the conformity assessment Among them, 43 imported APIs (India: 42, Spain: esteve: 1), accounting for 75.4%; 9 domestic APIs (New SECCO: 6, riming: 2, Asian States: 1), accounting for 15.7%; and 5 unknown ones Among the 8 enterprises that have passed the consistency evaluation, 5 are from India In the context of domestic 4 + 7-belt procurement and consistency evaluation, Indian APIs have already entered the market quietly or become the key There are four major current situations that hinder the development of domestic APIs First, the pressure on environmental protection and the intensity of supervision are increasingly strict Green water and green mountains are Jinshan and Yinshan In recent years, environmental protection has become more and more strict For example, in Inner Mongolia, the former thought that waste water can be discharged into the desert, but in fact, it can't be discharged into the desert All the waste gas is evaporated by Cohen, and the waste water can't be discharged into the desert In Hunan Province, the national environmental protection policy is very strict Some enterprises have made layout in advance, such as the state and xinsynthetic Ten years ago, they bought hundreds of mu or even thousands of mu of land, which has certain foresight This is a phenomenon of domestic environmental protection Second, the number of monopoly varieties is increasing The price of APIs has soared, and even they can't be bought with money There are 9069 approval numbers of APIs in China, including 509 imported ones and 8560 domestic ones The number of APIs is 1831, which means that an API has less than 5 numbers on average According to statistics of Huyuan pharmaceutical, there were 202 kinds of APIs monopolized by the end of 2018, which is a phenomenon worthy of vigilance Third, the quality needs to be improved The internal control standard of API produced by enterprises is higher than that of Pharmacopoeia Fourth, the way is unknown According to statistics, in 2017, China imported 7600 tons of APIs to India, including 316 varieties, about 250 buyers and more than 2150 tons of APIs mainly used for food and daily chemical menthol series imported under the generic name of non APIs The proportion of APIs without marketing license is large 3 India makes efforts to open up a new way for the import of APIs With the domestic trend, we can see that imported APIs are indispensable So how to choose imported APIs? Although there are still a certain amount and scale of API in Europe and America, the cost is on the high side, and with the highly developed and environmental protection is tense, API is gradually transferred to central and South Asia, mainly China and India Although Japan produces APIs, it is self-sufficient and provides little to the outside world; South Africa, Iran, Mexico and other industries are underdeveloped; Israel, South Korea and other varieties are few, limited and not large-scale; therefore, the main raw material market is still China and India What are the advantages of Indian APIs? 1 There are a large number of enterprises certified by FDA and EU There are 546 drug factories, 2633 drugs and 900 varieties certified by FDA With multiple CEP certificates in the EU, 20% of the world's generic drugs are from India and exported to more than 200 countries 2 The quality standard is higher Taking cetirizine hydrochloride as an example, CP total impurity is 1.0%, single impurity is 0.5%; import total impurity is 0.3%, single impurity is 0.1%, and impurity control is strict 3 The cost is low For example, the price of gefitinib, a lung cancer drug, is very high before purchase The price of domestic drug ranges from 3000 to 4000, and the price of imported drug ranges from 5000 to 10, but that of India is 30, 600 yuan Later, China reduced the price to a few hundred yuan, but compared with India's 30 tablets, multiplying by three is still more than 1000 yuan India's price is less than 600 yuan, which is more than 40% cheaper This is an example of taking patent medicine as an example APIs have at least 30% advantage, or even 100% 4 India's supply is relatively stable According to the experience of chairman Wang xiangxu from Shanghai Huyuan case, India's API quality and price are very stable, and there will be no risk of price increase in the middle of the process Except for special reasons, the price increase is controllable, and will not be doubled or monopolized by some enterprises How to choose India's imported APIs? There are nearly 20000 pharmaceutical companies in India, with varying levels, and they need to be very careful when choosing 1 Select the appropriate Indian pharmaceutical enterprises In Europe and the United States, if there is no marketing license, it will not be selected or re selected carefully; if there is no DMF capacity, it will not be selected; if the production scale is too small, it will not be selected; if the products have been stopped for sale in China, for example, from 2014 to 2018, the overseas production site inspection of imported drugs, 16 of the 160 tasks involved in API, 4 of which were ordered to stop import due to serious violations of China's GMP specifications, the proportion is not low and all come from India, so it's very important to choose which company 2 Select the varieties that India has advantages over China India's fermentation APIs are not strong, and most of the bulk varieties are uncompetitive The few varieties and APIs produced by domestic API enterprises are self-produced and self used, which form a de facto monopoly Indian sources can be considered 3 Select excellent API suppliers Now many domestic enterprises are introducing APIs and preparations from India Some enterprises entrust a company for registration, and many materials cannot be sent during registration What's the reason? The agent company doesn't know that only the registered company is more accurate After the registration, the products will go on the market and have no business qualification Then hang up the drug dealer to sell them The drug dealer who issues the invoice will issue the invoice In this process, there will be some problems The whole service is actually in fault, so it's very important to choose what kind of supplier in China, including reputation, capital strength The main choice is to provide comprehensive services such as registration ability, business qualification and sales ability The role of imported APIs in consistency evaluation 1 The data of DMF can be obtained This part of the data do more detailed, such as impurity analysis, genotoxicity and other data 2 The source of API is not affected After the consistency evaluation of the preparation, the shortage of API occurs due to environmental protection, monopoly and other reasons The results are self-evident for the preparation enterprises For example, for ruishuvastatin calcium tablets, there are four manufacturers that have passed the consistency evaluation, namely Zhejiang Jingxin, Nanjing Zhengda Tianqing, Nanjing Xiansheng and Zhejiang Huahai After the consistency evaluation, they must first consider their own interests, and there is a great possibility of no external supply Therefore, choosing an imported raw material can be used as a spare tire 3 Facilitate the preparation to go to the international market For APIs certified or tested in Europe and the United States, the preparations of their origin occupy a certain market share in Europe and the United States, which is convenient for other countries to export preparations of the API to Europe and the United States "There is an old saying in China that" there must be immediate worries if people have no foresight ", as is the case in the pharmaceutical industry In the process of drug production and research and development, there is no harm for enterprises We should make an early layout Even though it is impossible to build raw material pharmaceutical plants like all big companies, we can make a good plan in advance and do a good job of filing." That's what chairman Wang xiangxu said Statement: this opinion only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.