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The results of the new version of the drug GMP authentication show the increase in industrial concentration in the field of sterile drugs
Release time: 2013-12-20 & nbsp & nbsp & nbsp Source: Anonymous

    Business Club, December 19th News Aseminated Drug Production Enterprise New GMP Certification Countdown、Basic drug expansion、Consistency Evaluation of Imitation Drugs、Development and Reform Commission's cost of the drug company、Anti -commercial bribery in -depth、The new round of bidding purchases opened & hellip; & hellip; as a component of the Chinese economy,The pharmaceutical industry is also in the decline cycle of the growth rate since 2008,The road of development thorns,profit growth is constrained。But,Benefiting from the state's continuous increase in investment in pharmaceuticals and health、Advancement of industrial upgrading,and the increasing purification of the market environment,While the pharmaceutical industry meets the people's health needs,It is also painted with bright colors for China's economic development。In the first half of the year, the pharmaceutical industry stood out among the 12 industrial categories in the country,Become the fastest -growing area。So,For the pharmaceutical industry,2013 was the implementation of the golden age of the 1255 & rdquo;,Even & ldquo; steady growth & rdquo;、& ldquo;、& ldquo; The key year of promoting reform & rdquo;。
 
Looking back,It is to move forward bravely and wisdom。This version of the special organization reporters wrote & ldquo;,From the implementation of the new revised drug GMP certification、Basic drugs bid、Purify the business environment、Evaluation of the consistency evaluation of generic drugs,Comb and review the trajectory of the Chinese pharmaceutical industry this year,To explore & ldquo; create an effective way to create an upgraded version of the Chinese economy & rdquo;。
 
Near the end of the year,With the newly revised drug GMP authentication & ldquo; closure & rdquo; time approach,The health development trend in the field of sterile drug production is initially My stake betting appStake Sports Bettingexposed。Shen Xianji, a member of the Expert Committee of the China Chemical Pharmaceutical Industry Association, said,Excess capacity is a problem that has not been solved in the pharmaceutical industry for many years。In the past,Local protection is serious,Lack of exit mechanism。Strengthen the implementation of the newly revised drug GMP certification,It is conducive to improving industrial concentration,Eliminate backward production capacity。
 
Pioneer first taste the sweetness
 
According to the 2010 version of the drug GMP authentication schedule,my country is engaged in blood products、Vaccine、Pharmaceutical companies produced by sterile drugs such as injections,It must pass the newly revised drug GMP certification by the end of this year。According to Zhong Qian, a member of the Academic Committee of the General Institute of China Medical Industry Research Institute,,As of September this year,392 companies in 1319 sterile drug manufacturers in my country have passed the newly revised drug GMP certification,527 cards,The pass rate is 29.7%。Zhong Qian emphasized,Although the pass rate is less than 1/3,But the current capacity can meet 60%of the market demand。
 
At the 70th National Pharmaceutical Fair held in early December,The reporter learned that some companies' situation confirmed Zhong Qian's statement。Corporate people said,Sterile declaration certification in the second half of this year enters the peak period,Many companies have discontinued production due to certification、reduction of production,Leaves a lot of space for the market,But the shortage of drugs in the market did not happen。According to relevant regulations,Entrusted enterprises that have been approved during the enterprise certification period。Chongqing Kerry Pharmaceutical (Group) Co., Ltd., Shen Wenqiu for expressing,Kerry Pharmaceutical is currently undergoing new revised drug GMP certification,But it is not easy to find the company that commissioned the product & mdash; & mdash;。
 
Recently,Many securities companies have given good evaluation to high -quality pharmaceutical companies to the market market performance。Zhang Qili, Zhang Qili, the Medical Industry Research Institute of Guangfa Securities Research and Development Center,High -quality pharmaceutical companies have sufficient funds,Can be able to take the lead in passing the newly revised drug GMP authentication,Therefore, I tasted the good sweetness of sterile drugs。
 
This year,Sterile Materials Production Enterprise also obtained a good market return after passing the newly revised drug GMP certification。Data display from the Health Network,The varieties that have been observed at present are 7-ACA series、Large ringlone series、enzyme method amoxichalin。General Manager Wu Huifang of Health Network said,Antibiotic drugs are mainly sterile preparations,Sterile Materials stake sports betting appstake betting appPharmaceutical Production Enter。

Watchingman is disappointed
 
Dested,The industry has about 30%of the newly revised drug GMP certification pass rate in the field of sterile preparations.,This has also become some & ldquo; hope & rdquo;。Zhong Qian said,From the perspective of certified enterprises to meet the market conditions,Large -capacity injection and frozen dried powder injections have been revised by more than 70%of the GMP certification.,Plinking needle enterprise certification pass rate is close to 40%。Although the number of sterile preparation companies is less than half of,But the current certified production capacity has exceeded 60 %,Excessive worry is not necessary。
 
Excess capacity has always been a prominent problem in the development of my country's pharmaceutical industry,Newly revised Drug GMP certification from aseptic preparation manufacturers can also be seen。For example,Frozen dried powder injections enterprises pass the number of certifications less than 20%,But it can meet 70%of market demand,A huge contrast to pass the certification ratio and production capacity ratio,Fully illustrates my country's pharmaceutical industry to adjust the industrial structure、Reduce the huge capacity space for production capacity。
 
Wang Lifeng, general manager of Huinorong (Beijing) Pharmaceutical Technology Co., Ltd., said,2004-2007,Chinese drugs repeat registration and declaration more,formed a large amount of homogeneous production capacity。For example,Achicillin has two or three hundred batches nationwide,This is also the source of product malignant low -cost competition,It is extremely unfavorable to the healthy development of the industry。
 
This round of newly revised drug GMP certification,A small number of enterprises have always existed in watching emotions。Some people in the industry said,The reason for the wait -and -see of the enterprise is the problem of funds,Some corporate funds are tight,and not optimistic about the market prospects after the investment in a large amount of funds is completed;、Standard reduction is hopeful,Unwilling to certify early to increase production cost。
 
July this year,Relevant leaders of the State Food and Drug Administration once again reiterated that the newly revised drug GMP certification will be completed at the end of the year、Standard for not dropping,Fully shows that the manager's determination to promote the new revised drug GMP certification。The person in charge of a company said,After certification, the production cost of the enterprise is about 25%compared to the company's production cost,Many companies are afraid of early authentication,Product production costs increase and lose market competitiveness。Now some companies delay certification,To a large extent, due,Time Delay,stake online sports bettingPost Stake Sports Betting-certified enterprise has accounted for cheap front cars。So,Calling the enterprise appealed first,The management department must strictly implement the certification time limit,Guarantee fairness for advanced certification enterprises。
 
Multiple paths exited
 
Public information display,Since August this year,There is Haizheng Pharmaceutical、Many pharmaceutical companies such as Guizhou Bailing participated in the transfer of drug technology,Find the way for related companies。Deputy Secretary -General of the Development Promotion Association of China Pharmaceutical Enterprise、Rui Guozhong, director of the China Medical Science and Technology Achievement Transformation Center, said,This year's technical results transfer is more active。Through transfer of technical results,Enterprises not only preserve high -quality resources,and reduced social contradictions such as employment brought by closing。
 
At the end of last year,State Food and Drug Administration、Development and Reform Commission、The Ministry of Industry and Information Technology and other four ministries and commissions jointly issued the "Notice on Accelerating the Implementation of New Revised Drug Production Quality Management Specifications to Promote the Upgrade of the Medical Industry",Among them, encourage drug technology transfer becomes the biggest highlight。February this year,The State Food and Drug Administration issued an announcement,The overall relocation of the production enterprise、The transfer of drug technology involved in mergers and other is clear,The specific situation that stipulates that the transfer of drug technology transfer is: the overall relocation of the stake sports betting appstake betting appPharmaceutical Production enterprise or the overall relocation after being merged,The drug production technology of the original drug production enterprise can be transferred to the new site drug production enterprise; the merger and reorganization,Pharmaceutical manufacturers hold more than 50%of the equity or shares of the other party,Or both parties to control more than 50%of the equity or shares of the same enterprise,Both sides can transfer drug technology; abandon the pharmaceutical manufacturers of the entire factory or some dosage production transformation,The corresponding variety production technology can be transferred to an enterprise that has passed the newly revised drug GMP certification,But the production technology of all varieties of the same dose type is limited to one -time transfer to a pharmaceutical manufacturer。
 
Wang Lifeng said,From the case of technical transfer from Walnotong,,The transferee is mainly small and medium -sized enterprises,The main motivation for the acquirer is supplementing product lines,Transfer、Both parties are more rational。
 
My stake betting appstake online sports bettingIn addition to the transfer of technical results,Introduction and reorganization has also become one of the effects caused by the new revised drug GMP certification。Infusion Giant Koron Pharmaceutical、China Resources Shuanghe has expanded its own territory through mergers and acquisitions。Especially Collenine Pharmaceutical,Over the acquisition of Guangxi Colom、Establish a new Di Chemical、Absorption of Merge Pearl Pharmaceutical and Central South Colom、New Yilichuan Ning Anti -nexing Intermediate Project,Initially build a corporate antibiotic industry chain pattern。
 
At the annual summit of the Chinese chemical pharmaceutical industry in 2013,Relevant leaders of the State Food and Drug Administration said,Chinese pharmaceutical companies living in the moment are very happy: It is expected that the average growth rate of the Chinese pharmaceutical market from 2013 to 2020 will reach 12%; the size of the pharmaceutical market will exceed 1 trillion yuan in 2013; the Chinese pharmaceutical market size will be in 2019 will be Breaking through 2 trillion yuan。What cannot be ignored is,Although the market growth space is huge,But the structural contradiction in the industry is still prominent: the market share of the top ten companies in China is only 13.57%,and the top ten market share of the World Pharmaceuticals reached 40%。Repeated construction at low levels、Homogeneous production brings malignant competition。In the benign interaction of policies and markets,The pharmaceutical industry will gradually reverse this unfavorable situation。