Hualong is exposed that the extract injection purchased from the groceries shop flows to the whole country

Dozens of domestic pharmaceutical companies and health care products companies have been involved in the storm of unqualified Ginkgo biloba leaves Wuhan Hualong biopharmaceutical Co., Ltd has been shocked to buy intermediate products from cattle stores and make them into calf blood deproteinized extract injection to the market One wave is not flat and another is rising Dozens of domestic pharmaceutical companies and health care products companies have been involved in the storm of unqualified Ginkgo biloba leaves, and Wuhan Hualong biopharmaceutical Co., Ltd (hereinafter referred to as "Wuhan Hualong") has been shocked to buy intermediate products from cattle stores, and made into calf blood protein free extract injection to market According to the reporter of China business daily, although quality supervision departments are set up by the pharmaceutical enterprises and local governments themselves, Wuhan Hualong's illegal behavior was investigated and punished in the flight inspection of the State Food and Drug Administration (hereinafter referred to as "flight inspection") People in the industry question whether this is a hidden rule in the industry or whether some enterprises accidentally hit the gun when the human energy of the national regulatory authorities is limited? On June 17 of this year, the State Food and Drug Administration issued the circular on illegal production of calf blood deproteinized extract injection by Wuhan Hualong biopharmaceutical Co., Ltd (2015 No 21, hereinafter referred to as the circular), informing the illegal production behavior of Wuhan Hualong, ordering the enterprise to stop production and rectify in an all-round way, and withdrawing its GMP certificate Flight inspection is a kind of unannounced supervision and inspection carried out by the food and drug regulatory authorities for pharmaceutical enterprises, which is characterized by surprise, independence and efficiency According to incomplete statistics, as of July this year, more than 60 pharmaceutical companies have received GMP certificates, more than in previous years Industry insiders believe that from plant extracts to animal extracts, they have been purged one after another, and the flight inspection is significantly frequent, or become a normal way of supervision Wuhan Hualong, the secret of niuzadian, is a wholly-owned subsidiary of Guangxin science and education group, a leading enterprise in Hubei Province It has a history of more than ten years and obtained the new GMP certificate in February 2014 According to the company profile on the official website of Wuhan Hualong, Wuhan Hualong has also won a series of national level honorary titles such as "national torch plan project" undertaking unit, "national top three units of biological and biochemical drugs" And this is in dramatic contrast to the crimes that have been investigated at present The intermediate products of the pharmaceutical industry are not from the production line of the pharmaceutical factory, but from the shuntao cattle and miscellaneous agency in Yuhong District, Shenyang City According to reports, calf blood deproteinized extract injection is used in neurology to improve brain function According to the approved production process of deproteinized calf blood extract, the enterprise shall use the fresh calf blood or calf serum as the raw material in the production workshop of the enterprise certified by GMP, after alcohol precipitation, centrifugation and concentration, make the concentrated calf blood solution, and then make the deproteinized calf blood extract injection through ultrafiltration, dialysis, filling and other steps But the industry personage expresses, the country to biochemical medicine enterprise production request is continuous production, that is to say the whole production process cannot stop The raw materials used need to be purchased from prescribed legal channels, have the national registration and approval process and meet the pharmaceutical standards The animals used to extract pharmaceutical products will also have relevant quality conditions such as variety, age, feed, etc to control the safety of drugs However, the intermediate products of Hualong biology are purchased from the cattle shop without such qualification, which is surprising In addition, the relevant departments found that the environment for producing calf blood concentrate was very bad, which did not meet the basic requirements of drug production This means that the quality of calf blood deproteinized extract injection produced by the concentration can not be guaranteed Li Guoqing, director general of the Department of drug and cosmetics supervision of the State Food and drug administration, said to the public that the production records of Wuhan Hualong related products were all forged, while the intermediate products were purchased from the dealers of the grocer's shop, but recorded as their own production Li Guoqing said that the source of biochemical drugs is animals, with many more risk factors than chemicals and plant drugs, which are clearly required by the drug administration law and the GMP According to the announcement on the official website of Wuhan Hualong, as of June 13, 221902 pieces of production batch number from January 2014 to May 8, 2015 were recalled, while the actual total production was 3981491 pieces But its recall account shows that its calf blood deproteinized extract injection products almost cover the whole country, and the vast majority of regions show that the product "actual recall quantity" is 0, which means it has been used.