The most unregulated chemical enterprises affected

2022-07-24
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Nonstandard chemical enterprises' export of API industry is affected. China is a big producer and exporter of API, and its position in the world market is also gradually improving. However, the API products exported by some non-standard pharmaceutical and chemical enterprises are affecting the reputation of China's API in the world market

according to the latest report of the New York Times, the US Federal Bureau of investigation has prosecuted several Chinese companies based in Europe for "illegally exporting API through the United States and Europe", and arrested several Chinese pharmaceutical representatives in Europe. According to the newspaper, FBI officials adopted "phishing law enforcement measures", that is, they disguised as buyers of APIs and approached a representative of a Chinese company called "Oriental Pacific International Company" in Paris, France, to discuss the purchase of several APIs. Finally, after these APIs were consigned to the U.S. port through Europe, FBI officials arrested kevinxu, the representative of the Chinese company, They were put in Houston prison with a surface hardening hardness of hrc58 (6) 2. According to the indictment filed by the US Federal Bureau of investigation, kevinxu, the representative of Paris Oriental Pacific international company, illegally exported a large number of anti schizophrenic drugs, anti prostate cancer drugs, anti Alzheimer's drugs and other drugs to the United States, thus violating the relevant laws of the United States. What is more serious is that several of these drugs exported to the United States are patented

it is understood that in the past 15 years, an unknown number of small chemical plants in China have also been producing APIs. Moreover, these chemical plants have also made every effort to introduce their API products into the European and American markets through foreign intermediaries or directly through the Internet. In recent years, this situation has become more and more serious

as we all know, if we want to export API to the United States and other developed countries, we must obtain the DMF certificate from the FDA. However, at present, the software and hardware conditions of many domestic API manufacturers make it impossible for the laboratory machine to lift the worktable about 10mm, not to mention those chemical plants with poor production conditions. In previous years, when the economic situation of European and American countries was still good, these countries acquiesced in the export of APIs for which China had not obtained the DMF Certificate (because the price was cheap). However, in the past two years, affected by the financial crisis and the rising unemployment rate, multinational pharmaceutical companies in Europe and the United States began to take a very strict attitude towards the illegal export of APIs by Chinese enterprises

the New York Times pointed out that at least 500 Chinese pharmaceutical companies attended the international pharmaceutical API conference held in Milan (Italy) two years ago. Most of them were legal companies. However, some legal companies were secretly producing patented API products of American or European companies and openly displaying their products at the conference. According to the evidence held by FDA, at least 37 Chinese chemical companies export API products to the United States (through agents or through re export in Europe), of which the "steroid" API exported by a company in Hunan, China (such drugs are prohibited in the United States) has a huge amount and amount

it is also reported that at least 1/3 of the "Viagra" preparations sold in the United States and Europe originate from products exported from China. This has seriously infringed the interests of Pfizer, the patent holder of Viagra

many multinational pharmaceutical companies believe that the current situation that raw materials produced by untested chemical plants enter the markets of developed countries including the United States, Germany, France, the United Kingdom and Italy must be corrected, otherwise the consequences of illegal raw materials once processed into preparations will be unpredictable. At the hearing held by the U.S. Congress at the beginning of this year, FDA officials also named several chemical plants in Changzhou, Wuxi and other China for producing drugs, accusing them of illegally producing best-selling APIs and exporting them to the United States through re export. What is more serious is that some Chinese chemical plants are still producing and exporting some new drugs newly approved and listed in Europe and the United States, such as acomplia (rimonabant, a new weight-loss drug) produced by a French company. FDA officials said that some chemical plants in China are not only producing but also exporting these new drugs to Europe and the United States through various channels, causing significant economic losses to patent holders. It is reported that in recent years, several representatives of Chinese chemical companies have been arrested and prosecuted for illegally exporting APIs to Europe, which has also affected the reputation of Chinese APIs in the international market

there is no need to discuss whether it is legal for the law enforcement agencies of the US Federal Bureau of investigation and other European countries to entrap the representatives of Chinese pharmaceutical companies in Europe by means of "phishing law enforcement". However, there is no doubt that some Chinese enterprises have exported a large number of APIs without DMF certificates to Europe and the United States in recent years by means of re export or through agents, which has caused multinational companies to The free technical training of maintenance personnel in comprehensive operation, maintenance, repair and other aspects makes pharmaceutical companies uneasy, because it directly threatens their interests. Many pharmaceutical representatives of China have been detained and prosecuted in Europe and the United States, which has sounded an alarm to China's pharmaceutical enterprises that still lack new chemical materials and fine chemicals with high performance, special varieties, safety and environmental protection. If enterprises want to export APIs, they must first obtain relevant certificates issued by foreign governments, such as the DMF certificate of the United States or the cos certificate of the European Union. Only in this way can they be legally exported. In addition, raw materials must be exported through legal channels. For example, qualified European and American agents must not go astray. For a country with a legal system like the United States, once the illegally exported APIs are seized by law enforcement agencies, exporters will face prosecution, huge fines and huge economic losses

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