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    Home > Active Ingredient News > Drugs Articles > Which one of the domestic pharmaceutical companies can achieve "overtaking on a curve" with the FDA number?

    Which one of the domestic pharmaceutical companies can achieve "overtaking on a curve" with the FDA number?

    • Last Update: 2018-11-19
    • Source: Internet
    • Author: User
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    [China Pharmaceutical network industry news] it is reported that the FDA has approved 53 new drugs so far in 2018, and it is expected that the number of new drugs approved this year will reach a new high The author found that in November, the products of several pharmaceutical companies in China passed the FDA approval It is understood that FDA is a government health control monitoring agency composed of doctors, lawyers, microbiologists, pharmacologists, chemists, statisticians and other professionals who are committed to protecting, promoting and improving the national health of the United States The FDA's role is to ensure that all food, drugs, cosmetics and medical devices on the U.S market are safe and effective for the human body Among them, drug listing must be approved by FDA, and the process of applying for new drug approval is very complicated and strict In recent years, with the more and more strict regulation of drugs in China, many pharmaceutical enterprises are under the great pressure of policies It is a new way for them to explore the coordinated development of various products In this regard, some people also speculated that some domestic pharmaceutical companies have been so active in obtaining the FDA number, whether they intend to take advantage of the pharmaceutical products approved for listing in Europe and the United States, take the "shortcut" of overseas co production to realize "overtaking on the curve", so as to pass the consistency evaluation? On November 17, Yiling pharmaceutical announced that its wholly-owned subsidiary's preparation product, letrozole tablets, had obtained the approval number of the US FDA, while on November 15, another preparation product, anastrozole tablets, of Yiling Sun company had also obtained the approval of the US FDA It is reported that the indications of these two preparations are both used for breast cancer treatment Previously, Yiling Pharmaceutical Co., Ltd obtained the approval of FDA in October, June and March of this year, including felodipine sustained-release tablets, ciprofloxacin tablets of antibacterial drugs and acyclovir tablets of herpes virus infection drugs It is reported that the above five varieties have not passed the consistency evaluation Huahai pharmaceutical announced on November 11, 2018 that the Anda (American generic drug application) of tegrilol tablets declared by Huahai pharmaceutical to the US FDA has been temporarily approved According to the industry, the temporary approval number of tegrilol by the FDA marks the further promotion of the company's business in the field of generic drugs, which has a positive impact on the company's expansion of the U.S market But not long ago, on November 5, Huahai pharmaceutical announced that it had received the notice of approval from the FDA of the United States about the Anda of the Gelong ammonium bromide injection, which means that the company has the qualification to produce and sell the product in the U.S market At present, the product has not been listed and sold in China It is reported that Huahai pharmaceutical industry is expected to become a domestic Gelong ammonium bromide injection generic pharmaceutical enterprise through the way of "reporting abroad to China" In general, 2018 will be a good year for FDA It is reported that 41 new drugs have been approved in the first three quarters, and most of them contain drugs for rare diseases With the continuous development of Chinese enterprises and the support of related new drug R & D policies, more and more domestic pharmaceutical enterprises have appeared in various major disease fields It is believed that more domestic innovative drugs will be approved by FDA in the future, which will help China move from a big pharmaceutical country to a powerful pharmaceutical country.
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