Approval of the first domestic "Viagra" Baiyunshan "Jinge"
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Last Update: 2014-08-01
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Source: Internet
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Author: User
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According to the description on CFDA administrative Acceptance Center website, "approval completed - Certificate to be prepared" means that CFDA administrative acceptance service center is in the process of preparing approval documents (national drug standard issued by National Pharmacopoeia Committee); the "processing status" of application for API production registration approval documents of Baiyunshan Jinge has been updated to "in approval" at 14:31 on June 9, 2014 It is reported that the trade name of "Viagra" in Baiyunshan version of Guangyao, which has attracted much attention, is "Jinge" Baiyunshan "Jinge" obtained the new drug certificate of "sildenafil citrate" API and tablet in 2003, with the certificate numbers of "gjzz h20030493" and "gjzz h20030494" respectively; in view of the expiration of Pfizer's Viagra patent, it applied to the pharmaceutical regulatory department for production approval Industry insiders said that although the approval of Baiyunshan "Jinge" preparation is faster than that of raw materials, it is enough to show that among several enterprises applying for "Viagra" production approval documents, Baiyunshan Jinge has won the "top card" and become the first approved "Viagra" in China Baiyunshan of Guangyao said that after obtaining the production registration approval of APIs and tablets, relevant work will be promoted as soon as possible to realize the production and listing of "Jinge" as soon as possible.
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