Green Valley Pharmaceuticals said it had voluntarily withdrawn its application for a listing in Phase 9 of the new specification, which was not approved.
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Last Update: 2020-07-17
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Source: Internet
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Author: User
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On July 9, Green Valley Pharmaceuticals issued a Note on the Approval of the GlynTurner Capsule 450mg Specification Review, stating that "The Nine New Specifications Have Not Been Approved" was not an unapproved, but that it had applied to the State Drug Administration on April 2 to withdraw its application for the listing of 450mg Ganluttner Capsules (Commodity Name: Phase 9 1)according to the official website of the State Drug Administration issued "July 08, 2020 drug notice pending release", Green Valley Pharmaceutical's 450mg Ganluttner capsule (acceptance number: CHXS1800038) listing application suspended, causing a lot of heated debateresponded that it had submitted a listing application for 450mg and 150mg ganlutna capsules to the National Drug Review Center on October 18, 2018, of which 150mg Ganluttner Capsules (receiving no1800037) were approved for listing on November 2, 2019since then, due to the need for 450mg ganlutna capsule data update, Green Valley Pharmaceuticals has voluntarily applied to the National Drug Review Center to withdraw the previously submitted listing application, the National Drug Review Center subsequently concluded the technical review process, and made a recommendation conclusion to terminate the review process, and submitted it to the National Drug Administration for approval on June 23In its response,also stressed that it had relaunched its application for listing of 450mg Ganlutna Capsules in April 2020 after voluntarily withdrawing its application for listing of 450mg Ganlutna Capsules, and planned to launch a separate declaration of 450mg Ganlutna Capsulesit is worth noting that Phase 9 Phase III clinical trials were approved by the FDA on April 3 to conduct Phase III trials at international multi-centers, and Green Valley Pharmaceuticals said it is seeking to complete the global registration of the drug by 2025it is understood that Phase 9 Is China's first domestic Alzheimer's disease innovation drug, mainly used in the treatment of mild Alzheimer's disease, after the drug's clinical trial data authenticity, duration and drug effectiveness of the controversy.
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