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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 Green Valley Pharmaceuticals' official statement, 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 No. 1800037) were approved for listing on 2 November 2019.
since then, because of the need for 450mg ganlutna capsule data updates, Green Valley Pharmaceuticals has voluntarily applied to the National Drug Review Center to withdraw its previously submitted listing application, which subsequently concluded the technical review process and concluded its recommendation to terminate the review process, which was submitted to the National Drug Administration for approval on June 23.
Green Valley Pharmaceuticals also indicated that it had restarted 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 Ganluttner Capsules.
Its International Multicenter Phase III clinical trial was approved by the FDA on April 3, according to green valley pharmaceutical website, with the aim of completing the global registration of the drug by 2025.
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