益佰製藥(600594.SH)：被確認為貴州省中藥配方顆粒研究試點企業
格隆匯2月26日丨益佰製藥(600594.SH)公佈，2020年2月26日，公司收到貴州省藥品監督管理局下發的《省藥品監管局關於確認中藥配方顆粒研究試點企業的通知》(黔藥監函［2020］49號)，確認公司為貴州省中藥配方顆粒研究試點企業。
根據原省食品藥品監督管理局《關於開展中藥配方顆粒研究試點工作的通知》精神,經企業申報、專家評審、網上公示等程序,現確認貴州益佰製藥股份有限公司為貴州省中藥配方顆粒研究試點企業。
《通知》要求從中藥配方顆粒研究試點企業確認之日起兩年內，企業至少要完成400種中藥配方顆粒生產工藝規程、質量標準等研究工作。在中藥配方顆粒試點研究實施過程中,國家有關部門出台關於中藥配方顆粒新規定的,按照新規定執行。企業要切實履行主體責任,認真做好組織實施和管理。每年應向省藥品監督管理局提交中藥配方顆粒安全性、有效性及臨牀試點使用情況等的年度總結報告。
《通知》要求各市(州)市場監管局要加強對試點企業的檢查、指導。試點企業要積極穩妥推進產品研發,加強標準湯劑、生產工藝和臨牀使用的研究,重點研究中藥配方顆粒安全性和有效性,確保產品安全、有效。
近年來，中藥配方顆粒市場保持快速增長態勢，被確認為中藥配方顆粒試點研究企業，符合公司戰略規劃，有利於公司進一步完善產品結構，完善中藥全產業鏈佈局，滿足市場需求並進一步擴大公司品牌效應及市場份額，提高公司核心競爭能力，對公司未來業績增長帶來積極促進作用。
公司於2019年11月通過中藥飲片GMP認證，具備了中藥飲片、顆粒劑生產範圍和中藥飲片炮製、提取、濃縮、乾燥、制粒等完整生產能力，並已完成300種以上中藥配方顆粒生產工藝規程、質量標準等研究工作，在完成上述認證、研究相關工作後，公司符合資質被確認為貴州省中藥配方顆粒試點研究企業。公司將盡快按規定開展相關後續工作。
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