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益佰製藥(600594.SH)獲貴州省藥監局同意白芍配方顆粒等124個品種進入臨牀研究
格隆匯 06-24 18:36

格隆匯 6 月 24日丨益佰製藥(600594.SH)公佈,近日,公司收到貴州省藥品監督管理局(“省藥監局”)下發的《省藥品監管局關於同意貴州益佰製藥股份有限公司“白芍配方顆粒”等124個品種進入臨牀研究的函》(黔藥監函[2020]349號)(“《函》”),同意公司白芍配方顆粒等124個品種進入臨牀研究。

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》要求,公司已完成了白芍配方顆粒等124個品種質量標準複核研究工作。經專家會議審核通過,現同意公司白芍配方顆粒等124個品種進入臨牀研究。

《函》要求公司嚴格按照GMP等相關要求進行生產,並將醫療機構名單報省藥監局備案。試點過程中遇到的問題,及時向省藥監局報告。

近年來,中藥配方顆粒市場保持快速增長態勢,公司此次獲得省藥監局同意公司白芍配方顆粒等124個品種進入臨牀研究,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。公司將盡快按規定開展相關後續工作。

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