新天藥業(002873.SZ)獲得貴州省藥品監督管理局同意“白朮配方顆粒”等151個品種進入臨牀研究的函
格隆匯12月2日丨新天藥業(002873.SZ)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陽新天藥業股份有限公司“白朮配方顆粒”等151個品種進入臨牀研究的函》(黔藥監函〔2019〕255號)。
根據《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,公司已完成了白朮配方顆粒等151個品種質量標準複核研究工作。經專家會議審核通過,同意公司白朮配方顆粒等151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,在試點過程中遇到的問題,及時向省藥監局彙報。
近年來中藥配方顆粒市場保持快速增長態勢,公司本次獲得省藥監局同意白朮配方顆粒、仙鶴草配方顆粒等151個品種進入臨牀研究,有利於加快公司完善中藥產業鏈佈局、豐富產品結構、滿足市場需求並進一步擴大品牌效應及市場份額,構建公司新的利潤增長點,實現公司業績的進一步提升。
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