同和藥業(300636.SZ):原料藥塞來昔布通過日本PMDA現場檢查
格隆匯2月18日丨同和藥業(300636.SZ)公佈,公司於2019年12月3日至6日接受了日本PMDA(日本獨立行政法人醫藥品醫療器械綜合機構)官方的全面GMP(藥品生產質量管理規範)現場檢查,此次檢查為日本客户塞來昔布製劑獲批前關聯原料藥的GMP合規性調查。近日,公司收到日本PMDA簽發的《GMP調查結果報告書》,整體的現場檢查結論為合格,即公司原料藥塞來昔布通過了日本PMDA的GMP現場檢查。
塞來昔布主要用於緩解骨關節炎的症狀和體徵、緩解成人類風濕關節炎的症狀和體徵,還可用於治療成人急性疼痛。
公司此次順利通過日本PMDA現場檢查,為塞來昔布原料藥成功進入日本市場創造了條件,有利於公司加強與日本客户的合作,提高公司產品的市場競爭力,對公司進一步開拓日本市場和其他國際市場有着非常積極的作用。品的市場競爭力,對公司進一步開拓日本市場和其他國際市場
有着非常積極的作用。
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