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奧翔藥業(603229.SH):原料藥(恩替卡韋、雙環醇)獲GMP證書
格隆匯 12-04 16:26

格隆匯12月4日丨奧翔藥業(603229.SH)公佈,近日,公司收到浙江省藥品監督管理局頒發的《藥品GMP證書》,認證範圍:原料藥(恩替卡韋、雙環醇);有效期至:2024年11月10日。

此次認證的生產車間為一車間,涉及到的生產線設計產能情況為:恩替卡韋200公斤/年、雙環醇6噸/年。

恩替卡韋,主要用於治療伴有病毒複製活躍、血清轉氨酶持續增高的慢性乙型肝炎感染,由百時美施貴寶公司原研。

雙環醇是用於生產百賽諾仿製藥的原料藥,主要用於治療慢性肝炎所致的氨基轉移酶升高,由北京協和藥廠原研。

此次獲得《藥品GMP證書》,表明公司相關生產線符合GMP要求,有利於提升公司行業影響力和競爭力,對公司繼續保持穩定的產品質量、提升生產能力、滿足市場需求及未來穩健發展均有着積極意義。

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