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華森製藥(002907.SZ):甘桔冰梅片等7個產品獲藥品補充申請批件
格隆匯 04-09 20:26

格隆匯4月9日丨華森製藥(002907.SZ)公佈,公司於近日收到重慶市藥品監督管理局(“市藥監局”)簽發的甘桔冰梅片等7個產品的藥品補充申請批件。將7個產品生產場地變更為重慶市榮昌區昌州街道板橋路143號,即公司第五期新建GMP生產基地項目(即公司IPO和可轉債募投項目,“五期項目”或“募投項目”)生產車間。

此次獲得甘桔冰梅片等7個產品的藥品補充申請批件是公司五期項目獲得的第二批生產場地轉移生產批件,並將在五期項目進行生產。五期項目集成了MES、SCADA、DCS系統,結合大數據、人工智能,並將進行cGMP認證。項目建成正式投產,可極大地釋放產能,解決過去公司面臨的產能嚴重不足的問題,有利於更好地滿足銷售端需求,在形成規模效應後進一步降低生產成本。

此次所獲批件中包含公司五大獨家中成藥品種(甘桔冰梅片、都樑軟膠囊、痛瀉寧顆粒、六味安神膠囊、八味芪龍顆粒),且六味安神膠囊和八味芪龍顆粒為公司2019年新進入《國家醫保目錄》的品種,五大獨家中成藥品種具有明確的療效確切,多個產品銷量已位居國內市場細分領域前列,該等品種成功轉移至五期項目進行生產後,可更好地保證其藥品質量及市場供應。

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