華森製藥(002907.SZ)：鋁碳酸鎂咀嚼片獲得藥品補充申請註冊批件
格隆匯3月18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簽發的關於鋁碳酸鎂咀嚼片的藥品補充申請註冊批件(批件號：渝B202000010)，將該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，以下簡稱“五期項目”或“募投項目”)生產車間。
藥品通用名稱：鋁碳酸鎂咀嚼片；劑型：片劑；藥品分類：化學藥品；規格：0.5g；申請內容：申請將鋁碳酸鎂咀嚼片的生產場地由“重慶市榮昌區工業園區”變更為“重慶市榮昌區昌州街道板橋路143號”。審批結論：該品種經生產現場檢查並抽取試製樣品三批經重慶市食品藥品檢驗檢測研究院檢驗符合規定。經審查，同意該品種的生產場地由“重慶市榮昌區工業園區”變更為“重慶市榮昌區昌州街道板橋路143號”。説明書、標籤相應內容作修訂。
鋁碳酸鎂咀嚼片為消化系統一線用藥，具有抗酸、抗膽汁、保護粘膜的功效，三效合一整體治療上消化道疾病。該產品適用於廣泛治療多種胃部疾病：1.急、慢性胃炎；2.胃、十二指腸潰瘍；3.反流性食管炎；4.與胃酸有關的胃部不適症狀，如胃痛、胃灼熱、酸性噯氣、飽脹等；5.預防非甾體類藥物的胃黏膜損傷。可廣泛用於消化科、急診科、耳鼻喉科、神經內科等科室。其主藥鋁碳酸鎂為不溶於水的結晶性粉末，呈層狀網絡結構，口服之後不被胃腸道吸收，安全性高。此外，公司為國內第一家通過美國FDA的DMF備案的鋁碳酸鎂原料企業，具有出口資質，並實現原料製劑一體化，品質優良、保障供應。
此次獲得鋁碳酸鎂咀嚼片的藥品補充申請批件是公司五期項目獲得的首個生產場地轉移生產批件，標誌着公司募投項目可正式用於上市藥品的生產。募投項目集成了 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。同時，鋁碳酸鎂咀嚼片在第二次全國帶量採購中以首家順位中標，鋁碳酸鎂咀嚼片成功轉移至五期項目進行生產後，可更好地保證鋁碳酸鎂咀嚼片作為集採品種的藥品質量及市場供應。
同時，鋁碳酸鎂咀嚼片在第二批全國藥品集中採購中以首家順位中標，鋁碳酸鎂咀嚼片成功轉移至五期項目進行生產後，可更好地保證鋁碳酸鎂咀嚼片作為集採品種的藥品質量及市場供應。
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