普利製藥(300630.SZ):氫氧化鎂原料藥DMF和CEP申請獲FDA及EDQM接收
格隆匯1月23日丨普利製藥(300630.SZ)公佈,公司全資子公司安徽普利於近日分別收到美國食品藥品監督管理局(簡稱“FDA”)和歐洲藥品質量管理局(簡稱“EDQM”)簽發的氫氧化鎂原料藥DMF和CEP申請已接收的通知函。
氫氧化鎂原料藥為鹽類瀉藥,並有抗酸作用,其製劑主要用於胃/十二指腸潰瘍、胃炎(突發/慢性胃炎、藥物性(包括胃炎)、上消化道功能障礙(神經性厭食、包括所謂的胃下垂和胃酸過多)。
截至目前,根據EDQM和FDA網站公開信息顯示,氫氧化鎂原料藥全球現有3家企業原料藥獲得CEP證書,包括安徽普利在內的2家企業原料藥DMF在FDA狀態為“A”。安徽普利該品種已具備商業化生產能力,將進一步豐富公司產品線,豐富原料藥品種。
公司的氫氧化鎂原料藥其他市場的註冊工作也在持續推進中。
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