特一藥業(002728.SZ):子公司頭孢拉定膠囊藥品通過一致性評價
格隆匯 12 月 9日丨特一藥業(002728.SZ)公佈,公司之全資子公司海南海力製藥有限公司(“海力製藥”)於近日獲得國家藥品監督管理局核准簽發的“頭孢拉定膠囊”《藥品補充申請批准通知書》,批准該藥品通過仿製藥質量和療效一致性評價。此次海力製藥通過一次性評價的頭孢拉定膠囊共有2個規格,分別為0.25g、0.5g,其中0.5g規格的頭孢拉定膠囊藥品為國內首次通過一致性評價,海力製藥也是國內首家通過頭孢拉定膠囊(0.5g)仿製藥一致性評價的企業。
頭孢拉定屬於第一代頭孢菌素,本品通過抑制細胞壁的合成,使細胞內容物膨脹至破裂溶解,從而達到殺菌作用,對革蘭陽性菌(包括耐青黴素的金黃色葡萄球菌)相當有效,對革蘭陰性菌產生的β-內酰胺酶的穩定性較差。適用於敏感菌所致的急性咽炎、扁桃體炎、中耳炎、支氣管炎和肺炎等呼吸道感染、泌尿生殖道感染及皮膚軟組織感染等。本品為口服制劑,不宜用於嚴重感染。
此次頭孢拉定膠囊仿製藥質量和療效一致性評價的通過,是公司及海力製藥研發能力、生產及質量管理體系等綜合實力的體現,也是國家藥品監管部門對上述綜合能力和產品質量的認可;同時,也為公司後續品種通過仿製藥質量和療效一致性評價提供了重要的經驗借鑑。此次頭孢拉定膠囊通過仿製藥質量和療效一致性評價,對公司有積極影響,有利於提升產品市場競爭力,擴大產品的市場份額。
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