貴州百靈(002424.SZ):獲得諾氟沙星膠囊的藥品補充申請批准通知書
格隆匯12月31日丨貴州百靈(002424.SZ)公佈,公司全資子公司貴州百靈企業集團正鑫藥業有限公司(“正鑫藥業”)於近日收到國家藥品監督管理局(“國家藥監局”)核准籤發的《藥品補充申請批准通知書》。
藥物名稱為諾氟沙星膠囊,申請內容:1、一致性評價申請,處方工藝有變更。2、提高質量標準。3、完成餐前生物等效性研究。
審評結論:根據《中華人民共和國藥品管理法》、《國務院關於改革藥品醫療器械審評審批制度的意見》(國發[2015]44 號)和《關於仿製藥質量和療效一致性評價工作有關事項的公吿》(2017年第 100 號)的規定,經審查,“諾氟沙星膠囊”視同通過仿製藥質量和療效一致性評價。建議同意“諾氟沙星膠囊”處方、生產工藝的變更,以及質量標準的修訂。質量標準、説明書照所附執行。請對包裝標籤進行相應修改。本品內包裝採用鋁塑泡罩包裝(聚氯乙烯固體藥用硬片和藥用鋁箔),外套聚酯/鋁/流延聚丙烯藥品包裝用複合袋;藥品有效期為18個月。基於申報的生產線、生產設備與工藝驗證情況,本品的生產批量為10萬粒/批。今後的商業化生產如需放大批量,請注意開展相應的放大研究及驗證,必要時應針對生產規模放大提出補充申請。
“諾氟沙星膠囊”是正鑫藥業常年生產的品種,具有很好的市場基礎。通過此次一致性評價獲批,極大的提升了正鑫藥業所生產藥品的內在質量,是公司“始終將藥品質量安全放在首位”的承諾落到實處的具體表現,進一步增強了該品種的市場競爭力,為公司盈利能力提升產生積極影響。
Follow us
Find us on
Facebook,
Twitter ,
Instagram, and
YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the
uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!

Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.