西藏藥業(600211.SH):子公司獲得“注射用重組人腦利鈉肽”藥品補充申請批件
格隆匯 11 月 5日丨西藏藥業(600211.SH)公告,近日,本公司全資子公司成都諾迪康生物製藥有限公司(以下簡稱“成都諾迪康”)收到四川省藥品監督管理局頒發的《藥品補充申請批件》(編號:川B202000152)。
藥品通用名稱:注射用重組人腦利鈉肽
劑型:注射劑
藥品分類:治療用生物製品
規格:0.5mg/500U/瓶
藥品批准文號:國藥準字S20050033
藥品標準:國家食品藥品監督管理總局標準WS4-(S-001)-2016Z
原藥品生產企業:成都諾迪康生物製藥有限公司;生產地址:成都錦江工業開發區。
申請內容:申請注射用重組人腦利鈉肽的生產地址在“成都錦江工業開發區”原生產線的基礎上增加原液生產車間“基因車間B線”。申請理由:因公司發展需要,該公司已在成都錦江工業開發區新建原液生產車間“基因車間B線”。現申請本品的生產地址在“成都錦江工業開發區”原生產線的基礎上增加原液生產車間“基因車間B線”。
審批結論:根據《藥品註冊管理辦法》及相關規定,經審查,同意本品生產地址在“成都錦江工業開發區”原生產線的基礎上增加原液生產車間“基因車間B線”,請對藥品説明書及包裝標籤作相應修訂。
藥品生產企業:成都諾迪康生物製藥有限公司;生產地址:成都錦江工業開發區。
新活素系我公司的主要產品。近年來,由於新活素銷量大幅提升,為了滿足市場需求,公司進行了新生產線的擴建工作。成都諾迪康獲得上述《藥品補充申請批件》,新活素產能擴大,將更好的滿足市場需求,對公司未來發展產生積極作用,對當期業績無重大影響。
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.