You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
海普瑞(09989.HK):自歐洲藥品管理局取得藥品GMP證書
格隆匯 02-14 16:59

格隆匯2月14日丨海普瑞(09989.HK)發佈公告,公司已於近日收到波蘭衛生監督機構(Chief Pharmaceutical Inspector)根據歐洲藥品管理局(“EMA”)相關規定發出的“Certificate of GMP Compliance of a Manufacturer”(“藥品GMP證書”)。

海普瑞坪山園區的新建預灌封製劑生產線項目於2022年正式啓動。第一期工程涉及三條預灌封製劑生產線的建設,設計年產能爲330百萬支。該等生產線按照中國、歐洲及美國的藥物監管標準設計建造,並將用於生產依諾肝素鈉預灌注射液。截至2024年,該項目已完成並首次通過歐洲聯盟(“歐盟”)GMP認證。根據歐盟成員國之間的GMP互認制度,本次通過GMP認證表明本次接受認證的生產線已符合歐盟GMP標準。

歐洲乃公司全球製劑業務的重要市場。近年來,集團旗下依諾肝素鈉製劑的市場佔有率一直位居歐洲前二位。新制劑生產線獲得藥品GMP證書將爲集團進一步推進國際化戰略提供充足的產能保障,並有效提升集團的市場競爭力。此外,集團憑藉其強大的預灌製劑生產能力,以及成熟的自營銷售網絡及渠道,集團將可強力支持並推動協助中國製藥企業進軍歐美市場的戰略。我們相信,此舉將對公司未來的業務拓展產生深遠且積極的影響。

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 this article is for reference only. It does not constitute an offer, solicitation, recommendation, opinion or guarantee of any securities, financial products or instruments.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.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance.
uSMART
Wealth Growth Made Easy
Open Account