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.
天药股份(600488.SH):子公司产品通过美国FDA批准前现场检查
格隆汇 01-17 20:43

格隆汇1月17日丨天药股份(600488.SH)公布,公司子公司天津金耀药业有限公司(以下简称“金耀药业”)于2019年8月19日至8月27日接受了美国食品药品监督管理局(以下简称“FDA”)的现场检查,本次检查是美国FDA对金耀药业注射用甲泼尼龙琥珀酸钠新药简略申请(以下简称“ANDA”)批准前的现场检查(以下简称“PAI”)。近日,金耀药业收到美国FDA出具的现场核查报告,表明美国FDA对金耀药业的PAI检查目标已经达成,金耀药业已经具备该产品商业化生产能力并符合数据完整性要求。

金耀药业注射用甲泼尼龙琥珀酸钠生产车间位于天津市经济技术开发区黄海路221号,本次现场检查的生产线年设计产能约为1800万支。

注射用甲泼尼龙琥珀酸钠是一种糖皮质激素类药物,主要用于抗炎治疗、免疫抑制治疗、血液疾病和肿瘤的治疗、休克的治疗等,有40mg、125mg、500mg、1g和2g五种规格。根据IMS数据显示,2017-2018年该品种全球的销售额约为4.2-4.5亿美元,其中美国市场的销售额约为1.5-1.7亿美元,主要以辉瑞为主(市场份额约为99%)。

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.
uSMART
Wealth Growth Made Easy
Open Account