康龙化成公告全资子公司康龙化成（绍兴）药业有限公司于2025年5月29日至2025年6月4日接受了美国FDA的cGMP上市批准前检查。检查涵盖了质量体系、物料管理体系、生产管理体系等多个方面。近日康龙绍兴收到美国FDA出具的现场检查报告确认其生产设施顺利通过检查符合美国药品cGMP质量标准通过了美国FDA认证。这是公司绍兴原料药商业化生产基地首次通过美国FDA新药批准前检查也是继2025年4月宁波原料药生产车间通过检查后公司在华原料药生产车间再次通过美国FDA检查。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.