Group 1 - The announcement states that Chengdu Rongsheng Pharmaceutical Co., Ltd., a subsidiary of Beijing Tiantan Biological Products Co., Ltd., has received the Drug GMP Compliance Inspection Notice from the Sichuan Provincial Drug Administration [1][2] - The inspection was conducted from June 16 to June 19, 2025, and concluded that the production facility complies with the Drug Production Quality Management Standards (2010 revision) [2] - The inspected facility is focused on the production of therapeutic biological products, specifically the injection of recombinant human coagulation factor VIIa [1][2] Group 2 - The product "Injection of Recombinant Human Coagulation Factor VIIa" has completed Phase III clinical trials and has submitted a marketing authorization application, which is currently under review [3] - The receipt of the GMP Compliance Inspection Notice indicates that the production facility meets national GMP requirements, allowing for potential production upon obtaining the registration certificate and final production license for the product [3] - Future production of the product may be influenced by national policies and market conditions, indicating a level of uncertainty [3]
北京天坛生物制品股份有限公司关于下属企业获得《药品GMP符合性检查告知书》的公告