Tsis ntev los no, Beijing Fuyuan Pharmaceutical Co., Ltd. (tom qab no hu ua "Company" lossis "Fuyuan Pharmaceutical") tau txais lubDaim Ntawv Ceeb Toom Txog Kev Tshawb Fawb Txog Tshuaj GMP Ua Raws Cai(No.: Jing Yao Jian Yao GMP 〔2023〕0200112). Cov ntsiab lus tseem ceeb tau tshaj tawm hauv qab no:
I. Pharmaceutical GMP Inspection List
Lub npe lag luam: Beijing Fuyuan Pharmaceutical Co., Ltd.Nrhiav Chaw Nyob: Tsis yog . 5 Huatuo Road, Lingang Economic thiab Technological Development Zone, Cangzhou City, Hebei ProvinceInspection Scope: Bedaquiline Fumarate API (Bedaquiline Fumarate Ntau Lawm Kab hauv Rhiav 102) Lub Sijhawm Tshuaj Xyuas: Lub Kaum Ob Hlis 23 Lub Kaum Ob Hlis, 28 Kev Ntsuam Xyuas kev tshuaj xyuas no yog ua raws li cov kev cai ntawm lubKev Tsim Khoom Zoo rau Cov Tshuaj (Tshuaj Kho Dua Tshiab hauv 2010)thiab nws cov appendices.
II. Kev ua lag luam Status ntawm cov khoom tseem ceeb
| Serial No. | Cov khoom tseem ceeb | Dosage Form | Chaw kho mob | Kev ua lag luam |
|---|---|---|---|---|
| 1 | Bedaquiline Fumarate | API | Tshuaj-Resistant Tuberculosis | Lwm cov tuam txhab uas muaj npe APIs ntawm cov khoom no suav nrog Fujian Institute of Microbiology, Simcere Pharmaceutical Co., Ltd., Tuam Tshoj National Pharmaceutical Group Guorui Pharmaceutical Co., Ltd., Xuancheng Meinuohua Pharmaceutical Co., Ltd., thiab MSN LIFE SCIENCES PRIVATE LIMITED. Lub Tuam Txhab tsis tau txais cov ntaub ntawv muag khoom ntawm cov khoom no los ntawm cov pej xeem raws. |
