| Certificate Number |
CDRR-CGMP-FA-174-01
|
| Manufacturer |
KEXING BIOPHARM CO., LTD.
|
| Plant Address |
NO. 2666 CHUANGYE ROAD, BUCUN SUBDISTRICT, ZHANGQIU, JINAN, SHANDONG PROVINCE, CHINA
|
| Importer |
GOODFELLOW PHARMA CORPORATION
|
| Validity Date |
23 August 2027
|
| Type of Application |
INITIAL
|
| Product Line |
I. Human
1. Sterile*
1.1. Aseptic preparation
1.1.1. Biological medicinal products
1.1.1.1. Biotechnology products
1.1.1.1.1. Recombinant Human Erythropoietin
1.1.1.1.2. Recombinant Human Granulocyte Colony - Stimulating Factor
1.2. Drug Substance (APIs)
1.2.1.Recombinant DNA Technology (E. Coli, and CHO Cell)
*Primary and Secodnary packaging, and Quality control testing: Chemical/Physical, and Microbiological
|