| Certificate Number |
CDRR-CGMP-1660
|
| Manufacturer |
Qilu Pharmaceutical Hainan Co., Ltd._x000D_
|
| Plant Address |
No. 273-A, Nanhai Avenue, National High-Tech Zone, Haikou Hainan, 570314, China (CHN)
|
| Importer |
AMBICA INTERNATIONAL CORPORATION
|
| Validity Date |
04 August 2025
|
| Type of Application |
RENEWAL
|
| Product Line |
I. Human
1. General
1.1. Sterile*
1.1.1. Aseptic preparation
1.1.1.1. Lyophilisates
1.1.1.2. Small volume liquids
1.1.2. Terminal sterilization
1.1.2.1. Small volume liquids
1.2. Non-sterile*
1.2.1. Hard capsules
1.2.2. TaBlets
2. Cytotoxic
2.1. Sterile*
2.1.1. Aseptic preparation
2.1.1.1. Lyophilisates
2.1.1.2. Small volume liquids
2.1.2. Terminal sterilization
2.1.2.1. Small volume liquids
2.2. Non-sterile*
2.2.1. TaBlets
*Primary and Secondary packaging, and Quality control testing: Chemical/Physical, and MicroBiological: sterility and non-sterility
|