| Certificate Number |
CDRR-CGMP-5892
|
| Manufacturer |
GESELLSCHAFT FUR PRODUKTIONSHYGIENE UND STERILITÄTSSICHERUNG MBH
|
| Plant Address |
GESELLSCHAFT FUR PRODUKTIONSHYGIENE UND STERILITÄTSSICHERUNG MBH, TALBOTSTRABE 21, 52068 AACHEN, GERMANY
|
| Importer |
NOVARTIS HEALTHCARE PHILIPPINES, INC.
|
| Validity Date |
05 April 2025
|
| Type of Application |
INITIAL
|
| Product Line |
I. Human Medicinal Products
1. Quality control testing
1.1. Microbiological: sterility and non-sterility
This clearance is valid for the following test methods: Microbiological tests in particular for: Sterility testing Endotoxin testing Total viable aerobic microbial count Tests for specified microorganisms: - bile-tolerant gram-negative bacteria - Escherichia coli - Salmonella - Pseudomonas aeruginosa - Staphylococcus aureus
|