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Quality system
Certificates
Audit History
-
2016
·Finasteride and Progesterone passed US FDA inspection
·Progesterone passed EU EDQM inspection -
2019
·Finasteride, Progesterone,and Budesonide passed US FDA inspection
·Finasteride passed Japan PMDA inspection -
2020
·Cyproterone acetate passed Australia TGA
-
2021
·Oxcarbazepine passed P.R. China Hubei Drug Administration inspection
-
2023
·Oxcarbazepine and Dutasteride passed MFDS inspection
-
2024
·Cyproterone Acetate passed EDQM inspection
Main QC Instruments List
| Instrument | Type | Manufacturer |
| HPLC | 1100 | Agilent |
| 1200 | Agilent | |
| 1260 | Agilent | |
| 1290 | Agilent | |
| LC-20AT | Shimadzu | |
| LC-2030C PLUS | Shimadzu | |
| Ultimate 3000 | ThermoFisher | |
| Waters e2695 | Waters | |
| GC | 6890 | Agilent |
| 7697A | Agilent | |
| 7890 | Agilent | |
| GC-2030AF | Shimadzu | |
| IR | Avatar 380/iS10 | NICOLET |
| ALPHA-T | BRUKER | |
| UV-Vis | UV-2600/2000/1800 | Shimadzu |
| AAS | AA7000 | Shimadzu |
| Polarimeter | Autopol V/ⅠS2 | Rudolph |
| Autopol Ⅳ-T | Rudolph | |
| Laser Mastersizer | Mastersizer 3000 | Malvern |
| HELOS-RODOS | SYMPATEC | |
| TOC | TOC-VWP | Shimadzu |
| HTY-DI1500 | TAILIN | |
| Karl-Fisher Titrator | KF870/831/915 | Metrohm |
| Potential Titrator | 905/916 | Metrohm |
| Endotoxin Detector | PKF-96 | ACC |
| Air Jet Sieve | 200LS | Hosokawa alpine |
| pH Meter | PHS-3E | REX |
| Conductivity Meter | DDS-307 | REX |
| Temperature and Humidity Cabinet | Climacell 707 | MMM |
| Labonce-380GS | Labonce | |
| LHH-250SD | BLUEPARD | |
| CTHI-150B | STIK |
