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Quality system


Certificates


Audit History


Audit History



  • 2016

    ·Finasteride and Progesterone passed US Food and Drug Administration inspection
    ·Progesterone passed EU Polish Registration Office inspection
    ·Folinic acid passed P. R. China Hubei Food and Drug Administration inspection

  • 2017

    ·Finasteride, Progesterone, Budesonide and Gestodene) passed P. R. China Hubei Food and Drug Administration inspection

  • 2018

    ·Mifepristone, Anorethindrane dipropionate and Cyproterone acetate passed P. R. China Hubei Food and Drug Administration inspection
    ·Oxcarbazepine and Ganciclovir passed P. R. China Hubei Food and Drug Administration inspection

  • 2019

    ·Finasteride, Progesterone,and Budesonide passed US Food and Drug Administration inspection
    ·Finasteride passed Japan Pharmaceuticals and Medical Devices Agency inspection

  • 2020

    ·Cyproterone acetate passed Australia Therapeutic Goods Administration

  • 2021

    ·Oxcarbazepine passed P.R. China Hubei Drug Administration inspection
    ·Medroxyprogesterone Acetate, Estradiol, Tibolone and Methylprednisolone passed P. R. China Hubei Drug Administration 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



Audit History


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