US (FDA)

Date Description
July, 2024 Surveillance inspection & Eribulin DP FDP0011 PAI
November, 2022 Passed the 8th US FDA inspection, PAI for Mycophenolate Mofetil API, and PAI for Sevelamer Carbonate API combined.
November, 2018 It is a combined surveillance inspection and pre-approval inspection (Sevelamer Carbonate and Colesevelam Hydrochloride)
November, 2017 Sevelamer Carbonate pre-approval inspection
January, 2015 General GMP Inspection
May, 2012 General GMP Inspection
June, 2009 7 APIs (2 NDAs and 5 ANDAs)
March, 2006 Avobenzone
October, 2004 Leflunomide

Europe

Date Authority     Description
May, 2025 Poland (Chief Pharmaceutical Inspector) Eribulin Mesylate
March, 2013 EDQM
  • Anastrozole
  • Montelukast Sodium
  • Gadoterate Meglumine
  • Capsaicin
  • Leflunomide
  • Calcitriol
March, 2013 Germany (BGV)
  • Anastrozole
  • Gadoterate Meglumine
  • Montelukast & Capsaicin
December, 2011 Germany (BGV)
  • Montelukast sodium
  • Gadoterate meglumine
  • Anastrozole
November, 2007 Germany (BGV)
  • Anastrozole
  • Leflunomide & Montelukast

 

Japan (PMDA)

Date Description
March, 2024 Alfacalcidol
August, 2021 Alfacalcidol
January, 2021 Maxacalcitol
July, 2019 Linezolid
November, 2018

TS-1 (Gimeracil, Oteracil, Tegafur )
May, 2018

TS-1 (Gimeracil, Oteracil, Tegafur ), Taltirelin Hydrate
March, 2018 Levonorgestrel
January, 2018 Taltirelin Hydrate
December, 2017

TS-1 (Gimeracil, Oteracil, Tegafur)
January, 2017 Temozolomide
November, 2016 Levonorgestrel
July, 2016 Linzolid
July, 2015 Taltirelin Hydrate
Junuary, 2015 Linezolid
March, 2015 Linezolid
February, 2015 Maxacalcitol
August, 2014 Linezolid
May, 2014

Gadodiamide Hydrate
July, 2013

Gimeracil, Oteracil, Tegafur
Febryary, 2013 Taltirelin Hydrate
April, 2009

Gadodiamide Hydrate

 

Mexico (COFEPRIS)

Date Description
October, 2013
  • Calcitriol
  • Calcipotriol Anhydrous
  • Calcipotriol Monohydrate
  • Colestipol HCl
  • MMF
  • Benzonatate
  • Montelukast Sodium
  • Sevelamer HCl
  • Sevelamer Carbonate
  • Orlistat and Linezolid
June, 2013 Leflunomide
October, 2010 MMF

 

Brazil (ANVISA)

Date     Description
October, 2025 Temozolomide

 

Turkey (TITCK)

Date     Description
September, 2025 Eribulin Mesylate

 

Taiwan (FDA)

  
Date Description
December, 2025 Ergocalciferol
November, 2025 Passed Follow-up GMP Inspection by TFDA on API and drug product
March, 2025 Passed APIs and DP GDP inspection by TFDA
August, 2024 Passed GMP inspection for Biotechnology products: freeze-dried powder (aseptic preparation).
April, 2024
  • Clobetasol Propionate Nanomixture Intermediate 
  • GDP inspection for injection
September, 2023 Passed GMP inspection on  Plant H (expanded capacity for polymer products) by TFDA
July, 2023 Passed GMP & GDP inspection TFDA for Aseptic Preparation-small Volume Liquid Dosage
May, 2022 Passed APIs GDP inspection by TFDA
March, 2022

Rucaparib Camsylate
February, 2022

General GMP Inspection
November, 2021

Passed GMP inspection TFDA for Aseptic Preparation-small Volume Liquid Dosage
July, 2021
  • Gadoterate Meglumine
  • Paritomer Sorbitex Calcium
  • CDMO project
May, 2021

Tegafur (dossier assessment)
March, 2021
  • Passed GMP inspection by TFDA for Drug Product Packaging and Labeling
  • Passed GDP inspection for APIs by TFDA (dossier assessment)
March, 2020

General GMP Inspection
November, 2019
  • Nintedanib
  • Calcifediol
September, 2019

Oteracil Potassium (dossier assessment)
January, 2019

Nonivamide (Solidified mass)
July, 2018

General GMP Inspection
June, 2018
  • Teriflunomide
  • Nintedanib Esylate
December, 2016

GMP Inspection for CMO products
October, 2016

Nonivamide (Solidified mass)
May, 2015

General GMP Inspection
May, 2015
  • Imatinib Mesylate
  • Fludiazepam
  • Oteracil Potassium
  • Tegafur
  • Pazopanib Hydrochloride
  • Maxacalcitol
  • Calcium Acetate
  • Taltirelin Hydrate
September, 2014
  • Gimeracil
  • Linezolid
May, 2014
  • Levonorgestrel
  • Gadoterate Meglumine
January, 2014
  • Gadodiamide Hydrate
  • Lapatinib Ditosylate
November, 2013 Doxercalciferol
December, 2012 Flupentixol dihydrochloride, Melitracen hydrochloride, and others 19 products
October, 2012
  • Orlistat & Cacipotriol Monohydrate,
  • General GMP Inspection
December, 2010
  • Flupentixol Dihydrochloride
  • Melitracen HCl
July, 2010 Tomozolomide
October, 2009
  • PPV
  • Sevelamer Carbonate
  • Alfacalcidol
  • Colesevelam HCl
July, 2009
  • Paricalcitol
  • MMF
  • Sevelamer HCl
April, 2009
  • Colestipol HCl
  • Montelukast Sodium
September, 2008
  • Paricalcitol
  • MMF
  • Sevalamer HCl
June, 2008 Benzonatate
February, 2008

General GMP Inspection
May, 2007 Anastrozole
July, 2006

Calcipotriol Anhydrous
February, 2004 Miltefosine
November, 2003
  • Capsaicin
  • Balsalazide disodium dihydrate
  • Calcitriol
  • Apraclonidine hydrochloride
  • Miferpristone
November, 2002 Leflunomide

 
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