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官方查廠 
FDA (US)
Date Description
Oct. 25-28, 2004 Leflunomide
Mar. 13 – 16, 2006 Avobenzone
Jun. 16 -18, 2009 7 APIs (2 NDAs and 5 ANDAs)
May. 7 - 10, 2012  The general GMP inspection
Jan. 19 - 23, 2015 The general GMP inspection
Nov. 27 - Dec. 1, 2017 Sevelamer Carbonate pre-approval inspection
Nov. 5 - 9, 2018 It is a combined surveillance inspection and pre-approval inspection (Sevelamer Carbonate and Colesevelam Hydrochloride)
   
EDQM (EU)
Date Description
 Mar. 18 - 22, 2013 Anastrozole, Montelukast Sodium, Gadoterate Meglumine, Capsaicin, Leflunomide, Calcitriol
   
BGV (German)
Date Description
Nov. 12 - 14, 2007 Anastrozole , Leflunomide & Montelukast 
Mar. 18 - 22, 2013 Anastrozole, Gadoterate Meglumine, Montelukast & Capsaicin 
   
PMDA (Japan)
Date Description
Apr. 21 – 23, 2009 Gadodiamide Hydrate
Feb., 2013 Taltirelin Hydrate
Jul. 1, 2013 Gimeracil, Oteracil, Tegafur
May, 2014 Gadodiamide Hydrate
Aug., 2014 Linezolid
Feb., 2015 Maxacalcitol
Mar., 2015 Linezolid
Jun., 2015 Linezolid
Jul., 2015 Taltirelin Hydrate
Jul., 2016 Linzolid
Nov., 2016 Levonorgestrel
Jan., 2017 Temozolomide
Dec., 2017 TS-1 (Gimeracil, Oteracil, Tegafur)
Jan., 2018 Taltirelin Hydrate
Mar., 2018 Levonorgestrel
May. 8 – 11, 2018 TS-1 (Gimeracil, Oteracil, Tegafur ), Taltirelin Hydrate
Nov., 2018 TS-1 (Gimeracil, Oteracil, Tegafur )
Jul., 2019 Linezolid
Jan. 21, 2021 Maxacalcitol
   
COFEPRIS (Mexico)
Date Description
Oct. 8 - 12, 2010  MMF
Oct. 21 - 30, 2013 Calcitriol, Calcipotriol Anhydrous, Calcipotriol Monohydrate, Colestipol HCl, MMF, Benzonatate, Montelukast Sodium, Sevelamer HCl, Sevelamer Carbonate, Orlistat and Linezolid
   
FDA (Taiwan)
Date Description
Nov. 26-27, 2002 Leflunomide
 
Nov. 25-26, 2003 Capsaicin, Balsalazide disodium dihydrate, Calcitriol, Apraclonidine hydrochloride, Miferpristone
Feb. 6, 2004 Miltefosine
Jul. 25 - 26, 2006 Calcipotriol Anhydrous
May 3 - 4, 2007  Anastrozole
Feb. 19 – 20, 2008 The gereral GMP inspection
Jun. 26 – 27, 2008 Benzonatate
Sep. 10 – 11, 2008 Paricalcitol , MMF , Sevalamer HCl 
Apr. 7 – 9, 2009 Colestipol HCl , Montelukast Sodium
Jul. 3, 2009 Paricalcitol , MMF, Sevelamer HCl
Oct.14 - 16, 2009 PPV, Sevelamer Carbonate, Alfacalcidol, Colesevelam HCl
Dec. 6 - 9, 2010 Flupentixol Dihydrouchloride, Melitracen HCl
Dec. 6 - 9, 2010 The general GMP inspection
Jul. 20 - 21, 2010 Temozolomide
Oct. 16 - 19, 2012 Orlistat & Cacipotriol Monohydrate
Oct. 16 - 19, 2012 The general GMP inspection
Nov. 12 - 13, 2013 Doxercalciferol
Jan. 21 - 22, 2014 Gadodiamide Hydrate, Lapatinib Ditosylate
May 19 - 20, 2014 Levonorgestrel, Gadoterate Meglumine
Sep. 3 - 4, 2014 Gimeracil, Linezolid
May 25 -28, 2015 Imatinib Mesylate, Fludiazepam, Oteracil Potassium, Tegafur, Pazopanib Hydrochloride, Maxacalcitol, Calcium Acetate, Taltirelin Hydrate
May 25 -28, 2015 The general GMP inspection
Oct. 4 - 5, 2016 Nonivamide (Solidified mass)
Dec. 20-21, 2016 CMO product GMP inspection
Jun. 26 - 27, 2018 Teriflunomide, Nintedanib Esylate
Jul. 3 - 4, 2018 The gereral GMP inspection
Jan. 29 - 30, 2019 Nonivamide (Solidified mass)
Sep. 5, 2019 Oteracil Potassium (dossier assessment)
Nov. 12 - 14, 2019 Nintedanib, Calcifediol
Mar. 26 - 27, 2020 The General GMP inspection
May. 11, 2021 Tegafur (dossier assessment)


 
 
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