| 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) |
| Nov. 7 - 11, 2022 |
Passed 8th US FDA inspection, PAI for Mycophenolate Mofetil API and PoAI for Sevelamer Carbonate API combined. |
| |
|
| 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 |
| Aug. 25, 2021 |
Alfacalcidol |
| |
|
| 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) |
| Jul. 7-9, 2021 |
Gadoterate Meglumine, Paritomer Sorbitex Calcium, CDMO project |
| Oct. 26, 2021 |
Passed GMP inspection by TFDA for packaging and labeling of medicinal products.
Passed GDP inspection by TFDA for medicinal products. |
| Nov. 8-11, 2021 |
Passed GMP inspection TFDA for D line injection (aseptic preparation-small volume liquid) |
| Feb. 22-24, 2022 |
The general GMP inspection |
| Mar. 10-11, 2022 |
Rucaparib Camsylate. |
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