FDA (US)
| Date | Description |
|---|---|
| Nov. 7-11, 2022 | Passed 8th US FDA inspection, PAI for Mycophenolate Mofetil API and PoAI for Sevelamer Carbonate API combined. |
| Nov. 5-9, 2018 | It is a combined surveillance inspection and pre-approval inspection (Sevelamer Carbonate and Colesevelam Hydrochloride) |
| Nov. 27-Dec. 1, 2017 | Sevelamer Carbonate pre-approval inspection |
| Jan. 19-23, 2015 | The general GMP inspection |
| May 7-10, 2012 | The general GMP inspection |
| Jun. 16-18, 2009 | 7 APIs (2 NDAs and 5 ANDAs) |
| Mar. 13-16, 2006 | Avobenzone |
| Oct. 25-28, 2004 | Leflunomide |
EDQM (EU)
| Date | Description |
|---|---|
| Mar. 18 - 22, 2013 | ● Anastrozole ● Montelukast Sodium ● Gadoterate Meglumine ● Capsaicin ● Leflunomide ● Calcitriol |
BGV (German)
| Date | Description |
|---|---|
| Mar. 18 - 22, 2013 | ● Anastrozole |
| Nov. 12 - 14, 2007 | ● Anastrozole |
PMDA (Japan)
| Date | Description |
|---|---|
| Aug. 25, 2021 | Alfacalcidol |
| Jan. 21, 2021 | Maxacalcitol |
| Jul., 2019 | Linezolid |
| Nov., 2018 | TS-1 (Gimeracil, Oteracil, Tegafur ) |
| May 8-11, 2018 | TS-1 (Gimeracil, Oteracil, Tegafur ), Taltirelin Hydrate |
| Mar., 2018 | Levonorgestrel |
| Jan., 2018 | Taltirelin Hydrate |
| Dec., 2017 | TS-1 (Gimeracil, Oteracil, Tegafur) |
| Jan., 2017 | Temozolomide |
| Nov., 2016 | Levonorgestrel |
| Jul., 2016 | Linzolid |
| Jul., 2015 | Taltirelin Hydrate |
| Jun., 2015 | Linezolid |
| Mar., 2015 | Linezolid |
| Feb., 2015 | Maxacalcitol |
| Aug., 2014 | Linezolid |
| May, 2014 | Gadodiamide Hydrate |
| Jul. 1, 2013 | Gimeracil, Oteracil, Tegafur |
| Feb., 2013 | Taltirelin Hydrate |
| Apr. 21-23, 2009 | Gadodiamide Hydrate |
COFEPRIS (Mexico)
| Date | Description |
|---|---|
| Oct. 21-30, 2013 | ● Calcitriol |
| Oct. 8-12, 2010 | MMF |
FDA (Taiwan)
| Date | Description |
|---|---|
| Sep. 13-14, 2023 | Passed GMP inspection on Plant H (expanded capacity for polymer products) by TFDA |
| Jul. 18-20, 2023 | Passed GMP & GDP inspection TFDA for D line injection (aseptic preparation-small volume liquid) |
| May 23, 2022 | Passed APIs GDP inspection by TFDA |
| Mar. 10-11, 2022 | Rucaparib Camsylate |
| Feb. 22-24, 2022 | The general GMP inspection |
| Nov. 8-11, 2021 | Passed GMP inspection TFDA for D line injection (aseptic preparation-small volume liquid) |
| Jul. 7-9, 2021 | ● Gadoterate Meglumine |
| May 11, 2021 | Tegafur (dossier assessment) |
| Mar., 2021 | ● Passed GMP inspection by TFDA for Drug Product Packaging and Labeling |
| Mar. 26-27, 2020 | The General GMP inspection |
| Nov. 12-14, 2019 | ● Nintedanib |
| Sep. 5, 2019 | Oteracil Potassium (dossier assessment) |
| Jan. 29-30, 2019 | Nonivamide (Solidified mass) |
| Jul. 3-4, 2018 | The gereral GMP inspection |
| Jun. 26-27, 2018 | ● Teriflunomide |
| Dec. 20-21, 2016 | CMO product GMP inspection |
| Oct. 4-5, 2016 | Nonivamide (Solidified mass) |
| May 25-28, 2015 | The general GMP inspection |
| May 25-28, 2015 | ● Imatinib Mesylate |
| Sep. 3-4, 2014 | ● Gimeracil |
| May 19-20, 2014 | ● Levonorgestrel |
| Jan. 21-22, 2014 | ● Gadodiamide Hydrate |
| Nov. 12-13, 2013 | Doxercalciferol |
| Oct. 16-19, 2012 | The general GMP inspection |
| Oct. 16-19, 2012 | Orlistat & Cacipotriol Monohydrate |
| Jul. 20-21, 2010 | Temozolomide |
| Dec. 6-9, 2010 | The general GMP inspection |
| Dec. 6-9, 2010 | ● Flupentixol Dihydrouchloride |
| Oct. 14-16, 2009 | ● PPV |
| Jul. 3, 2009 | ● Paricalcitol |
| Apr. 7-9, 2009 | ● Colestipol HCl |
| Sep. 10-11, 2008 | ● Paricalcitol |
| Jun. 26-27, 2008 | Benzonatate |
| Feb. 19-20, 2008 | The gereral GMP inspection |
| May 3-4, 2007 | Anastrozole |
| Jul. 25-26, 2006 | Calcipotriol Anhydrous |
| Feb. 6, 2004 | Miltefosine |
| Nov. 25-26, 2003 | ● Capsaicin |
| Nov. 26-27, 2002 | Leflunomide |