FDA (US)
| Date | Description |
|---|---|
| July, 2024 | Surveillance inspection & Eribulin DP FDP0011 PAI |
| November, 2022 | Passed the 8th US FDA inspection, PAI for Mycophenolate Mofetil API, and PoAI 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 |
EDQM (EU)
| Date | Description |
|---|---|
| March, 2013 |
|
BGV (German)
| Date | Description |
|---|---|
| March, 2013 |
|
| December, 2011 |
|
| November, 2007 |
|
PMDA (Japan)
| 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 |
COFEPRIS (Mexico)
| Date | Description |
|---|---|
| October, 2013 |
|
| June, 2013 | Leflunomide |
| October, 2010 | MMF |
FDA (Taiwan)
| Date | Description |
|---|---|
| August, 2024 | GMP Inspection for CMO products |
| April, 2024 |
|
| Septerber, 2023 | Passed GMP inspection on Plant H (expanded capacity for polymer products) by TFDA |
| July, 2023 | Passed GMP & GDP inspection TFDA for D line injection (aseptic preparation-small volume liquid) |
| May, 2022 | Passed APIs GDP inspection by TFDA |
| March, 2022 | Rucaparib Camsylate |
| February, 2022 | General GMP Inspection |
| November, 2021 | Passed GMP inspection TFDA for D line injection (aseptic preparation-small volume liquid) |
| July, 2021 |
|
| May, 2021 | Tegafur (dossier assessment) |
| March, 2021 |
|
| March, 2020 | General GMP Inspection |
| November, 2019 |
|
| September, 2019 | Oteracil Potassium (dossier assessment) |
| January, 2019 | Nonivamide (Solidified mass) |
| July, 2018 | Gereral GMP Inspection |
| June, 2018 |
|
| December, 2016 | GMP Inspection for CMO products |
| October, 2016 | Nonivamide (Solidified mass) |
| May, 2015 | General GMP Inspection |
| May, 2015 |
|
| September, 2014 |
|
| May, 2014 |
|
| January, 2014 |
|
| November, 2013 | Doxercalciferol |
| December, 2012 | Flupentixol dihydrochloride, Melitracen hydrochloride, and others 19 products |
| October, 2012 |
|
| December, 2010 |
|
| July, 2010 | Tomozolomide |
| October, 2009 |
|
| July, 2009 |
|
| April, 2009 |
|
| September, 2008 |
|
| June, 2008 | Benzonatate |
| February, 2008 | Gereral GMP Inspection |
| May, 2007 | Anastrozole |
| July, 2006 | Calcipotriol Anhydrous |
| February, 2004 | Miltefosine |
| November, 2003 |
|
| November, 2002 | Leflunomide |