| US FDA |
| Date |
Certificates |
| Oct. 2004 |
Leflunomide |
| Mar. 2006 |
Parsol 1789 |
| Jun. 2009 |
Anastrozole, Balsalazide Disodium, Benzonatate, Calcipotriol Anhydrous, Capsaicin, Doxercalciferol, Paricalcitol. |
May 2012
|
Calcipotriol anhydrous, Calcitriol, Doxercalciferol, Ergocalciferol, Paricalcitol, Meprobamate, Iloperidone, Colesevelam HCl, Colestipol HCl, Sevelamer HCl, Sevelamer Carbonate, Balsalazide Disodium, Levonorgestrel . |
| Jan. 2015 |
This site manufactures the following commercial API's that have been marketed to the US market: Calcipotriol Anhydrous, Colestipol HCI, Balsalazide Disodium Dihydrate, Paricalcitol, Levonorgestrel, Tasimelteon, Leflunomide, Iloperidone, Doxercalciferol and Trans-Capsaicin. |
| Nov. 2017 |
The inspection focused primarily on a PAI for Sevelamer Carbonate. |
| Nov. 2018 |
It is a combined surveillance inspection and pre-approval inspection (Sevelamer Carbonate and Colesevelam Hydrochloride) |
| |
|
| EDQM |
| Date |
Certificates |
| Mar. 2013 |
Anastrozole, Montelukast Sodium, Gadoterate Meglumine, Capsaicin, Leflunomide, Calcitriol |
| |
|
| BGV |
| Date |
Certificates |
| Mar. 2013 |
Anastrozole , Gadoterate Meglumine, Montelukast & Capsaicin |
| |
|
| PMDA |
| Date |
Certificates |
| May. 2018 |
TS-1 (Gimeracil, Oteracil, Tegafur ) & Taltirelin Hydrate |
| |
|
| TFDA |
| Date |
Certificates |
| Jul. 2018 |
Alfacalcidol, Balsalazide Disodium Dihydrate, Benzonatate, Calcitriol, Calcipotriol Anhydrous, Calcipotriol Monohydrate, Calcium Acetate, Capsaicin, Colesevelam Hydrochloride, Colestipol Hydrochloride, Doxercalciferol, Fludiazepam, Flupentixol Dihydrochloride, Gadodiamide Hydrate, Gadoterate Meglumine, Gimeracil, Imatinib Mesylate, Lapatinib Ditosylate, Leflunomide,Levonorgestrel, Linezolid, Maxacalcitol, Melitracen Hydrochloride, Mifepristone, Montelukast Sodium, Mycophenolate Mofetil, Nonivamide (Solidified mass),Nintedanib Esylate, Orlistat, Paricalcitol, Pazopanib Hydrochloride, Sevelamer Carbonate, Sevelamer Hydrochloride, Taltirelin Hydrate, Temozolomide, Teriflunomide |
| |
|
| Kosher |
| Date |
Certificates |
| Jan. 2023 |
Kosher certificate issued by Federation of Synagogues, UK |
| |
|
| Halal |
| Date |
Certificates |
| Aug. 2018 |
Halal certificate issued by Taiwan Halal Integrity Development Association |
| |
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