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品質與法規 
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品質認證 
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)
Nov. 2022 The inspection focused primarily on Sevelamer Carbonate (PoAI) and Mycophenolate Mofetil (PAI). 
   
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
 Feb. 2022 Alfacalcidol, Balsalazide Disodium Dihydrate, Benzonatate, Calcifediol, Calcitriol, Calcipotriol Anhydrous, Calcipotriol Monohydrate, Calcium Acetate, Capsaicin, Colesevelam Hydrochloride, Colestipol Hydrochloride, Doxercalciferol, Elagolix Sodium, Eribulin Mesylate "F.L.", Fludiazepam, Flupentixol Dihydrochloride, Gadodiamide Hydrate, Gadoterate Meglumine, Gimeracil, Iloperidone, Imatinib Mesylate, Lapatinib Ditosylate, Leflunomide, Levonorgestrel, Linezolid, Maxacalcitol, Melitracen Hydrochloride, Mifepristone, Montelukast Sodium, Mycophenolate Mofetil, Mycophenolate Sodium, Nonivamide (Solidified mass),Nintedanib Esylate, Orlistat, Oteracil Potassium, Paricalcitol, Patiromer Sorbitex Calcium, Pazopanib Hydrochloride, Rucaparib Camsylate, Sevelamer Carbonate, Sevelamer Hydrochloride, Tegafur, Taltirelin Hydrate, Temozolomide, Teriflunomide
   
Kosher
Date Certificates
Dec. 2023 Kosher certificate issued by Federation of Synagogues, UK 
   
Halal
Date Certificates
Aug. 2023  Halal certificate issued by Taiwan Halal Integrity Development Association 
   


 
 
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