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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)
   
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
   
   
SHE
Date Certificates
Sep. 2017 ISO 14001:2015 certificate by SGS, TW
Sep. 2017 OHSAS 18001:2007 certificate by SGS, TW
Sep. 2017 CNS 15506: 2011 certificate issued by SGS, TW
   
Kosher
Date Certificates
Oct. 2018  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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