US FDA

DateCertificates
July, 2024The inspection focused primarily on surveillance inspections for Active Pharmaceutical Ingredients (APIs) and Pre-Approval Inspection (PAI) for a sterile finished drug
November, 2022The inspection focused primarily on Sevelamer Carbonate (PoAI) and Mycophenolate Mofetil (PAI)
November, 2018

It is a combined surveillance inspection and pre-approval inspection (Sevelamer Carbonate and Colesevelam Hydrochloride)

November, 2017

The inspection focused primarily on a PAI for Sevelamer Carbonate

January, 2015This 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
● Trans-Capsaicin

May, 2012

● Calcipotriol anhydrous
● Calcitriol
● Doxercalciferol
● Ergocalciferol
● Paricalcitol
● Meprobamate
● Iloperidone
● Colesevelam HCl
● Colestipol HCl
● Sevelamer HCl
● Sevelamer Carbonate
● Balsalazide Disodium
● Levonorgestrel

June, 2009

● Anastrozole
● Balsalazide Disodium
● Benzonatate
● Calcipotriol Anhydrous
● Capsaicin
● Doxercalciferol
● Paricalcitol

March, 2006Parsol 1789
October, 2004Leflunomide

 

EDQM

DateCertificates
March, 2013● Anastrozole
● Montelukast Sodium
● Gadoterate Meglumine
● Capsaicin
● Leflunomide
● Calcitriol

 

CHIEF PHARMACEUTICAL INSPECTOR (Poland)

Date    Description
May, 2025Eribulin Mesylate

 

BGV

DateCertificates
March, 2013● Anastrozole
● Gadoterate Meglumine
● Montelukast & Capsaicin 

 

PMDA

DateCertificates
May, 2018TS-1 (Gimeracil, Oteracil, Tegafur ) & Taltirelin Hydrate

 

TFDA

DateCertificates
Feburary, 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
● Orlistat
● Oteracil Potassium
● Paricalcitol
● Patiromer Sorbitex Calcium
● Pazopanib Hydrochloride
● Rucaparib Camsylate
● Sevelamer Carbonate
● Sevelamer Hydrochloride
● Tegafur
● Taltirelin
● Temozolomide
● Teriflunomide

 

Kosher

DateCertificates
 December, 2023Kosher certificate issued by Federation of Synagogues, UK

 

Halal

DateCertificates
August, 2025 Halal certificate issued by Taiwan Halal Integrity Development Association   社團法人台灣清真產業品質保證推廣協會
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