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Inspection History of API Site

Regulatory Authority/Agency Year of Inspection Products Inspected Status
European Union - Germany Nov-05, Nov-07 Sertraline Hydrochloride Facility approved
European Union - Germany Apr-11 Sertraline Hydrochloride, Ofloxacin, Venlaflaxin Hydrochloride Facility approved
European Union - Germany Aug-12 Multiple Products Facility approved
European Union - Danish Medicine Agency Jan-08 Multiple Products Facility approved
European Union - Danish Medicine Agency Nov-15 Multiple Products Facility approved
MFDS-Korea Feb-15 Dexketoprofen Trometamol Facility approved
WHO-Geneva Jul-13, Apr-16 & Oct-19 Diethyl Carbamazine Citrate Facility approved
USFDA Mar-15, Mar-17 & Mar-18 Homatropine Methylbromide Facility approved
PMDA-Japan May-19 Pregabalin Facility approved
TGA-Australia Based on EUGMP & USFDA Atropine Sulfate & Clopidogrel Besylate Facility approved
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