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
Apr-11
Sertraline Hydrochloride Ofloxacin Venlaflaxin Hydrochloride
Facility approved
Aug-12
Multiple Products
Facility approved
European Union - Danish Medicine Agency
Jan-08
Multiple Products
Facility approved
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