candesartan cilexetil (CTAN) 16 mg tablet bottle, Generic Partners Pty Ltd, CON-169
Product name
candesartan cilexetil (CTAN) 16 mg tablet bottle
Sponsor name
Generic Partners Pty Ltd
ARTG
195494
Consent start
Consent no.
CON-169
Standard
The products that do not conform to the requirements of the individual USP monograph for Candesartan Cilexetil Tablets.
Non-compliance with standard
The candesartan impurity E content exceeds the USP monograph requirement of not
more than (NMT) 0.2%.
Conditions imposed
The candesartan impurity E expiry limit in drug product is the same as that
currently approved (NMT 0.5%).
Therapeutic product type
Prescription medicines