candesartan cilexetil (CANDESAN) 4 mg tablet blister pack, Arrow Pharma Pty Ltd, CON-171
Product name
candesartan cilexetil (CANDESAN) 4 mg tablet blister pack
Sponsor name
Arrow Pharma Pty Ltd
Consent start
Consent no.
CON-171
Standard
Does 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 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