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APO-CANDESARTAN HCTZ 32/25 candesartan cilexetil 32 mg hydrochlorothiazide 25 mg tablet blister pack, Apotex Pty Ltd, CON-188
Product name
APO-CANDESARTAN HCTZ 32/25 candesartan cilexetil 32 mg hydrochlorothiazide 25 mg tablet blister pack
Sponsor name
Apotex Pty Ltd
Consent start
Consent no.
CON-188
Standard
USP monograph Candesartan Cilexetil and Hydrochlorothiazide 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