ACETEC 10 enalapril maleate 10 mg tablet blister pack, Alphapharm Pty Ltd, CON-250
Product name
ACETEC 10 enalapril maleate 10 mg tablet blister pack
Sponsor name
Alphapharm Pty Ltd
Consent start
Consent no.
CON-250
Standard
The British Pharmacopoeia monograph for Enalapril Tablets.
Non-compliance with standard
The content of the impurity 'enalaprilat' (aka Impurity C) must be NMT 1.5% w/w.
As requested, the allowable limit for this impurity is NMT 2.0% w/w.
Conditions imposed
No other changes have been made to the product.
Therapeutic product type
Prescription medicines