glipizide (MINIDIAB) 5 mg tablet blister pack, Pfizer Australia Pty Ltd, CON-78
Product name
glipizide (MINIDIAB) 5 mg tablet blister pack
Sponsor name
Pfizer Australia Pty Ltd
Consent start
Consent no.
CON-78
Standard
Therapeutic Goods Order No. 78 'Standard for tablets and Capsules'
Non-compliance with standard
The products do not comply with Section 8 of the Order in that the finished
product specifications do not meet the requirements of the current British
Pharmacopoeia (BP) monograph for Glipizide Tablets with respect to content of
Impurity A.
Conditions imposed
The release and expiry limits applied to Impurity A of the BP monograph for
Glipizide Tablets for content of Impurity A in the finished product
specifications are those detailed in the submission dated 13 April 2016.
Therapeutic product type
Prescription medicines