CYCLONEX cyclophosphamide 50mg (anhydrous) tablet blister pack, The SPD Company Pty Ltd, CON-300
Product name
CYCLONEX cyclophosphamide 50mg (anhydrous) tablet blister pack
Sponsor name
The SPD Company Pty Ltd
Batches
Batch number 17001A 'Batch number 17002A 'Batch number 17003A
Consent start
Consent no.
CON-300
Standard
Therapeutic Goods Order No. 78 Standard for tablets and capsules - British Pharmacopoeia monograph for cyclophosphamide tablets
Non-compliance with standard
The product does not comply with assay limits in the British Pharmacopoeia
monograph (92.5-107.5%).
Conditions imposed
The batches mustcomply with the USP monograph limits for Assay
(90.0-110.0%).
This decision is also extended to a further six subsequently manufactured
batches, for which batch numbers are not yet assigned. It is expected that
records of these numbers will be kept and related back to this consent.
Therapeutic product type
Prescription medicines