SITAGLIPTIN/METFORMIN AMEDA 50/1000 sitagliptin (as phosphate)50 mg metformin hydrochloride 1000 mg tablet blister pack, Accord Healthcare Pty Ltd, CON-1414
Product name
SITAGLIPTIN/METFORMIN AMEDA 50/1000 sitagliptin (as phosphate)50 mg metformin hydrochloride 1000 mg tablet blister pack
Sponsor name
Accord Healthcare Pty Ltd
Consent start
Consent no.
CON-1414
Duration
The consent is effective from 23 September 2025 until 22 September 2026.
Standard
'Metformin and Sitagliptin Tablet' monograph of British Pharmacopoeia
Non-compliance with standard
The products do not comply because: The Metformin total impurities limit of 0.5%
is wider than the monograph limit for sum of the areas of secondary peaks not
greater than 0.2%. The Sitagliptin total impurities limit of 0.6% is wider than
the monograph limit for sum of the areas of secondary peaks not greater than
0.2%. The method equivalency of the in-house Assay and Related substances
methods to the methods specified by the standards has not been established.
Conditions imposed
1.Action will be taken to align the Metformin total impurities and Sitagliptin
total impurities limits with the Metformin and Sitagliptin Tablet British
Pharmacopeia monograph.
2.Studies are undertaken to demonstrate that in-house Assay and Related
substances methods are equivalent to the Metformin and Sitagliptin Tablet
British Pharmacopeia monograph or to adopt the monograph analytical methods.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines