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CLOPIDOGREL-WGR clopidogrel (as besilate) 75 mg tablet blister pack, GM Pharma International Pty Ltd, CON-1436
Product name
CLOPIDOGREL-WGR clopidogrel (as besilate) 75 mg tablet blister pack
Sponsor name
GM Pharma International Pty Ltd
Consent start
Consent no.
CON-1436
Duration
The consent is effective from 3 December 2025 until 3 December 2027.
Standard
The related substance limits in the BP Monograph for Clopidogrel besilate tablets of British Pharmacopoeia
Non-compliance with standard
The products do not conform because following the introduction of a new
monograph, the product may not comply with the limits set for Impurity A and
Impurity C, as well as Total Unspecified Impurities across the full shelf life
(36 months) of the product.
Conditions imposed
1. The sponsor will provide the TGA with the outcome of the discussions with the
British Pharmacopoeia within 2 weeks of receiving information from their expert
committee.
2. If the discussions with the BP do not lead to a widening of the limits, the
sponsor will be required to provide the TGA with a plan on how they intend on
ensuring the product meets all standards over its shelf-life.
Import, Supply, &/or Export
import and supply
Therapeutic product type
Prescription medicines