Portugal will have to suspend sales and revoke approvals for 111 generic drugs tested by Synapse Labs in India, following a recommendation made this Friday by the European Commission to European Union (EU) member states.
The list for Portugal includes 111 drugs from pharmaceutical companies such as Generis and Sandoz that should be withdrawn or whose marketing should not be allowed, with the decision taken by the Community Executive on the recommendation of the European Medicines Agency (EMA). EMA (English abbreviation).
According to a statement from the community leader, this is an EMA assessment of generic Synapse at the request of the Spanish Medicines Agency, which concluded that there is no or insufficient data to “demonstrate bioequivalence”, which happens when two Medicines release the same active substance in body at the same rate and in the same volume under similar conditions.