News about GMP/cGMP


Counterfeit Drugs on German Market

The German BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) published a statement about counterfeit CellCept® 500 mg film-coated tablets on March 14, 2018. The medicinal product which is manufactured by Roche Reg. Ltd., is used to avoid rejection reactions after transplantations.

Several batches with counterfeit CellCept® were detected in German pharmacies and wholesale companies. The real existing batches were intended for the Norwegian, Dutch and French market, but were illegally repacked in a Dutch-German appearance and then supplied to the German market.

Roche investigated those findings closely. They showed that only the folding boxes were faked but the blister and film-coated tablets were original. The folding boxes of the counterfeit CellCept® 500 mg film-coated tablets carried purple imprints of the batch number and the expiry date instead of black ones.

It is certain that counterfeits have entered the German market. Further investigation to find out the origin of the counterfeits is ongoing in close contact with the German State Authorities and the EMA.


BfArM: Accouncement