News about GMP/cGMP

15.02.2021

EMA: Manufacturers to test rifampicin for nitrosamine impurities

EMA: Manufacturers to test rifampicin for nitrosamine impurities

Following the detection of 1-nitroso-4-methyl-piperazine (MeNP) impurities in some batches of rifampicin in February 2021, the EMA is requesting manufacturers to test the drug for the presence of MeNP. 


This involves close collaboration between authorities, manufacturers and official medicines control laboratories (OMCLs).
Rifampicin is primarily used to treat tuberculosis, as well as some other serious diseases such as blood infections and leprosy. 
Patients should continue to take the drug, however, because the dangers of not taking it outweigh the risks of possible contamination. According to the EMA, the tests should be seen as a precautionary measure. 


Source:

EMA: Nitrosamine impurities – Rifampicin medicines 


 

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