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News about GMP/cGMP

2018-11-27

EMA reports impurities in Valsartan from Mylan

On 19 November 2018, the EMA informed on their website that Valsartan from the Indian manufacturer Mylan Labortories is currently not allowed to be used for the production of medicinal products containing Valsartan for the EU. The CEP (Certificate of Suitability) of Mylan has been suspended by EDQM (European Directorate for the Quality of Medicines and Healthcare) because N-nitrodiethylamine (NDEA) has been found in some batches of valsartan.

 

In its communication, the EMA writes that the national authorities are taking action and are already recalling the batches concerned. At the same time, further investigations into the extent of NDEA contamination are ongoing.

As EMA further announces, additional investigations of sartan-containing drugs for contamination with nitrosamines are also being carried out. These could be related to the synthesis of a specific ring structure (tetrazole). Manufacturers of such drugs have already been informed and are currently testing their products for impurities.

As with previous findings of NDEA and NDMA, there is no immediate risk to patients. It is riskier for patients to suddenly stop taking high blood pressure medication. Patients should therefore not stop any treatments without consulting their doctor or pharmacist.

Source:

EMA: Press release

 

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