EU suspends Mylan’s valsartan certificate of suitability (COS/CEP)




After the warning letter, there was more trouble waiting for the maker of EpiPens. Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India.

Both NDEA and N-nitrosodimethylamine (NDMA) found in ‘sartans’ made by several manufacturers over the last few months, are classified as probable human carcinogens (substances that could cause cancer).

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has suspended the certificate of suitability to the monographs of the European Pharmacopeia (CEP) for Mylan’s facility in Hyderabad.

CEP is a certificate of compliance with European standards for quality testing. The suspension of CEP effectively prohibits the use of valsartan made by Mylan’s India facility in EU medicines.

National authorities in the EU have also started recalling affected batches of medicines containing Mylan’s valsartan and are conducting further tests to determine the extent of the contamination.

In the United States, Mylan announced a voluntary nationwide recall of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, seven lots of Valsartan Tablets, USP and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength.

EMA is reviewing the blood pressure medicines candesartanirbesartanlosartanolmesartan and valsartan in relation to impurities found in some batches of these medicines.

The presence of impurities in valsartan medicines and other sartans is thought to be linked to the synthesis of a specific ring structure (tetrazole) which is present in some sartan medicines.

EMA’s review of sartans is continuing and the agency is working closely with national authorities, international partners and the EDQM.

The review will evaluate the root cause for the presence of these impurities, their possible impact on patients and measures that can be taken to reduce or eliminate these impurities from future batches of sartans.

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