The European Directorate for the Quality of Medicines and Healthcare has suspended the manufacturer’s certificate of suitability to the monographs of the European Pharmacopoeia (CEP).
The certificate had served to validate Mylan’s compliance with European standards for quality testing, and without it, the firm’s valsartan can no longer be used in EU medicines.
The detection of N-nitrosodiethylamine (NDEA) in some of Mylan’s valsartan batches prompted the decision. NDEA and the related compound N-nitrosodimethylamine (NDMA) are classified by the International Agency for Research on Cancer as probable carcinogens.
According to the European Medicines Agency (EMA), EU Member States have instigated recalls of affected batches of medicines and are conducting tests to further investigate the contamination.
The agency continued: “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.”
Mylan did not respond to a request for comment ahead of publication.
A growing number of affected suppliers
Mylan is the latest active pharmaceutical ingredient (API) manufacturer to experience NDEA or NDMA contamination issues this year.
In June, certain batches of valsartan manufactured by Chinese API maker Zhejiang Huahai Pharmaceuticals were found to contain the NDMA impurity, and in September, the EMA also detected low levels of NDEA in an API from Indian manufacturer, Hetero Labs.
Another Indian manufacturer, Aurobindo Pharma Limited, has since announced that trace amounts of NDEA has been detected in its irbesartan drug product.
