Review of common medicines used to treat hypertension – valsartan – due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen! (Part VI)

16 октября 2018
active substance, API, Aurobindo Pharma, cancer, candesartan, carcinogen, CEP, corrective measures, drug product, EDQM, EMA, FDA, GMP, headspace GC/MS, human, hypertension, impurity, inspection, irbesartan, losartan, MAH, manufacturer, manufacturing, manufacturing site, marketing authorisation holders, medicinal product, medicines, method, monitor, N-nitrosodimethylamine, NDEA, NDMA, nitrosamine, non-compliance, N‑nitrosodiethylamine, olmesartan, OMCL, recall, review, sartans, specific ring structure, statement, suspension, test, tetrazole, UHPLC-APCI-MS/MS, valsartan, Zhejiang Huahai Pharmaceuticals,

EMA EU authorities are placing the Chinese company Zheijiang Huahai under increased supervision following European and US inspections which revealed weaknesses in quality management at the company’s Chuannan site in Linhai, China and will supervise the manufacture of other active substances produced by this company more closely. Low levels of NDEA have now also

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Review of common medicines used to treat hypertension – valsartan – due to detection of impurity, N-nitrosodimethylamine (NDMA), a probable human carcinogen! (Part V)

3 октября 2018
active substance, APCI-UHPLC-MS/MS, API, cancer, candesartan, carcinogen, CEP, drug product, EDQM, EMA, FDA, formation, GMP, headspace GC/MS, Hetero Labs Limited, HPLC-UV, human, hypertension, import alert, impurity, inspection, intermediate, irbesartan, losartan, MAH, manufacturer, manufacturing, manufacturing site, marketing authorisation holders, medicinal product, medicines, method, N-nitrosodimethylamine, NDEA, NDMA, nitrosamine, non-compliance, N‑nitrosodiethylamine, olmesartan, OMCL, patient, process, recall, review, risk, sartans, specific ring structure, statement, suspension, test, tetrazole, valsartan, Zhejiang Huahai Pharmaceuticals,

EMA The European Medicines Agency (EMA) is expanding its review of impurities in valsartan following the detection of very low levels of N-nitrosodiethylamine (NDEA) in another active substance, losartan, made by Hetero Labs in India. As a result of the detection of this impurity by German authorities, the review will now include medicines containing

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