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

29 August 2018
active substance, API, cancer, carcinogen, CEP, detection, EDQM, FDA, final product, headspace GC/MS, Hetero Labs Limited, holder, human, hypertension, impurity, investigation, manufacturer, manufacturing, medicinal product, medicines, method, N-nitrosodimethylamine, NDMA, nitrosamine, OMCL, patient, process, quantification, recall, review, risk, suspension, Torrent Pharmaceuticals Limited, valsartan, Zhejiang Changming Pharmaceutical Co. Ltd., Zhejiang Huahai Pharmaceuticals, Zhejiang Tianyu Pharmaceutical Co. Ltd.,

EDQM The EDQM is continuing the investigations and actions which started in July 2018 to address the issue related to the detection of a nitrosamine (N-nitrosodimethylamine (NDMA)) in a source of active substance valsartan. Following the suspension of the CEP on valsartan held by Zhejiang Huahai Pharmaceutical Co. Ltd, the EDQM has also

Revision of the EU GMP Guide – Annex 2

27 August 2018
active substance, Annex 2, API, biological, EC, GMP, manufacture, medicinal product, revision,

The revised Annex 2: Manufacture of Biological active substances and Medicinal Products for Human Use of the EU GMP Guide came into operation on 26 June 2018. Annex 2 has been revised as a consequence of the adoption of the Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. The previous version of

Revision of the EU GMP Guide – Annex 17 (Part II)

23 August 2018
Annex 17, batch, CAPA, change, CoA, control, control strategy, decision, deviation, EC, finished product, GMP, MA, parametric release, PAT, pharmaceutical development, PQS, predictor, program, QbD, QRM, release, RTRT, strategy,

Recently, the European Commission published a revised version of Annex 17: Real Time Release Testing and Parametric Release of the EU GMP Guide. The new annex will come into operation on 26 December 2018. We have already informed on our website about a consultation document on Annex 17: Real Time Release Testing, published by European

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

20 August 2018
active substance, API, carcinogen, CEP, distribution, EDQM, EMA, human, hypertension, impurity, manufacturer, manufacturing, medicinal product, medicines, N-nitrosodimethylamine, NDMA, recall, review, stopping, suspension, valsartan, Zhejiang Tianyu,

The company Zhejiang Tianyu is no longer authorised to manufacture the valsartan active substance for EU medicines following the suspension of its CEP – a certificate verifying that the quality of its valsartan meets European requirements. The suspension of the certificate by the European Directorate for the Quality of Medicines and Healthcare (EDQM) comes after

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

16 August 2018
active substance, animal test, API, cancer, carcinogen, CEP, change, EDQM, EMA, FDA, final product, formation, health effect, Hetero Labs Limited, human, hypertension, impurity, manufacturer, manufacturing, medicinal product, medicines, N-nitrosodimethylamine, NDMA, OMCL, patient, process, recall, review, risk, safety profile, side product, suspension, valsartan, Zhejiang Huahai Pharmaceuticals, Zhejiang Tianyu,

The European Medicines Agency (EMA) is reviewing medicines containing the active substance valsartan. Valsartan medicines are used to treat patients with high blood pressure in order to reduce complications such as heart attack and stroke. It is also used in patients who have had heart failure or a recent heart attack. It should be noted