European Medicines Agency

Impurity found in valsartan manufactured by second company in China, EMA says

Low levels of the potentially harmful impurity N-nitrosodimethylamine (NDMA) have been , the European Medicines Agency (EMA) has learnt.

Originally, NDMA was found in the active substance manufactured by Chinese pharmaceutical company Zhejiang Huahai Pharmaceutical, but now the impurity has been detected in valsartan manufactured by another Chinese company, Zhejiang Tianyu Pharmaceutical.

However, the NDMA levels detected in batches of valsartan from Zhejiang Tianyu are much lower than levels seen in the active substance from Zhejiang Huahai, which triggered a recall of several valsartan medicines in July 2018.

The EMA said it is working closely with international partners to review the impact of the NDMA detected in valsartan manufactured by Zhejiang Tianyu and will communicate its findings as soon as possible.

According to the EMA, there is “no immediate risk to patients” and “patients should not stop taking any valsartan medicines without consulting their doctor or pharmacist”.

Citation: The Salvadore DOI: 10.1211/PJ.2018.20205317

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Pharmacy Registration Assessment Questions

    Pharmacy Registration Assessment Questions features over 400 closed book and calculation questions. With the registration exam having gone through a complete transformation in 2016, this volume has been developed around the new General Pharmaceutical Council (GPhC) guidelines.

    £33.00
  • Patient Care in Community Practice

    Patient Care in Community Practice is a unique, practical guide for healthcare professionals or carers. Covers a range of non-medicinal products suitable for use at home.

    £22.00
  • FASTtrack: Pharmacology

    FASTtrack: Pharmacology is a study guide providing an account of drug action, as well as dealing with molecular pharmacology at a more advanced level.

    £25.00
  • FASTtrack: Physical Pharmacy

    A revision book for students giving bullet points of basic information on physical pharmacy. Includes memory maps, questions and answers to aid revision.

    £25.00
  • FASTtrack: Pharmaceutics - Dosage Form and Design

    FASTtrack: Pharmaceutics – Dosage Form and Design removes the complexity from the major dosage forms that are commonly encountered by pharmacists in professional practice.

    £25.00

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.

станозолол купить

левитра купить днепр

comprare generico levitra