EMA withdraws authorization of Chinese valsartan product maker
The Chinese company Zhejiang Tianyu is no longer authorized to manufacture the valsartan active substance for European Union medicines following the suspension of its CEP – a certificate verifying that the quality of its valsartan meets European requirements, the European Medicines Agency announced today (August 20).
The suspension of the certificate by the European Directorate for the Quality of Medicines and Healthcare (EDQM) comes after the detection of low levels of NDMA in the valsartan produced by the Chinese company. Valsartan is the active ingredient of Novartis’ (NOVN: VX) former block-buster blood pressure drug Diovan.
NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The US Food and Drug Administration has also taken action on this substance,
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
More on this story...
Today's issue
Company Spotlight
More Features in Generics
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze