Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

The Reaction To Valsartan Impurities: More Scrutiny, More Testing And Tighter Limits

Potent Carcinogens Stir Up Anxieties Over Unknown Unknowns In Pharmaceutical Process Chemistry

Executive Summary

In the months since US and EU authorities restricted Zhejiang Huahai’s market access over the discovery of nitrosamine impurities in its valsartan API, the broader regulatory consequences for drug manufacturers are coming into focus.

You may also be interested in...



Metformin Testing Prompts New Finding Of NDMA And Cancer Risk

The US FDA requests several manufacturers recall extended-release metformin based on studies confirming a higher NDMA impurity threshhold; previous testing found no significant risks.

New Testing Prompts New Finding Of NDMA, Cancer Risk In Metformin Products

The US FDA requests several manufacturers recall extended-release metformin based on studies confirming a higher NDMA impurity threshhold; previous testing found no significant risks. 

Why US FDA Requested Ranitidine Withdrawal, And How Other Drugs Could Follow

FDA made request after finding unacceptable levels of nitrosamine NDMA can form during storage above room temperature or beyond expiry. Forthcoming guidance on detecting impurities like nitrosamines in any drug will call for routine testing as well as a chemical risk assessment “to look at what is the probability of generating them.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS124733

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel