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
UsernamePublicRestriction

EMA Identifies Potential Sources Of Nitrosamine Contamination

Information Will Help Companies Review Their Manufacturing Processes

Executive Summary

As companies evaluate scores of products for the possible presence of nitrosamine impurities, the EU regulator has listed potential sources of contamination identified to date to help sponsors develop a risk-based approach for their evaluations.

You may also be interested in...



UK Adds MMR Vaccine To Export Ban List

There are now 31 medicines on the UK’s list of products that cannot be parallel exported to other European Economic Area countries as part of government efforts to tackle drug shortages. The parallel trade industry has attacked the initiative for lack of transparency.

EU Guidance Assists With Nitrosamine Evaluations

The EU guide covers medicines authorized at the national level and under the mutual recognition and decentralized procedures.

EU Offers Practical Guide To Help Pharma With Nitrosamine Evaluations

The EU guide covers medicines authorized at the national level and under the mutual recognition and decentralized procedures.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1127674

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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