Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

US FDA Experts Advise Industry On How To Rid Drug Manufacturing Processes Of Nitrosamines

No Uniform Checklist for Performing Risk Assessments

Executive Summary

FDA officials say that process and supply chain risks are some of the root causes driving many of the nitrosamine contamination problems in recent months and manufacturers should work to contain and control these risks.

You may also be interested in...



US FDA Gives Industry An Extension On Nitrosamine Risk Assessments

Drug makers win one-month reprieve for their nitrosamine risk assessments for new drug products and approved products.

Perrigo Among Firms Requesting Delay In Conducting US Nitrosamine Risk Assessments

Perrigo, Pfizer want FDA to postpone its March deadline for conducting nitrosamine risk assessments. Generics executive cites “serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.

Manufacturers Want Delay In Conducting US Nitrosamine Risk Assessments

Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec cites“serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS143056

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