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

Generic Firms Object To Policy Behind Residual Solvents Deficiency Letters

Executive Summary

FDA's Office of Generic Drugs has interpreted a new pharmacopoeial standard for residual solvents in an unexpectedly rigorous manner, rejecting dozens of applications and raising the ire of generic drug manufacturers

You may also be interested in...



In Final Guidance On Residual Solvents, FDA Allows Control, Not Just Testing, Verification

Agency accepts industry comments on testing issue, but document may still contain hurdles for approval of some generic drugs.

FDA Offers More Flexibility on Residual Solvents in Generic Drug Applications

FDA's Office of Generic Drugs has taken a more flexible approach in implementing the U.S. Pharmacopeia's General Chapter <467> on residual solvents

FDA Offers More Flexibility on Residual Solvents in Generic Drug Applications

FDA's Office of Generic Drugs has taken a more flexible approach in implementing the U.S. Pharmacopeia's General Chapter <467> on residual solvents

Latest News
See All
UsernamePublicRestriction

Register

PS050145

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