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

Foreign-Source Bulk Ibuprofen Impurity Review Urged By Suppliers

This article was originally published in The Tan Sheet

Executive Summary

Incremental consumer exposure to lead or chromium impurities in bulk ibuprofen produced off-shore should be addressed by FDA as it develops a final rule to include the ingredient in the internal analgesics monograph, ingredient suppliers recommend in comments to the agency

You may also be interested in...



Ibuprofen Detailed Renal, GI Warnings Required For Monograph Inclusion

Clinical study data and adverse event reports support inclusion of a warning on OTC ibuprofen labeling to alert consumers at risk for developing acute renal failure to consult a doctor, FDA says

Ibuprofen Safety Confirmed by Recent Literature, Whitehall Says

Studies on ibuprofen published in the 1990s confirm the drug's safety at OTC doses, Whitehall-Robins tells FDA in a Sept. 18 submission. The submission contains supplemental information to the company's November 1997 citizen petition requesting the agency include ibuprofen 200 mg in the TFM for Internal Analgesic, Antipyretic & Antirheumatic Drug Products ("The Tan Sheet" Dec. 8, 1997, p. 4).

People In Brief

Perrigo promotes in pricing, planning

Topics

UsernamePublicRestriction

Register

PS094874

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