FDA Excipient Database Plagued By Inaccuracies, Causes Confusion
This article was originally published in The Tan Sheet
Executive Summary
The pharma industry says major problems continue with FDA’s Inactive Ingredient Database, including listing inaccurate potencies and using different names for the same excipient. A recent update has some firms in a ‘panic’ to reformulate products for pending ANDAs because of lowered potency limits or outright removal of some excipients from the database.
You may also be interested in...
FDA Shifts On Measuring Daily Limits For Excipients From Potency To Maximum Exposure
International Pharmaceutical Excipients Council of the Americas supports the maximum daily exposure limit but suggests FDA retain potency limit field until it finishes adding MDE information to avoid causing confusion.
New Exposure Limits For Excipients Applauded
The US FDA has launched the second phase of an effort to improve its inactive ingredients database by replacing confusing potency amounts with maximum daily exposure limits, a change sought by generic drug and excipient manufacturers.
New Exposure Limits For Excipients Applauded While Loss Of Old Potency Limits Bemoaned
The US FDA has launched the second phase of an effort to improve its inactive ingredients database by replacing confusing potency amounts with maximum daily exposure limits, a change sought by generic drug and excipient manufactures.