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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.

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