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FDA’s Excipient Database Continues to be Plagued With Problems

This article was originally published in The Gold Sheet

Executive Summary

The pharmaceutical industry said that FDA’s Inactive Ingredient Database continues to have major problems, including listing excipients with inaccurate potencies and using different names for the same excipient. A recent update has some drug companies in a ‘panic’ to reformulate their products for pending ANDAs because of lowered potency limits or outright removal of some excipients from the database.

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