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US FDA Guidance Explains Upcoming Enhancements To Inactive Ingredients Database

Executive Summary

Next year, generic drug manufacturers will finally get some of the improvements they have been asking for in the US FDA’s Inactive Ingredient Database, such as being able to access the maximum daily intake (MDI) for each excipient. This information is helpful to industry in formulating products.

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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.

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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.

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