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U.S. FDA Drug Intermediates Establishment Registration
Drug Intermediates are materials produced during the steps in the synthesis of an Active Pharmaceutical Ingredient (API) that must undergo further molecular change or processing before becoming an API.
Intermediates intended for use as a drug component may be considered drugs by the U.S. FDA. As such, establishments that manufacturer or process Drug Intermediates are considered drug manufacturers. Therefore, Drug Intermediate Establishments are subject to U.S. FDA drug registration requirements.
MEDERA Consulting assists companies with the following Drug Intermediate requirements:
MEDERA can provide a Free Assessment of how these regulations apply to your particular product. Simply contact us to find out more about our regulatory consulting services. Click here to receive a free copy of our white paper on marketing a therapeutic product in US.