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Sunday, September 25, 2016 6:31:02 PM
FDA regulations and standards require that all ingredients in drugs, as well as their chemical decomposition products, be identified and shown to be safe.
Often, more excipient is found in a final drug formulation than active ingredient, and practically all marketed drugs contain excipients.
As with new drug substances and dosage forms thereof, novel excipients themselves can be patented; sometimes, however, a particular formulation involving them is kept as a trade secret instead (if not easily reverse-engineered).
Top Medications with FD&C Blue No. 1 excipient:
https://www.drugs.com/inactive/fd-c-blue-no-1-244.html
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