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what is difference between drug products and drug substance?
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Answer Posted / aditya
A pharmaceutical product type, for example, tablet, capsule, solution, cream, etc.,
which has not previously been registered in a region or Member State, and which
contains a drug ingredient generally, but not necessarily, in association with
excipients. is drug product
The designated therapeutic moiety, which has not previously been registered in a
region or Member State (also referred to as a new molecular entity or new chemical
entity). It may be a complex, simple ester, or salt of a previously approved drug
substance.
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