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This advice is not meant to determine registration and/or submitting requirements or modify pharmacopoeial specifications. This direction would not have an impact on the power from the liable regulatory agency to determine unique registration/submitting necessities regarding APIs within the context of marketing/producing authorizations or drug apps
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This document discusses monophasic liquid dosage types, which have elements dissolved in an individual period. It offers samples of interior monophasic liquids like syrups and elixirs, and external liquids like gargles and enemas.Intention of the do the job is to provide a whole & correct history of effects of drugs on the healthy human organisms.(
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