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This guidance just isn't intended to define registration and/or filing demands or modify pharmacopoeial prerequisites. This guidance isn't going to affect the ability of the liable regulatory company to determine particular registration/filing necessities about APIs within the context of selling/production authorizations or drug purposes. All commi

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-          An entire list of Uncooked products and intermediates specified by names or codes sufficiently distinct to detect any Particular high quality attributes;·         Theoretical produce & real yield at appropriate stage of production along with rationalization, if variation further than expectation observed-       Â

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