Eudralex Volume 3 Quality Working Party questions and answers on API mix

Title:
Eudralex Volume 3 Quality Working Party questions and answers on API mix

https://www.gmp-compliance.org/files/guidemgr/WC500205040.pdf

Origin/Publisher:

EMA 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK

Document Type:
Q&A Document
Content:
This document provides information on how mixtures of active pharmaceutical ingredient and excipients (API mix) are considered in a marketing authorisation procedure.

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