Guidelines - Active Pharmaceutical Ingredient (API)

Template and Declaration Letter for API

Written by Jauze · 16 January 2019

 

Document Name Download Updated
Declaration Letter for an Approved API in New Product Registration Application DOWNLOAD Dec-19
Declaration on GMP of API Intermediate DOWNLOAD Aug-18
Declaration on Quality of Atypical API (Letter_AAPI_V1) DOWNLOAD Oct-19
Template Cover Letter for DMF Submission DOWNLOAD Dec-19

 

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