Guidelines on Active Pharmaceutical Ingredient (API)

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Document Name Download Updated
Guidance Notes Required Documents for API Information Version 2.0 Aug-18
Appendix 1: API Submission Checklist Version 2.0 Aug-18
Appendix 2: API Administrative Procedure_Q3+ Version 2.0 Aug-18
Guideline on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product (FPP):
Quality Part.
WHO Technical Report Series, No. 953, 2009 Annex 2: 
Stability testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products

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