Guidelines on Active Pharmaceutical Ingredient (API)

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Guidelines on Active Pharmaceutical Ingredient (API)

: Posted By Pharm Mee Ngoh; 16 January 2019; Hits: 39413

User Rating: 5 / 5

Document Name	Download	Updated
DRGD - Appendix 11 : Regulatory Control Of Active Pharmaceutical Ingredients (APIs)		Jan-2024
Guidance Notes for API Information for Product Registration Application via QUEST (Version 6.1)		Jul-2022
Appendix IV: List of Atypical APIs		Jul-2023
List of Updates for Guidance Notes		Jul-2022
Guideline on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product (FPP):Quality Part.		Jan-2012
WHO Technical Report Series, No. 953, 2009 Annex 2: Stability testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products		Jan-2009

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