Guidelines on Active Pharmaceutical Ingredient (API)

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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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National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

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