Guidelines on Active Pharmaceutical Ingredient (API)

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Document Name Download Updated
DRGD - Appendix 6 : Guideline On Regulatory Control Of Active Pharmaceutical Ingredients (APIs) Jul-18
Guidance Notes Required Documents for API Information (Version 4.1) Dec-19
Appendix 1: API Submission Checklist (Version 4.0) Dec-19
Appendix 2: API Administrative Procedure_Q3+ (Version 4.0) Dec-19
Guideline on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product (FPP):Quality Part. Jan-12
WHO Technical Report Series, No. 953, 2009 Annex 2: 
Stability testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products		 Jan-09
List of Updates for Guidance Notes  Dec-19

 

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National Pharmaceutical Regulatory Agency (NPRA)
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  • Email: npra@npra.gov.my
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