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 3.0 Oct-19
Appendix 1: API Submission Checklist Version 3.0 Oct-19
Appendix 2: API Administrative Procedure_Q3+ Version 3.0 Oct-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 Oct-19

 

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National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
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