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-2018
Guidance Notes Required Documents for API Information (Version 5.0) Jun-2020
List of Updates for Guidance Notes  Jun-2020
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 Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
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