Guidelines on Active Pharmaceutical Ingredient (API)

Kadar pengguna: 5 / 5

bintang aktifbintang aktifbintang aktifbintang aktifbintang aktif


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 2.0 Aug-18
Appendix 1: API Submission Checklist Version 2.0 Aug-18
Appendix 2: API Administrative Procedure_Q3+ Version 2.0 Aug-18
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



National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email:
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075


The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Site Last Modified

  • Last Modified: Jumaat 20 September 2019, 16:39:36.
© Copyright 2019 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Menu Utama

Choose Your Language