Guidelines on Active Pharmaceutical Ingredient (API)

User Rating: 5 / 5

Star ActiveStar ActiveStar ActiveStar ActiveStar Active
 

 

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

 

API-Main-Page-Button

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

DISCLAIMER

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: Friday 07 August 2020, 10:54:03.
© Copyright 2019 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Main Menu English

Choose Your Language