The actual raw material that is employed in the manufacturing process shall be named. For example:

  • Where the raw material used is the salt (e.g. ampicillin trihydrate) which will yield an equivalent effective component from its base content (i.e. ampicillin), the substance name is the salt and the equivalent base component should be indicated in remarks on substance field, if any.


Please refer:

Drug Registration Guidance Document (DRGD) - Appendix 8.1 List of Prohibited and Restricted Active Ingredients and Combinations.

How to Access Active Ingredient in QUEST3+ System ? 

Product Registration >> New Application Form >> Product Validation >> Active Ingredients



National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400




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 12 July 2024, 15:24:37.
© Copyright 2023 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA


Main Menu English