·         Please refer Appendix 8.2 List of Prohibited and Restricted Excipients; and Appendix 8.3 Lists of Permitted and Restricted Colouring Agents    

  • For each excipient ingredient included in a formulation must have a justifiable excipient role and shall be controlled by specifications.
  • New excipient will require safety and/or other additional data to support the function in the product prior to addition into the Quest 3 database.
  • Please enter function of excipients, e.g. sweetener, preservative, thickening agent, etc. which can be selected from the drop-down list.



How to Access Excipient in QUEST3+ System ? 

Product Registration >> New Application Form >> Product Validation >> Excipient


National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • 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.

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  • Last Modified: Rabu 10 Ogos 2022, 14:45:29.
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