·         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)

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  • Phone: +603-7883 5400




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