4.1 Excipient name

4.2 Strength of Excipient (Quantity unit/ dose)

4.3 Function of excipient (e.g. absorbent, diluents, bulking agent, coating agent,

      anti-caking agent etc.)

4.4 Source of excipient

4.5 Remarks (if any)


· 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.


Reference National Pharmacy Regulatory Agency (formally known as National Pharmaceutical Control Bureau):

Drug Registration Guidance Document (DRGD)-Appendix 8.2 List of Prohibited and Restricted Excipients; & Appendix 8.3 Lists of Permitted and Restricted Colouring Agents



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


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