Excipient(s)

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