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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

 

 

National Pharmaceutical Regulatory Agency (NPRA)

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

  • Phone: +603-7883 5400

 

 

DISCLAIMER

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.

Site Last Modified

  • Last Modified: Jumaat 08 November 2024, 07:07:02.

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