Active Ingredient(s)

3.1 Active Ingredient Name

3.2 Salt Form

3.3 Strength of Active Ingredient (Quantity unit/ dose)

3.4 Strength Salt-Free

3.5 Source of Active Ingredient (Animal – e.g. Bovine, Porcine, Ovine or Others/ Plant/ Others)

3.6 Form of Substance

3.7 Remarks (if any)

3.8 Status

 

  • Listed active ingredients can be checked through http://npra.moh.gov.my/ of product search. Ingredients not listed will require safety and/or efficacy data evaluation prior to addition to this list.
  • Substances that are included in the formulation as active ingredients must make a contribution to the proposed indications for the product.
  • Please specify the source such as animal, plant, synthetic or others.
  • Please check whether the product contains active ingredients listed in the PROTECTED/ ENDANGERED WILDLIFE OR BOTANICAL SPECIES as in the DRGD. The applicant shall contact the appointed department as listed in DRGD to obtain the necessary permit / license.

Strength of active ingredient :

  • To enter the content of active ingredients (numerical) and then select the weights and measures from the given list.
  • The content of ingredients shall be expressed as appropriate in the following manner:
  1. a) quantity per dose unit (e.g. for unit dose formulations - tablet, capsule, lozenge, etc.)
  2. b) percentage composition - %w/w, %w/v, %v/v, etc.
  3. c) weight per ml. (e.g. for solutions, suspension etc.)
  • Quantity (percentage or amount) per measured dose (e.g. oral liquids, drops, etc.)
  • Metric weights and measures shall be used.

 

 


How to Access Active Ingredient in QUEST3+ System ? 

Product Registration >> New Application Form >> Product Validation >> Active Ingredients

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 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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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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