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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 (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: Rabu 02 Oktober 2024, 21:12:35.

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