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Guidelines on Active Pharmaceutical Ingredient (API)

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Document Name Download Updated
DRGD - Appendix 11 : Regulatory Control Of Active Pharmaceutical Ingredients (APIs) Jan-2021
Guidance Notes for API Information for Product Registration Application via QUEST (Version 6.0) Mar-2021
List of Updates for Guidance Notes  Mar-2021
Guideline on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product (FPP):Quality Part. Jan-2012
WHO Technical Report Series, No. 953, 2009 Annex 2: 
Stability testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products		 Jan-2009

 

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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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