Guidelines on Active Pharmaceutical Ingredient (API)

Kadar pengguna: 5 / 5

bintang aktifbintang aktifbintang aktifbintang aktifbintang aktif
 

 

Document Name Download Updated
DRGD - Appendix 11 : Regulatory Control Of Active Pharmaceutical Ingredients (APIs) Jan-2023
Guidance Notes for API Information for Product Registration Application via QUEST (Version 6.1) Jul-2022
List of Updates for Guidance Notes  Jul-2022
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

 

API-Main-Page-Button

National Pharmaceutical Regulatory Agency (NPRA)

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

  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

 

 

Image   Image   Image   Image  

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.

Mobile Web :

Site Last Modified

  • Last Modified: Selasa 07 Februari 2023, 17:10:26.
© Copyright 2023 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

Search

Menu Utama