Guidelines - Active Pharmaceutical Ingredient (API)
Guidelines on Active Pharmaceutical Ingredient (API)
Written by Pharm Mee Ngoh · 16 January 2019
| Document Name | Download | Updated |
|---|---|---|
| DRGD - Appendix 11 : Regulatory Control Of Active Pharmaceutical Ingredients (APIs) | DOWNLOAD | Jan-2024 |
| Guidance Notes for API Information for Product Registration Application via QUEST (Version 6.1) | DOWNLOAD | Jul-2022 |
| Appendix IV: List of Atypical APIs | DOWNLOAD | Jul-2023 |
| List of Updates for Guidance Notes | DOWNLOAD | Jul-2022 |
| Guideline on Submission of Documentation for a Multisource (Generic) Finished Pharmaceutical Product (FPP):Quality Part. | DOWNLOAD | Jan-2012 |
| WHO Technical Report Series, No. 953, 2009 Annex 2: Stability testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products |
DOWNLOAD | Jan-2009 |
