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