Guidelines - Active Pharmaceutical Ingredient (API)
Template and Declaration Letter for API
Written by Jauze · 16 January 2019
| Document Name | Download | Updated |
|---|---|---|
| Declaration Letter for an Approved API in New Product Registration Application | DOWNLOAD | Dec-19 |
| Declaration on GMP of API Intermediate | DOWNLOAD | Aug-18 |
| Declaration on Quality of Atypical API (Letter_AAPI_V1) | DOWNLOAD | Oct-19 |
| Template Cover Letter for DMF Submission | DOWNLOAD | Dec-19 |