DARAXON / SHANGHAI
API expertise. Formulation perspective.
4 core APIs and complementary Daraxonrasib SDD materials for pharmaceutical development and registration teams.
Company identity
Daraxon
SHANGHAI DA'AN XIN BIOMEDICAL CO LTD is the company name in the FDA DMF list. SHANGHAI DARAXON BIOMEDICAL CO LTD is an alternative English rendering of the same company. Daraxon is the brand used on this website.
Our portfolio includes Daraxonrasib, Vopimetostat, Zoldonrasib and Silevertinib APIs, plus Daraxonrasib SDD spray-dried powder and an excipient-containing SDD premix for direct compression.
Supply portfolio
API supply with formulation support.
Company statement
Daraxon is the world’s first supplier of Daraxonrasib, Vopimetostat and Zoldonrasib APIs, and of Daraxonrasib SDD spray-dried powder and excipient-containing SDD premix for direct compression. The portfolio also includes silevertinib (BDTX-1535) API, FDA DMF 44854.
Global-first positioning is a company statement. FDA DMF records identify files and holders; they do not certify global supplier rankings.
Public filing records / 2026 Q3
4 APIs. 4 Type II DMFs.
The FDA 2026 Q3 public list contains the following four API records under our FDA-listed holder name. These are quarterly snapshots; DMF filings are not drug marketing approvals.
| API | FDA DMF | Type / status | Submitted |
|---|---|---|---|
| DARAXONRASIB | 43871 | II / A (Active) | 2026-03-17 |
| VOPIMETOSTAT | 44318 | II / A (Active) | 2026-06-11 |
| ZOLDONRASIB | 44304 | II / A (Active) | 2026-06-08 |
| SILEVERTINIB | 44854 | II / A (Active) | 2026-09-22 |
Work with Daraxon
Tell us what your program needs.
Start with material selection, specifications and the documentation for your program.