Batch Certificate of Analysis
Product specification, test items and the actual results for the supplied batch.
Quality documentation / FDA DMF
Traceable materials. Clear documentation.
Specifications and documentation defined for three APIs and two SDD material formats.
FDA / 2026 Q2
Three API records in the FDA public list.
Holder: SHANGHAI DA'AN XIN BIOMEDICAL CO LTD
| API | FDA DMF | Type / status | Submitted |
|---|---|---|---|
| DARAXONRASIB | 43871 | II / A (Active) | 2026-03-17 |
| ZOLDONRASIB | 44304 | II / A (Active) | 2026-06-08 |
| VOPIMETOSTAT | 44318 | II / A (Active) | 2026-06-11 |
Status, type and dates were checked against the FDA List of Drug Master Files, 2nd Quarter 2026. They describe that quarterly snapshot, not real-time status. Each product name has one record in that list. DMFs are neither approved nor disapproved, do not constitute drug marketing approval and cannot by themselves establish global commercial supply chronology.
Identity & analytical records
Identity, HPLC and method information within the agreed documentation package.
SDD & premix parameters
Drug loading, carrier or excipient composition, solid-state and downstream process requirements.
Regulatory references
DMF reference and authorization needs, destination market and scope of support.
Storage & handling
Packaging, shipping, storage and retest information for the specific material and lot.
Ongoing supply
Quality agreements, change notification and follow-on requirements defined with your team.
Material-specific requirements
API, SDD and premix are specified separately.
The commercial target for Daraxonrasib API is ≥99% purity by HPLC, with actual results established by the batch CoA. SDD and premix materials contain carriers or excipients; loading, composition and formulation performance require their own specifications, rather than the API purity criterion.
DMF 43871 identifies the Daraxonrasib API. It is not presented here as a separate DMF for the SDD or premix products.
Documentation request
Request the package for your program.
Include product, intended use, quantity, destination and required documents.