| 1 |
USDMF # 039031 |
SN-38 |
PV & DMF filing completed |
 |
| 2 |
USDMF # 043412 |
Exatecan mesylate |
PV & DMF filing completed |
 |
| 3 |
USDMF # 043966 |
Camptothecin |
PV & DMF filing completed |
 |
| 4 |
To be filled |
MMAE |
GMP material supply can be done, |
 |
| Plant validation in progress, will be completed by Dec 2026,
DMF by Apr 2027 |
| Topotecan Hydrochloride |
Lab validation in progress, PV by Mar 2027 |
 |
| 10-Hydroxycamptothecin |
Lab validation completed, Plant validation to be initiated |
 |
| 5 |
Cas # 1599440-33-1 |
Dxd |
Process development completed for non-GMP material supply |
 |
| 6 |
Cas # 2353529-47-0 |
MMAU Triflate (β-D-glucuronylmonomethylauristatin E) |
 |
| 7 |
NA |
Belotecan |
Process development in progress |
 |