About the API
Systematic name
N-[(2S,3R,4R,6R)-3-methoxy-2-methyl-16-oxo-29-oxa-1,7,17-triazaoctacyclo[12.12.2.1^{2,6}.0^{7,28}.0^{8,13}.0^{15,19}.0^{20,27}.0^{21,26}]nonacosa-8(13),9,11,14(28),15(19),20(27),21(26),22,24-nonaen-4-yl]-N-methylbenzamide
Trade name(s)
Rydapt
Molecular Formula
C35H30N4O4
Molecular Weight
570.649 g
Therapeutic category
Oncology
Available formulations
Oral Solid
Regulations
US DMF
US DMF
General Information
Midostaurin is a kinase inhibitor indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutationpositive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
At Teva api, we offer two forms of midostaurin for development purposes — amorphous and Form II. Our deep expertise in the development and production of fermentation products, as well as 50+ years of experience in strain improvement performed in a dedicated site, really set us apart.
