Dasatinib 10mg/mL Oral Suspension
Product Overview | |
Generic Name | Dasatinib 10mg/mL Oral Suspension |
Brand Name(s) | Sprycel |
Form | 10mg/mL Powder for Oral Suspension (pediatric) |
Strength | 10 mg /mL. |
Therapeutic Class | Tyrosine-kinase inhibitor (BCR-ABL1, Src-family kinases) |
ATC Code | L01EA02 |
Manufacturing & Regulatory | |
Manufacturer | Bristol‑Myers Squibb/Zydus/Otsuka |
Country | USA/India |
GMP Compliance | WHO-GMP certified |
DMF/CEP | Type II/III |
COFEPRIS | Pending |
Free Sale Certificate | Yes |
Logistics & Export | |
MOQ | 10 units |
Shelf Life | 36 months |
Storage | Store at 20–25 °C |
Incoterms | EXW/FOB/CIF negotiable |
Lead Time | 7 to 10 Days |
Documentation | |
Certificate of Analysis (COA) | Yes |
SDS | Upon Request |
CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
Dasatinib: Presentation: 10mg/mL Powder for Oral Suspension (pediatric)
Indications & Usage: Dasatinib is indicated for Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) (chronic phase, accelerated, blast phase; treatment‑naïve or imatinib-resistant/intolerant) and Ph+ acute lymphoblastic leukemia (ALL) (treatment‑naïve in combination, or imatinib-resistant/intolerant) in adults and pediatric patients ≥ 1 year. It inhibits BCR‑ABL and Src‑family kinases to block malignant proliferation