Dasatinib 20mg
| Product Overview | |
| Generic Name | Dasatinib 20mg |
| Brand Name(s) | SPRYCEL® |
| Form | 60 Film-coated tablets |
| Strength | 20 mg |
| Therapeutic Class | Tyrosine-kinase inhibitor (BCR-ABL1, Src-family kinases) |
| ATC Code | L01EA02 |
| Manufacturing & Regulatory | |
| Manufacturer | Teva, Bristol‑Myers Squibb/Zydus/Otsuka |
| Country | USA/India |
| GMP Compliance | WHO-GMP certified |
| DMF/CEP | Type II/III |
| COFEPRIS | 104M2007 SSA IV |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 10 units |
| Shelf Life | 36 months |
| Storage | Store at 20–25 °C |
| Incoterms | EXW |
| Lead Time | 7 to 10 Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes—lot-specific Certificate of Analysis |
| SDS | Upon Request |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
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
