Dasatinib 50mg
Product Overview
| Generic Name | Dasatinib 50mg |
| Brand Name(s) | SPRYCEL® |
| Category | Antineoplastic / Cancer |
| Form | 60 Film-coated tablets |
| Strength | 50 mg |
| Therapeutic Class | Tyrosine-kinase inhibitor (BCR-ABL1, Src-family kinases) |
| ATC Code | L01EA02 |
Manufacturing & Regulatory
| Manufacturer | Teva, Bristol‑Myers Squibb/Zydus/Otsuka |
| GMP Compliance | WHO-GMP certified |
| DMF/CEP | Type II/III |
| COFEPRIS | 010.000.4323.00 |
| Free Sale Certificate | Yes |
Logistics & Export
| MOQ | 5 units |
| Shelf Life | 36 months |
| Storage | Store at 20–25 °C |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 to 10 Days |
Documentation Available Upon Request
| Certificate of Analysis (PDF) | Yes |
| SDS-Safety Data Sheet (PDF) | Upon Request |
| CTD Summary (PDF) | CTD available to regulators; summary available to qualified partners |
Special Notes
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