GLEEVEC (imatinib mesylate) 400 mg
| Product Overview | |
| Generic Name | GLEEVEC (imatinib mesylate) 400 mg |
| Brand Name(s) | Gleevec / Glivec |
| Product Type | Originator Brand |
| Form | 30 Oral Tablets |
| Strength | 400 mg |
| Therapeutic Class | BCR-ABL Tyrosine-kinase inhibitor molecular targeted inhibitor |
| ATC Code | L01EA01 |
| Manufacturing & Regulatory | |
| Manufacturer | Novartis de Marca, Teva de generico |
| Country | USA, Canada |
| GMP Compliance | FDA/EMA/WHO-GMP |
| DMF/CEP | DMF 041536 / 041545. |
| COFEPRIS | 010.000.4227.00 |
| Free Sale Certificate | may obtain export certificate from regulatory authority |
| Logistics & Export | |
| MOQ | 10 units |
| Shelf Life | 24 months |
| Storage | 20–25 °C |
| Incoterms | Ex-Works, HS 30049099 |
| Lead Time | 7 to 10 Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes—lot-specific Certificate of Analysis |
| SDS | Upon Request, not publicly posted |
| CTD Summary | CTD available to regulators; summary available to qualified partners |
Description
GLEEVEC (Imatinib) is a tyrosine kinase inhibitor indicated for the treatment of chronic myeloid leukemia (CML), Philadelphia chromosome–positive acute lymphoblastic leukemia (Ph+ ALL), gastrointestinal stromal tumors (GIST), and other malignancies driven by BCR-ABL, KIT, or PDGFR mutations. It works by inhibiting abnormal tyrosine kinase signaling involved in cancer cell proliferation.
