Imatinib 400 mg Tablet
| Product Overview | |
| Generic Name | Imatinib 400 mg Tablet |
| Brand Name(s) | Gleevec |
| Form | Oral Tablets 400mg x 30 tab |
| Strength | 400 mg |
| Therapeutic Class | Tyrosine-kinase inhibitor |
| ATC Code | L01EA01 |
| Manufacturing & Regulatory | |
| Manufacturer | Novartis |
| Country | India/USA/EU |
| GMP Compliance | WHO-GMP certified |
| DMF/CEP | Type II/III |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 months |
| Storage | 20–25 °C |
| Incoterms | Ex-Works Mexico |
| Lead Time | 7 to 10 Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes |
| SDS | Provided by manufacturer on request (standard viral vaccine document) |
| CTD Summary | CTD from originator; generic use abbreviated formats |
Description
Use and Indications for Imatinib: 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.
