Sunitinib 12.5mg Cap
| Product Overview | |
| Generic Name | Sunitinib 12.5mg Cap |
| Brand Name(s) | Sutent |
| Form | Oral hard gelatin capsules |
| Strength | 12.5 mg |
| Therapeutic Class | Small-molecule multikinase inhibitor (targets VEGFR, PDGFR, c-KIT) |
| ATC Code | L01EX01 |
| Manufacturing & Regulatory | |
| Manufacturer | Pfizer |
| Country | India/USA/EU |
| GMP Compliance | WHO-GMP |
| DMF/CEP | Type II |
| COFEPRIS | Under Registration (2025) |
| Free Sale Certificate | Yes |
| Logistics & Export | |
| MOQ | 100 units |
| Shelf Life | 24 months |
| Storage | 20-25 °C (15-30 °C allowed) |
| Incoterms | Ex-Works Mexico |
| Lead Time | 7 to 10 Days |
| Documentation | |
| Certificate of Analysis (COA) | Yes |
| SDS | Upon Request, not publicly posted |
| CTD Summary | Full CTD dossier proprietary; available under commercial agreement/license |
Description
Sunitinib is an oral multi-targeted tyrosine kinase inhibitor indicated for the treatment of several advanced malignancies. Its primary uses include: (1) first-line treatment of advanced renal cell carcinoma (RCC); (2) adjuvant treatment of high-risk RCC following nephrectomy; (3) treatment of gastrointestinal stromal tumors (GIST) in patients who are intolerant to or whose disease has progressed on imatinib; and (4) treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNETs) in patients with unresectable, locally advanced, or metastatic disease. Sunitinib works by inhibiting multiple receptor tyrosine kinases involved in tumor growth, angiogenesis, and metastasis, including VEGFR, PDGFR, and KIT.
