Paclitaxel 100 mg/16.7 mL
| Product Overview | |
| Generic Name | Paclitaxel 100 mg/16.7 mL |
| Brand Name(s) | Pacliltax, Nanoxel, Z-Taxel, Altaxel, Plaxel |
| Form | Intravenous Multidose vial, Includes solution/albumin‑bound pwdr for reconstitution |
| Strength | 100 mg in 16.7 mL (6 mg/mL) |
| Therapeutic Class | Antimicrotubule taxane agent |
| ATC Code | L01CD01 |
| Manufacturing & Regulatory | |
| Manufacturer | Bristol‑Myers Squibb (Taxol, Abraxane) Teva, Cipla, Glenmark, Ocean Pharma, Fresenius Kabi, Aetos, Biogen, Cipla |
| Country | USA, India, Mexico, Israel |
| GMP Compliance | WHO-GMP, FDA-compliant |
| DMF/CEP | Manufacturer-specific, not public |
| COFEPRIS | 010.000.5435.00 (300mg/50mL) |
| Free Sale Certificate | Available from supplier on request |
| Logistics & Export | |
| MOQ | 10 Vials |
| Shelf Life | 24 Months |
| Storage | Store at 2–8 °C or 15–25 °C per label |
| Incoterms | EXW/FOB/CIF negotiable |
| Lead Time | 7 days |
| Documentation | |
| Certificate of Analysis (COA) | Provided with each batch |
| SDS | Upon Request |
| CTD Summary | CTD from originator; generic use abbreviated formats |
Description
Indications & Usage: Paclitaxel is a taxane-class chemotherapy drug used in ovarian, breast, non‑small cell lung cancer and Kaposi’s sarcoma. It functions by stabilizing microtubules, blocking cell division. Standard regimen: 175 mg/m² IV over 3 hours every 3 weeks (for standard); albumin-bound form at 260 mg/m² over 30 minutes for select indications. Premedication required for hypersensitivity; main toxicities include neuropathy, myelosuppression, and hypersensitivity.