Pan Am Farma

Paclitaxel 100 mg/16.7 mL

Product Overview
Generic NamePaclitaxel 100 mg/16.7 mL
Brand Name(s)Pacliltax, Nanoxel, Z-Taxel, Altaxel, Plaxel
FormIntravenous Multidose vial, Includes solution/albumin‑bound pwdr for reconstitution
Strength100 mg in 16.7 mL (6 mg/mL)
Therapeutic ClassAntimicrotubule taxane agent
ATC CodeL01CD01
Manufacturing & Regulatory
ManufacturerBristol‑Myers Squibb (Taxol, Abraxane) Teva, Cipla, Glenmark, Ocean Pharma, Fresenius Kabi, Aetos, Biogen, Cipla
CountryUSA, India, Mexico, Israel
GMP ComplianceWHO-GMP, FDA-compliant
DMF/CEPManufacturer-specific, not public
COFEPRIS010.000.5435.00 (300mg/50mL)
Free Sale CertificateAvailable from supplier on request
Logistics & Export
MOQ10 Vials
Shelf Life24 Months
StorageStore at 2–8 °C or 15–25 °C per label
IncotermsEXW/FOB/CIF negotiable
Lead Time7 days
Documentation
Certificate of Analysis (COA)Provided with each batch
SDSUpon Request
CTD SummaryCTD 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.

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