Daratumumab 100mg

Daratumumab 100mg

Product Overview

Generic NameDaratumumab 100mg
Brand Name(s)DARZALEX (IV); DARZALEX FASPRO
CategoryAntineoplastic / Cancer
FormSolución para infusión IV (concentrado 20 mg/mL)
StrengthIV: 100 mg/5 mL
Therapeutic ClassAnticuerpo monoclonal anti-CD38 para mieloma múltiple
ATC CodeL01XC24

Manufacturing & Regulatory

ManufacturerJanssen-Cilag International N.V.
GMP ComplianceWHO-GMP
DMF/CEPNot publicly disclosed
COFEPRIS010.000.6207.00
Free Sale Certificatemay obtain export certificate from regulatory authority

Logistics & Export

MOQ10 Vials
Shelf Life24 Months
Storage2–8 °C, protect from light
IncotermsEXW/CIF negotiable
Lead Time7 - 10 Business Days

Documentation Available Upon Request

Certificate of Analysis (PDF)Supplied per batch upon request
SDS-Safety Data Sheet (PDF)Manufacturer provides standard SDS (biologic/aqueous injectable)
CTD Summary (PDF)CTD available to regulators; summary available to qualified partners