Cabozantinib Mabate API

Cabozantinib Mabate API

CAS No.1140909-48-3
Therapeutic CategoryAnti-Cancer/ Oncology
TechnologySynthetic
Dosage FormOral Solids
Innovator BrandCabometyx  (USA )
Registration StatusPilot
Polymorph/
GMPFDA(USA)/NMPA(China)/MFDS(Korea) approved
EHSISO 14001 & 45001 certified

Product Description

  • Grade: Active Pharmaceutical Ingredient(API)
  • Chemical Name:N-(4-(1-cyanocyclopentyl)phenyl)-2-((pyridin-4-ylmethyl)amino)nicotinamide
  • Molecular Formula:C32H30FN3O10
  • Molecular Weight:635.6
  • Specification: Enterprise Standard established according to ChP/USP/EP
  • Appearance: Powder
  • Total impurities: not more than 0.5%
  • Purity: not less than 99%
  • Residual Solvents: fully comply with ICH Q3C
  • Mutagenic impurities: fully comply with ICH M8
  • Nitrosamine assessment: available
  • Particle size: regular grade or milling/sieving according to customer’s requirement.
  • Storage: Room temperature
  • Production capacity: Commercial
  • Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement

Applications of Cabozantinib Mabate

  • Cabozantinib malate is a small-molecule C-Met regulator. Cabozantinib malate can act as an effective multi-target inhibitor of VEGFR2, Met, FLT3, Tie2, Kit and Ret, with IC50 values of 0.035, 1.8, 14.4, 14.3 and 4.6 nM for VEGFR2, Met, FLT3, Tie2 and Kit respectively. Chemicalbook Cabozantinib malate shows dose-dependent inhibition of tumor growth and tumor regression, which is related to the disruption of the tumor vasculature and extensive tumor cell apoptosis.

Why Choose Us as Your Manufacturer?

  • Qingmu’s Cabozantinib Mabate has been filed in China(DMF filed and listed on CDE’s website), DMF in CTD format is available and can be supported for registration worldwide.
  • Qingmu’s factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, no risk to remove factory. A new API factory is under design and is predicted to be put into use in 2025.
  • Qingmu’s team has rich experience in patent challenges on crystalline form & synthesis processes and also synthetic route development and scale-up & quality research. We are always responsible for our products.
  • Qingmu’s lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. We passed the site inspection from NMPA(China), FDA(USA) and MFDS(Korea) and also customer audits from Europe, USA and Japan, etc.
  • As a manufacturer, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.

FAQ

A1: We are a manufacturer.

A2: Negotiate via email→ sign the contract →ship the good

A3: We have GMP certificate issued by Chinese NMPA, EIR letter issued by USFDA, GMP certificate issued by Korean MFDS, CEP certificate, etc.

A4: Our factory is managed by GMP, we have our own QC lab to test the material and APIs.

A5: We have compliant SOP as per GMP requirement and will be handled according to SOP.

A6: