Cabozantinib Malate API

Cabozantinib Malate 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

Cabozantinib Malate API is an active pharmaceutical ingredient used in oncology therapeutic applications.

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 Malate

  • Cabozantinib malate is a small-molecule multi-target tyrosine kinase inhibitor used in oncology research and pharmaceutical development. It primarily targets VEGFR2, MET, FLT3, TIE2, KIT, and RET signaling pathways, playing a key role in inhibiting tumor angiogenesis and cancer cell proliferation. Cabozantinib malate demonstrates dose-dependent inhibition of tumor growth and tumor regression. This mechanism is associated with disruption of tumor vasculature and induction of cancer cell apoptosis. This API is widely used in pharmaceutical R&D and oral solid dosage formulation development, and supports preclinical and clinical stage drug development programs.
  • Cabozantinib Malate API is extensively used in oncology formulation development, particularly in oral solid dosage forms such as tablets and capsules, supporting formulation optimization and preclinical research studies.
  • Cabozantinib Malate plays an important role in pharmaceutical process development and scale-up production, including impurity control, crystallization studies, and quality consistency evaluation during commercial manufacturing.
  • Cabozantinib Malate API is suitable for use in both early-stage research and late-stage pharmaceutical development programs. It provides consistent quality performance required for formulation screening, bioavailability evaluation, and stability assessment in oral solid dosage development. The API is also compatible with various process development workflows, supporting optimization of manufacturing parameters and scale-up activities in regulated pharmaceutical environments. With stable physicochemical properties, it enables reproducible results in laboratory and pilot-scale studies, making it a reliable active ingredient for oncology-focused drug development pipelines.
  • Cabozantinib Malate API is supported by consistent analytical quality control systems, including HPLC-based impurity profiling and stability-indicating methods, ensuring reliable performance across different stages of pharmaceutical development and regulatory submission requirements.

Why Choose Us as Your Manufacturer?

  • 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.
  • 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: