Nilotinib Hydrochloride API

Nilotinib Hydrochloride API

CAS No.923288-90-8
Therapeutic CategoryAnti-Cancer/Oncology
Dosage FormOral Solids
Innovator BrandTasigna(USA)
Registration StatusTechnical Package
PolymorphForm B monohydrate; Form A dihydrate
GMPFDA(USA)/NMPA(China)/MFDS(Korea) approved
EHSISO 14001 & 45001 certified

Product Description

  • Grade: Active Pharmaceutical Ingredient(API)
  • Chemical Name: 4-methyl-N-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyridin-3-ylpyrimidin-2-yl)amino]benzamide,hydrate,hydrochloride
  • Molecular Formula: C28H25ClF3N7O2
  • Molecular Weight: 583.992
  • 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 Nilotinib API

  • Nilotinib Hydrochloride Monohydrate is the monohydrate monohydrochloride form of nilotinib, an orally bioavailable aminopyrimidine-derivative Bcr-Abl tyrosine kinase inhibitor with antineoplastic activity. Designed to overcome imatinib resistance resulting from Bcr-Abl kinase mutations, upon administration, nilotinib binds to and stabilizes the inactive conformation of the kinase domain of the Abl portion of the Bcr-Abl fusion protein, resulting in the inhibition of the constitutive kinase activity of Bcr-Abl protein. This inhibits the Bcr-Abl-mediated proliferation of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) cells. Nilotinib Hydrochloride also inhibits the receptor tyrosine kinases platelet-derived growth factor receptor (PDGF-R; PDGFR), mast/stem cell growth factor receptor Kit (c-Kit), and, to a lesser extent, colony-stimulating factor 1 receptor (CSF-1R; CSF1R), and discoidin domain-containing receptor 1 (DDR1).

Why Choose Us as Your Nilotinib Supplier?

  • Qigmu is a Nilotinib supplier in China. Our factory is established according to ICH/USFDA/EU/JAPAN/China regulations and current GMP, totally complies with environmental law in China, no risk to removing the 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.
  • Qingmu’s lab is equipped with HPLC, GC, ICP-MS, GC-MS, CAD, microbalance, Malvern particle analyzer, etc. Qingmu passed the site inspection from NMPA(China), FDA(USA), and MFDS(Korea) and also customer audits from Europe, USA, Japan, etc.
  • As a reliable Nilotinib API manufacturer, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.


A1: We have GMP certificate issued by Chinese NMPA, EIR letter issued by USFDA, GMP certificate issued by Korean MFDS, CEP certificate, etc.

A2: Our factory is managed by GMP, we have our own QC lab to test the material and APIs.

A3: It’s needs to discussed as per each product.

A4: Yes. We will gratefully welcome your visit.

A5: Yes. We are looking for distributors and agents all over the world.