Axitinib API

CAS No.	319460-85-0
Therapeutic Category	Anti-Cancer/ Oncology
Technology	Synthetic
Dosage Form	Oral Solids
Innovator Brand	Inlyta(USA)
Registration Status	China: A (Tablets of mother company launched in China) Other countries: DMF
Polymorph	Form α
GMP	FDA(USA)/NMPA(China)/MFDS(Korea) approved
EHS	ISO 14001 & 45001 certified

Product Description of Axitinib API

Grade: non-sterile Active Pharmaceutical Ingredient(API)
Product Name: Axitinib
Chemical Name: N-Methyl-2-({3-[(E)-2-(2-pyridinyl)vinyl]-1H-indazol-6-yl}sulfanyl)benzamide
Molecular Formula: C22H18N4OS
Molecular Weight: 386.470
Specification: In-house established according to ChP/USP/EP, etc.
Appearance: White to light yellow powder
Related substances:
Single known impurities: not more than 0.15%
Any other impurity: not more than 0.10%
Total impurities: not more than 0.5%
Purity: not less than 99.5%
Assay: 98.0%~102.0% (On dried basis)
Heavy Metals: not more than 20ppm
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.
Microbial limit:
Total aerobic microbial count: NMT 10^³CFU/g
Total yeasts and molds count: NMT 10²CFU/g
E. coli: Should not be detected per 1g
Storage: Preserve in an airtight container, protected from light.
Production capacity: Commercial
Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement

Sold under the brand name Inlyta® by Pfizer, Inc., Axitinib API was approved by the FDA in January 2012 for the treatment of advanced renal cell carcinoma (RCC), specifically after the failure of other systemic treatments. Axitinib slows cancer cell proliferation by inhibition of the vascular endothelial growth factor (VEGF)/VEGF receptor tyrosine (RTK) signaling pathway. In particular, axitinib is a potent inhibitor of VEGF/RTK 1-3, which selectively slows angiogenesis, vascular permeability, and blood flow in solid tumors.
Axitinib API belongs to selective vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors. It works by blocking VEGFR‑1/2/3 signaling pathways to restrain tumor angiogenesis, slow tumor growth and metastasis. Its primary pharmaceutical application is producing finished drugs for the treatment of advanced renal cell carcinoma after failure of prior systemic therapy.

Qingmu’s Axitinib API has been filed in China(DMF filed and listed on CDE’s website), DMF in CTD format English version 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. Dedicated OEB-4 and OEB-5 factory for oncology APIs.
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 an Axitinib API manufacturer, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.