Dacomitinib API

Dacomitinib API

CAS No.1110813-31-4
Therapeutic CategoryAnti-Cancer/ Oncology
TechnologySynthetic
Dosage FormOral Solids
Innovator BrandVizimpro(USA)
Registration StatusChina: I
Others: DMF
PolymorphForm II monohydrate
GMPFDA(USA)/NMPA(China)/MFDS(Korea) approved
EHSISO 14001 & 45001 certified

Product Description

  • Grade: Active Pharmaceutical Ingredient(API)
  • Chemical Name: (E)-N-[4-(3-chloro-4-fluoroanilino)-7-methoxyquinazolin-6-yl]-4-piperidin-1-ylbut-2-enamide
  • Molecular Formula: C24H25ClFN5O2
  • Molecular Weight:469.939
  • 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 and micronized(D90<10μm)
  • Storage: Room temperature
  • Production capacity: Commercial
  • Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement

Applications of Dacomitinib API

  • Dacomitinib, designed as (2E)-N-16-4-(piperidin-1-yl) but-2-enamide, is an oral highly selective quinazalone part of the second-generation tyrosine kinase inhibitors which are characterized by the irreversible binding at the ATP domain of the epidermal growth factor receptor family kinase domains
  • Dacomitinib was developed by Pfizer Inc and approved by the FDA on September 27, 2018. Some evidence in the literature suggests the therapeutic potential of dacomitinib in the epithelial ovarian cancer model, although further investigations are needed.

Why Choose Us as Your Manufacturer?

  • Qingmu’s Dacomitinib 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.
  • As a Dacomitinib manufacturer, 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 and Japan, etc.
  • Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil. We are always ready to provide customers with the best quality products and services.

FAQ

A1: Yes if it’s listed on Pharmacopopeia, if not, we’ll establish our own standard according to USP/EP/JP/ChP

A2: One standard package during the commercial stage, but a sub-package can be arranged to support your development.

A3: Yes, it can be discussed.

A4: We support T/T, L/C, and DP.

A5: You can receive our reply within 24 hours if your inquiry was sent in working hours.

A6: Yes, we’re able to enlarge the batch size if current batch size couldn’t meet your requirement.