Ponatinib HCL API

Ponatinib HCL API

CAS No.943319-70-8
Therapeutic CategoryAnti-Cancer/ Oncology
TechnologySynthetic
Dosage FormOral Solids
Innovator BrandIclusig, Ariad (USA)
Registration StatusR&D
PolymorphTBD
GMPFDA(USA)/NMPA(China)/MFDS(Korea) approved
EHSISO 14001 & 45001 certified

Product Description

  • Grade: Active Pharmaceutical Ingredient(API)
  • Chemical Name: 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl]benzamide
  • Molecular Formula: C29H27F3N6O
  • Molecular Weight: 532.56
  • 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: R&D
  • Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement

Applications of Ponatinib API

  • Ponatinib is a kind of Human API. Applied to chronic myeloid leukemia that is resistant or intolerant to previous medications,
  • Recurrent or refractory Philadelphia chromosome positive acute lymphocytic leukemia
  • T315 positive chronic myeloid leukemia or T315 positive Philadelphia chromosome positive acute lymphocytic leukemia

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. 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. Please feel free to choose us.
  • 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.
  • As an Ponatinib API manufacturer, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.

FAQ

A1: Negotiate via email→ sign the contract →ship the good

A2: We usually ship the goods by courier, Air, or Sea.

A3: We use Bag, Drum, Carton Box, Alu Tin, etc

A4: We have compliant SOP as per GMP requirement and will be handled according to SOP.

A5: Yes, we’re able to enlarge the batch size if current batch size couldn’t meet your requirement.

A6: