Ponatinib HCL API
| CAS No. | 943319-70-8 |
| Therapeutic Category | Anti-Cancer/ Oncology |
| Technology | Synthetic |
| Dosage Form | Oral Solids |
| Innovator Brand | Iclusig, Ariad (USA) |
| Registration Status | R&D |
| Polymorph | TBD |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 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 API 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 Ponatinib API 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.
