Darolutamide API
| CAS No. | 1297538-32-9 |
| Therapeutic Category | Anti-Cancer/ Oncology |
| Technology | Synthetic |
| Dosage Form | Oral Solids |
| Innovator Brand | Nubeqa(Germany) |
| Registration Status | Lab |
| Polymorph | / |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Product Description
- Grade: Active Pharmaceutical Ingredient(API)
- Chemical Name:N-{(2S)-1-[3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl]propan-2-yl}-5-[(1RS)-1-hydroxyethyl]-1H-pyrazole-3-carboxamide
- Molecular Formula:C19H19ClN6O2
- Molecular Weight:398.85
- 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: -20°C Freezer, Under inert atmosphere
- Production capacity: Commercial
- Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement
Applications of Darolutamide
- Darolutamide, is a novel oral anti-androgen therapy used for the treatment of non-metastatic and metastatic prostate cancer. As a non-steroidal anti-androgen, it has high selectivity and affinity, can inhibit the activity of androgen receptors in prostate cancer cells, thereby prolonging the survival period of patients and improving the quality of life of patients..
Why Choose Us as Your Manufacturer?
- Qingmu’s Darolutamide 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. 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 a manufacturer, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.
