Ticagrelor API
| CAS No. | 274693-27-5 |
| Therapeutic Category | Cardiovascular |
| Technology | Synthetic |
| Dosage Form | Oral Solids |
| Innovator Brand | Brilinta(USA) |
| Registration Status | China: A US: DMF 34210 Others: DMF |
| Polymorph | Form II |
| GMP | FDA(USA)/NMPA(China)/MFDS(Korea) approved |
| EHS | ISO 14001 & 45001 certified |
Product Description
- Grade: Active Pharmaceutical Ingredient(API)
- ChemicalName: (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylsulfanyl)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol
- Molecular Formula: C23H28F2N6O4S
- Molecular Weight: 522.568
- 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: Room temperature
- Production capacity: Commercial
- Standard Package: 1kg/bag, 5kg/bag, or according to the customer’s requirement
Applications of Ticagrelor
- Ticagrelor is a reversible antagonist of the platelet purinergic P2Y12 receptor (Ki = 14 nM; IC50 = 1.8 μM), which is the main receptor responsible for ADP-induced platelet aggregation. It functions by directly changing the conformation of the P2Y12 receptor to inhibit ADP binding. Formulations containing ticagrelor have been used to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome.
- Ticagrelor was first described in the literature in 2003. Ticagrelor is an ADP derivative developed for its P2Y12 receptor antagonism. Unlike clopidogrel, ticagrelor is not a prodrug. It is marketed by Astra Zeneca as Brilinta in the US and Brilique or Possia in the EU. Ticagrelor was granted EMA approval on 3 December 2010. Ticagrelor was granted FDA approval on 20 July 2011.
Why Choose Us as Your Manufacturer?
- As a Ticagrelor manufacturer, Qingmu’s Ticagrelor has been approved in China(DMF filed and listed on CDE’s website), DMF in CTD format is available and can be supported for registration worldwide.
- Qingmu is a ticagrelor manufacturing company, Our 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, synthetic route development, scale-up & quality research.
- 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 our customer with the best quality products and services.
