Dabigatran Etexilate Mesylate API

CAS No.	872728-81-9
Therapeutic Category	Cardiovascular
Technology	Synthetic
Dosage Form	Oral Solids
Innovator Brand	Pradaxa(USA)
Registration Status	China: A, Written Confirmation US: DMF 36539 Japan: MF under registration EU: CEP under application Others: DMF
Polymorph	Form I
GMP	FDA(USA)/NMPA(China)/MFDS(Korea) approved
EHS	ISO 14001 & 45001 certified

Product Description

Grade: Active Pharmaceutical Ingredient(API)
Chemical Name: N-[[2-[[[4-[[[(HEXYLOXY)CARBONYL]AMINO]IMINOMETHYL]PHENYL]AMINO]METHYL]-1-METHYL-1H-BENZIMIDAZOL-5-Y
Molecular Formula: C35H45N7O8S
Molecular Weight:723.839
Specification: EP, 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

Dabigatran, sold under the brand name Pradaxa among others, is an anticoagulant used to treat and prevent blood clots and stroke in people with atrial fibrillation. Specifically, it is used to prevent blood clots following hip or knee replacement and in those with a history of prior clots. It is used as an alternative to warfarin and does not require monitoring by blood tests. In a meta-analysis of 7 different studies, there was no benefit of dabigatran over warfarin in preventing ischemic stroke; however, dabigatran was associated with a lower hazard for intracranial bleeding compared with warfarin but also had a higher risk of gastrointestinal bleeding relative to warfarin. It is taken by mouth.
Common side effects include bleeding and gastritis. Other side effects may include bleeding around the spine and allergic reactions such as anaphylaxis. In cases of severe bleeding, it can be reversed with the antidote, idarucizumab. Use is not recommended during pregnancy or breastfeeding. Compared to warfarin it has fewer interactions with other medications. It is a direct thrombin inhibitor.
Dabigatran was approved for medical use in the United States in 2010. It is on the World Health Organization’s List of Essential Medicines. In 2020, it was the 306th most commonly prescribed medication in the United States, with more than 1 million prescriptions. Dabigatran is available as a generic medication.

Qingmu’s Dabigatran Etexilate Mesylate has been approved in China(DMF filed and listed on CDE’s website), and also submitted to USDMF, will apply CEP certificate in EDQM and MF in Japan PMDA soon, DMF in CTD format will be available and can be supported for the registration in 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 removing the 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. So you can rest assured 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 a Dabigatran manufacturer, Qingmu successfully exported products to more than 40 countries including Japan, USA, Germany, Spain, the Netherlands, Russia, South Korea, and Brazil.