High-purity pharmaceutical ingredients manufactured under rigorous global quality control standards.
Comprehensive chemical analysis, polymorph optimization, particle size distribution engineering, and active pharmaceutical ingredient (API) manufacturing benchmarks.
Dabigatran Etexilate Mesilate (CAS Number: 211915-06-9; IUPAC: ethyl N-{[2-({[4-(hexoxycarbonylcarbamimidoyl)phenyl]amino}methyl)-1-methyl-1H-1,3-benzodiazol-5-yl]carbonyl}-N-(pyridin-2-yl)-β-alaninate methanesulfonate) represents a cornerstone in modern cardiovascular pharmacotherapy. As an oral prodrug of the direct thrombin inhibitor Dabigatran, it plays a vital role in preventing thromboembolic events, deep vein thrombosis (DVT), pulmonary embolism (PE), and non-valvular atrial fibrillation (NVAF) strokes globally.
Because the active moiety (Dabigatran) exhibits high polarity and low oral bioavailability, the etexilate prodrug ester form was designed to penetrate the intestinal mucosa efficiently. Upon absorption, endogenous esterases rapidly hydrolyze Dabigatran Etexilate Mesilate into active Dabigatran, which reversibly binds to the active site of both free and clot-bound thrombin (Factor IIa) without requiring antithrombin III as a cofactor.
| Parameter | Industrial Specification Benchmark |
|---|---|
| Chemical Name | Dabigatran Etexilate Mesilate |
| CAS Registry Number | 211915-06-9 / 872728-81-9 (Mesilate salt) |
| Molecular Formula | C34H41N7O5 · CH4O3S |
| Molecular Weight | 727.83 g/mol |
| API Purity (HPLC) | ≥ 99.5% (Individual Impurity < 0.10%) |
| Polymorphic Form | Polymorph Form I / Stable Form II (Customized) |
| Particle Size (d90) | 10 µm - 50 µm (Micronized / Standard options) |
| Heavy Metals | ≤ 10 ppm (ICP-MS Validated) |
| Nitrosamine Limits | ND (Below threshold of toxicological concern - TTC) |
Overcoming direct thrombin inhibitor supply chain vulnerabilities through backward integration, risk mitigation, and continuous process analytical technology (PAT).
We mitigate raw material volatility by synthesizing crucial raw building blocks in-house, such as ethyl 3-(2-(((4-carbamimidoylphenyl)amino)methyl)-1-methyl-N-(pyridin-2-yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate and hexyl chloroformate. This upstream control yields unmatched batch-to-batch predictability.
With stringent global regulators checking for NDMA and N-nitroso-dabigatran impurities, our synthetic lines deploy secondary amine-free reaction pathways and validated LC-MS/MS testing techniques to guarantee non-detectable nitrosamine thresholds.
By employing PAT-guided continuous crystallization units, we accurately control polymorph nucleations (Form I vs Form II), avoiding meta-stable solid-state transitions during commercial scaling and extended storage in humid climates (Zone IVb).
Assisting solid oral dosage (FDF) developers in overcoming low intrinsic aqueous solubility across gastrointestinal pH gradients.
Dabigatran Etexilate Mesilate displays a steep pH-dependent solubility profile—it is soluble in acidic environments but drops significantly in neutral to alkaline intestinal environments. Consequently, standard formulation matrices risk incomplete drug absorption and wide intra-patient bioavailability variability.
Our technical team assists generic drug makers and licensing partners with customized physical API characteristics:
Recommended Excipients: Acacia, Tartaric Acid, Hydroxypropyl Cellulose, Hypromellose, Talc, Dimethicone, Isopropyl Alcohol, and Methacrylic Acid copolymer suspensions.
Bioequivalence (BE) Guidance: Our API batches carry consistent polymorphic distributions matching the reference listed drug (RLD) Pradaxa®, minimizing bioequivalence trial failures.
Storage Stability: Stable under long-term testing conditions ($25^\circ\text{C} / 60\%\, \text{RH}$) and accelerated testing conditions ($40^\circ\text{C} / 75\%\, \text{RH}$) with fully documented stability data packages.
Connecting the world with high-performance active pharmaceutical ingredients, custom peptide synthesis, and seamless global distribution solutions.
Gentolex’s goal is to create opportunities connecting the world with better services and guaranteed products. Up to date, Gentolex Group has been serving customers from more than 10 countries, specially, representatives are established in Mexico and South Africa. Our main services focus on supplying peptides APIs and Custom Peptides, FDF license out, Technical Support & Consultation, Product Line and Lab Setup, Sourcing & Supply Chain Solutions.
An overall factory construction area of 250,000 square meters under international standard to offer flexible, scalable and cost-effective solutions.
Gentolex offers an extensive range of APIs and intermediates for development study and commercial application with cGMP standard from long-term collaborations. Documents and Certificates are supported to customers worldwide.
State-of-the-art research laboratories equipped with automated synthesis modules, LC-MS, NMR, and high-throughput analytical screening systems.
For those clients who prefer to avoid the complexity of dealing with multiple points of contact, we provide extra customized procurement services with the most superior and comprehensive supply chain sources.
Audit-ready facilities meeting US FDA, EDQM, PMDA, and NMPA standards.
Explore our latest publications, research insights, and synthetic breakthroughs across API chemistry and peptide engineering.
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View DetailsPioneering green synthesis metrics, automated crystallization, and advanced quality by design (QbD) frameworks.
By replacing toxic organic solvents with recyclable catalytic medium systems during benzimidazole coupling, our manufacturing facilities have achieved a 35% reduction in overall waste mass ratio (E-Factor), promoting sustainable pharmaceutical production.
Integrating artificial intelligence algorithms with inline Process Analytical Technology (PAT) allows real-time tracking of particle size growth and polymorphic transformation during mass crystallization, guaranteeing zero batch discard rates.
Supporting next-gen co-formulation initiatives combining Dabigatran Etexilate Mesilate with complementary cardiovascular agents. We offer co-processed micronized grades with modified release profiles tailored for multi-layer tablet technology.
Expert technical answers addressing formulation challenges, regulatory filings, quality metrics, and order handling.
Explore our specialized chemical list and customized sourcing solutions available for immediate dispatch.
