The report provides a detailed analysis essential for establishing a Dabigatran Etexilate production plant. It encompasses all critical aspects necessary for Dabigatran Etexilate production, including the cost of Dabigatran Etexilate production, Dabigatran Etexilate plant cost, Dabigatran Etexilate production costs, and the overall Dabigatran Etexilate production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Dabigatran Etexilate production plant. These encompass production processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.
Dabigatran Etexilate is an anticoagulant medication that helps to avoid blood clots, mainly in patients who recently had knee or hip replacement surgery, because these procedures raise the possibility of developing blood clots in the veins. It is extensively employed in the form of pellets to treat conditions related with venous thromboembolism. It is also recommended in capsule form for patients with atrial fibrillation, a disorder that results in irregular heartbeats and raises the risk of strokes.
The market for Dabigatran Etexilate is driven by its application in clinical practice as an anticoagulant drug which is used in the treatment of thromboembolic disorders and atrial fibrillation, hence increasing its demand in the pharmaceutical and medical industries. The rising cases of conditions that leads to the formation of venous thromboembolism (VTE) like atrial fibrillation coupled with the increasing orthopedic surgical procedures (like hip and knee replacements) is significantly increasing the demand for Dabigatran Etexilate.
Its effectiveness in counteracting side effects such as heparin-induced thrombocytopenia makes this a better choice over other anticoagulants such as warfarin, thus amplifying its market appeal. Overall, industrial Dabigatran Etexilate procurement is influenced by its usage in the pharmaceutical and medical industries as an anticoagulant, rising cases of thromboembolic disorders and atrial fibrillation, fewer side effects than conventional anticoagulants, increasing healthcare awareness, and regulatory approvals.
Raw Material for Dabigatran Etexilate Production
According to the Dabigatran Etexilate production plant project report, the key raw material used in the production of Dabigatran Etexilate includes 2-cyanophenyl amino acetic acid.
Production Process of Dabigatran Etexilate
The extensive Dabigatran Etexilate production cost report consists of the following major industrial production process:
- Production from 2-cyanophenyl amino acetic acid: The production process of Dabigatran Etexilate starts with the condensation reaction of the starting compound with ethyl-3-(3-amino-4-(methylamino)benzoyl(piperidin-2- yl)amino)propante in the presence of oxalic acid to form an oxalate salt, which on further treatment with HCl gas gives the hydrochloride salt. Finally, the hydrochloride salt undergoes an acylation reaction with hexyl chloroformate to produce Dabigatran Etexilate as the final product.
Dabigatran Etexilate, commercially known as Pradaxa, is a whitish-yellow to yellow crystalline powder having the molecular formula C34H41N7O5 and a molecular weight of 627.7 g/mol. It has a melting point of around 180 °C. It is soluble to some extent in water, having a solubility of 1.8mg/ml. It has an estimated water solubility of 0.00466 mg/mL. It has poor solubility in neutral and basic solutions but dissolves better in acidic solutions. It is also slightly soluble in DMSO and methanol. It has a log P value of 3.8. The value of its dissociation constant, pKa, is 17.89. It is an oral prodrug that hydrolyzes to produce the reversible and competitive direct thrombin inhibitor dabigatran.
