Prasugrel Production Cost Reports

The report provides a detailed analysis essential for establishing a prasugrel production plant. It encompasses all critical aspects necessary for prasugrel production, including the cost of prasugrel production, prasugrel plant cost, prasugrel production costs, and the overall prasugrel production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a prasugrel 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.

Prasugrel is a thienopyridine antiplatelet drug that acts as a prodrug. It irreversibly inhibits the P2Y12 ADP receptor on platelets to prevent aggregation and thrombus formation after metabolism by CYP enzymes. It offers faster and stronger platelet inhibition than clopidogrel. It is used with aspirin to reduce thrombotic cardiovascular events like myocardial infarction, stroke, and stent thrombosis. It is utilised in acute coronary syndrome patients undergoing percutaneous coronary intervention, including those with unstable angina, NSTEMI, or STEMI. It is administered as a 60 mg oral loading dose followed by 10 mg daily maintenance. It effectively lowers recurrent ischemic risks but carries increased bleeding potential, particularly in those over 75.

The market for prasugrel is driven by the rising global burden of cardiovascular diseases. The increasing rates of acute coronary syndrome and percutaneous coronary interventions contribute to its market growth. The ageing population and its growing adoption in high-risk patients fuel the market. North America leads because of its advanced cardiology infrastructure, while the Asia-Pacific region grows fastest from urbanisation and disease cases. The industrial prasugrel procurement is influenced by reliance on GMP-certified API suppliers amid patent expiries, boosting generics. Also, unstable pricing from trade tensions and negotiations, quality audits, and multi-sourcing to mitigate supply risks impacts its sourcing strategies.

Raw Material for Prasugrel Production

According to the prasugrel production plant project report, the key raw materials used in the production of prasugrel include 2-cyclopropyl-4,5,6,7-tetrahydrothieno[3,2-c]pyridine, cyclopentyl chloroformate, trifluoromethanesulfonic anhydride, and aryl boronic acid.

Production Process of Prasugrel

The extensive prasugrel production cost report consists of the following major industrial production process:

1. From 2-cyclopropyl-4,5,6,7-tetrahydrothieno[3,2-c]pyridine: The production process of prasugrel involves a multi-step process. It starts with the reaction of 2-cyclopropyl-4,5,6,7-tetrahydrothieno[3,2-c]pyridine with an activated cyclopentyl isocyanate equivalent. This is followed by cyclisation to form the core thienopyridine ring. Also, deprotection of the cyclopropyl acetal, triflation of the hydroxyl group, and Suzuki coupling with a boronic acid derivative take place. Finally, treatment with HCl in a solvent like IPA or acetone gives prasugrel hydrochloride.

Prasugrel is a thienopyridine prodrug antiplatelet agent, has the molecular formula C20H20FNO3S and a molecular weight of 373.44 g/mol. It appears as a white to off-white crystalline solid or light yellow to orange powder. It has a melting point of 120-124 degree Celsius, and is a solid at room temperature. Its solubility is high at pH 2, moderate at pH 3-4, and very low at pH 6-7.5. It features a tetrahydrothieno[3,2-c]pyridine core esterified with acetic acid, a cyclopropyl ketone linked to a 2-fluorophenyl group. It shows moderate lipophilicity suitable for oral absorption, with storage recommended refrigerated to maintain stability. All these physical and chemical makes it useful as an antiplatelet drug.