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Country of origin : India

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3 products found

argatroban

Vials, injection 1 mg/ml - 50 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
FDA
Comments
ANDA / R &D Status: Approved ; US RLD / Holder: "Argatroban / Hikma Pharm"; Indication: Anticoagulants, Thrombin inhibitor;
Manufacturer #8216
This fast-growing pharmaceutical company boasts a dominant presence in Latin America, Francophone Africa, and a growing footprint in regulated markets like the EU and North America. Founded in 1990, it initially focused on ointments and creams before expanding its product range significantly. With over 4,000 global product licenses, they cater primarily to the "Bottom of the Pyramid" through their owned distribution networks. The company's manufacturing facility holds multiple certifications including US FDA approval (with three successful inspections since 2016), EU-GMP, ANVISA-Brazil, INVIMA-Colombia, and COFEPRIS-Mexico. They prioritize innovation with a significant portion of their earnings invested in research and development of safe and effective products across various dosage forms. Key therapy areas are not specified.

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Argatroban:

Argatroban is a medication belonging to a group of pharmaceutical products which function as anticoagulants, with it specifically being a small molecule direct thrombin inhibitor. Argatroban’s original manufacturers successfully petitioned the FDA in the United States and it was subsequently approved in 2000 for the treatment of prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia. In 2002 argatroban manufacturers and argatroban suppliers further got it approved to be sold for use during percutaneous coronary interventions in patients who have HIT or are at risk for developing it, with it finally being licenced in 2012 by the MHRA in the UK for sale on the medical marketplace for anticoagulation in patients with heparin-induced thrombocytopenia type II (HIT) who require parenteral antithrombotic therapy. Currently, it can be found for sale and wholesale at various price points by distributors on the global marketplace.

Method of action of argatroban:

Argatroban is a synthetic direct thrombin inhibitor derived from L-arginine indicated as an anticoagulant. Its anticoagulant nature is mediated by inhibiting thrombin-catalysed or through inducing reactions such as fibrin formation. Which involves the activation of coagulation factors V, VIII, and XIII, as well as protein C, and platelet aggregation. This effect is highly selective for thrombin and at therapeutic concentrations, it does not have any effect on related serine proteases including trypsin, factor Xa, plasmin, and kallikrein. As such, argatroban can inhibit the action of both free and clot associated thrombin, making it effective in its designed treatments.

Form and dosage of argatroban:

As with all drugs, the final packaging is dependent on both the manufacturers and suppliers. However, argatroban is typically produced by manufacturers and sold by distributors in forms including vials, solution for infusions, and concentrate for solution. This prescribed medication is predominantly administered by way of a continuous intravenous infusion, which can only be prescribed by a medical professional. Recommended doses differ based on the patient and the underlying cause of treatment. Typical regimens consist of an initial 2 micrograms/kg/minute, with it being increased according to activated partial thromboplastin time, up to 10 micrograms/kg/minute for a maximum duration of 14 days.

Argatroban on Pipelinepharma:

Currently, at the time of writing, we could not find any argatroban manufacturers or argatroban suppliers from our online global list of trusted B2B wholesale distributors. This list is constantly being updated with the most current and relevant information. Each company listed on our online platform has been verified, in a time consuming and cost intensive manner, according to strict quality control by the Pipelinepharma team. As such, it is likely that argatroban manufacturers and argatroban suppliers are awaiting approval and will be listed soon.

Price of argatroban and how to buy:

Although argatroban is not currently available to order through our online pharmaceutical products B2B platform, this is subject to change at any moment, contingent on the verification of trusted suppliers. When a listing is published by a seller it will appear with either a ‘Get offer’ button or an ‘Accept’ and ‘Negotiate’ button. ‘Accept’ and ‘Negotiate’ will only appear if the manufacturers have provided the desired cost for their product. This streamlines the transaction process, providing a baseline for negotiations and expectations.

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