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Bivalirudin bulk supplier for pharma manufacturers

Bivalirudin 250 mg Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 250 mg

Reference Brands: Angiomax (USA)

Category: Anaesthetics

Bivalirudin is a Anaesthetics product available as Injection in strengths 250 mg. It corresponds to the reference brand Angiomax (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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📘 Sourcing Guide

Product Description:

Bivalirudin is a direct thrombin inhibitor widely used in the management of patients undergoing percutaneous coronary intervention (PCI), particularly in cases of acute myocardial infarction. It plays a critical role in preventing thrombus formation during interventional cardiac procedures by providing rapid, predictable, and controllable anticoagulation. In addition to its established use in PCI, bivalirudin has broader clinical applications, including the management of thromboembolic disorders, cardiopulmonary bypass procedures, and extracorporeal membrane oxygenation, where precise anticoagulant control is essential.

Chemically, bivalirudin is a short, synthetic peptide derived from hirudin, a naturally occurring anticoagulant found in the saliva of the medicinal leech Hirudo medicinalis. It acts by directly and reversibly binding to thrombin, inhibiting both circulating and clot-bound thrombin, as well as thrombin-mediated platelet activation and aggregation. Unlike indirect thrombin inhibitors such as heparin, bivalirudin does not require antithrombin as a cofactor, does not bind to plasma proteins or red blood cells, and does not activate platelets.

Bivalirudin has a rapid onset of action and a short half-life, resulting in a predictable antithrombotic response. Importantly, it carries no risk of heparin-induced thrombocytopenia, making it a reliable alternative to heparin in high-risk patients.

Bivalirudin — third party manufacturing & bulk supply

Bivalirudin 250 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Bivalirudin listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Frequently Asked Questions


Bivalirudin is used as an anticoagulant to reduce the risk of blood clot formation during percutaneous coronary intervention and other interventional cardiac procedures. It is commonly administered in patients with unstable angina or myocardial infarction undergoing angioplasty and is particularly useful in patients with or at risk of heparin-induced thrombocytopenia.


Bivalirudin is a synthetic peptide composed of 20 amino acids. It is specifically designed to bind directly to thrombin, inhibiting its activity without requiring cofactors such as antithrombin III.


Bivalirudin is marketed under the trade names Angiomax in the United States and Angiox in the European Union and the United Kingdom.


Bivalirudin is manufactured by multiple pharmaceutical companies worldwide, including originator and generic injectable manufacturers that supply hospital and regulated markets, depending on regional approvals.


The generic name of the product is bivalirudin.


The well-known brand names of bivalirudin include Angiomax and Angiox.


Bivalirudin is manufactured in several countries, including the United States, India, and various European countries, by GMP-compliant pharmaceutical manufacturers supplying injectable formulations for hospital use.

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