Bivalirudin is a 20 amino acid long synthetic peptide with thrombin-specific anticoagulant properties. Bivalirudin reversibly binds thrombin, free as well as clot bound, at the catalytic site and the anion-binding exosite, thereby preventing the formation and activation of fibrin, factor XIIIa, and other coagulation factors. This drug is primarily used during coronary angioplasty procedures, in combination with aspirin, in patients with unstable angina.
API | Excipient name: Bivalirudin
Synonyms: 128270-60-0, Angiomax, Bivalirudin trifluoroacetate, Bg-8967, Bg8967, Hirulog
Cas Number: 128270-60-0
A Bivalirudin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bivalirudin, including repackagers and relabelers. The FDA regulates Bivalirudin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bivalirudin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Bivalirudin supplier is an individual or a company that provides Bivalirudin active pharmaceutical ingredient (API) or Bivalirudin finished formulations upon request. The Bivalirudin suppliers may include Bivalirudin API manufacturers, exporters, distributors and traders.
A Bivalirudin DMF (Drug Master File) is a document detailing the whole manufacturing process of Bivalirudin active pharmaceutical ingredient (API) in detail. Different forms of Bivalirudin DMFs exist exist since differing nations have different regulations, such as Bivalirudin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bivalirudin DMF submitted to regulatory agencies in the US is known as a USDMF. Bivalirudin USDMF includes data on Bivalirudin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bivalirudin USDMF is kept confidential to protect the manufacturer’s intellectual property.
We have 12 companies offering Bivalirudin
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For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
Looking for 128270-60-0 / Bivalirudin API manufacturers, exporters & distributors? PharmaCompass offers a list of Bivalirudin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Bivalirudin manufacturer or Bivalirudin supplier for your needs.
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PharmaCompass also assists you with knowing the Bivalirudin API Price utilized in the formulation of products. Bivalirudin API Price is not always fixed or binding as the Bivalirudin Price is obtained through a variety of data sources. The Bivalirudin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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