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    Chemistry

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    Also known as: Dabigatran etexilate mesylate, 872728-81-9, Pradaxa, Ethyl 3-[[2-[[4-[(z)-n'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic acid, Dtxsid20236248, Ex-a1966
    Molecular Formula
    C35H45N7O8S
    Molecular Weight
    723.8  g/mol
    InChI Key
    XETBXHPXHHOLOE-UHFFFAOYSA-N
    Dabigatran Etexilate Mesylate
    A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation.
    1 2D Structure

    Dabigatran Etexilate Mesylate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    ethyl 3-[[2-[[4-[(Z)-N'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic acid
    2.1.2 InChI
    InChI=1S/C34H41N7O5.CH4O3S/c1-4-6-7-10-21-46-34(44)39-32(35)24-12-15-26(16-13-24)37-23-30-38-27-22-25(14-17-28(27)40(30)3)33(43)41(20-18-31(42)45-5-2)29-11-8-9-19-36-29;1-5(2,3)4/h8-9,11-17,19,22,37H,4-7,10,18,20-21,23H2,1-3H3,(H2,35,39,44);1H3,(H,2,3,4)
    2.1.3 InChI Key
    XETBXHPXHHOLOE-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCCCCCOC(=O)N=C(C1=CC=C(C=C1)NCC2=NC3=C(N2C)C=CC(=C3)C(=O)N(CCC(=O)OCC)C4=CC=CC=N4)N.CS(=O)(=O)O
    2.1.5 Isomeric SMILES
    CCCCCCOC(=O)/N=C(/C1=CC=C(C=C1)NCC2=NC3=C(N2C)C=CC(=C3)C(=O)N(CCC(=O)OCC)C4=CC=CC=N4)\N.CS(=O)(=O)O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Bibr 1048

    2. Dabigatran

    3. Dabigatran Etexilate

    4. Dabigatran Etexilate Mesylate

    5. Etexilate Mesylate, Dabigatran

    6. Etexilate, Dabigatran

    7. Mesylate, Dabigatran Etexilate

    8. N-((2-(((4-(aminoiminomethyl)phenyl)amino)methyl)-1-methyl-1h-benzimidazol-5-yl)carbonyl)-n-2-pyridinyl-beta-alanine

    9. Pradaxa

    2.2.2 Depositor-Supplied Synonyms

    1. Dabigatran Etexilate Mesylate

    2. 872728-81-9

    3. Pradaxa

    4. Ethyl 3-[[2-[[4-[(z)-n'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic Acid

    5. Dtxsid20236248

    6. Ex-a1966

    7. Mfcd25424070

    8. S5960

    9. Ccg-213236

    10. Cs-w004358

    11. (z)-ethyl 3-(2-(((4-(n'-((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-n-(pyridin-2-yl)-1h-benzo[d]imidazole-5-carboxamido)propanoate Methanesulfonate

    12. 728p819

    2.3 Create Date
    2006-10-26
    3 Chemical and Physical Properties
    Molecular Weight 723.8 g/mol
    Molecular Formula C35H45N7O8S
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count11
    Rotatable Bond Count17
    Exact Mass723.30503259 g/mol
    Monoisotopic Mass723.30503259 g/mol
    Topological Polar Surface Area217 Ų
    Heavy Atom Count51
    Formal Charge0
    Complexity1100
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NamePradaxa
    PubMed HealthDabigatran (By mouth)
    Drug ClassesAnticoagulant
    Drug LabelThe chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is -Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfo...
    Active IngredientDabigatran etexilate mesylate
    Dosage FormCapsule
    RouteOral
    Strengtheq 150mg base; eq 75mg base
    Market StatusPrescription
    CompanyBoehringer Ingelheim

    2 of 2  
    Drug NamePradaxa
    PubMed HealthDabigatran (By mouth)
    Drug ClassesAnticoagulant
    Drug LabelThe chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is -Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfo...
    Active IngredientDabigatran etexilate mesylate
    Dosage FormCapsule
    RouteOral
    Strengtheq 150mg base; eq 75mg base
    Market StatusPrescription
    CompanyBoehringer Ingelheim

    4.2 Drug Indication

    Pradaxa 75 mg

    - Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

    Pradaxa 110 mg

    - Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

    - Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age 75 years; heart failure (NYHA Class II); diabetes mellitus; hypertension.

    - Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

    Pradaxa 150 mg

    - Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age 75 years; heart failure (NYHA Class II); diabetes mellitus; hypertension.

    - Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Antithrombins

    Endogenous factors and drugs that directly inhibit the action of THROMBIN, usually by blocking its enzymatic activity. They are distinguished from INDIRECT THROMBIN INHIBITORS, such as HEPARIN, which act by enhancing the inhibitory effects of antithrombins. (See all compounds classified as Antithrombins.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Thrombin Inhibitors [MoA]; Direct Thrombin Inhibitor [EPC]
    5.3 ATC Code

    B01AE07

    API Reference Price

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    07-Jan-2022
    30-Jun-2025
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    DOSAGE - CAPSULE;ORAL - EQ 110MG BASE

    USFDA APPLICATION NUMBER - 22512

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    ABOUT THIS PAGE

    Looking for 872728-81-9 / Dabigatran Etexilate Mesylate API manufacturers, exporters & distributors?

    Dabigatran Etexilate Mesylate manufacturers, exporters & distributors 1

    14

    PharmaCompass offers a list of Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate manufacturer or Dabigatran Etexilate Mesylate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dabigatran Etexilate Mesylate manufacturer or Dabigatran Etexilate Mesylate supplier.

    PharmaCompass also assists you with knowing the Dabigatran Etexilate Mesylate API Price utilized in the formulation of products. Dabigatran Etexilate Mesylate API Price is not always fixed or binding as the Dabigatran Etexilate Mesylate Price is obtained through a variety of data sources. The Dabigatran Etexilate Mesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Dabigatran Etexilate Mesylate

    Synonyms

    872728-81-9, Pradaxa, Ethyl 3-[[2-[[4-[(z)-n'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic acid, Dtxsid20236248, Ex-a1966, Mfcd25424070

    Cas Number

    872728-81-9

    About Dabigatran Etexilate Mesylate

    A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation.

    Pradaxa Manufacturers

    A Pradaxa manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pradaxa, including repackagers and relabelers. The FDA regulates Pradaxa manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pradaxa API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Pradaxa manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Pradaxa Suppliers

    A Pradaxa supplier is an individual or a company that provides Pradaxa active pharmaceutical ingredient (API) or Pradaxa finished formulations upon request. The Pradaxa suppliers may include Pradaxa API manufacturers, exporters, distributors and traders.

    click here to find a list of Pradaxa suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Pradaxa USDMF

    A Pradaxa DMF (Drug Master File) is a document detailing the whole manufacturing process of Pradaxa active pharmaceutical ingredient (API) in detail. Different forms of Pradaxa DMFs exist exist since differing nations have different regulations, such as Pradaxa USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Pradaxa DMF submitted to regulatory agencies in the US is known as a USDMF. Pradaxa USDMF includes data on Pradaxa's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pradaxa USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Pradaxa suppliers with USDMF on PharmaCompass.

    Pradaxa KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Pradaxa Drug Master File in Korea (Pradaxa KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pradaxa. The MFDS reviews the Pradaxa KDMF as part of the drug registration process and uses the information provided in the Pradaxa KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Pradaxa KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Pradaxa API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Pradaxa suppliers with KDMF on PharmaCompass.

    Pradaxa CEP

    A Pradaxa CEP of the European Pharmacopoeia monograph is often referred to as a Pradaxa Certificate of Suitability (COS). The purpose of a Pradaxa CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pradaxa EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pradaxa to their clients by showing that a Pradaxa CEP has been issued for it. The manufacturer submits a Pradaxa CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pradaxa CEP holder for the record. Additionally, the data presented in the Pradaxa CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pradaxa DMF.

    A Pradaxa CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pradaxa CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Pradaxa suppliers with CEP (COS) on PharmaCompass.

    Pradaxa WC

    A Pradaxa written confirmation (Pradaxa WC) is an official document issued by a regulatory agency to a Pradaxa manufacturer, verifying that the manufacturing facility of a Pradaxa active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pradaxa APIs or Pradaxa finished pharmaceutical products to another nation, regulatory agencies frequently require a Pradaxa WC (written confirmation) as part of the regulatory process.

    click here to find a list of Pradaxa suppliers with Written Confirmation (WC) on PharmaCompass.

    Pradaxa NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Pradaxa as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Pradaxa API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Pradaxa as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Pradaxa and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pradaxa NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Pradaxa suppliers with NDC on PharmaCompass.

    Pradaxa GMP

    Pradaxa Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Pradaxa GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Pradaxa GMP manufacturer or Pradaxa GMP API supplier for your needs.

    Pradaxa CoA

    A Pradaxa CoA (Certificate of Analysis) is a formal document that attests to Pradaxa's compliance with Pradaxa specifications and serves as a tool for batch-level quality control.

    Pradaxa CoA mostly includes findings from lab analyses of a specific batch. For each Pradaxa CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Pradaxa may be tested according to a variety of international standards, such as European Pharmacopoeia (Pradaxa EP), Pradaxa JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pradaxa USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    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.
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