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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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V. ROAD","city":"MUMBAI,MAHARASHTRA.","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"UNICHEM LABORATORIES LTD","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"360","totalValueFC":"3672.3","currency":"USD","unitRateINR":"31554","date":"30-Jun-2025","totalValueINR":"315540","totalValueInUsd":"3672.3","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"2968380","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"XUNQIAO, LINHAI, ZHEJIANG 317024, C HINA , , China SDNF China","customerAddress":"UNICHEM BHAVAN, S. V. ROAD"}]
    07-Jan-2022
    30-Jun-2025
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    Drugs in Development

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    Breckenridge Announces Tentative Approval of its ANDA for Dabigatran Etexilate Capsules (generic for Pradaxa®)

    Details:

    Dabigatran Etexilate Capsules (generic for Pradaxa®), is good at preventing blood clots that can cause a stroke or heart attack, but it can be very expensive and must be used carefully in patients with kidney problems.


    Lead Product(s): Dabigatran Etexilate Mesylate

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Dabigatran Etexilate-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 22, 2022

    Breckenridge Pharmaceutical

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    Breckenridge Pharmaceutical

    U.S.A
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    Lead Product(s) : Dabigatran Etexilate Mesylate

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Breckenridge Announces Tentative Approval of its ANDA for Dabigatran Etexilate Capsules (generic f...

    Details : Dabigatran Etexilate Capsules (generic for Pradaxa®), is good at preventing blood clots that can cause a stroke or heart attack, but it can be very expensive and must be used carefully in patients with kidney problems.

    Product Name : Dabigatran Etexilate-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    April 22, 2022

    Breckenridge Pharmaceutical

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    Alembic Gets USFDA Nod for Generic Medication

    Details:

    Dabigatran etexilate mesylate is an approved direct thrombin inhibitor, which is indicated for deep vein thrombosis and pulmonary embolism.


    Lead Product(s): Dabigatran Etexilate Mesylate

    Therapeutic Area: Hematology Brand Name: Pradaxa-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 13, 2024

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    Alembic Pharmaceuticals Limited

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    Lead Product(s) : Dabigatran Etexilate Mesylate

    Therapeutic Area : Hematology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Alembic Gets USFDA Nod for Generic Medication

    Details : Dabigatran etexilate mesylate is an approved direct thrombin inhibitor, which is indicated for deep vein thrombosis and pulmonary embolism.

    Product Name : Pradaxa-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    August 13, 2024

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    Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules

    Details:

    Pradaxa-Generic (dabigatran etexilate) is a USFDA approved direct thrombin inhibitor, which is indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation.


    Lead Product(s): Dabigatran Etexilate Mesylate

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Pradaxa-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 19, 2024

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    03

    Alembic Pharmaceuticals Limited

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    Lead Product(s) : Dabigatran Etexilate Mesylate

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Alembic Pharmaceuticals gets USFDA final approval for Dabigatran Etexilate capsules

    Details : Pradaxa-Generic (dabigatran etexilate) is a USFDA approved direct thrombin inhibitor, which is indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation.

    Product Name : Pradaxa-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    June 19, 2024

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    Alembic Pharmaceuticals announces USFDA Tentative Approval for Dabigatran Etexilate Capsules, 150 mg.

    Details:

    Dabigatran etexilate reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5 to 10 days


    Lead Product(s): Dabigatran Etexilate Mesylate

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Pradaxa-Generic

    Study Phase: Approved FDFProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 23, 2021

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    Alembic Pharmaceuticals Limited

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    Lead Product(s) : Dabigatran Etexilate Mesylate

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Alembic Pharmaceuticals announces USFDA Tentative Approval for Dabigatran Etexilate Capsules, 150 ...

    Details : Dabigatran etexilate reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagul...

    Product Name : Pradaxa-Generic

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    November 23, 2021

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    Boehringer Ingelheim Gets Positive CHMP Opinion for Use of Pradaxa® to Treat venous thromboembolic events in Newsborns and Adults

    Details:

    Positive opinion is based on a dedicated clinical pediatric program for dabigatran, including the DIVERSITY study,2 which supplements dabigatran's established and well-documented safety and efficacy profile in adults


    Lead Product(s): Dabigatran Etexilate Mesylate

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Pradaxa

    Study Phase: Phase II/ Phase IIIProduct Type: Other Small Molecule

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable November 16, 2020

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    Boehringer Ingelheim GmbH

    Germany
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    Lead Product(s) : Dabigatran Etexilate Mesylate

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase II/ Phase III

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Boehringer Ingelheim Gets Positive CHMP Opinion for Use of Pradaxa® to Treat venous thromboemboli...

    Details : Positive opinion is based on a dedicated clinical pediatric program for dabigatran, including the DIVERSITY study,2 which supplements dabigatran's established and well-documented safety and efficacy profile in adults

    Product Name : Pradaxa

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    November 16, 2020

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    INTERMEDIATE SUPPLIERS

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    Shanghai Minbiotech

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    Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

    N-(4-Cyano-Phenyl)-Glycine

    CAS Number : 42288-26-6

    End Use API : Dabigatran Etexilate Mesylate

    About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

    Shanghai Minbiotech CB

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    Shanghai Minbiotech

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    4-Methylamino-3-nitro benzoic acid

    CAS Number : 41263-74-5

    End Use API : Dabigatran Etexilate Mesylate

    About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

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    Shanghai Minbiotech

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    N-Ethyl 3-(pyridin-2-ylamino)propanoate

    CAS Number : 103041-38-9

    End Use API : Dabigatran Etexilate Mesylate

    About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

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    Shanghai Minbiotech

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    ethyl N-[3-amino-4- (methylamino)benzoyl]-N- pyrid...

    CAS Number : 212322-56-0

    End Use API : Dabigatran Etexilate Mesylate

    About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

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    Shanghai Minbiotech

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    N-(4-cyanophenyl)-Glycine

    CAS Number : 42288-26-6

    End Use API : Dabigatran Etexilate Mesylate

    About The Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...

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    Sichuan Qingmu Pharmaceutical

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    4-Aminobenzamidine dihydrochloride

    CAS Number : 2498-50-2

    End Use API : Dabigatran Etexilate Mesylate

    About The Company : Sichuan Qingmu Pharmaceutical Co., Ltd. is an innovation-driven pharmaceutical company focused on regulated markets. We specialize in the R&D and manufacturing ...

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    Actis Generics Pvt Ltd

    India
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    N-(4-Cyanophenyl)glycine(or) 2-(4-Cyanophenylamino...

    CAS Number : 42288-26-6

    End Use API : Dabigatran Etexilate Mesylate

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    3-[(3-Amino-4-methylaminobenzoyl)pyridin-2-ylamino...

    CAS Number : 212322-56-0

    End Use API : Dabigatran Etexilate Mesylate

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    3-Amino-4-(Methylamino)-Benzoic Acid

    CAS Number : 66315-15-9

    End Use API : Dabigatran Etexilate Mesylate

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    Ethyl 3-(pyridin-2-ylamino) propanoate

    CAS Number : 103041-38-9

    End Use API : Dabigatran Etexilate Mesylate

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - CAPSULE;ORAL - EQ 110MG BASE

    USFDA APPLICATION NUMBER - 22512

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    DOSAGE - CAPSULE;ORAL - EQ 150MG BASE

    USFDA APPLICATION NUMBER - 22512

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    DOSAGE - CAPSULE;ORAL - EQ 75MG 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

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    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.

    Dabigatran Manufacturers

    A Dabigatran manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dabigatran, including repackagers and relabelers. The FDA regulates Dabigatran manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dabigatran 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 Dabigatran manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Dabigatran Suppliers

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

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

    Dabigatran USDMF

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

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

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

    Dabigatran KDMF

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

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

    After submitting a Dabigatran 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 Dabigatran API can apply through the Korea Drug Master File (KDMF).

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

    Dabigatran CEP

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

    A Dabigatran CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dabigatran 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 Dabigatran suppliers with CEP (COS) on PharmaCompass.

    Dabigatran WC

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

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

    Dabigatran 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 Dabigatran as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Dabigatran 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 Dabigatran 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 Dabigatran and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dabigatran NDC to their finished compounded human drug products, they may choose to do so.

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

    Dabigatran GMP

    Dabigatran 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 Dabigatran 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 Dabigatran GMP manufacturer or Dabigatran GMP API supplier for your needs.

    Dabigatran CoA

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

    Dabigatran CoA mostly includes findings from lab analyses of a specific batch. For each Dabigatran 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.

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