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    Chemistry

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    Also known as: 480449-70-5, 912273-65-5, Du-176, Du-176b, Ndu3j18apo, N1-(5-chloropyridin-2-yl)-n2-((1s,2r,4s)-4-(dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl)oxalamide
    Molecular Formula
    C24H30ClN7O4S
    Molecular Weight
    548.1  g/mol
    InChI Key
    HGVDHZBSSITLCT-JLJPHGGASA-N
    FDA UNII
    NDU3J18APO
    Edoxaban Tosylate
    Edoxaban is an orally active inhibitor of coagulation factor Xa (activated factor X) with anticoagulant activity. Edoxaban is administered as edoxaban tosylate. This agent has an elimination half-life of 9-11 hours and undergoes renal excretion.
    Edoxaban is a Factor Xa Inhibitor. The mechanism of action of edoxaban is as a Factor Xa Inhibitor.
    1 2D Structure

    Edoxaban Tosylate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N'-(5-chloropyridin-2-yl)-N-[(1S,2R,4S)-4-(dimethylcarbamoyl)-2-[(5-methyl-6,7-dihydro-4H-[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl]oxamide
    2.1.2 InChI
    InChI=1S/C24H30ClN7O4S/c1-31(2)24(36)13-4-6-15(27-20(33)21(34)30-19-7-5-14(25)11-26-19)17(10-13)28-22(35)23-29-16-8-9-32(3)12-18(16)37-23/h5,7,11,13,15,17H,4,6,8-10,12H2,1-3H3,(H,27,33)(H,28,35)(H,26,30,34)/t13-,15-,17+/m0/s1
    2.1.3 InChI Key
    HGVDHZBSSITLCT-JLJPHGGASA-N
    2.1.4 Canonical SMILES
    CN1CCC2=C(C1)SC(=N2)C(=O)NC3CC(CCC3NC(=O)C(=O)NC4=NC=C(C=C4)Cl)C(=O)N(C)C
    2.1.5 Isomeric SMILES
    CN1CCC2=C(C1)SC(=N2)C(=O)N[C@@H]3C[C@H](CC[C@@H]3NC(=O)C(=O)NC4=NC=C(C=C4)Cl)C(=O)N(C)C
    2.2 Other Identifiers
    2.2.1 UNII
    NDU3J18APO
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Du-176

    2. Du-176b

    3. Edoxaban Tosylate

    4. N-(5-chloropyridin-2-yl)-n'-((1s,2r,4s)-4-(n,n-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7- Tetrahydro(1,3)thiazolo(5,4-c)pyridine-2-carboxamido)cyclohexyl)oxamide

    5. N-(5-chloropyridin-2-yl)-n'-((1s,2r,4s)-4-(n,n-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo(5,4-c)pyridine-2-carboxamido)cyclohexyl)ethanediamide P-toluenesulfonate Monohydrate

    6. Savaysa

    2.3.2 Depositor-Supplied Synonyms

    1. 480449-70-5

    2. 912273-65-5

    3. Du-176

    4. Du-176b

    5. Ndu3j18apo

    6. N1-(5-chloropyridin-2-yl)-n2-((1s,2r,4s)-4-(dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl)oxalamide

    7. Chembl1269025

    8. Chebi:85973

    9. 480449-70-5 (free Base)

    10. N-(5-chloropyridin-2-yl)-n'-((1s,2r,4s)-4-(n,n-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7- Tetrahydro(1,3)thiazolo(5,4-c)pyridine-2-carboxamido)cyclohexyl)oxamide

    11. Edoxaban [usan]

    12. Ethanediamide, N1-(5-chloro-2-pyridinyl)-n2-((1s,2r,4s)-4- ((dimethylamino)carbonyl)- 2-(((4,5,6,7-tetrahydro-5-methylthiazolo(5,4-c)pyridin-2-yl)carbonyl)amino)cyclohexyl)-

    13. Edoxaban [usan:inn]

    14. Unii-ndu3j18apo

    15. Edoxaban (usan/inn)

    16. Edoxaban [inn]

    17. Edoxaban [mi]

    18. Edoxaban [mart.]

    19. Edoxaban [who-dd]

    20. Schembl330046

    21. Amy508

    22. Gtpl7575

    23. Hsdb 8406

    24. Dtxsid50197398

    25. Ex-a5582

    26. Bdbm50328731

    27. Mfcd13195544

    28. S4429

    29. Zinc43200832

    30. Akos005146069

    31. Cs-1331

    32. Db09075

    33. Ncgc00378907-01

    34. Ncgc00378907-02

    35. Ncgc00378907-03

    36. Ac-35419

    37. As-35107

    38. Hy-10264

    39. N-(5-chloro-2-pyridinyl)-n'-[(1s,2r,4s)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]ethanediamide

    40. D09710

    41. 449e705

    42. A860576

    43. Q21011234

    44. N'-(5-chloropyridin-2-yl)-n-[(1s,2r,4s)-4-(dimethylcarbamoyl)-2-[(5-methyl-6,7-dihydro-4h-[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl]oxamide

    45. N'-(5-chloropyridin-2-yl)-n-[(1s,2r,4s)-4-(dimethylcarbamoyl)-2-[(5-methyl6,7-dihydro-4h-[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl]oxamide

    46. N(1)-(5-chloropyridin-2-yl)-n(2)-{(1s,2r,4s)-4-(dimethylcarbamoyl)-2-[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl}ethanediamide

    47. N-(5-chloro-2-pyridinyl)-n'-[4-(dimethylcarbamoyl)-2-{[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl]ethanediamide;

    48. N-(5-chloropyridin-2-yl)-n'-[(1s,2r,4s)-4-(dimethylcarbamoyl)-2-[(5-methyl-6,7-dihydro-4h-[1,3]thiazolo[5,4-c]pyridine-2-carbonyl)amino]cyclohexyl]oxamide

    49. N-(5-chloropyridin-2-yl)-n'-[(1s,2r,4s)-4-(dimethylcarbamoyl)-2-{[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl]ethanediamide

    50. N1-(5-chloropyridin-2-yl)-n2-((1s,2r,4s)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5, 6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl) Ethanediamide

    51. N1-(5-chloropyridin-2-yl)-n2-((1s,2r,4s)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide

    52. N1-(5-chloropyridin-2-yl)-n2-[(1s,2r,4s)-4-(dimethylcarbamoyl)-2-{[(5-methyl-4,5,6,7-tetrahydro[1,3]thiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl]ethanediamide

    2.3.3 Other Synonyms

    1. Edoxaban (tosylate)

    2. Edoxaban Tsoh Salt

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 548.1 g/mol
    Molecular Formula C24H30ClN7O4S
    XLogP31.4
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count5
    Exact Mass547.1768513 g/mol
    Monoisotopic Mass547.1768513 g/mol
    Topological Polar Surface Area165 Ų
    Heavy Atom Count37
    Formal Charge0
    Complexity880
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    Factor Xa Inhibitors

    National Library of Medicine's Medical Subject Headings. Edoxaban. Online file (MeSH, 2018). Available from, as of March 7, 2018: https://meshb.nlm.nih.gov/search

    /CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Edoxaban is included in the database.

    NIH/NLM; ClinicalTrials.Gov. Available from, as of March 7, 2018: https://clinicaltrials.gov/

    Savaysa is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). /Included in US product label/

    NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

    Savaysa is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

    For more Therapeutic Uses (Complete) data for Edoxaban (7 total), please visit the HSDB record page.

    4.2 Drug Warning

    /BOXED WARNING/ REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS WITH CRCL > 95 ML/MIN. Savaysa should not be used in patients with CrCL > 95 mL/min. In the ENGAGE AF-TIMI 48 study, nonvalvular atrial fibrillation patients with CrCL > 95 mL/min had an increased rate of ischemic stroke with Savaysa 60 mg once daily compared to patients treated with warfarin. In these patients another anticoagulant should be used.

    NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

    /BOXED WARNING/ PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS. Premature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk of ischemic events. If Savaysa is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant as described in the transition guidance.

    NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

    /BOXED WARNING/ SPINAL/EPIDURAL HEMATOMA. Epidural or spinal hematomas may occur in patients treated with Savaysa who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters; concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants; a history of traumatic or repeated epidural or spinal punctures; a history of spinal deformity or spinal surgery; optimal timing between the administration of Savaysa and neuraxial procedures is not known. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessar. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.

    NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

    Safety and efficacy of edoxaban have not been evaluated in patients with mechanical heart valves or moderate to severe mitral stenosis; use of the drug is not recommended in such patients.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 1639

    For more Drug Warnings (Complete) data for Edoxaban (18 total), please visit the HSDB record page.

    4.3 Drug Indication

    Edoxaban is indicated for reducing the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). However, it should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg). It is also indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5-10 days of initial therapy with a parenteral anticoagulant.

    FDA Label

    Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).

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

    Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).

    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 Pharmacology

    Administration of edoxaban results in prolongation of clotting time tests such as aPTT (activated partial thromboplastin time), PT (prothrombin time), and INR (international normalized ratio).

    5.2 MeSH Pharmacological Classification

    Factor Xa Inhibitors

    Endogenous factors and drugs that inhibit or block the activity of FACTOR XA. (See all compounds classified as Factor Xa Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    EDOXABAN
    5.3.2 FDA UNII
    NDU3J18APO
    5.3.3 Pharmacological Classes
    Mechanisms of Action [MoA] - Factor Xa Inhibitors
    5.4 ATC Code

    B01

    B01AF03

    B - Blood and blood forming organs

    B01 - Antithrombotic agents

    B01A - Antithrombotic agents

    B01AF - Direct factor xa inhibitors

    B01AF03 - Edoxaban

    5.5 Absorption, Distribution and Excretion

    Absorption

    Following oral administration, peak plasma edoxaban concentrations are observed within 1-2 hours. Absolute bioavailability is 62%.

    Route of Elimination

    Edoxaban is eliminated primarily as unchanged drug in urine. Renal clearance (11 L/hour) accounts for approximately 50% of the total clearance of edoxaban (22 L/hour). Metabolism and biliary/intestinal excretion account for the remaining clearance.

    Volume of Distribution

    The steady state volume of distribution is 107 L.

    Clearance

    22 L/hr

    /MILK/ There are no data on the presence of edoxaban in human milk ... . Edoxaban was present in rat milk. ...

    NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

    Disposition is biphasic. The steady-state volume of distribution (Vdss) is 107 (19.9) L (mean (SD)). In vitro plasma protein binding is approximately 55%. There is no clinically relevant accumulation of edoxaban (accumulation ratio 1.14) with once daily dosing.

    NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

    Administration of a crushed 60 mg tablet, either mixed into applesauce or suspended in water and given through a nasogastric tube, showed similar exposure compared to administration of an intact tablet.

    NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

    Edoxaban is eliminated primarily as unchanged drug in the urine. Renal clearance (11 L/hour) accounts for approximately 50% of the total clearance of edoxaban (22 L/hour). Metabolism and biliary/intestinal excretion account for the remaining clearance.

    NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

    Following oral administration, peak plasma edoxaban concentrations are observed within 1-2 hours. Absolute bioavailability is 62%. Food does not affect total systemic exposure to edoxaban. Savaysa was administered with or without food in the ENGAGE AF-TIMI 48 and Hokusai VTE trials.

    NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

    5.6 Metabolism/Metabolites

    Edoxaban is not extensively metabolized by CYP3A4 resulting in minimal drug-drug interactions. However, it does interact with drugs that inhibit p-gp (p-glycoprotein), which is used to transport edoxaban across the intestinal wall. Unchanged edoxaban is the predominant form in plasma. There is minimal metabolism via hydrolysis (mediated by carboxylesterase 1), conjugation, and oxidation by CYP3A4. The predominant metabolite M-4, formed by hydrolysis, is human-specific and active and reaches less than 10% of the exposure of the parent compound in healthy subjects. Exposure to the other metabolites is less than 5% of exposure to edoxaban.

    ... All subjects received a single oral 60 mg edoxaban dose in period 1, and 7 days of 600 mg rifampin (2 x 300 mg capsules once daily) with a single oral edoxaban 60 mg dose administered concomitantly on day 7 in period 2. A 6-day washout period separated the treatments. Plasma concentrations of edoxaban and its metabolites M4 and M6 were measured, and limited assessments of pharmacodynamic markers of coagulation were performed. In total, 34 healthy subjects were enrolled; 32 completed the study. Coadministration of rifampin with edoxaban decreased edoxaban exposure but increased active metabolite exposure. Rifampin increased apparent oral clearance of edoxaban by 33% and decreased its half-life by 50%. Anticoagulant effects based on the prothrombin time (PT) and the activated partial thromboplastin time (aPTT) with and without rifampin at early time points were maintained to a greater-than-expected degree than with edoxaban exposure alone, presumably because of an increased contribution from the active metabolites. Edoxaban was well tolerated in this healthy adult population. Rifampin reduced exposure to edoxaban while increasing exposure to its active metabolites M4 and M6. PT and aPTT at early time points did not change appreciably; however, the data should be interpreted with caution.

    PMID:26068927 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4488474 Mendell J et al; Clin Drug Investig 35 (7): 447-53 (2015)

    Edoxaban and its low-abundance, active metabolite M4 are substrates of P-glycoprotein (P-gp; MDR1) and organic anion transporter protein 1B1 (OATP1B1), respectively, and pharmacological inhibitors of P-gp and OATP1B1 can affect edoxaban and M4 pharmacokinetics (PK). In this integrated pharmacogenomic analysis, genotype and concentration-time data from 458 healthy volunteers in 14 completed phase 1 studies were pooled to examine the impact on edoxaban PK parameters of allelic variants of ABCB1 (rs1045642: C3435T) and SLCO1B1 (rs4149056: T521C), which encode for P-gp and OATP1B1. Although some pharmacologic inhibitors of P-gp and OATP1B1 increase edoxaban exposure, neither the ABCB1 C3435T nor the SLCO1B1 T521C polymorphism affected edoxaban PK. A slight elevation in M4 exposure was observed among SLCO1B1 C-allele carriers; however, this elevation is unlikely to be clinically significant as plasma M4 concentrations comprise <10% of total edoxaban levels.

    PMID:27897269 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5817390 Vandell AG et al; Pharmacogenomics J 18 (1): 153-159 (2018)

    The predominant metabolite M-4, formed by hydrolysis, is human-specific and active and reaches less than 10% of the exposure of the parent compound in healthy subjects. Exposure to the other metabolites is less than 5% of exposure to edoxaban.

    NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

    Unchanged edoxaban is the predominant form in plasma. There is minimal metabolism via hydrolysis (mediated by carboxylesterase 1), conjugation, and oxidation by CYP3A4.

    NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

    5.7 Biological Half-Life

    The terminal elimination half-life of edoxaban following oral administration is 10 to 14 hours.

    The terminal elimination half-life of edoxaban following oral administration is 10 to 14 hours.

    NIH; DailyMed. Current Medication Information for Savaysa (Edoxaban Tosylate) Tablet, Film-coated (Updated: November 6, 2017). Available from, as of March 22, 2018: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66

    5.8 Mechanism of Action

    Edoxaban is a selective inhibitor of factor Xa, a serine endopeptidase of the clotting cascade required for cleavage of prothrombin into thrombin.

    Edoxaban tosylate monohydrate, an oral, direct activated factor X (Xa) inhibitor, is an anticoagulant. Factor Xa plays a central role in the blood coagulation cascade by serving as the convergence point for the intrinsic and extrinsic pathways; inhibition of coagulation factor Xa by edoxaban prevents conversion of prothrombin to thrombin and subsequent thrombus formation. The drug binds directly and selectively to factor Xa without the need for a cofactor (e.g., antithrombin III), and inhibits both free and prothrombinase-bound factor Xa as well as thrombin-induced platelet aggregation.

    American Society of Health-System Pharmacists 2017; Drug Information 2017. Bethesda, MD. 2017, p. 1640

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    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38201

    Submission : 2023-03-24

    Status : Active

    Type : II

    AMI Lifesciences

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    02

    Metrochem Api Private Ltd

    India
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    CPhI North America
    Attending
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    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37896

    Submission : 2022-12-23

    Status : Active

    Type : II

    Metrochem

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    03

    Biophore India Pharmaceuticals Pvt L...

    India
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    Booth #1015
    • fda
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    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 42199

    Submission : 2025-07-01

    Status : Active

    Type : II

    Biophore

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    04

    Dr Reddys Laboratories Ltd

    India
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    CPhI North America
    Attending
    • fda
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    • WHO-GMP

    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 42061

    Submission : 2025-07-29

    Status : Active

    Type : II

    Dr Reddy Company Banner

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    05

    Honour Lab Ltd

    India
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    RDD
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    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2018-03-13

    Pay. Date : 2017-12-29

    DMF Number : 32401

    Submission : 2018-02-06

    Status : Active

    Type : II

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    06

    Daiichi Sankyo Co Ltd

    Japan

    USDMF

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    RDD
    Not Confirmed

    06

    Daiichi Sankyo Co Ltd

    Japan
    arrow
    RDD
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17162

    Submission : 2004-02-13

    Status : Inactive

    Type : II

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    07

    RDD
    Not Confirmed

    07

    Msn Life Sciences Private Ltd

    India
    arrow
    RDD
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32330

    Submission : 2017-12-30

    Status : Active

    Type : II

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    08

    Phospholipid Gmbh

    Germany

    USDMF

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    RDD
    Not Confirmed

    08

    Phospholipid Gmbh

    Germany
    arrow
    RDD
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15480

    Submission : 2001-06-11

    Status : Active

    Type : IV

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    09

    RDD
    Not Confirmed

    09

    Shanghai Desano Chemical Pharmaceuti...

    China
    arrow
    RDD
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-02-17

    Pay. Date : 2021-12-29

    DMF Number : 36062

    Submission : 2021-07-09

    Status : Active

    Type : II

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    10

    RDD
    Not Confirmed

    10

    Zhejiang Supor Pharmaceuticals Co Lt...

    China
    arrow
    RDD
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32963

    Submission : 2018-07-09

    Status : Active

    Type : II

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    NDC API

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    01

    Metrochem API Private Limited

    India
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    CPhI North America
    Attending
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    • EDQM
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    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    EDOXABAN TOSYLATE MONOHYDRATE

    NDC Package Code : 42765-063

    Start Marketing Date : 2023-07-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    Metrochem

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    02

    METROCHEM API PRIVATE LIMITED

    India
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    CPhI North America
    Attending
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    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    EDOXABAN TOSYLATE MONOHYDRATE

    NDC Package Code : 42765-056

    Start Marketing Date : 2023-01-24

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (10kg/10kg)

    Marketing Category : BULK INGREDIENT

    Metrochem

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    03

    Chunghwa Chemical Synthesis & Biote...

    Taiwan
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    CPhI China
    Exhibiting
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    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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    EDOXABAN TOSYLATE MONOHYDRATE

    NDC Package Code : 52076-6256

    Start Marketing Date : 2016-02-24

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    CCSB Company Banner

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    04

    Honour Lab Limited

    India
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    Not Confirmed
    • fda
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    Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

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    EDOXABAN TOSYLATE MONOHYDRATE

    NDC Package Code : 69037-0037

    Start Marketing Date : 2015-01-08

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    05

    Biocon Limited

    India
    RDD
    Not Confirmed
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    Biocon Limited

    India
    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    EDOXABAN TOSYLATE MONOHYDRATE

    NDC Package Code : 65727-113

    Start Marketing Date : 2026-02-27

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    06

    HIKAL LIMITED

    India
    RDD
    Not Confirmed
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    HIKAL LIMITED

    India
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    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    EDOXABAN TOSYLATE MONOHYDRATE

    NDC Package Code : 66651-932

    Start Marketing Date : 2024-10-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    07

    MSN Life Sciences Private Limited

    India
    RDD
    Not Confirmed
    arrow

    MSN Life Sciences Private Limited

    India
    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    EDOXABAN TOSYLATE MONOHYDRATE

    NDC Package Code : 69766-044

    Start Marketing Date : 2017-12-29

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    08

    Saptagir Laboratories Private Limit...

    India
    RDD
    Not Confirmed
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    Saptagir Laboratories Private Limit...

    India
    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Virtual Booth Virtual Booth
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    EDOXABAN TOSYLATE MONOHYDRATE

    NDC Package Code : 87009-0001

    Start Marketing Date : 2025-08-12

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    09

    Shanghai Desano Chemical Pharmaceut...

    China
    RDD
    Not Confirmed
    arrow

    Shanghai Desano Chemical Pharmaceut...

    China
    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    EDOXABAN TOSYLATE MONOHYDRATE

    NDC Package Code : 42931-267

    Start Marketing Date : 2022-02-21

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    10

    Viyash Life Sciences Private Limite...

    India
    RDD
    Not Confirmed
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    Viyash Life Sciences Private Limite...

    India
    arrow
    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    EDOXABAN TOSYLATE MONOHYDRATE

    NDC Package Code : 82245-0219

    Start Marketing Date : 2026-01-01

    End Marketing Date : 2027-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Listed Suppliers

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    01

    Ami Lifesciences Private Limited

    India
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    RDD
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothAMI Lifesciences is Driven by Chemistry. Powered by People.

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    Edoxaban Tosilate

    About the Company : Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory thera...

    Ami Lifesciences, established in 2006, is a rapidly growing API manufacturing company in India with strong capabilities in cardiovascular, anti-diabetic, CNS, and respiratory therapies. The company offers a diverse portfolio of APIs, intermediates, key starting materials, and contract bulk manufacturing services. Its advanced manufacturing facilities in Gujarat and Karnataka feature dedicated clean rooms and comply with EU-GMP, WHO-GMP, PMDA, and COFEPRIS standards. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    AMI Lifesciences

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    02

    Metrochem API Private Limited

    India
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    CPhI North America
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothMetrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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    Edoxaban Tosylate

    About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...

    Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
    Metrochem

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    03

    Biophore India Pharmaceuticals Pvt ...

    India
    arrow
    CPhI North America
    Booth #1015
    • fda
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    • WHO-GMP

    Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    Edoxaban Tosylate

    About the Company : Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&...

    Biophore, founded in 2007, develops and manufactures niche and complex pharmaceutical products. With USFDA- and EU-approved API facilities, a dedicated intermediates site and an R&D center of 400 scientists, the company is a leading global API player. Biophore ranks among the top US DMF filers, holds 150+ patents and maintains a strong compliance record with major regulatory agencies. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer.
    Biophore

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    04

    Neuland Laboratories

    India
    arrow
    TIDES USA
    Booth #1009
    • fda
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    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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    Edoxaban

    About the Company : Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compound...

    Neuland Laboratories, established in 1984 and headquartered in Hyderabad, is a publicly listed company offering solutions for pharmaceutical chemistry needs—from library compounds to NCEs and advanced intermediates. It manufactures APIs and intermediates in USFDA-approved facilities, applying advanced process chemistry in a regulatory-compliant environment for clinical and commercial stages. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Neuland

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    05

    LGM Pharma

    U.S.A
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    CPhI North America
    Booth #730
    • fda
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    • WHO-GMP

    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Edoxaban

    About the Company : LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product ...

    LGM Pharma is a global leader in sourcing APIs, including hard-to-find drug substances, for pharmaceutical and biotech industries. LGM also operates as a full-service drug product CDMO, offering formulation, analytical method development and testing, regulatory support, and commercial manufacturing. Supported by a network of over 220 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    LGM Pharma CB

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    06

    Rochem International Inc

    U.S.A
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    Sweets & Snacks Expo
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    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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    Edoxaban Tosylate

    About the Company : Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered i...

    Rochem, established in 1994, is a global distributor of pharmaceutical, food, nutritional, and animal health ingredients, sourcing high-quality products from China. Headquartered in Hauppauge, New York, it operates 16 offices worldwide. Rochem’s operations are fully cGMP compliant and have been audited by the USFDA and several multinational organizations. The company also trains and audits its partners to ensure FDA-compliant technologies and systems. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Rochem

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    07

    Cohance Lifesciences

    India
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    RDD
    Not Confirmed
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    • WHO-GMP

    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Edoxaban

    About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...

    Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expertise in complex chemistries, we provide end-to-end CDMO solutions to global innovators. As a global API player, we serve customers in nearly 60 countries with 80+ molecules, supported by robust R&D, regulatory capabilities, and advanced manufacturing infrastructure, including strong backward-integrated pellet manufacturing. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Cohance

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    08

    Dr. Reddy's Laboratories

    India
    arrow
    CPhI North America
    Attending
    • fda
    • EDQM
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Edoxaban Tosylate

    About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

    Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
    Dr Reddy Company Banner

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    09

    IOL Chemicals and Pharmaceuticals

    India
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    CPhI North America
    Attending
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    • EDQM
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    Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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    Edoxaban

    About the Company : IOL Chemicals and Pharmaceuticals Limited, with over three decades of experience, is an innovation-driven company specializing in bulk drugs, intermediates, and specialty chemicals...

    IOL Chemicals and Pharmaceuticals Limited, with over three decades of experience, is an innovation-driven company specializing in bulk drugs, intermediates, and specialty chemicals. As an API-based manufacturer, it offers economies of scale and cost advantages with substantial production capacity. Its API portfolio covers pain management, anti-diabetic, anti-hypertensive, and anti-convulsant categories. IOL Chemicals is backward-integrated, producing all intermediates and key starting materials for ibuprofen. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    IOL Chemicals

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    10

    Moehs Iberica

    Spain
    arrow
    FCE Pharma
    Attending
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    Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

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    Edoxaban Tosylate

    About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...

    Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical, veterinary, agrochemical, nutraceutical, cosmetic, and fine chemical products. Our facilities meet the highest standards, including GMP, ICH, FDA, and TGA approvals, ensuring reliable and safe manufacturing. Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only.
    Moehs Iberica

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    01

    Shandong Chenghui Shuangda Pharmace...

    China
    CPhI China
    Booth #W1D26
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    Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress

    tert-Butyl [(1R,2S,5S)-2-amino-5-[(dimethylamino)c...

    CAS Number : 1210348-34-7

    End Use API : Edoxaban Tosylate

    About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM se...

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    Shandong Chenghui Shuangda Pharmace...

    China
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    Virtual BoothChina’s top API & intermediate manufacturer, delivering advanced CMO/CDMO solutions to 60+ countries, empowering global health progress

    (1S,4S,5S)-4-Bromo-6-oxabicyclo[3.2.1]octan-7-one

    CAS Number : 139893-81-5

    End Use API : Edoxaban Tosylate

    About The Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in API and advanced intermediate R&D and manufacturing, delivering comprehensive CDMO/CRO/OEM se...

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    Aarti Pharmalabs

    India
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    Virtual BoothAarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.

    5-Methyl-4,5,6,7-tetrahydrothiazolo[5,4-c] pyridin...

    CAS Number : 720720-96-7

    End Use API : Edoxaban Tosylate

    About The Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Deri...

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    Aarti Pharmalabs

    India
    CPhI North America
    Booth #1636
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    Virtual BoothAarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.

    tert-Butyl [(1R,2S,5S)-2-Amino-5-[(dimethylamino) ...

    CAS Number : 365998-36-3

    End Use API : Edoxaban Tosylate

    About The Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Deri...

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    Aarti Pharmalabs

    India
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    Virtual BoothAarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.

    Ethyl 2-((5-chloropyridin-2-yl) amino)-2-oxoacetat...

    CAS Number : 1243308-37-3

    End Use API : Edoxaban Tosylate

    About The Company : Aarti Pharmalabs is generic APIs & Intermediates manufacturing company & small molecule drug substance CDMO and the largest Indian manufacturer of Xanthine Deri...

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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.

    tert-Butyl [(1R,2S,5S)-2- amino-5- [(dimethylamino...

    CAS Number : 1210348-34-7

    End Use API : Edoxaban Tosylate

    About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

    Shanghai Minbiotech CB

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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.

    5-Methyl-4,5,6,7- tetrahydrothiazolo[5,4- c]pyridi...

    CAS Number : 720720-96-7

    End Use API : Edoxaban Tosylate

    About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

    Shanghai Minbiotech CB

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    Shanghai Minbiotech

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

    2-[(5-Chloropyridin-2- yl)amino]-2-oxoacetic acid ...

    CAS Number : 1243308-37-3

    End Use API : Edoxaban Tosylate

    About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

    Shanghai Minbiotech CB

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    Shanghai Minbiotech

    China
    RDD
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    • WHO-GMP

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

    5-Methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine...

    CAS Number : 720720-96-7

    End Use API : Edoxaban Tosylate

    About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

    Shanghai Minbiotech CB

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    10

    Shanghai Minbiotech

    China
    RDD
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    • EDQM
    • WHO-GMP

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

    tert-Butyl [(1R,2S,5S)-2-amino-5- [(dimethylamino)...

    CAS Number : 1210348-34-7

    End Use API : Edoxaban Tosylate

    About The Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square mete...

    Shanghai Minbiotech CB

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    HongKong.png
    Edoxaban API needed in Hong Kong [ENA25124]
    A company that focuses on the manufacturing of various finished formulations is looking for suppliers of Edoxaban API for development purposes. The suppliers must support this enquiry with CoA.
    22 Jan 2026

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    22 Jan 2026

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    22 Jan 2026

    india-flag.png
    Edoxaban API needed in India [ENA23464]
    A company that focuses on the development and manufacturing of various finished formulations is looking for suppliers of Edoxaban API. The required quantity is 2 kg for development and later more than 50 kg for commercial purposes. The suppliers must support this enquiry with GMP & CoA.
    09 Jul 2025

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    09 Jul 2025

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    09 Jul 2025

    india-flag.png
    Edoxaban Tosylate Monohydrate (800 kg - 1 MT) API needed in India [ENA22321]
    A globally renowned company that focuses on research, development, manufacturing and marketing of pharmaceuticals & biopharmaceutical formulations is looking for suppliers of Edoxaban Tosylate Monohydrate (800 kg - 1 MT) API for commercial purposes. The suppliers must support this enquiry with DMF, GMP and CoA.
    11 Mar 2025

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    11 Mar 2025

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    11 Mar 2025

    Oman.png
    Edoxaban Tosylate API needed in Oman [ENA19821]
    A company that focuses on manufacturing and development of various finished formulation including oral solid, oral liquid & topical dosage forms is looking for suppliers of USP/ Ph. Eur. Grade Edoxaban Tosylate API for both development & commercial purposes. The required quantity 3.5 kg for first year, 17.1 kg for second year, 32.1 kg for third year, 39.3 kg for fourth year, 47.4 kg for fifth year & 56 kg for sixth year. The suppliers must support this enquiry with USDMF/ CEP/WC, GMP & CoA.
    27 Jun 2024

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    27 Jun 2024

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    27 Jun 2024

    india-flag.png
    Edoxaban API needed in India [ENA18797]
    A CDMO that focuses on the research, development & manufacturing of tablets, capsules, creams, gels and sprays is looking for suppliers of Edoxaban API (2 kg - 5 kg) API for development purposes. The suppliers must support this enquiry with CoA.
    21 Dec 2023

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    21 Dec 2023

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    Reply Comment (3)

    21 Dec 2023

    korearepublicofnew.png
    Various APIs needed in South Korea [ENA14553]
    A company that focuses in development, manufacturing & marketing a wide range of finished formulations is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with KDMF. 1. Apixaban API 2. Edoxaban API
    02 Aug 2022

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    02 Aug 2022

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    Reply Comment (7)

    02 Aug 2022

    india-flag.png
    Various APIs needed in India [ENA14327]
    A company that focuses in the research & development of active pharmaceutical ingredients, intermediates and related substances is looking for suppliers of Various APIs for development purpose. 1. Edoxaban (5 g or 10 g) API 2. Lumateperone (10 g) API 3. Tenofovir Alafenamide Fumarate (5 g or 10 g) API 4. Emtricitabine (5 g or 10 g) API
    14 Jul 2022

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    14 Jul 2022

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    14 Jul 2022

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    Various APIs needed in India [ENA14139]
    A CRO that focuses in formulation & analytical development is looking for suppliers of Various APIs for development purpose. The suppliers must support this enquiry with EDMF/ CEP & CoA. The final market is Europe. 1. BP/ EP Grade Lumateperone Tosylate (5 kg - 10 kg) API 2. BP/ EP Grade Edoxaban (5 kg - 10 kg) API 3. BP/ EP Grade Emtricitabine (20 kg) API 4. BP/ EP Grade Tenofovir Alafenamide Fumarate (20 kg) API
    29 Jun 2022

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    29 Jun 2022

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    29 Jun 2022

    japan.png
    Edoxaban (50 g - 100 g) API needed in Japan [ENA11949]
    A company that deals in the research & development of various pharmaceutical products is looking for suppliers of Edoxaban (50 g - 100 g) API for development purpose.
    27 Nov 2021

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    27 Nov 2021

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    27 Nov 2021

    korearepublicofnew.png
    Various APIs needed in Korea [ENA09880]
    Rihu Healthcare, a leading value-added and multifunctional trader and distributor of pharmaceutical products, chemicals and functional health industries is looking for suppliers of Various APIs. The suppliers must support this enquiry with WHO GMP, COA and CTD for KDMF registration. Interested suppliers can contat them via their email: justin.lim@rihuhealthcare.com. 1. Valsartan Sodium API 2. Edoxaban Base API 3. Edoxaban Tosylate API
    05 Mar 2021

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    05 Mar 2021

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    05 Mar 2021

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    ABOUT THIS PAGE

    Looking for 480449-70-5 / Edoxaban Tosylate API manufacturers, exporters & distributors?

    Edoxaban Tosylate manufacturers, exporters & distributors 1

    70

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

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

    API | Excipient name

    Edoxaban Tosylate

    Synonyms

    480449-70-5, 912273-65-5, Du-176, Du-176b, Ndu3j18apo, N1-(5-chloropyridin-2-yl)-n2-((1s,2r,4s)-4-(dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridine-2-carboxamido)cyclohexyl)oxalamide

    Cas Number

    480449-70-5

    Unique Ingredient Identifier (UNII)

    NDU3J18APO

    About Edoxaban Tosylate

    Edoxaban is an orally active inhibitor of coagulation factor Xa (activated factor X) with anticoagulant activity. Edoxaban is administered as edoxaban tosylate. This agent has an elimination half-life of 9-11 hours and undergoes renal excretion.

    Edoxaban Manufacturers

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

    Edoxaban Suppliers

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

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

    Edoxaban USDMF

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

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

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

    Edoxaban JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Edoxaban Drug Master File in Japan (Edoxaban JDMF) empowers Edoxaban API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Edoxaban JDMF during the approval evaluation for pharmaceutical products. At the time of Edoxaban JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Edoxaban suppliers with JDMF on PharmaCompass.

    Edoxaban KDMF

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

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

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

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

    Edoxaban WC

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

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

    Edoxaban 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 Edoxaban as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Edoxaban GMP

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

    Edoxaban CoA

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

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

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