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    Chemistry

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    Also known as: 366789-02-8, Xarelto, Bay 59-7939, (s)-5-chloro-n-((2-oxo-3-(4-(3-oxomorpholino)phenyl)oxazolidin-5-yl)methyl)thiophene-2-carboxamide, Bay59-7939, Bay-59-7939
    Molecular Formula
    C19H18ClN3O5S
    Molecular Weight
    435.9  g/mol
    InChI Key
    KGFYHTZWPPHNLQ-AWEZNQCLSA-N
    FDA UNII
    9NDF7JZ4M3
    Rivaroxaban
    A morpholine and thiophene derivative that functions as a FACTOR XA INHIBITOR and is used in the treatment and prevention of DEEP-VEIN THROMBOSIS and PULMONARY EMBOLISM. It is also used for the prevention of STROKE and systemic embolization in patients with non-valvular ATRIAL FIBRILLATION, and for the prevention of atherothrombotic events in patients after an ACUTE CORONARY SYNDROME.
    Rivaroxaban is a Factor Xa Inhibitor. The mechanism of action of rivaroxaban is as a Factor Xa Inhibitor.
    1 2D Structure

    Rivaroxaban

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-chloro-N-[[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl]thiophene-2-carboxamide
    2.1.2 InChI
    InChI=1S/C19H18ClN3O5S/c20-16-6-5-15(29-16)18(25)21-9-14-10-23(19(26)28-14)13-3-1-12(2-4-13)22-7-8-27-11-17(22)24/h1-6,14H,7-11H2,(H,21,25)/t14-/m0/s1
    2.1.3 InChI Key
    KGFYHTZWPPHNLQ-AWEZNQCLSA-N
    2.1.4 Canonical SMILES
    C1COCC(=O)N1C2=CC=C(C=C2)N3CC(OC3=O)CNC(=O)C4=CC=C(S4)Cl
    2.1.5 Isomeric SMILES
    C1COCC(=O)N1C2=CC=C(C=C2)N3C[C@@H](OC3=O)CNC(=O)C4=CC=C(S4)Cl
    2.2 Other Identifiers
    2.2.1 UNII
    9NDF7JZ4M3
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 5-chloro-n-(((5s)-2-oxo-3-(4-(3-oxomorpholin-4-yl)phenyl)-1,3-oxazolidin-5-yl)methyl)thiophene-2-carboxamide

    2. Bay 59 7939

    3. Bay 59-7939

    4. Bay 597939

    5. Xarelto

    2.3.2 Depositor-Supplied Synonyms

    1. 366789-02-8

    2. Xarelto

    3. Bay 59-7939

    4. (s)-5-chloro-n-((2-oxo-3-(4-(3-oxomorpholino)phenyl)oxazolidin-5-yl)methyl)thiophene-2-carboxamide

    5. Bay59-7939

    6. Bay-59-7939

    7. 9ndf7jz4m3

    8. C19h18cln3o5s

    9. 5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide

    10. Chebi:68579

    11. Jnj39039039

    12. Jnj-39039039

    13. 5-chloro-n-(((5s)-2-oxo-3-(4-(3-oxomorpholin-4-yl)phenyl)-1,3-oxazolidin-5-yl)methyl)thiophene-2-carboxamide

    14. 5-chloro-n-{[(5s)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl}thiophene-2-carboxamide

    15. Rivaroxaban (xarelto)

    16. 2-thiophenecarboxamide, 5-chloro-n-(((5s)-2-oxo-3-(4-(3-oxo-4-morpholinyl)phenyl)-5-oxazolidinyl)methyl)-

    17. 5-chloro-n-[[(5s)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl]thiophene-2-carboxamide

    18. Xarelto (tn)

    19. Rivaroxaban [inn]

    20. Unii-9ndf7jz4m3

    21. Hsdb 8149

    22. Riv

    23. Rivaroxaban [usan:inn:ban:jan]

    24. Rivaroxaban- Bio-x

    25. Rivaroxaban [mi]

    26. Rivaroxaban [jan]

    27. Rivaroxaban [usan]

    28. Rivaroxaban [vandf]

    29. Schembl3914

    30. Rivaroxaban [mart.]

    31. Rivaroxaban [usp-rs]

    32. Rivaroxaban [who-dd]

    33. Mls006010027

    34. Rivaroxaban (jan/usan/inn)

    35. Rivaroxaban [ema Epar]

    36. Bdbm7840

    37. Chembl198362

    38. Gtpl6388

    39. Dtxsid3057723

    40. Amy1799

    41. Ex-a206

    42. Rivaroxaban [orange Book]

    43. 2w26

    44. Rivaroxaban [ep Monograph]

    45. Rivaroxaban Enantiomer (r-isomer)

    46. Zinc3964126

    47. Rivaroxaban,xarelto,bay 59-7939

    48. Mfcd11974010

    49. Akos005145918

    50. Ccg-212899

    51. Cs-0555

    52. Db06228

    53. Ncgc00262945-10

    54. Ncgc00379033-04

    55. Br164355

    56. Hy-50903

    57. Smr002529611

    58. A14979

    59. D07086

    60. Ab01563270_01

    61. Us8822458, 44

    62. Us8822458, 97

    63. 789r028

    64. Q420262

    65. Sr-01000944189

    66. Q-102503

    67. Sr-01000944189-1

    68. Brd-k37130656-001-01-2

    69. (s)-5-chloro-n-((2-oxo-3-(4-(3-oxomorpholino)phenyl)-oxazolidin-5-yl)methyl )thiophene-2-carboxamide

    70. (s)-5-chloro-n-((2-oxo-3-(4-(3-oxomorpholino)phenyl)-oxazolidin-5-yl)methyl)thiophene-2-carboxamide

    71. 1429742-50-6

    72. 5-chlor-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide

    73. 5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl) Phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide

    74. 5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-thiophenecarboxamide

    75. 5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophencarboxamide

    76. 5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophene-carboxamide

    77. 5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide

    78. 5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl} Methyl)thiophene-2-carboxamide

    79. 5-chloro-n-[[(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]methyl]-2-thiophenecarboxamide

    80. 5-chloro-n-[[(s)-3-(4-(3-oxomorpholin-4-yl)phenyl)-2-oxo-1,3-oxazolidin-5-yl]methyl]-thiophene-2-carboxamide

    81. 5-chloro-n-{[(5s)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]oxazolidin-5-yl]methyl}thiophene-2-carboxamide

    82. R-rivaroxaban; Ent-rivaroxaban; [({(5r)-2-oxo-3-[p-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)amino](5-chloro-2-thienyl)formaldehyde; 5-chloro-n-[[(5r)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]methyl]-2-thiophenecarboxamide

    83. Rivaroxaban; (s)-5-chloro-n-((2-oxo-3-(4-(3-oxomorpholino)phenyl)oxazolidin-5-yl)methyl)thiophene-2-carboxamide

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 435.9 g/mol
    Molecular Formula C19H18ClN3O5S
    XLogP32.5
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count5
    Exact Mass435.0655696 g/mol
    Monoisotopic Mass435.0655696 g/mol
    Topological Polar Surface Area116 Ų
    Heavy Atom Count29
    Formal Charge0
    Complexity645
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameXarelto
    PubMed HealthRivaroxaban (By mouth)
    Drug ClassesAnticoagulant
    Drug LabelRivaroxaban, a FXa inhibitor, is the active ingredient in XARELTO Tablets with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19...
    Active IngredientRivaroxaban
    Dosage FormTablet
    Routeoral; Oral
    Strength15mg; 10mg; 20mg
    Market StatusPrescription
    CompanyJanssen Pharms

    2 of 2  
    Drug NameXarelto
    PubMed HealthRivaroxaban (By mouth)
    Drug ClassesAnticoagulant
    Drug LabelRivaroxaban, a FXa inhibitor, is the active ingredient in XARELTO Tablets with the chemical name 5-Chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide. The molecular formula of rivaroxaban is C19...
    Active IngredientRivaroxaban
    Dosage FormTablet
    Routeoral; Oral
    Strength15mg; 10mg; 20mg
    Market StatusPrescription
    CompanyJanssen Pharms

    4.2 Therapeutic Uses

    Anticoagulant

    National Library of Medicine's Medical Subject Headings. Rivaroxaban. Online file (MeSH, 2014). Available from, as of November 19, 2013: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    Xarelto is indicated for the treatment of deep vein thrombosis (DVT). /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for XARELTO (rivaroxaban) tablet, film coated (August 2013). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610

    Xarelto is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. There are limited data on the relative effectiveness of Xarelto and warfarin in reducing the risk of stroke and systemic embolism when warfarin therapy is well-controlled. /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for XARELTO (rivaroxaban) tablet, film coated (August 2013). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610

    Xarelto is indicated for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery. /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for XARELTO (rivaroxaban) tablet, film coated (August 2013). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610

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

    4.3 Drug Warning

    /BOXED WARNING/ WARNING: PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS. Premature discontinuation of any oral anticoagulant, including Xarelto, increases the risk of thrombotic events. If anticoagulation with Xarelto is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant

    US Natl Inst Health; DailyMed. Current Medication Information for XARELTO (rivaroxaban) tablet, film coated (August 2013). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610

    /BOXED WARNING/ WARNING: SPINAL/EPIDURAL HEMATOMA. Epidural or spinal hematomas have occurred in patients treated with Xarelto 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 non-steroidal 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. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis

    US Natl Inst Health; DailyMed. Current Medication Information for XARELTO (rivaroxaban) tablet, film coated (August 2013). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610

    Rivaroxaban increases the risk of hemorrhage and can cause serious or fatal bleeding. Bleeding complications were the most common adverse effects of rivaroxaban reported in clinical trials.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 1472

    Use of rivaroxaban should be avoided in patients with moderate (Child-Pugh class B) or severe (Child-Pugh class C) hepatic impairment or with any hepatic disease associated with coagulopathy; systemic exposure and risk of bleeding may be increased in such patients.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 1471

    For more Drug Warnings (Complete) data for Rivaroxaban (13 total), please visit the HSDB record page.

    4.4 Drug Indication

    Rivaroxaban is indicated for the prevention of venous thromboembolic events (VTE) in patients who have undergone total hips replacements and total knee replacement surgery; prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE); to reduce risk of recurrent DVT and/or PE. Rivaroxaban is also indicated, in combination with aspirin, for reducing the risk of major cardiovascular events in patients with chronic coronary artery disease or peripheral artery disease. Its use is also not recommended in those with severe renal impairment (<30mL/min). Rivaroxaban is also indicated for the treatment and prevention of VTE in pediatric patients (from birth to 18 years of age) and for thromboprophylaxis in pediatric patients 2 years old with congenital heart disease following the Fontan procedure.

    FDA Label

    Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.

    Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.

    Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.

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

    Adults

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

    Paediatric population

    Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

    Paediatric population

    Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

    Prevention of thromboembolic events, Treatment of thromboembolic events

    Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.

    Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4. 4 for haemodynamically unstable PE patients.

    Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4. 4 for haemodynamically unstable PE patients).

    * Adults:

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

    Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4. 4 for haemodynamically unstable PE patients. )

    * Paediatric population:

    Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

    Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA) alone or with ASA plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4. 3, 4. 4 and 5. 1).

    Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.

    * Adults:

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

    Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4. 4 for haemodynamically unstable PE patients. )

    * Paediatric population:

    Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

    Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.

    Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.

    ------

    Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.

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

    -------

    * Adults:

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

    * Paediatric population:

    Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

    * Paediatric population:

    Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Rivaroxaban is an anticoagulant which binds directly to factor Xa. Thereafter, it effectively blocks the amplification of the coagulation cascade, preventing the formation of thrombus. Rivaroxaban is a unqiue anticoagulant for two reasons. First of all, it is does not involve antithrombin III (ATIII) to exert its anticoagulant effects. Secondly, it is an oral agent whereas the widely used unfractionated heparin and low molecular weight heparins are for parenteral use only. Although the activated partial thromboplastin time (aPTT) and HepTest (a test developed to assay low molecular weight heparins) are prolonged in a dose-dependant manner, neither test is recommended for the assessment of the pharmacodynamic effects of rivaroxaban. Anti-Xa activity and inhibition of anti-Xa activity monitoring is also not recommended despite being influenced by rivaroxaban.

    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
    RIVAROXABAN
    5.3.2 FDA UNII
    9NDF7JZ4M3
    5.3.3 Pharmacological Classes
    Factor Xa Inhibitors [MoA]; Factor Xa Inhibitor [EPC]
    5.4 ATC Code

    B01AF01

    B01AF01

    B01AF01

    B - Blood and blood forming organs

    B01 - Antithrombotic agents

    B01A - Antithrombotic agents

    B01AF - Direct factor xa inhibitors

    B01AF01 - Rivaroxaban

    5.5 Absorption, Distribution and Excretion

    Absorption

    Following oral administration, rivaroxaban is rapidly absorbed and reaches peak plasma concentration in 2-4 hours. Bioavailability of the 10 mg dose is >80%. However, the 15-20 mg dose have a lower bioavailability if taken in the fasted state and consequently should be taken with food.

    Route of Elimination

    Approximately two-thirds of rivaroxaban is excreted into urine (via active tubular secretion in which approximately 36% as unchanged drug and 30% as inactive metabolism). The remaining third of the administered dose is excreted via feces in which 7% is in the form of unchanged drug and 21% as inactive metabolites.

    Volume of Distribution

    The steady state Vd is 50 L

    Clearance

    Systemic clearance is approximately 10 L/h, so rivaroxaban is considered a drug with low clearance. Renal clearance is ~3-4 L/h.

    Following oral administration, approximately one-third of the absorbed dose is excreted unchanged in the urine, with the remaining two-thirds excreted as inactive metabolites in both the urine and feces. In a Phase 1 study, following the administration of a (14)C-rivaroxaban dose, 66% of the radioactive dose was recovered in urine (36% as unchanged drug) and 28% was recovered in feces (7% as unchanged drug). Unchanged drug is excreted into urine, mainly via active tubular secretion and to a lesser extent via glomerular filtration (approximate 5:1 ratio). Rivaroxaban is a substrate of the efflux transporter proteins P-gp and ABCG2 (also abbreviated Bcrp). Rivaroxaban's affinity for influx transporter proteins is unknown.

    US Natl Inst Health; DailyMed. Current Medication Information for XARELTO (rivaroxaban) tablet, film coated (August 2013). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610

    Plasma protein binding of rivaroxaban in human plasma is approximately 92% to 95%, with albumin being the main binding component. The steady-state volume of distribution in healthy subjects is approximately 50 L.

    US Natl Inst Health; DailyMed. Current Medication Information for XARELTO (rivaroxaban) tablet, film coated (August 2013). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610

    Absorption of rivaroxaban is dependent on the site of drug release in the GI tract. A 29% and 56% decrease in AUC and Cmax compared to tablet was reported when rivaroxaban granulate is released in the proximal small intestine. Exposure is further reduced when drug is released in the distal small intestine, or ascending colon. Avoid administration of rivaroxaban distal to the stomach which can result in reduced absorption and related drug exposure.

    US Natl Inst Health; DailyMed. Current Medication Information for XARELTO (rivaroxaban) tablet, film coated (August 2013). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610

    The absolute bioavailability of rivaroxaban is dose-dependent. For the 10 mg dose, it is estimated to be 80% to 100% and is not affected by food. Xarelto 10 mg tablets can be taken with or without food. For the 20 mg dose in the fasted state, the absolute bioavailability is approximately 66%. Coadministration of Xarelto with food increases the bioavailability of the 20 mg dose (mean AUC and Cmax increasing by 39% and 76% respectively with food). Xarelto 15 mg and 20 mg tablets should be taken with food.

    US Natl Inst Health; DailyMed. Current Medication Information for XARELTO (rivaroxaban) tablet, film coated (August 2013). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610

    For more Absorption, Distribution and Excretion (Complete) data for Rivaroxaban (8 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Approximately two-thirds of the dose is metabolized. It is metabolized by CYP3A4, CYP3A5, CYP2J2 and CYP-independant mechanisms

    Rivaroxaban undergoes oxidative degradation by cytochrome P-450 (CYP) isoenzymes 3A4/5 and 2J2 and hydrolysis; metabolites are subsequently eliminated through renal and fecal/biliary routes. No major circulating metabolites have been identified in plasma.

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 1474

    5.7 Biological Half-Life

    The terminal half life is 5-9 hours in adults and 11-13 hours in the elderly.

    The terminal elimination half-life is 11 to 13 hours in the elderly.

    US Natl Inst Health; DailyMed. Current Medication Information for XARELTO (rivaroxaban) tablet, film coated (August 2013). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610

    The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years.

    US Natl Inst Health; DailyMed. Current Medication Information for XARELTO (rivaroxaban) tablet, film coated (August 2013). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610

    5.8 Mechanism of Action

    Rivaroxaban competitively inhibits free and clot bound factor Xa. Factor Xa is needed to activate prothrombin (factor II) to thrombin (factor IIa). Thrombin is a serine protease that is required to activate fibrinogen to fibrin, which is the loose meshwork that completes the clotting process. Since one molecule of factor Xa can generate more than 1000 molecules of thrombin, selective inhibitors of factor Xa are profoundly useful in terminating the amplification of thrombin generation. The action of rivaroxaban is irreversible.

    Rivaroxaban, 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 rivaroxaban prevents conversion of prothrombin to thrombin and subsequent thrombus formation. Rivaroxaban inhibits both free and prothrombinase-bound factor Xa. Unlike fondaparinux, heparin, and the low molecular weight heparins, rivaroxaban binds directly to the active site of factor Xa without the need for a cofactor (e.g., antithrombin III). Rivaroxaban inhibits factor Xa with more than 100,000-fold greater selectivity than other biologically important serine proteases (e.g., thrombin, trypsin, plasmin, factor VIIa, factor IXa, urokinase, activated protein C).

    American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 1474

    Xarelto is an orally bioavailable factor Xa inhibitor that selectively blocks the active site of factor Xa and does not require a cofactor (such as Anti-thrombin III) for activity. Activation of factor X to factor Xa (FXa) via the intrinsic and extrinsic pathways plays a central role in the cascade of blood coagulation.

    US Natl Inst Health; DailyMed. Current Medication Information for XARELTO (rivaroxaban) tablet, film coated (August 2013). Available from, as of November 13, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=10db92f9-2300-4a80-836b-673e1ae91610

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    Rivaroxaban

    Registration Number : 302MF10079

    Registrant's Address : 78, Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea

    Initial Date of Registration : 2020-07-09

    Latest Date of Registration : 2024-05-15

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    05

    HETERO DRUGS LIMITED.

    India
    Pharmacy Expo
    Not Confirmed
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    HETERO DRUGS LIMITED.

    India
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    Rivaroxaban [D]

    Registration Number : 306MF10121

    Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...

    Initial Date of Registration : 2024-09-11

    Latest Date of Registration : 2024-09-11

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    06

    Jiangxi Synergy Pharmaceutical Co. ...

    China
    Pharmacy Expo
    Not Confirmed
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    Jiangxi Synergy Pharmaceutical Co. ...

    China
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    Rivaroxaban

    Registration Number : 304MF10027

    Registrant's Address : Jiangxi Fengxin Industrial Park, Fengxin, 330700, Jiangxi Province, P. R. China

    Initial Date of Registration : 2022-02-10

    Latest Date of Registration : 2022-02-10

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    07

    Sumitomo Chemical Co., Ltd.

    Japan
    Pharmacy Expo
    Not Confirmed
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    Sumitomo Chemical Co., Ltd.

    Japan
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    Not Confirmed
    • fda
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    Rivaroxaban

    Registration Number : 304MF10101

    Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo

    Initial Date of Registration : 2022-07-13

    Latest Date of Registration : 2022-07-13

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    08

    Sanyo Chemical Research Institute C...

    Gabon
    Pharmacy Expo
    Not Confirmed
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    Sanyo Chemical Research Institute C...

    Gabon
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    Not Confirmed
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    Rivaroxaban

    Registration Number : 303MF10102

    Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture

    Initial Date of Registration : 2021-07-06

    Latest Date of Registration : 2021-07-06

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    01

    Polpharma

    Poland
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    IOPC
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    Virtual BoothPolpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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    Rivaroxaban

    About the Company : Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API...

    Polpharma API, part of a leading Polish pharmaceutical group, has over 70 years of experience in process development and cGMP manufacturing. We offer end-to-end solutions, from API development to scale-up, at our FDA-approved plant in Central Europe. Our expert team provides high-quality, tailor-made services for small molecule API clinical candidates, with strong regulatory support and world-class facilities. Trusted by global partners, we specialize in complex chemical processes and deliver exceptional customer experiences. Polpharma API – Your reliable European CDMO partner.
    Polpharma CB

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    02

    Moehs Iberica

    Spain
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    CPhI China
    Booth #E1A32
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    Virtual BoothMoehs Group, a reference company in the production of pharmaceutical active ingredients.

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    Rivaroxaban

    About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...

    Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 years, MOEHS has considerable technical experience in the production of these substances. At Moehs Group we have a large tradition and experience in the area of manufacturing of active pharmaceutical and veterinary ingredients, agrochemicals, nutraceutical, cosmetic, as well as fine chemistry in general, with high levels of quality and safety standards-GMP´s, ICH, approved by the FDA and TGA.
    Moehs Iberica

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    03

    Dr. Reddy's Laboratories

    India
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    Booth #E1H28
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    Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Rivaroxaban

    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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    04

    Suanfarma

    Spain
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    CPhI China
    Booth #E1N28
    • fda
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    Virtual BoothSuanfarma, at the Core of a Better Life.

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    Rivaroxaban

    About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indus...

    Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical industry innovatively & sustainably. Backed by a robust global network of 12 strategically located local offices, we cater to the needs of over 400 active customers in 70+ countries. At Suanfarma we offer our CDMO capacity for fermentation & chemical synthesis projects, offering a One Stop Shop service with a solid track record, & which allows us to achieve success in the development, scaling, manufacturing, & commercialization of an API, either innovative or generic.
    Suanfarma

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    05

    Inke S.A

    Spain
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    Virtual BoothInke S.A: APIs manufacturing plant.

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    Rivaroxaban

    About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...

    Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse therapeutic areas, but mainly for use in Respiratory. Inke has been successfully inspected by every major global authority for a wide array of products (last inspection on behalf of US-FDA was in 2023). For the last two decades, the company has made strong strides to become a prestige provider of respiratory APIs for inhalation.
    Inke Company Banner

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    06

    LGM Pharma

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

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    Rivaroxaban

    About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

    LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
    LGM Pharma CB

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    07

    Metrochem API Private Limited

    India
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    CPhI China
    Booth #E1H57
    • fda
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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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    Rivaroxaban

    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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    08

    Rochem International Inc

    U.S.A
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    CPhI China
    Booth #W2B28
    • fda
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    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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    Rivaroxaban

    About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

    Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.
    Rochem

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    09

    Cohance Lifesciences

    India
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    Pharmacy Expo
    Not Confirmed
    • fda
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Rivaroxaban

    About the Company : Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...

    Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our expertise in complex chemistries, we provide end-to-end CDMO services to global innovators and have delivered numerous projects from concept to commercialization over the years.As a global API player, we serve customers across nearly 60 countries with 80+ molecules backed by robust R&D, regulatory capabilities and manufacturing infrastructure. We are among the top backward integrated exporters of pellets and have strong development and manufacturing capabilities.
    Cohance

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    10

    Egis Pharmaceuticals PLC

    Hungary
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    euroPLX 88 Lisbon
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    Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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    Rivaroxaban

    About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...

    Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its products under Egis’ brand names in 18 countries. In total, the company’s APIs & finished products reach 100 countries. Egis’ focus lies on treating diseases of cardiovascular & central nervous systems; however, it also provides modern treatment solutions in the fields of diabetology, dermatology & wound care. Our research and development activities focus on high-quality, value-added branded generic products. From 2023, Egis offers its CDMO & CMO services as well.
    Egis Pharmaceuticals

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    01

    Brand Name : Xarelto

    Rivaroxaban

    arrow
    GRx+Biosims
    Not Confirmed

    Brand Name : Xarelto

    U.S.A
    arrow
    GRx+Biosims
    Not Confirmed

    Johnson & Johnson

    Rivaroxaban

    Main Therapeutic Indication : Cardiovascular Diseases

    Currency : USD

    2020 Revenue in Millions : 2,345

    2019 Revenue in Millions : 2,313

    Growth (%) : 1

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    02

    Brand Name : Xarelto

    Rivaroxaban

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    GRx+Biosims
    Not Confirmed

    Brand Name : Xarelto

    Germany
    arrow
    GRx+Biosims
    Not Confirmed

    Bayer

    Rivaroxaban

    Main Therapeutic Indication : Cardiovascular Diseases

    Currency : USD

    2020 Revenue in Millions : 5,461

    2019 Revenue in Millions : 4,991

    Growth (%) : 9

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    03

    Brand Name : Xarelto

    Rivaroxaban

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    GRx+Biosims
    Not Confirmed

    Brand Name : Xarelto

    Germany
    arrow
    GRx+Biosims
    Not Confirmed

    Bayer

    Rivaroxaban

    Main Therapeutic Indication : Cardiovascular Diseases

    Currency : USD

    2021 Revenue in Millions : 5,213

    2020 Revenue in Millions : 5,461

    Growth (%) : 5

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    04

    Brand Name : Xarelto

    Rivaroxaban

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    GRx+Biosims
    Not Confirmed

    Brand Name : Xarelto

    U.S.A
    arrow
    GRx+Biosims
    Not Confirmed

    Johnson & Johnson

    Rivaroxaban

    Main Therapeutic Indication : Cardiovascular Diseases

    Currency : USD

    2021 Revenue in Millions : 2,438

    2020 Revenue in Millions : 2,345

    Growth (%) : 4

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    05

    Brand Name : Xarelto

    Rivaroxaban

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    GRx+Biosims
    Not Confirmed

    Brand Name : Xarelto

    U.S.A
    arrow
    GRx+Biosims
    Not Confirmed

    Johnson & Johnson

    Rivaroxaban

    Main Therapeutic Indication : Cardiology/Vascular Diseases

    Currency : USD

    2022 Revenue in Millions : 2,473

    2021 Revenue in Millions : 2,438

    Growth (%) : 1

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    06

    Brand Name : Xarelto

    Rivaroxaban

    arrow
    GRx+Biosims
    Not Confirmed

    Brand Name : Xarelto

    Germany
    arrow
    GRx+Biosims
    Not Confirmed

    Bayer

    Rivaroxaban

    Main Therapeutic Indication : Cardiology/Vascular Diseases

    Currency : USD

    2022 Revenue in Millions : 4,742

    2021 Revenue in Millions : 5,213

    Growth (%) : -9

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    07

    Brand Name : Xarelto

    Rivaroxaban

    arrow
    GRx+Biosims
    Not Confirmed

    Brand Name : Xarelto

    U.S.A
    arrow
    GRx+Biosims
    Not Confirmed

    Johnson & Johnson

    Rivaroxaban

    Main Therapeutic Indication : Cardiology/Vascular Diseases

    Currency : USD

    2023 Revenue in Millions : 2,365

    2022 Revenue in Millions : 2,473

    Growth (%) : -4

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    08

    Brand Name : Xarelto

    Rivaroxaban

    arrow
    GRx+Biosims
    Not Confirmed

    Brand Name : Xarelto

    Germany
    arrow
    GRx+Biosims
    Not Confirmed

    Bayer

    Rivaroxaban

    Main Therapeutic Indication : Cardiology/Vascular Diseases

    Currency : USD

    2023 Revenue in Millions : 4,428

    2022 Revenue in Millions : 4,742

    Growth (%) : -10

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    09

    Brand Name : Xarelto

    Rivaroxaban

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    GRx+Biosims
    Not Confirmed

    Brand Name : Xarelto

    U.S.A
    arrow
    GRx+Biosims
    Not Confirmed

    Johnson & Johnson

    Rivaroxaban

    Main Therapeutic Indication : Anticoagulants

    Currency : USD

    2014 Revenue in Millions : 76.20%

    2013 Revenue in Millions :

    Growth (%) :

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    10

    Brand Name : Xarelto

    Rivaroxaban

    arrow
    GRx+Biosims
    Not Confirmed

    Brand Name : Xarelto

    Germany
    arrow
    GRx+Biosims
    Not Confirmed

    Bayer

    Rivaroxaban

    Main Therapeutic Indication : Anticoagulants

    Currency : USD

    2015 Revenue in Millions : 1,847

    2014 Revenue in Millions : 2,477

    Growth (%) : 34%

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    india-flag.png
    Rivaroxaban (200 kg) API needed in India [ENA22948]
    A globally renowned company that focuses on research, development, manufacturing and marketing of pharmaceuticals & biopharmaceutical formulations is looking for suppliers of Rivaroxaban (200 kg) API for commercial purposes. The suppliers must support this enquiry with USDMF & CEP, GMP and CoA.
    13 May 2025

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    13 May 2025

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    13 May 2025

    india-flag.png
    Rivaroxaban API needed in India [ENA21201]
    A company that focuses on research, development & manufacturing of OSDs, liquids, semi soilds and injectables in various therapeutic areas is looking for suppliers of Rivaroxaban API for development purposes. The suppliers must support this enquiry with CoA.
    22 Nov 2024

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    22 Nov 2024

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    Reply Comment (3)

    22 Nov 2024

    india-flag.png
    Rivaroxaban (50 kg) API needed in India [ENA20221]
    A company that focuses strongly on development and manufacturing of products in various specialties including antibiotics, anti-allergic, anti-inflammatory, anti-hypertensive, antacids, anti-infective, anti-malarial & respiratory is looking for suppliers of Rivaroxaban (50 kg) API for both development and commercial purposes. The suppliers must support this enquiry with ODMF & CoA.
    08 Aug 2024

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    08 Aug 2024

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    Reply Comment (9)

    08 Aug 2024

    Nepal-1536751262.png
    Rivaroxaban (1 kg) API needed in Nepal [ENA20125]
    A company that focuses on manufacturing and marketing of various finished formulations is looking for suppliers of Rivaroxaban (1 kg) API for development purposes. The suppliers must support this enquiry with ODMF & CoA.
    29 Jul 2024

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    29 Jul 2024

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    Reply Comment (6)

    29 Jul 2024

    india-flag.png
    Rivaroxaban API needed in India [ENA19298]
    A company, structured into three divisions, dedicated to the manufacturing and development of various finished formulations & medical devices is looking for suppliers of Rivaroxaban API for development purposes. The suppliers must support this enquiry with DMF & CoA.
    05 Apr 2024

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    05 Apr 2024

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    Reply Comment (5)

    05 Apr 2024

    india-flag.png
    Rivaroxaban (500 g - 1 kg) API needed in India [ENA18343]
    A company that focuses on the development & manufacturing of tablets and capsules is looking for suppliers of Rivaroxaban (500 g - 1 kg) API for development purposes. The suppliers must support this enquiry with DMF & CoA.
    16 Oct 2023

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    16 Oct 2023

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    Reply Comment (2)

    16 Oct 2023

    india-flag.png
    Rivaroxaban (1 kg) API needed in India [ENA18240]
    A company that deals in various pharmaceutical products is looking for suppliers of Rivaroxaban (1 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
    07 Oct 2023

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    07 Oct 2023

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    07 Oct 2023

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    Various APIs needed in India [ENA16316]
    A company that focuses on the manufacturing of tablets, creams & ointments, injectables, and ophthalmic is looking for suppliers of Various APIs for commercial purposes. The required quantity is MOQ for each. The suppliers must support this enquiry with open part DMF, GMP & CoA. 1. Lisinopril API 2. Allopurinol API 3. Norepinephrine API 4. Adrenaline API 5. Rivaroxaban API 6. Atropine API 7. Atropine Sulfate Monohydrate API 8. Vildagliptin API
    06 Feb 2023

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    06 Feb 2023

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    Reply Comment (13)

    06 Feb 2023

    Latvia.png
    Ph. Eur. Grade Micronized Rivaroxaban API needed in Latvia [ENA13989]
    A leading manufacturer that deals in the key areas of specialization in FDFs including neurology, cardiology, infectology and allergology is looking for suppliers of Ph. Eur. Grade Micronized Rivaroxaban API for commercial purpose. The suppliers must support this enquiry with CoA.
    16 Jun 2022

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    16 Jun 2022

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    16 Jun 2022

    india-flag.png
    Various APIs needed in India [ENA13178]
    A pharmaceutical manufacturing company that deals in beta-lactam, non beta-lactam and food supplements for both tablets and capsules is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with CoA. 1. Terbinafine HCl (10 kg) API 2. Lacosamide (MOQ) API 3. Rivaroxaban (MOQ) API 4. Vilazodone (MOQ) API 5. Ranolazine (MOQ) API 6. Pirfenidone (MOQ) API
    01 Apr 2022

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    01 Apr 2022

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    01 Apr 2022

    Only 10 entries up to this point, click to access all click full view read-more
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    Patents & EXCLUSIVITIES

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    US Patents

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    01

    JANSSEN PHARMS

    RIVAROXABAN

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    Patent Expiration Date : 2025-05-13

    RIVAROXABAN

    US Patent Number : 9415053*PED

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    Application Number : 22406

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    Patent Expiration Date : 2025-05-13

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    Patent Expiration Date : 2025-02-28

    RIVAROXABAN

    US Patent Number : 7157456*PED

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    Application Number : 22406

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    Patent Expiration Date : 2025-02-28

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    Patent Expiration Date : 2025-02-28

    RIVAROXABAN

    US Patent Number : 7157456*PED

    Drug Substance Claim :

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    Application Number : 22406

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    Patent Expiration Date : 2025-02-28

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    Patent Expiration Date : 2034-02-17

    RIVAROXABAN

    US Patent Number : 9539218

    Drug Substance Claim :

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    Application Number : 22406

    Patent Use Code : U-1953

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    Patent Expiration Date : 2034-08-17

    RIVAROXABAN

    US Patent Number : 9539218*PED

    Drug Substance Claim :

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    Application Number : 22406

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    Patent Expiration Date : 2034-08-17

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    Patent Expiration Date : 2034-02-17

    RIVAROXABAN

    US Patent Number : 9539218

    Drug Substance Claim :

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    Application Number : 22406

    Patent Use Code : U-1957

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    Patent Expiration Date : 2034-08-17

    RIVAROXABAN

    US Patent Number : 9539218*PED

    Drug Substance Claim :

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    Application Number : 22406

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    Patent Expiration Date : 2034-08-17

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    Patent Expiration Date : 2034-02-17

    RIVAROXABAN

    US Patent Number : 9539218

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 22406

    Patent Use Code : U-1954

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    Patent Use Description :

    Patent Expiration Date : 2034-02-17

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    Patent Expiration Date : 2025-05-13

    RIVAROXABAN

    US Patent Number : 9415053*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 22406

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    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2025-05-13

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    Patent Expiration Date : 2034-02-17

    RIVAROXABAN

    US Patent Number : 9539218

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 22406

    Patent Use Code : U-1955

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2034-02-17

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    ABOUT THIS PAGE

    Looking for 366789-02-8 / Rivaroxaban API manufacturers, exporters & distributors?

    Rivaroxaban manufacturers, exporters & distributors 1

    79

    PharmaCompass offers a list of Rivaroxaban 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 Rivaroxaban manufacturer or Rivaroxaban supplier for your needs.

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

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

    API | Excipient name

    Rivaroxaban

    Synonyms

    366789-02-8, Xarelto, Bay 59-7939, (s)-5-chloro-n-((2-oxo-3-(4-(3-oxomorpholino)phenyl)oxazolidin-5-yl)methyl)thiophene-2-carboxamide, Bay59-7939, Bay-59-7939

    Cas Number

    366789-02-8

    Unique Ingredient Identifier (UNII)

    9NDF7JZ4M3

    About Rivaroxaban

    A morpholine and thiophene derivative that functions as a FACTOR XA INHIBITOR and is used in the treatment and prevention of DEEP-VEIN THROMBOSIS and PULMONARY EMBOLISM. It is also used for the prevention of STROKE and systemic embolization in patients with non-valvular ATRIAL FIBRILLATION, and for the prevention of atherothrombotic events in patients after an ACUTE CORONARY SYNDROME.

    Rivaroxaban (JAN/USAN/INN) Manufacturers

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

    Rivaroxaban (JAN/USAN/INN) Suppliers

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

    click here to find a list of Rivaroxaban (JAN/USAN/INN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Rivaroxaban (JAN/USAN/INN) USDMF

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

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

    click here to find a list of Rivaroxaban (JAN/USAN/INN) suppliers with USDMF on PharmaCompass.

    Rivaroxaban (JAN/USAN/INN) 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 Rivaroxaban (JAN/USAN/INN) Drug Master File in Japan (Rivaroxaban (JAN/USAN/INN) JDMF) empowers Rivaroxaban (JAN/USAN/INN) 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 Rivaroxaban (JAN/USAN/INN) JDMF during the approval evaluation for pharmaceutical products. At the time of Rivaroxaban (JAN/USAN/INN) 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 Rivaroxaban (JAN/USAN/INN) suppliers with JDMF on PharmaCompass.

    Rivaroxaban (JAN/USAN/INN) KDMF

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

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

    After submitting a Rivaroxaban (JAN/USAN/INN) 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 Rivaroxaban (JAN/USAN/INN) API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Rivaroxaban (JAN/USAN/INN) suppliers with KDMF on PharmaCompass.

    Rivaroxaban (JAN/USAN/INN) CEP

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

    A Rivaroxaban (JAN/USAN/INN) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rivaroxaban (JAN/USAN/INN) 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 Rivaroxaban (JAN/USAN/INN) suppliers with CEP (COS) on PharmaCompass.

    Rivaroxaban (JAN/USAN/INN) WC

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

    click here to find a list of Rivaroxaban (JAN/USAN/INN) suppliers with Written Confirmation (WC) on PharmaCompass.

    Rivaroxaban (JAN/USAN/INN) 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 Rivaroxaban (JAN/USAN/INN) as an active pharmaceutical ingredient (API).

    Finished drug products

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

    click here to find a list of Rivaroxaban (JAN/USAN/INN) suppliers with NDC on PharmaCompass.

    Rivaroxaban (JAN/USAN/INN) GMP

    Rivaroxaban (JAN/USAN/INN) 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 Rivaroxaban (JAN/USAN/INN) 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 Rivaroxaban (JAN/USAN/INN) GMP manufacturer or Rivaroxaban (JAN/USAN/INN) GMP API supplier for your needs.

    Rivaroxaban (JAN/USAN/INN) CoA

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

    Rivaroxaban (JAN/USAN/INN) CoA mostly includes findings from lab analyses of a specific batch. For each Rivaroxaban (JAN/USAN/INN) 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.

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