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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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    Company : Janssen Pharm.

    Rivaroxaban

    Drug Cost (USD) : 4,077,247,672

    Year : 2019

    Prescribers : 1134222

    Prescriptions : 6314429

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    Brand Name : Xarelto

    U.S.A
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    Brand Name : Xarelto

    U.S.A
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    Company : Janssen Pharm.

    Rivaroxaban

    Drug Cost (USD) : 3,358,810,708

    Year : 2018

    Prescribers : 1050679

    Prescriptions : 5896570

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    07

    Brand Name : Xarelto

    U.S.A
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    Company : Janssen Pharm.

    Rivaroxaban

    Drug Cost (USD) : 2,611,721,793

    Year : 2017

    Prescribers : 952951

    Prescriptions : 5246003

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    U.S.A
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    Company : Janssen Pharm.

    Rivaroxaban

    Drug Cost (USD) : 1,955,000,085

    Year : 2016

    Prescribers : 807973

    Prescriptions : 4403891

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    Regulatory FDF Prices

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    Brand Name : RIVAROXABAN DOC

    Italy
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    Brand Name : RIVAROXABAN DOC

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    DOC GENERICI SRL

    Rivaroxaban

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 2.5 mg

    Price Per Pack (Euro) : 29.02

    Published in :

    Country : Italy

    RX/OTC/DISCN :

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    Brand Name : RIVAROXABAN EG

    Italy
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    Brand Name : RIVAROXABAN EG

    Italy
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    EG SPA

    Rivaroxaban

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 2.5 mg

    Price Per Pack (Euro) : 29.02

    Published in :

    Country : Italy

    RX/OTC/DISCN :

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    03

    Brand Name : RIVAROXABAN SANDZ

    Switzerland
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    Brand Name : RIVAROXABAN SANDZ

    Switzerland
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    SANDOZ SPA

    Rivaroxaban

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 2.5 mg

    Price Per Pack (Euro) : 24.9

    Published in :

    Country : Italy

    RX/OTC/DISCN :

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    Brand Name : RIVAROXABAN TEVA

    Israel
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    Brand Name : RIVAROXABAN TEVA

    Israel
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    TEVA ITALIA SRL

    Rivaroxaban

    Dosage Form : Film-Coated Tablets

    Dosage Strength : 2.5 mg

    Price Per Pack (Euro) : 29.02

    Published in :

    Country : Italy

    RX/OTC/DISCN :

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    Brand Name : XARELTO

    Germany
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    Brand Name : XARELTO

    Germany
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    BAYER AG

    Rivaroxaban

    Dosage Form : Film-Coated Tablets Oral Use

    Dosage Strength : 2.5 mg

    Price Per Pack (Euro) : 96.76

    Published in :

    Country : Italy

    RX/OTC/DISCN :

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    Brand Name : Xarelto

    Germany
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    Brand Name : Xarelto

    Germany
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    BAYER PHARMA AG

    Rivaroxaban

    Dosage Form : Rivaroxaban 10Mg 10 Units Oral U...

    Dosage Strength : 10 cpr riv 10 mg

    Price Per Pack (Euro) : 36.38

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class A

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    Brand Name : Xarelto

    Germany
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    Germany
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    BAYER PHARMA AG

    Rivaroxaban

    Dosage Form : Rivaroxaban 10Mg 30 Joined' Oral...

    Dosage Strength : 30 cpr riv 10 mg

    Price Per Pack (Euro) : 109.13

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class A

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    Brand Name : Xarelto

    Germany
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    Brand Name : Xarelto

    Germany
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    BAYER PHARMA AG

    Rivaroxaban

    Dosage Form : Rivaroxaban 10Mg 5 Units' Oral U...

    Dosage Strength : 5 cpr riv 10 mg

    Price Per Pack (Euro) : 18.18

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class A

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    09

    Brand Name : Xarelto

    Germany
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    Brand Name : Xarelto

    Germany
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    BAYER PHARMA AG

    Rivaroxaban

    Dosage Form : Rivaroxaban 15Mg 42 Combined Ora...

    Dosage Strength : 42 cpr riv 15 mg

    Price Per Pack (Euro) : 152.77

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class A

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    Brand Name : Xarelto

    Germany
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    Brand Name : Xarelto

    Germany
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    BAYER PHARMA AG

    Rivaroxaban

    Dosage Form : Rivaroxaban 20Mg 28 Combined Ora...

    Dosage Strength : 28 cpr riv 20 mg

    Price Per Pack (Euro) : 101.85

    Published in :

    Country : Italy

    RX/OTC/DISCN : Class A

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    Annual Reports

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    Brand Name : Xarelto

    Rivaroxaban

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    Brand Name : Xarelto

    U.S.A
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    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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    Brand Name : Xarelto

    Rivaroxaban

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    Brand Name : Xarelto

    Germany
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    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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    Brand Name : Xarelto

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    Brand Name : Xarelto

    Germany
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    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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    Brand Name : Xarelto

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    U.S.A
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    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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    Brand Name : Xarelto

    Rivaroxaban

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    Brand Name : Xarelto

    U.S.A
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    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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    Brand Name : Xarelto

    Rivaroxaban

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    Brand Name : Xarelto

    Germany
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    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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    Brand Name : Xarelto

    Rivaroxaban

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    Brand Name : Xarelto

    U.S.A
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    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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    Brand Name : Xarelto

    Rivaroxaban

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    Brand Name : Xarelto

    Germany
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    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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    Brand Name : Xarelto

    Rivaroxaban

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    Brand Name : Xarelto

    Germany
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    Bayer

    Rivaroxaban

    Main Therapeutic Indication : Cardiology/Vascular Diseases

    Currency : USD

    2024 Revenue in Millions : 3,665

    2023 Revenue in Millions : 4,428

    Growth (%) : -17

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    Brand Name : Xarelto

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    Johnson & Johnson

    Rivaroxaban

    Main Therapeutic Indication : Cardiology/Vascular Diseases

    Currency : USD

    2024 Revenue in Millions : 2,373

    2023 Revenue in Millions : 2,365

    Growth (%) : 0

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    USP Grade Rivaroxaban (1 kg) API needed in India [ENA24434]
    A company that focuses on developing, manufacturing, and marketing of innovative products is looking for suppliers of USP Grade Rivaroxaban (1 kg) API for development purposes. The suppliers must support this enquiry with CoA.
    30 Oct 2025

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    30 Oct 2025

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    30 Oct 2025

    india-flag.png
    Rivaroxaban API needed in India [ENA23905]
    A company that focuses on the development and manufacturing of various liquids, ointments and personal care products is looking for suppliers of Rivaroxaban API for development purposes. The suppliers must support this enquiry with GMP & CoA.
    30 Aug 2025

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    30 Aug 2025

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    30 Aug 2025

    Egypt.png
    USP Grade Rivaroxaban (750 g) API needed in Egypt [ENA23331]
    A company that focuses on the manufacturing of various finished formulations is looking for suppliers of USP Grade Rivaroxaban (750 g) API for development purposes. The suppliers must support this enquiry with DMF, GMP & CoA.
    24 Jun 2025

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    24 Jun 2025

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    24 Jun 2025

    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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    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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    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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    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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    Reply Comment (1)

    07 Oct 2023

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    ABOUT THIS PAGE

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

    Rivaroxaban manufacturers, exporters & distributors 1

    31

    PharmaCompass offers a list of Rivaroxaban 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 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.

    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.

    QCR-276 Manufacturers

    A QCR-276 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of QCR-276, including repackagers and relabelers. The FDA regulates QCR-276 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. QCR-276 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 QCR-276 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

    QCR-276 Suppliers

    A QCR-276 supplier is an individual or a company that provides QCR-276 active pharmaceutical ingredient (API) or QCR-276 finished formulations upon request. The QCR-276 suppliers may include QCR-276 API manufacturers, exporters, distributors and traders.

    click here to find a list of QCR-276 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

    QCR-276 USDMF

    A QCR-276 DMF (Drug Master File) is a document detailing the whole manufacturing process of QCR-276 active pharmaceutical ingredient (API) in detail. Different forms of QCR-276 DMFs exist exist since differing nations have different regulations, such as QCR-276 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A QCR-276 DMF submitted to regulatory agencies in the US is known as a USDMF. QCR-276 USDMF includes data on QCR-276's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The QCR-276 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of QCR-276 suppliers with USDMF on PharmaCompass.

    QCR-276 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 QCR-276 Drug Master File in Japan (QCR-276 JDMF) empowers QCR-276 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 QCR-276 JDMF during the approval evaluation for pharmaceutical products. At the time of QCR-276 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 QCR-276 suppliers with JDMF on PharmaCompass.

    QCR-276 KDMF

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

    Pharmaceutical companies submit a QCR-276 Drug Master File in Korea (QCR-276 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of QCR-276. The MFDS reviews the QCR-276 KDMF as part of the drug registration process and uses the information provided in the QCR-276 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a QCR-276 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 QCR-276 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of QCR-276 suppliers with KDMF on PharmaCompass.

    QCR-276 CEP

    A QCR-276 CEP of the European Pharmacopoeia monograph is often referred to as a QCR-276 Certificate of Suitability (COS). The purpose of a QCR-276 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of QCR-276 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of QCR-276 to their clients by showing that a QCR-276 CEP has been issued for it. The manufacturer submits a QCR-276 CEP (COS) as part of the market authorization procedure, and it takes on the role of a QCR-276 CEP holder for the record. Additionally, the data presented in the QCR-276 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the QCR-276 DMF.

    A QCR-276 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. QCR-276 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 QCR-276 suppliers with CEP (COS) on PharmaCompass.

    QCR-276 WC

    A QCR-276 written confirmation (QCR-276 WC) is an official document issued by a regulatory agency to a QCR-276 manufacturer, verifying that the manufacturing facility of a QCR-276 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting QCR-276 APIs or QCR-276 finished pharmaceutical products to another nation, regulatory agencies frequently require a QCR-276 WC (written confirmation) as part of the regulatory process.

    click here to find a list of QCR-276 suppliers with Written Confirmation (WC) on PharmaCompass.

    QCR-276 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 QCR-276 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for QCR-276 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 QCR-276 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 QCR-276 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a QCR-276 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of QCR-276 suppliers with NDC on PharmaCompass.

    QCR-276 GMP

    QCR-276 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 QCR-276 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right QCR-276 GMP manufacturer or QCR-276 GMP API supplier for your needs.

    QCR-276 CoA

    A QCR-276 CoA (Certificate of Analysis) is a formal document that attests to QCR-276's compliance with QCR-276 specifications and serves as a tool for batch-level quality control.

    QCR-276 CoA mostly includes findings from lab analyses of a specific batch. For each QCR-276 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.

    QCR-276 may be tested according to a variety of international standards, such as European Pharmacopoeia (QCR-276 EP), QCR-276 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (QCR-276 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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