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    Chemistry

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    Also known as: 518048-05-0, Mk-0518, Isentress, Raltegravir (mk-0518), Mk0518, Raltegravir (inn)
    Molecular Formula
    C20H21FN6O5
    Molecular Weight
    444.4  g/mol
    InChI Key
    CZFFBEXEKNGXKS-UHFFFAOYSA-N
    FDA UNII
    22VKV8053U
    Raltegravir Potassium
    A pyrrolidinone derivative and HIV INTEGRASE INHIBITOR that is used in combination with other ANTI-HIV AGENTS for the treatment of HIV INFECTION.
    Raltegravir is a Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor. The mechanism of action of raltegravir is as a HIV Integrase Inhibitor.
    1 2D Structure

    Raltegravir Potassium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-[2-[4-[(4-fluorophenyl)methylcarbamoyl]-5-hydroxy-1-methyl-6-oxopyrimidin-2-yl]propan-2-yl]-5-methyl-1,3,4-oxadiazole-2-carboxamide
    2.1.2 InChI
    InChI=1S/C20H21FN6O5/c1-10-25-26-17(32-10)16(30)24-20(2,3)19-23-13(14(28)18(31)27(19)4)15(29)22-9-11-5-7-12(21)8-6-11/h5-8,28H,9H2,1-4H3,(H,22,29)(H,24,30)
    2.1.3 InChI Key
    CZFFBEXEKNGXKS-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=NN=C(O1)C(=O)NC(C)(C)C2=NC(=C(C(=O)N2C)O)C(=O)NCC3=CC=C(C=C3)F
    2.2 Other Identifiers
    2.2.1 UNII
    22VKV8053U
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 0518, Mk

    2. Isentress

    3. Mk 0518

    4. Mk-0518

    5. Mk0518

    6. Potassium, Raltegravir

    7. Raltegravir Potassium

    2.3.2 Depositor-Supplied Synonyms

    1. 518048-05-0

    2. Mk-0518

    3. Isentress

    4. Raltegravir (mk-0518)

    5. Mk0518

    6. Raltegravir (inn)

    7. Mk 0518

    8. N-(2-(4-((4-fluorobenzyl)carbamoyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidin-2-yl)propan-2-yl)-5-methyl-1,3,4-oxadiazole-2-carboxamide

    9. 22vkv8053u

    10. 518048-05-0 (free)

    11. 4-pyrimidinecarboxamide, N-((4-fluorophenyl)methyl)-1,6-dihydro-5-hydroxy-1-methyl-2-(1-methyl-1-(((5-methyl-1,3,4-oxadiazol-2-yl)carbonyl)amino)ethyl)-6-oxo-

    12. N-(2-(4-(4-fluorobenzylcarbamoyl)-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidin-2-yl)propan-2-yl)-5-methyl-1,3,4-oxadiazole-2-carboxamide

    13. Ncgc00184997-01

    14. Raltegravir [inn]

    15. Dsstox_cid_28586

    16. Dsstox_rid_82857

    17. Dsstox_gsid_48660

    18. N-[(4-fluorophenyl)methyl]-5-hydroxy-1-methyl-2-{2-[(5-methyl-1,3,4-oxadiazol-2-yl)formamido]propan-2-yl}-6-oxo-1,6-dihydropyrimidine-4-carboxamide

    19. Isentress(tm)

    20. N-[2-[4-[(4-fluorophenyl)methylcarbamoyl]-5-hydroxy-1-methyl-6-oxopyrimidin-2-yl]propan-2-yl]-5-methyl-1,3,4-oxadiazole-2-carboxamide

    21. Cas-518048-05-0

    22. Raltegravir [usan:inn]

    23. Raltegravirum

    24. Unii-22vkv8053u

    25. Hsdb 8124

    26. N-(4-fluorobenzyl)-5-hydroxy-1-methyl-2-(1-methyl-1-(((5-methyl-1,3,4-oxadiazol-2-yl)carbonyl)amino)ethyl)-6-oxo-1,6-dihydropyrimidine-4-carboxamide

    27. N-(4-fluorobenzyl)-5-hydroxy-1-methyl-2-(1-methyl-1-{[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino}ethyl)-6-oxo-1,6-di Hydropyrimidine-4-carboxamide

    28. N-(4-fluorobenzyl)-5-hydroxy-1-methyl-2-(1-methyl-1-{[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino}ethyl)-6-oxo-1,6-dihydropyrimidine-4-carboxamide

    29. Rlt

    30. Raltegravir- Bio-x

    31. Raltegravir [mi]

    32. N-[1-[4-[(4-fluorophenyl)methylcarbamoyl]-5-hydroxy-1-methyl-6-oxo-pyrimidin-2-yl]-1-methyl-ethyl]-5-methyl-1,3,4-oxadiazole-2-carboxamide

    33. Raltegravir; Mk-0518

    34. K-0518

    35. Raltegravir [vandf]

    36. Raltegravir - Mk-0518

    37. Raltegravir [mart.]

    38. Hydropyrimidine-4-carboxamide

    39. Schembl51817

    40. Raltegravir [who-dd]

    41. Mls006011985

    42. Schembl996804

    43. Raltegravir [ema Epar]

    44. Chembl254316

    45. Schembl2112870

    46. Dtxsid2048660

    47. Bdbm25351

    48. Chebi:82960

    49. Gtpl11571

    50. Bcpp000093

    51. Hms3655b09

    52. Bcp01394

    53. Ex-a2147

    54. Tox21_113019

    55. Mfcd10698872

    56. Nsc762522

    57. S2005

    58. Zinc13831130

    59. Akos015902444

    60. Akos025149884

    61. Akos032960305

    62. Tox21_113019_1

    63. Zinc114994525

    64. Ac-5261

    65. Ccg-269170

    66. Db06817

    67. Nsc-762522

    68. Pb13312

    69. Sb20935

    70. Ncgc00274066-01

    71. Ncgc00274066-05

    72. As-16992

    73. Br164312

    74. Hy-10353

    75. Smr003601806

    76. Ft-0649660

    77. Sw220138-1

    78. A25486

    79. D06676

    80. Mk-0518;mk 0518;mk0518

    81. Yl}-6-oxo-1,6-dihydropyrimidine-4-carboxamide

    82. Ab01566833_01

    83. 038r721

    84. 048r050

    85. A828788

    86. Q421552

    87. Brd-k05658747-237-01-1

    88. [(5-methyl-1,3,4-oxadiazol-2-yl)formamido]propan-2-

    89. N-[(4-fluorophenyl)methyl]-5-hydroxy-1-methyl-2-{2-

    90. Z1551429745

    91. (z)-n-(2-(4-(((4-fluorophenyl)(methyl)amino)(hydroxy)methylene)-1-methyl-5,6-dioxo-1,4,5,6-tetrahydropyrimidin-2-yl)propan-2-yl)-5-methyl-1,3,4-oxadiazole-2-carboxamide

    92. Mk-0518;n-[(4-fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide Potassium Salt

    93. N-(2-(4-(4-fluorobenzylcarbamoyl)-5-hydroxy-1-methyl-6-oxo-1, 6-dihydropyrimidin-2-yl)propan-2-yl) -5-methyl-1,3,4-oxadiazole-2- Carboxamide

    94. N-(2-(4-(4-fluorobenzylcarbamoyl)-5-hydroxy-1-methyl-6-oxo-1,6- Dihydropyrimidin-2-yl)propan-2-yl)-5-methyl-1,3,4-oxadiazole-2-carboxamide

    95. N-(2-(4-(4-fluorobenzylcarbamoyl)-5-oh-1-me-6-oxo-pyrimidin-2-yl)propan-2-yl)-5-me-1,3,4-oxadiazole-2-carboxamide

    96. N-(4-fluorobenzyl)-5-hydroxy-1-methyl-2-(1-methyl-1-{[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino}ethyl)-6-oxo-1,6-di

    97. N-(4-fluorobenzyl)-5-hydroxy-1-methyl-2-(2-{[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino}propan-2-yl)-6-oxo-1,6-dihydropyrimidine-4-carboxamide

    98. N-[2-(4-{[(4-fluorophenyl)methyl]carbamoyl}-5-hydroxy-1-methyl-6-oxo-1,6-dihydropyrimidin-2-yl)propan-2-yl]-5-methyl-1,3,4-oxadiazole-2-carboxamide

    2.4 Create Date
    2011-12-26
    3 Chemical and Physical Properties
    Molecular Weight 444.4 g/mol
    Molecular Formula C20H21FN6O5
    XLogP31.1
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count9
    Rotatable Bond Count6
    Exact Mass444.15574595 g/mol
    Monoisotopic Mass444.15574595 g/mol
    Topological Polar Surface Area150 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity836
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    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 4  
    Drug NameIsentress
    PubMed HealthRaltegravir (By mouth)
    Drug ClassesAntiretroviral Agent
    Drug LabelISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxa...
    Active IngredientRaltegravir potassium
    Dosage FormTablet; Powder; Tablet, chewable
    RouteOral
    Strengtheq 100mg base; eq 400mg base; eq 100mg base/packet; eq 25mg base
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    2 of 4  
    Drug NameRaltegravir
    PubMed HealthRaltegravir (By mouth)
    Drug ClassesAntiretroviral Agent
    Drug LabelISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxa...
    Active IngredientRaltegravir
    Dosage FormTablet
    RouteOral
    Strength400mg
    Market StatusTentative Approval
    CompanyHetero Labs Ltd Iii

    3 of 4  
    Drug NameIsentress
    PubMed HealthRaltegravir (By mouth)
    Drug ClassesAntiretroviral Agent
    Drug LabelISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxa...
    Active IngredientRaltegravir potassium
    Dosage FormTablet; Powder; Tablet, chewable
    RouteOral
    Strengtheq 100mg base; eq 400mg base; eq 100mg base/packet; eq 25mg base
    Market StatusPrescription
    CompanyMerck Sharp Dohme

    4 of 4  
    Drug NameRaltegravir
    PubMed HealthRaltegravir (By mouth)
    Drug ClassesAntiretroviral Agent
    Drug LabelISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorophenyl)methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxa...
    Active IngredientRaltegravir
    Dosage FormTablet
    RouteOral
    Strength400mg
    Market StatusTentative Approval
    CompanyHetero Labs Ltd Iii

    4.2 Therapeutic Uses

    Pyrrolidinones

    National Library of Medicine's Medical Subject Headings online file (MeSH, 2009)

    ISENTRESS (raltegravir) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for ISENTRESS (raltegravir) tablet, film coated; tablet, chewable (Janurary 2013). Available from, as of March 14, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=89a5ec53-d956-4329-8004-0f40f51c88a3

    ISENTRESS (raltegravir) is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in children and adolescents 2 years of age and older and weighing at least 10 kg. /Included in US product label/

    US Natl Inst Health; DailyMed. Current Medication Information for ISENTRESS (raltegravir) tablet, film coated; tablet, chewable (Janurary 2013). Available from, as of March 14, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=89a5ec53-d956-4329-8004-0f40f51c88a3

    /EXPERIMENTAL THER/ /Investigators/ describe five patients with HIV-2 infection (four antiretroviral-experienced and one antiretroviral-naive) treated with a regimen containing raltegravir. All responded to treatment as demonstrated by viral load and CD4(+) T-cell count monitoring. /This/ series confirms the clinical effectiveness of raltegravir in HIV-2-infected patients when given with other antiretrovirals to which the virus is susceptible.

    PMID:22892365 Peterson K et al; Antivir Ther.17 (6):1097-100 (2012)

    /EXPERIMENTALTHER VET/ Feline leukemia virus (FeLV) is a gammaretrovirus that is a significant cause of neoplastic-related disorders affecting cats worldwide. Treatment options for FeLV are limited, associated with serious side effects, and can be cost-prohibitive. The development of drugs used to treat a related retrovirus, human immunodeficiency virus type 1 (HIV-1), has been rapid, leading to the approval of five drug classes. Although structural differences affect the susceptibility of gammaretroviruses to anti-HIV drugs, the similarities in mechanism of replication suggest that some anti-HIV-1 drugs may also inhibit FeLV. This study demonstrates the anti-FeLV activity of four drugs approved by the US FDA (Food and Drug Administration) at non-toxic concentrations. Of these, tenofovir and raltegravir are anti-HIV-1 drugs, while decitabine and gemcitabine are approved to treat myelodysplastic syndromes and pancreatic cancer, respectively, but also have anti-HIV-1 activity in cell culture. Our results indicate that these drugs may be useful for FeLV treatment and should be investigated for mechanism of action and suitability for veterinary use.

    PMID:22258856 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3542715 Greggs WM 3rd et al; J Gen Virol. 93 (Pt 4): 900-5 (2012)

    4.3 Drug Warning

    Severe, potentially life-threatening skin reactions have been reported, including some fatalities. Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction (including hepatic failure) have occurred.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012

    Raltegravir and any other suspect agents should be discontinued immediately if signs or symptoms of severe skin or hypersensitivity reactions occur, including (but not limited to) severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, or angioedema. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated. A life-threatening reaction could occur if there is a delay in discontinuing raltegravir or other suspect agents after the onset of severe rash.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012

    During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium, M. tuberculosis, cytomegalovirus (CMV), Pneumocystis jiroveci (formerly P. carinii), varicella-zoster virus (VZV)); this may necessitate further evaluation and treatment. Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome) have been reported to occur in the setting of immune reconstitution; the time to onset is more variable and can occur many months after initiation of antiretroviral therapy.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 691

    Individuals with phenylketonuria (i.e., homozygous genetic deficiency of phenylalanine hydroxylase) and other individuals who must restrict their intake of phenylalanine should be advised that raltegravir chewable tablets contain aspartame (NutraSweet), which is metabolized in the GI tract to phenylalanine. Each 25-mg chewable tablet provides approximately 0.05 mg of phenylalanine and each 100-mg chewable tablet provides approximately 0.1 mg of phenylalanine.

    American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012

    For more Drug Warnings (Complete) data for Raltegravir (12 total), please visit the HSDB record page.

    4.4 Drug Indication

    For the treatment of HIV-1 infection in conjunction with other antiretrovirals.

    FDA Label

    Isentress is indicated in combination with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV 1) infection.

    Treatment of human immunodeficiency virus (HIV-1) infection

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-HIV Agents

    Agents used to treat AIDS and/or stop the spread of the HIV infection. These do not include drugs used to treat symptoms or opportunistic infections associated with AIDS. (See all compounds classified as Anti-HIV Agents.)

    HIV Integrase Inhibitors

    Inhibitors of HIV INTEGRASE, an enzyme required for integration of viral DNA into cellular DNA. (See all compounds classified as HIV Integrase Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    RALTEGRAVIR
    5.2.2 FDA UNII
    22VKV8053U
    5.2.3 Pharmacological Classes
    Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]; HIV Integrase Inhibitors [MoA]
    5.3 ATC Code

    J05AJ01

    J05AX08

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    J - Antiinfectives for systemic use

    J05 - Antivirals for systemic use

    J05A - Direct acting antivirals

    J05AJ - Integrase inhibitors

    J05AJ01 - Raltegravir

    5.4 Absorption, Distribution and Excretion

    Absorption

    Absorbed from the gastrointestinal tract.

    Route of Elimination

    Feces and urine

    Volume of Distribution

    Approximately 83% bound to human plasma protein and is minimally distributed into red blood cells (blood-to-plasma partitioning ratio of 0.6).

    Clearance

    The major mechanism of clearance of raltegravir in humans is glucuronidation mediated by UGT1A1, the renal clearance of unchanged drug is a minor pathway of elimination of raltegravir (9% of total dose).

    Raltegravir (film-coated tablet) is absorbed with a Tmax of approximately 3 hours postdose in the fasted state. Raltegravir AUC and Cmax increase dose proportionally over the dose range 100 mg to 1600 mg. Raltegravir C12hr increases dose proportionally over the dose range of 100 to 800 mg and increases slightly less than dose proportionally over the dose range 100 mg to 1600 mg.

    US Natl Inst Health; DailyMed. Current Medication Information for ISENTRESS (raltegravir) tablet, film coated; tablet, chewable (Janurary 2013). Available from, as of March 14, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=89a5ec53-d956-4329-8004-0f40f51c88a3

    With twice-daily dosing, pharmacokinetic steady state is achieved within approximately the first 2 days of dosing. There is little to no accumulation in AUC and Cmax. The average accumulation ratio for C12hr ranged from approximately 1.2 to 1.6.

    US Natl Inst Health; DailyMed. Current Medication Information for ISENTRESS (raltegravir) tablet, film coated; tablet, chewable (Janurary 2013). Available from, as of March 14, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=89a5ec53-d956-4329-8004-0f40f51c88a3

    The absolute bioavailability of raltegravir has not been established. Based on a formulation comparison study in healthy adult volunteers, the chewable tablet has higher oral bioavailability compared to the 400 mg film-coated tablet.

    US Natl Inst Health; DailyMed. Current Medication Information for ISENTRESS (raltegravir) tablet, film coated; tablet, chewable (Janurary 2013). Available from, as of March 14, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=89a5ec53-d956-4329-8004-0f40f51c88a3

    In subjects who received 400 mg twice daily alone, raltegravir drug exposures were characterized by a geometric mean AUC0-12hr of 14.3 uM.hr and C12hr of 142 nM.

    US Natl Inst Health; DailyMed. Current Medication Information for ISENTRESS (raltegravir) tablet, film coated; tablet, chewable (Janurary 2013). Available from, as of March 14, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=89a5ec53-d956-4329-8004-0f40f51c88a3

    For more Absorption, Distribution and Excretion (Complete) data for Raltegravir (13 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    Hepatic (UGT1A1)

    In feces, only raltegravir was present, most of which is likely derived from hydrolysis of raltegravir-glucuronide secreted in bile as observed in preclinical species. Two components, namely raltegravir and raltegravir-glucuronide, were detected in urine and accounted for approximately 9 and 23% of the dose, respectively. The major circulating entity was raltegravir and represented approximately 70% of the total radioactivity; the remaining radioactivity in plasma was accounted for by raltegravir-glucuronide.

    US Natl Inst Health; DailyMed. Current Medication Information for ISENTRESS (raltegravir) tablet, film coated; tablet, chewable (Janurary 2013). Available from, as of March 14, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=89a5ec53-d956-4329-8004-0f40f51c88a3

    Studies using isoform-selective chemical inhibitors and cDNA-expressed UDP-glucuronosyltransferases (UGT) show that UGT1A1 is the main enzyme responsible for the formation of raltegravir-glucuronide. Thus, the data indicate that the major mechanism of clearance of raltegravir in humans is UGT1A1-mediated glucuronidation.

    US Natl Inst Health; DailyMed. Current Medication Information for ISENTRESS (raltegravir) tablet, film coated; tablet, chewable (Janurary 2013). Available from, as of March 14, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=89a5ec53-d956-4329-8004-0f40f51c88a3

    5.6 Biological Half-Life

    9 hours

    The apparent terminal half-life of raltegravir is approximately 9 hours, with a shorter alpha-phase half-life (approximetly1 hour) accounting for much of the AUC.

    US Natl Inst Health; DailyMed. Current Medication Information for ISENTRESS (raltegravir) tablet, film coated; tablet, chewable (Janurary 2013). Available from, as of March 14, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=89a5ec53-d956-4329-8004-0f40f51c88a3

    5.7 Mechanism of Action

    Raltegravir inhibits HIV integrase to prevent the viral genome being incorporated into the human genome. Raltegravir is primarily metabolized by glucuronidation.

    Raltegravir inhibits the catalytic activity of HIV-1 integrase, an HIV-1 encoded enzyme that is required for viral replication. Inhibition of integrase prevents the covalent insertion, or integration, of unintegrated linear HIV-1 DNA into the host cell genome preventing the formation of the HIV-1 provirus. The provirus is required to direct the production of progeny virus, so inhibiting integration prevents propagation of the viral infection. Raltegravir did not significantly inhibit human phosphoryltransferases including DNA polymerases alpha, beta, and gamma.

    US Natl Inst Health; DailyMed. Current Medication Information for ISENTRESS (raltegravir) tablet, film coated; tablet, chewable (Janurary 2013). Available from, as of March 14, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=89a5ec53-d956-4329-8004-0f40f51c88a3

    API Reference Price

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DONG","customer":"CIPLA","customerCountry":"INDIA","quantity":"14.00","actualQuantity":"14","unit":"KGS","unitRateFc":"1200","totalValueFC":"16981.9","currency":"USD","unitRateINR":"90360","date":"28-Jan-2022","totalValueINR":"1265040","totalValueInUsd":"16981.9","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"7267943","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1654799400,"product":"RALTEGRAVIR POTASSIUM","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"CIPLA","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"1200","totalValueFC":"24149.1","currency":"USD","unitRateINR":"94200","date":"10-Jun-2022","totalValueINR":"1884000","totalValueInUsd":"24149.1","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"9059123","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1670524200,"product":"RALTEGRAVIR POTASSIUM","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"CIPLA","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"1190","totalValueFC":"11841.3","currency":"USD","unitRateINR":"97580","date":"09-Dec-2022","totalValueINR":"975800","totalValueInUsd":"11841.3","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"3671794","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688409000,"product":"RALTEGRAVIR POTASSIUM (FOR TESTING PURPOSE ONLY)","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"CIPLA","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"1190","totalValueFC":"12024.6","currency":"USD","unitRateINR":"98829.6","date":"04-Jul-2023","totalValueINR":"988295.357","totalValueInUsd":"12024.6","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688409000,"product":"RALTEGRAVIR POTASSIUM (FOR TESTING PURPOSE ONLY)","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"DESANO 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DONG","customer":"CIPLA","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1190","totalValueFC":"6031.5","currency":"USD","unitRateINR":"100257.5","date":"05-Jan-2024","totalValueINR":"501287.5","totalValueInUsd":"6031.5","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"9544840","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO. 1479 ZHANGHENG ROAD,ZHANGJIANGHI-TECH PARK, SHANGHAI 201203 , , China China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705343400,"product":"RALTEGRAVIR POTASSIUM","address":"7\/1,CORPORATE PARK,SION-TROMBAY","city":"MUMBAI","supplier":"SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"FLAMINGO PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1590","totalValueFC":"1611.8","currency":"USD","unitRateINR":"133957.5","date":"16-Jan-2024","totalValueINR":"133957.5","totalValueInUsd":"1611.8","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"9688786","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"TICAL CO.,LTD.THE ECONOMIC DEVELOPMENT ZONE,PINGYUAN COUNTY,DEZHOU CITY,SHANDONG PROVINCE CHINA","customerAddress":"7\/1,CORPORATE PARK,SION-TROMBAY"}]
    23-Feb-2021
    24-Oct-2024
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    ABOUT THIS PAGE

    Raltegravir Potassium Manufacturers

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

    Raltegravir Potassium Suppliers

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

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

    Raltegravir Potassium USDMF

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

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

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

    Raltegravir Potassium KDMF

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

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

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

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

    Raltegravir Potassium CEP

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

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

    Raltegravir Potassium WC

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

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

    Raltegravir Potassium 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 Raltegravir Potassium as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Raltegravir Potassium GMP

    Raltegravir Potassium 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 Raltegravir Potassium 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 Raltegravir Potassium GMP manufacturer or Raltegravir Potassium GMP API supplier for your needs.

    Raltegravir Potassium CoA

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

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

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