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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

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      Written Confirmation Number : WC-0407

      Address of the Firm : Sy. No. 205, 222 to 226, IDA Bonthapally, Bonthapally (Village), Gummadidala (Ma...

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      08

      Viatris

      U.S.A
      ACS GCI
      Not Confirmed
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      Viatris

      U.S.A
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      Raltegravir Potassium IH

      Date of Issue : 2022-07-06

      Valid Till : 2025-08-04

      Written Confirmation Number : WC-0118

      Address of the Firm : Unit-1, Survey No. 10, Gaddapotharam (V), Kazipally Industrial Area, Jinnaram (M...

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      Listed Suppliers

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      01

      LGM Pharma

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

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      Raltegravir Potassium

      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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      02

      HRV Global Life Sciences

      India
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      CPhI China
      Attending
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      Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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      Raltegravir Potassium

      About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

      HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
      HRV Global Life Sciences

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      03

      Acura Labs

      India
      ACS GCI
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      Acura Labs

      India
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      Raltegravir Potassium

      About the Company : Acura Labs is one of the fastest-growing pharmaceutical companies backed by a solid and innovative R&D facility and a top-notch Active Pharmaceutical Ingredients (APIs) manufacturi...

      Acura Labs is one of the fastest-growing pharmaceutical companies backed by a solid and innovative R&D facility and a top-notch Active Pharmaceutical Ingredients (APIs) manufacturing facility. We have a robust product portfolio of APIs spread across various therapeutic areas, capable of handling novel, complex and critical reactions. We are equipped with adaptable, versatile, and cutting-edge infrastructure tailored to fit any complex chemistry molecules and satisfy the needs of global innovators.
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      04

      Arene Lifesciences

      India
      ACS GCI
      Not Confirmed
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      Arene Lifesciences

      India
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      Not Confirmed
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      Raltegravir Potassium

      About the Company : Since 2004, Arene Lifesciences Private Limited is committed to a cause to deliver the best and to aim for continuous improvement in order to transform new knowledge into innovative...

      Since 2004, Arene Lifesciences Private Limited is committed to a cause to deliver the best and to aim for continuous improvement in order to transform new knowledge into innovative synthetic processes, designed to ensure quality, efficiency and sustainability. Our leaders step outside to do things that symbolize our vision “to be recognized as a one of the leading Global manufacturers of Quality API and their intermediates”.Our expert teams maintain the highest global standards of quality and regulatory compliance, while our unparalleled customer support and attention will help our customers to maintain a competitive edge in the market.
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      05

      Chromo Laboratories

      India
      ACS GCI
      Not Confirmed
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      Chromo Laboratories

      India
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      Raltegravir Potassium

      About the Company : Chromo Laboratories India Pvt. Ltd, is a Hyderabad based Manufacturer of Intermediates and Active Pharmaceutical Ingredients. The manufacturing facility is located at Pashamylaram...

      Chromo Laboratories India Pvt. Ltd, is a Hyderabad based Manufacturer of Intermediates and Active Pharmaceutical Ingredients. The manufacturing facility is located at Pashamylaram, Near Patancheru, Which is 27 KM from Hyderabad. It aggressively engage in expanding product portfolio strategy and focuses on its growth . Chromo Laboratories India views its fully equipped R&D centre capabilities as a vital component of its business strategy that will provide the company with a sustainable, long-term competitive advantage. It is focusing on providing cost effective products to the Pharmaceutical Market. 
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      06

      Corey Organics

      India
      ACS GCI
      Not Confirmed
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      Corey Organics

      India
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      Not Confirmed
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      Raltegravir Potassium

      About the Company : Corey Organics is focused in developing and manufacturing of Active Pharmaceutical Ingredients (APIs), registered Pharma Intermediates, Fine Chemicals and Pyridine Derivatives for ...

      Corey Organics is focused in developing and manufacturing of Active Pharmaceutical Ingredients (APIs), registered Pharma Intermediates, Fine Chemicals and Pyridine Derivatives for catering to the domestic as well as international market. Corey Organics has well manufacturing facilities and the affairs of the Company are taken care by Persons with handful of experience and expertise in the line of Bulk drugs and its intermediates manufacturing to facilitate healthy business to the Clients sharing worldwide.
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      07

      Laurus Labs

      India
      ACS GCI
      Not Confirmed
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      Laurus Labs

      India
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      ACS GCI
      Not Confirmed
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      Raltegravir

      About the Company : Laurus Labs is a leading research and development-driven pharmaceutical company in India. The company has grown consistently to become one of the leading manufacturers of Active Ph...

      Laurus Labs is a leading research and development-driven pharmaceutical company in India. The company has grown consistently to become one of the leading manufacturers of Active Pharmaceutical Ingredients (APIs) for anti-retroviral (ARV) and Hepatitis C. Laurus Labs also manufactures APIs in oncology and other therapeutic areas. Its strategic and early investments in R&D and manufacturing infrastructure have enabled it to become one of the leading suppliers of APIs in the ARV therapeutic area. Out of Ten largest generic pharmaceutical companies in the world, by revenues, are our customers.
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      08

      Saintsun Pharma

      China
      ACS GCI
      Not Confirmed
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      Saintsun Pharma

      China
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      Not Confirmed
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      Raltegravir

      About the Company : SAINTSUN PHARMA, we are engaging mainly in the manufacturing and distributing APIs, Pharmaceutical Intermediates, Chemicals, Formulations, Medical supplies, etc... With a self-owne...

      SAINTSUN PHARMA, we are engaging mainly in the manufacturing and distributing APIs, Pharmaceutical Intermediates, Chemicals, Formulations, Medical supplies, etc... With a self-owned brand of "SAINTSUN PHARMA", after more than 12 years efforts, our products are successfully expanded to different continents like Asia, South America, Africa more than 35 countries and regions.
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      09

      SGMR Pharmaceuticals

      India
      ACS GCI
      Not Confirmed
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      SGMR Pharmaceuticals

      India
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      ACS GCI
      Not Confirmed
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      Raltegravir Potassium

      About the Company : SGMR Pharmaceuticals is a renowned Loan License manufacturer of API’s and Intermediates. They specialize in the product manufacturing and export of Bulk drugs Products and Inter...

      SGMR Pharmaceuticals is a renowned Loan License manufacturer of API’s and Intermediates. They specialize in the product manufacturing and export of Bulk drugs Products and Intermediates. The customers and buyers include reputed pharmaceutical companies of the US, Europe, Middle-East, Africa, Latin America, and the CIS region, Asian Countries. Starting from a single product line, SGMR Pharmaceuticals Pvt Ltd has emerged as a diversified multi-product company, with interests in the production of API Products and API Intermediates
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      10

      Shenzhen Oriental Pharmaceutical

      China
      ACS GCI
      Not Confirmed
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      Shenzhen Oriental Pharmaceutical

      China
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      ACS GCI
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      Raltegravir

      About the Company : Founded in 1995, Shenzhen Oriental Pharma focussed on the production of Active Pharma Ingredients (APIs), Now the main product is Phenylephrine Hcl (PE), Doxylamine succinate.We ha...

      Founded in 1995, Shenzhen Oriental Pharma focussed on the production of Active Pharma Ingredients (APIs), Now the main product is Phenylephrine Hcl (PE), Doxylamine succinate.We have 14 years production experience for Phenylephrine Hcl, granted the GMP for PE in 2004,re-certified in 2009. A DMF has been submitted to FDA in 2005 (DMF # 18799), this product passed the US FDA inspection in March 2014. According to the customer’s needs, we can supply the APIs conforming to the current standard of USP, EP and CP .At the same time, we can supply various particle sizes product.
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      Only 10 entries up to this point, click to access all click full view read-more
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      API Reference Price

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      [{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1641321000,"product":"RALTEGRAVIR POTASSIUM","address":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD","city":"HYDERABAD,A.P.","supplier":"DIVIS LABORATORIES LIMITED","supplierCountry":"INDIA","foreign_port":"SINGAPORE","customer":"MSD SINGAPORE TRADING PTE LTD","customerCountry":"SINGAPORE","quantity":"4046.00","actualQuantity":"4046","unit":"KGS","unitRateFc":"742.3","totalValueFC":"2991565.5","currency":"USD","unitRateINR":55079.588976767176,"date":"05-Jan-2022","totalValueINR":"222852017","totalValueInUsd":"2991565.5","indian_port":"Vizag-DLL SEZ","hs_no":"29349990","bill_no":"4000020","productDescription":"API","marketType":"","country":"SINGAPORE","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-DLL SEZ","supplierAddress":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD, HYDERABAD,A.P.","customerAddress":""},{"dataSource":"API 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Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1656873000,"product":"RALTEGRAVIR POTASSIUM (FORM-I) (TAX INV","address":"PLOT NO.C-24, MSN HOUSE,,INDUSTRIA L ESTATE, SANATH NAGAR,","city":"HYDERABAD,TELANGANA","supplier":"MAITHRI DRUGS PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"MOSCOW","customer":"TO","customerCountry":"RUSSIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"3000","totalValueFC":"2741.6","currency":"USD","unitRateINR":218000,"date":"04-Jul-2022","totalValueINR":"218000","totalValueInUsd":"2741.6","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"2587178","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"PLOT NO.C-24, MSN HOUSE,,INDUSTRIA L ESTATE, SANATH NAGAR,, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API 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HIGHWAY, SANTACRUZ (EAST) ,\u00a0 MUMBAI , \u00a0MUMBAI SUBURBAN ,\u00a0 MAHARASHTRA,\u00a0 400055, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748025000,"product":"RALTEGRAVIR POTASSIUM CRYSTALLINE","address":"KALPATARU INSPIRE 3RD FLOOR, ,\u00a0 OFF. W.E. HIGHWAY, SANTACRUZ (EAST) ,\u00a0 MUMBAI , \u00a0MUMBAI SUBURBAN ,\u00a0 MAHARASHTRA,\u00a0 400055","city":"N\/A","supplier":"LUPIN MANUFACTURING SOLUTIONS LIMITED","supplierCountry":"INDIA","foreign_port":"MADC LTD.","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"40.11","actualQuantity":"40.11","unit":"KGS","unitRateFc":"1528.9","totalValueFC":"60962.5","currency":"N\/A","unitRateINR":129494.9813014211,"date":"24-May-2025","totalValueINR":"5194043.7","totalValueInUsd":"60962.5","indian_port":"M\/s MAHARASHTRA AIRPORT DEVELOPMENTCOMPANYLIMITED","hs_no":"29420090","bill_no":"2107590","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Crystalline","supplierPort":"M\/s MAHARASHTRA AIRPORT DEVELOPMENTCOMPANYLIMITED","supplierAddress":"KALPATARU INSPIRE 3RD FLOOR, ,\u00a0 OFF. W.E. HIGHWAY, SANTACRUZ (EAST) ,\u00a0 MUMBAI , \u00a0MUMBAI SUBURBAN ,\u00a0 MAHARASHTRA,\u00a0 400055, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748025000,"product":"RALTEGRAVIR POTASSIUM CRYSTALLINE","address":"KALPATARU INSPIRE 3RD FLOOR, ,\u00a0 OFF. W.E. HIGHWAY, SANTACRUZ (EAST) ,\u00a0 MUMBAI , \u00a0MUMBAI SUBURBAN ,\u00a0 MAHARASHTRA,\u00a0 400055","city":"N\/A","supplier":"LUPIN MANUFACTURING SOLUTIONS LIMITED","supplierCountry":"INDIA","foreign_port":"MADC LTD.","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"40.62","actualQuantity":"40.62","unit":"KGS","unitRateFc":"1528.9","totalValueFC":"61737.6","currency":"N\/A","unitRateINR":129494.97907434762,"date":"24-May-2025","totalValueINR":"5260086.05","totalValueInUsd":"61737.6","indian_port":"M\/s MAHARASHTRA AIRPORT DEVELOPMENTCOMPANYLIMITED","hs_no":"29420090","bill_no":"2107590","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Crystalline","supplierPort":"M\/s MAHARASHTRA AIRPORT DEVELOPMENTCOMPANYLIMITED","supplierAddress":"KALPATARU INSPIRE 3RD FLOOR, ,\u00a0 OFF. W.E. HIGHWAY, SANTACRUZ (EAST) ,\u00a0 MUMBAI , \u00a0MUMBAI SUBURBAN ,\u00a0 MAHARASHTRA,\u00a0 400055, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748025000,"product":"RALTEGRAVIR POTASSIUM CRYSTALLINE","address":"KALPATARU INSPIRE 3RD FLOOR, ,\u00a0 OFF. W.E. HIGHWAY, SANTACRUZ (EAST) ,\u00a0 MUMBAI , \u00a0MUMBAI SUBURBAN ,\u00a0 MAHARASHTRA,\u00a0 400055","city":"N\/A","supplier":"LUPIN MANUFACTURING SOLUTIONS LIMITED","supplierCountry":"INDIA","foreign_port":"MADC LTD.","customer":"LUPIN LTD","customerCountry":"INDIA","quantity":"40.93","actualQuantity":"40.93","unit":"KGS","unitRateFc":"1528.9","totalValueFC":"62208.8","currency":"N\/A","unitRateINR":129495.01954556561,"date":"24-May-2025","totalValueINR":"5300231.15","totalValueInUsd":"62208.8","indian_port":"M\/s MAHARASHTRA AIRPORT DEVELOPMENTCOMPANYLIMITED","hs_no":"29420090","bill_no":"2107590","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Crystalline","supplierPort":"M\/s MAHARASHTRA AIRPORT DEVELOPMENTCOMPANYLIMITED","supplierAddress":"KALPATARU INSPIRE 3RD FLOOR, ,\u00a0 OFF. W.E. HIGHWAY, SANTACRUZ (EAST) ,\u00a0 MUMBAI , \u00a0MUMBAI SUBURBAN ,\u00a0 MAHARASHTRA,\u00a0 400055, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748543400,"product":"RALTEGRAVIR POTASSIUM FORM-III PH.EUR","address":"7-2-A2, HETERO CORPORATE,","city":"HYDERABAD-A.P.","supplier":"HETERO DRUGS LIMITED","supplierCountry":"INDIA","foreign_port":"VNUKOVO","customer":"JSC PHS-LEKSREDSTVA","customerCountry":"RUSSIA","quantity":"31.00","actualQuantity":"31","unit":"KGS","unitRateFc":"1200","totalValueFC":"36009.7","currency":"N\/A","unitRateINR":98969.38322580645,"date":"30-May-2025","totalValueINR":"3068050.88","totalValueInUsd":"36009.7","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"2288791","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"7-2-A2, HETERO CORPORATE,, HYDERABAD-A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748629800,"product":"RALTEGRAVIR POTASSIUM API (GST INVOICE NO:U1\/25-26\/EXP\/033 DT:30\/05\/2025)","address":"48,49,50,209,210 211.PHASE-II","city":"N\/A","supplier":"ARENE LIFE SCIENCES PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"SHEREMETYEVO","customer":"PSK PHARMA LTD","customerCountry":"RUSSIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"62000","totalValueFC":"21363.3","currency":"INR","unitRateINR":60672.26666666667,"date":"31-May-2025","totalValueINR":"1820168","totalValueInUsd":"21363.3","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"2331695","productDescription":"API","marketType":"","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"48,49,50,209,210 211.PHASE-II, N\/A","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643308200,"product":"RALTEGRAVIR POTASSIUM (LIST-3\/ITEM SR NO.116)","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"CIPLA LIMITED","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 LIMITED","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":"2023","qtr":"Q1","strtotime":1677436200,"product":"RALTEGRAVIR POTASSIUM (LIST 3 SR NO.116)","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 LIMITED","customerCountry":"INDIA","quantity":"110.00","actualQuantity":"110","unit":"KGS","unitRateFc":"1190","totalValueFC":"132580","currency":"USD","unitRateINR":"99543.5","date":"27-Feb-2023","totalValueINR":"10949785","totalValueInUsd":"132580","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"4823119","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":"2024","qtr":"Q1","strtotime":1704393000,"product":"RALTEGRAVIR POTASSIUM (FOR TESTING PURPOSE ONLY)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"CIPLA LIMITED","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":1704997800,"product":"RALTEGRAVIR POTASSIUM (FOR TESTING PURPOSE ONLY)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"N\/A","customer":"CIPLA LIMITED","customerCountry":"INDIA","quantity":"32.00","actualQuantity":"32","unit":"KGS","unitRateFc":"1190","totalValueFC":"38601.5","currency":"USD","unitRateINR":"100257.5","date":"12-Jan-2024","totalValueINR":"3208240","totalValueInUsd":"38601.5","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"9642946","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"NO 1479 ZHANGHENG ROAD,SHANGHAI CHINA CN","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734287400,"product":"RALTEGRAVIR POTASSIUM(RE IMPORT)(SB NO.2690853 & DT:25.07.2024)ORGANIC CHEMICALS","address":"2ND FLOOR, SERENE CHAMBERS,","city":"","supplier":"CORIPHARMA EHF","supplierCountry":"INDIA","foreign_port":"COPENHAGEN","customer":"LAURUS LABS LIMITED","customerCountry":"INDIA","quantity":"92.45","actualQuantity":"92.45","unit":"KGS","unitRateFc":"1197.3","totalValueFC":"111578.2","currency":"USD","unitRateINR":"102549.3","date":"16-Dec-2024","totalValueINR":"9480682.91","totalValueInUsd":"111578.2","indian_port":"Madras Air","hs_no":"29349990","bill_no":"7267671","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"COPENHAGEN","supplierAddress":"KT.491002-3280 VSK 76941 REYKJAVIKURVEGI 78-80 220 HAFNARJORDUR IS","customerAddress":"2ND FLOOR, SERENE CHAMBERS,"}]
      05-Jan-2022
      31-May-2025
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      DOSAGE - TABLET;ORAL - EQ 400MG BASE

      USFDA APPLICATION NUMBER - 22145

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      DOSAGE - TABLET;ORAL - EQ 600MG BASE

      USFDA APPLICATION NUMBER - 22145

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      ABOUT THIS PAGE

      Looking for 518048-05-0 / Raltegravir Potassium API manufacturers, exporters & distributors?

      Raltegravir Potassium manufacturers, exporters & distributors 1

      10

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

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

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

      API | Excipient name

      Raltegravir Potassium

      Synonyms

      518048-05-0, Mk-0518, Isentress, Raltegravir (mk-0518), Mk0518, Raltegravir (inn)

      Cas Number

      518048-05-0

      Unique Ingredient Identifier (UNII)

      22VKV8053U

      About 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.

      871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 Manufacturers

      A 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133, including repackagers and relabelers. The FDA regulates 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 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 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

      871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 Suppliers

      A 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 supplier is an individual or a company that provides 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 active pharmaceutical ingredient (API) or 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 finished formulations upon request. The 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 suppliers may include 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 API manufacturers, exporters, distributors and traders.

      click here to find a list of 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

      871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 USDMF

      A 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 DMF (Drug Master File) is a document detailing the whole manufacturing process of 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 active pharmaceutical ingredient (API) in detail. Different forms of 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 DMFs exist exist since differing nations have different regulations, such as 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

      A 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 DMF submitted to regulatory agencies in the US is known as a USDMF. 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 USDMF includes data on 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 USDMF is kept confidential to protect the manufacturer’s intellectual property.

      click here to find a list of 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 suppliers with USDMF on PharmaCompass.

      871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 KDMF

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

      Pharmaceutical companies submit a 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 Drug Master File in Korea (871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133. The MFDS reviews the 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 KDMF as part of the drug registration process and uses the information provided in the 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 KDMF to evaluate the safety and efficacy of the drug.

      After submitting a 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 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 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 API can apply through the Korea Drug Master File (KDMF).

      click here to find a list of 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 suppliers with KDMF on PharmaCompass.

      871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 CEP

      A 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 CEP of the European Pharmacopoeia monograph is often referred to as a 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 Certificate of Suitability (COS). The purpose of a 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 to their clients by showing that a 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 CEP has been issued for it. The manufacturer submits a 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 CEP (COS) as part of the market authorization procedure, and it takes on the role of a 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 CEP holder for the record. Additionally, the data presented in the 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 DMF.

      A 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 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 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 suppliers with CEP (COS) on PharmaCompass.

      871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 WC

      A 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 written confirmation (871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 WC) is an official document issued by a regulatory agency to a 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 manufacturer, verifying that the manufacturing facility of a 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 APIs or 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 finished pharmaceutical products to another nation, regulatory agencies frequently require a 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 WC (written confirmation) as part of the regulatory process.

      click here to find a list of 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 suppliers with Written Confirmation (WC) on PharmaCompass.

      871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 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 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 as an active pharmaceutical ingredient (API).

      Finished drug products

      The FDA updates the NDC directory daily. The NDC numbers for 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 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 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 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 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 NDC to their finished compounded human drug products, they may choose to do so.

      click here to find a list of 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 suppliers with NDC on PharmaCompass.

      871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 GMP

      871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 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 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 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 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 GMP manufacturer or 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 GMP API supplier for your needs.

      871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 CoA

      A 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 CoA (Certificate of Analysis) is a formal document that attests to 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133's compliance with 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 specifications and serves as a tool for batch-level quality control.

      871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 CoA mostly includes findings from lab analyses of a specific batch. For each 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 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.

      871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 may be tested according to a variety of international standards, such as European Pharmacopoeia (871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 EP), 871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (871038-72-1, Isentress, Raltegravir potassium, MK-518, D07133 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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