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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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Viatris

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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American Pharma Summit
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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06

Hetero Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

American Pharma Summit
Not Confirmed
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Hetero Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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American Pharma Summit
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WCarrow-down NDC arrow-down KDMF VMF Others AUDIT
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07

Hetero Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

American Pharma Summit
Not Confirmed
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Hetero Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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American Pharma Summit
Not Confirmed
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08

Maithri Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

American Pharma Summit
Not Confirmed
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Maithri Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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American Pharma Summit
Not Confirmed
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09

Lupin Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

American Pharma Summit
Not Confirmed
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Lupin Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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American Pharma Summit
Not Confirmed
USDMF Inactive-api CEP/COS JDMF EU-WCInactive-api NDC KDMF VMF Others AUDIT
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10

Laurus Labs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

American Pharma Summit
Not Confirmed
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Laurus Labs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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American Pharma Summit
Not Confirmed
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Listed Suppliers

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01

LGM Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content

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

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Flag India
Digital Content Digital Content

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

03

Acura Labs

India
euroPLX 86 Munich
Not Confirmed
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Acura Labs

India
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euroPLX 86 Munich
Not Confirmed

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

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

Raltegravir Potassium

About the Company : Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent ...

Aspire group was established in the year 2000 with a motto of quality drug for better health of all. In its journey till date, aspire has developed enormous reputation, consistent growth, unique technologies and world class quality healthcare products. Aspire is pioneer in manufacturing and sourcing unique healthcare products. True to the statement, “Where the future started yesterday” with a foresight on the current trends in the healthcare market, Aspire has grown from strength combining its research strength, Human resources and well established quality systems. Aspire has crossed numerous milestones in a comparatively short period since its inception.
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05

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

Raltegravir Potassium

About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company comme...

Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others.
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06

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

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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07

Hetero Drugs

India
euroPLX 86 Munich
Not Confirmed
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Hetero Drugs

India
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euroPLX 86 Munich
Not Confirmed

Raltegravir Potassium

About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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08

Laurus Labs

India
euroPLX 86 Munich
Not Confirmed
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Laurus Labs

India
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euroPLX 86 Munich
Not Confirmed

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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09

Lupin Ltd

India
euroPLX 86 Munich
Not Confirmed
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Lupin Ltd

India
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euroPLX 86 Munich
Not Confirmed

Raltegravir Potassium

About the Company : "The company was named after the Lupin flower because of the inherent qualities of the flower and what it personifies and stands for. The Lupin flower is known to nourish the land,...

"The company was named after the Lupin flower because of the inherent qualities of the flower and what it personifies and stands for. The Lupin flower is known to nourish the land, the very soil it grows in. The Lupin flower is also known to be tolerant of infertile soils and capable of pioneering change in barren and poor climes. The Lupin flower and bean pods have also long been used as food and sources of nourishment, thus protecting and nurturing life.
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10

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

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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API Reference Price

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ROAD,KALINA, SANTACRUZ (E), MUMBAI,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"RALTEGRAVIR POTASSIUM","year":"2021","qtr":"Q2","strtotime":1620239400,"product":"RALTEGRAVIR POTASSIUM","address":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD","city":"HYDERABAD,A.P.","supplier":"DIVIS LABORATORIES","supplierCountry":"INDIA","foreign_port":"SHANGHAI","customer":"MERCK & CO","customerCountry":"CHINA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"728","totalValueFC":"73993.3","currency":"USD","unitRateINR":54199.599999999999,"date":"06-May-2021","totalValueINR":"5419960","totalValueInUsd":"73993.3","indian_port":"Vizag-DLL SEZ","hs_no":"29349990","bill_no":"4000662","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-DLL SEZ","supplierAddress":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD, HYDERABAD,A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"RALTEGRAVIR POTASSIUM","year":"2021","qtr":"Q2","strtotime":1622140200,"product":"RALTEGRAVIR POTASSIUM CRYSTALLINE","address":"159, C.S.T. 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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":"Q1","strtotime":1646764200,"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":"NA","customer":"CIPLA","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1200","totalValueFC":"6033.9","currency":"USD","unitRateINR":"91980","date":"09-Mar-2022","totalValueINR":"459900","totalValueInUsd":"6033.9","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"7794978","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":"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":"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","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":"2023","qtr":"Q2","strtotime":1681669800,"product":"RALTEGRAVIR POTASSIUM","address":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta","city":"MEDAK","supplier":"ACEBRIGHT GROUP","supplierCountry":"CHINA","foreign_port":"NA","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"2900","totalValueFC":"2931.7","currency":"USD","unitRateINR":"240265","date":"17-Apr-2023","totalValueINR":"240265","totalValueInUsd":"2931.7","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"5546728","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta"},{"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","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,"}]
24-Feb-2021
23-Oct-2024
KGS
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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Drugs in Development

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Details:

Raltegravir is an approved, small molecule, HIV-1 integrase inhibitor, available as a film coated tablet for the treatment of HIV in adult and paediatric patients weighing at least 40kg.


Lead Product(s): Raltegravir Potassium

Therapeutic Area: Infections and Infectious Diseases Brand Name: Raltegravir-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Zentiva

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 22, 2024

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01

Lupin Ltd

India
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euroPLX 86 Munich
Not Confirmed

Lupin Ltd

India
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euroPLX 86 Munich
Not Confirmed

Details : Raltegravir is an approved, small molecule, HIV-1 integrase inhibitor, available as a film coated tablet for the treatment of HIV in adult and paediatric patients weighing at least 40kg.

Brand Name : Raltegravir-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 22, 2024

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Details:

Corifarma and Midas entered into an exclusive out-licensing cooperation for the European territory. The respective product, Raltegravir, can be launched in the EU in 2023 as a generic and is used in treatment of HIV/AIDS.


Lead Product(s): Raltegravir Potassium

Therapeutic Area: Infections and Infectious Diseases Brand Name: Raltegravir-Generic

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Midas Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement September 23, 2020

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02

Coripharma

Iceland
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euroPLX 86 Munich
Not Confirmed

Coripharma

Iceland
arrow
euroPLX 86 Munich
Not Confirmed

Details : Corifarma and Midas entered into an exclusive out-licensing cooperation for the European territory. The respective product, Raltegravir, can be launched in the EU in 2023 as a generic and is used in treatment of HIV/AIDS.

Brand Name : Raltegravir-Generic

Molecule Type : Small molecule

Upfront Cash : Undisclosed

September 23, 2020

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INTERMEDIATES SUPPLIERS

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01

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed
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CAS Number : CAS-888504-28-7

End Use API : Raltegravir Potassium

About The Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutic...

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02

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed
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CAS Number : CAS-888504-27-6

End Use API : Raltegravir Potassium

About The Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutic...

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03

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed
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CAS Number : 762-42-5

End Use API : Raltegravir Potassium

About The Company : Chengda Pharmaceutical Co., Ltd. was founded in 1999. It is located in the Hangzhou-Jiaxing-Huzhou plain, Jiashan Economic & Technological Development Zone (nat...

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04

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed
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CAS Number : 888504-27-6

End Use API : Raltegravir Potassium

About The Company : TEXLAB INDUSTRIES was established in 1971, manufacturing & trading related business. TEXLAB INDUSTRIES - company launched by Late Shree AMBALAL MISTRY for local...

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05

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed
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CAS Number : 518048-02-7

End Use API : Raltegravir Potassium

About The Company : TEXLAB INDUSTRIES was established in 1971, manufacturing & trading related business. TEXLAB INDUSTRIES - company launched by Late Shree AMBALAL MISTRY for local...

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06

euroPLX 86 Munich
Not Confirmed
arrow
euroPLX 86 Munich
Not Confirmed
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CAS Number : 888504-28-7

End Use API : Raltegravir Potassium

About The Company : TEXLAB INDUSTRIES was established in 1971, manufacturing & trading related business. TEXLAB INDUSTRIES - company launched by Late Shree AMBALAL MISTRY for local...

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07

euroPLX 86 Munich
Not Confirmed
arrow
euroPLX 86 Munich
Not Confirmed
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CAS Number : 888504-28-7

End Use API : Raltegravir Potassium

About The Company : Jinan Chenghui Shuangda Chemical Co., Ltd is subordinate to Chengchuang Pharmaceutical Group, which is formally established in March, 2002. It is a high-tech en...

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08

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed
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CAS Number : 519032-08-7

End Use API : Raltegravir Potassium

About The Company : Jinan Chenghui Shuangda Chemical Co., Ltd is subordinate to Chengchuang Pharmaceutical Group, which is formally established in March, 2002. It is a high-tech en...

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09

euroPLX 86 Munich
Not Confirmed
arrow
euroPLX 86 Munich
Not Confirmed
arrow

CAS Number : 518048-02-7

End Use API : Raltegravir Potassium

About The Company : Jinan Chenghui Shuangda Chemical Co., Ltd is subordinate to Chengchuang Pharmaceutical Group, which is formally established in March, 2002. It is a high-tech en...

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10

euroPLX 86 Munich
Not Confirmed
arrow
euroPLX 86 Munich
Not Confirmed
arrow

CAS Number : 518048-03-8

End Use API : Raltegravir Potassium

About The Company : Jinan Chenghui Shuangda Chemical Co., Ltd is subordinate to Chengchuang Pharmaceutical Group, which is formally established in March, 2002. It is a high-tech en...

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FDA Orange Book

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01

BioFlorida Conference
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BioFlorida Conference
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RALTEGRAVIR

Brand Name : RALTEGRAVIR

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date :

Application Number : 203540

RX/OTC/DISCN :

RLD :

TE Code :

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02

BioFlorida Conference
Not Confirmed
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BioFlorida Conference
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LAMIVUDINE; RALTEGRAVIR POTASSIUM

Brand Name : DUTREBIS

Dosage Form : TABLET;ORAL

Dosage Strength : 150MG;EQ 300MG BASE

Approval Date : 2015-02-06

Application Number : 206510

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

BioFlorida Conference
Not Confirmed
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BioFlorida Conference
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RALTEGRAVIR POTASSIUM

Brand Name : ISENTRESS

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 2007-10-12

Application Number : 22145

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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04

BioFlorida Conference
Not Confirmed
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BioFlorida Conference
Not Confirmed

RALTEGRAVIR POTASSIUM

Brand Name : ISENTRESS HD

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 600MG BASE

Approval Date : 2017-05-26

Application Number : 22145

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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05

BioFlorida Conference
Not Confirmed
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BioFlorida Conference
Not Confirmed

RALTEGRAVIR POTASSIUM

Brand Name : ISENTRESS

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : EQ 25MG BASE

Approval Date : 2011-12-21

Application Number : 203045

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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06

BioFlorida Conference
Not Confirmed
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BioFlorida Conference
Not Confirmed

RALTEGRAVIR POTASSIUM

Brand Name : ISENTRESS

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2011-12-21

Application Number : 203045

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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07

BioFlorida Conference
Not Confirmed
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BioFlorida Conference
Not Confirmed

RALTEGRAVIR POTASSIUM

Brand Name : ISENTRESS

Dosage Form : POWDER;ORAL

Dosage Strength : EQ 100MG BASE/PACKET

Approval Date : 2013-12-20

Application Number : 205786

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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DRUG PRODUCT COMPOSITIONS

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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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Coating Systems & Additives

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Direct Compression

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Controlled & Modified Release

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Thickeners and Stabilizers

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Taste Masking

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Lubricants & Glidants

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Disintegrants & Superdisintegrants

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Chewable & Orodispersible Aids

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Film Formers & Plasticizers

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Co-Processed Excipients

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Solubilizers

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Rheology Modifiers

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Empty Capsules

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API Stability Enhancers

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Soft Gelatin

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Surfactant & Foaming Agents

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DATA COMPILATION #PharmaFlow

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