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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

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 Formula	C₂₀H₂₁FN₆O₅
Molecular Weight	444.4 g/mol
XLogP3	1.1
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	9
Rotatable Bond Count	6
Exact Mass	444.15574595 g/mol
Monoisotopic Mass	444.15574595 g/mol
Topological Polar Surface Area	150 Å²
Heavy Atom Count	32
Formal Charge	0
Complexity	836
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Isentress
PubMed Health	Raltegravir (By mouth)
Drug Classes	Antiretroviral Agent
Drug Label	ISENTRESS 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 Ingredient	Raltegravir potassium
Dosage Form	Tablet; Powder; Tablet, chewable
Route	Oral
Strength	eq 100mg base; eq 400mg base; eq 100mg base/packet; eq 25mg base
Market Status	Prescription
Company	Merck Sharp Dohme

2 of 4
Drug Name	Raltegravir
PubMed Health	Raltegravir (By mouth)
Drug Classes	Antiretroviral Agent
Drug Label	ISENTRESS 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 Ingredient	Raltegravir
Dosage Form	Tablet
Route	Oral
Strength	400mg
Market Status	Tentative Approval
Company	Hetero Labs Ltd Iii

3 of 4
Drug Name	Isentress
PubMed Health	Raltegravir (By mouth)
Drug Classes	Antiretroviral Agent
Drug Label	ISENTRESS 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 Ingredient	Raltegravir potassium
Dosage Form	Tablet; Powder; Tablet, chewable
Route	Oral
Strength	eq 100mg base; eq 400mg base; eq 100mg base/packet; eq 25mg base
Market Status	Prescription
Company	Merck Sharp Dohme

4 of 4
Drug Name	Raltegravir
PubMed Health	Raltegravir (By mouth)
Drug Classes	Antiretroviral Agent
Drug Label	ISENTRESS 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 Ingredient	Raltegravir
Dosage Form	Tablet
Route	Oral
Strength	400mg
Market Status	Tentative Approval
Company	Hetero 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/

/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.

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.

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.

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.

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.

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.

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.

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.

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CEP/COS

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EU WC

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KDMF

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NDC API

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Listed Suppliers

01

LGM Pharma

U.S.A

BioFlorida Conference

Attending

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

Contact Supplier

U.S.A

Virtual Booth

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.

02

HRV Global Life Sciences

India

CPhI India 2024

Booth #2.D38

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

Contact Supplier

India

Virtual Booth

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 and 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 and the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.

03

Arene Lifesciences

India

SupplySide West 2024

Not Confirmed

04

Lee Pharma

India

SupplySide West 2024

Not Confirmed

Not Confirmed

Only 10 entries up to this point, click to access all

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API Reference Price

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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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DOSAGE - TABLET;ORAL - EQ 400MG BASE

USFDA APPLICATION NUMBER - 22145

DOSAGE - TABLET;ORAL - EQ 600MG BASE

USFDA APPLICATION NUMBER - 22145

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers

10 USDMF

1 CEP/COS

5 EU WC

4 KDMF

8 NDC API

21 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

INTERMEDIATES

17 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

29 FDF Dossiers

7 FDA Orange Book

13 Europe

3 Canada

2 Australia

3 South Africa

1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 400MG BASE

TABLET;ORAL - EQ 600MG BASE

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2 Pfanstiehl

1 ACG Worldwide

5 Actylis

1 Aeon Procare

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6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

6 BASF

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5 DFE Pharma

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2 Novo Excipients

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6 Pluviaendo

4 Prachin Chemical

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5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

3 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

3 The Dow Chemical Company

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EXCIPIENTS BY APPLICATIONS

72 Fillers, Diluents & Binders

56 Coating Systems & Additives

33 Direct Compression

26 Controlled & Modified Release

25 Thickeners and Stabilizers

25 Taste Masking