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Chemistry

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Also known as: 151767-02-1, Singulair, Montair, Montelukast sodium salt, Montelukast sodium [usan], Montelukast (sodium)
Molecular Formula
C35H35ClNNaO3S
Molecular Weight
608.2  g/mol
InChI Key
LBFBRXGCXUHRJY-HKHDRNBDSA-M
FDA UNII
U1O3J18SFL

Montelukast Sodium
Montelukast Sodium is the orally bioavailable monosodium salt of montelukast, a selective cysteinyl leukotriene receptor antagonist with anti-inflammatory and bronchodilating activities. Montelukast selectively and competitively blocks the cysteinyl leukotriene 1 (CysLT1) receptor, preventing binding of the inflammatory mediator leukotriene D4 (LTD4). Inhibition of LTD4 activity results in inhibition of leukotriene-mediated inflammatory events including: migration of eosinophils and neutrophils; adhesion of leukocytes to vascular endothelium, monocyte and neutrophil aggregation; increased airway edema; increased capillary permeability; and bronchoconstriction. The CysLT1 receptor is found in a number of tissues including spleen, lung, placenta, small intestine, and nasal mucosa, and in a variety of cell types including monocyte/macrophages, mast cells, eosinophils, CD34-positive hemopoietic progenitor cells, neutrophils and endothelial cells.
1 2D Structure

Montelukast Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;2-[1-[[(1R)-1-[3-[(E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetate
2.1.2 InChI
InChI=1S/C35H36ClNO3S.Na/c1-34(2,40)30-9-4-3-7-25(30)13-17-32(41-23-35(18-19-35)22-33(38)39)27-8-5-6-24(20-27)10-15-29-16-12-26-11-14-28(36)21-31(26)37-29;/h3-12,14-16,20-21,32,40H,13,17-19,22-23H2,1-2H3,(H,38,39);/q;+1/p-1/b15-10+;/t32-;/m1./s1
2.1.3 InChI Key
LBFBRXGCXUHRJY-HKHDRNBDSA-M
2.1.4 Canonical SMILES
CC(C)(C1=CC=CC=C1CCC(C2=CC=CC(=C2)C=CC3=NC4=C(C=CC(=C4)Cl)C=C3)SCC5(CC5)CC(=O)[O-])O.[Na+]
2.1.5 Isomeric SMILES
CC(C)(C1=CC=CC=C1CC[C@H](C2=CC=CC(=C2)/C=C/C3=NC4=C(C=CC(=C4)Cl)C=C3)SCC5(CC5)CC(=O)[O-])O.[Na+]
2.2 Other Identifiers
2.2.1 UNII
U1O3J18SFL
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1-((((1r)-1-(3-((e)-2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)-cyclopropaneacetic Acid

2. Mk 0476

3. Mk-0476

4. Montelukast

5. Singulair

6. Sodium 1-(((1-(3-(2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropylacetate

2.3.2 Depositor-Supplied Synonyms

1. 151767-02-1

2. Singulair

3. Montair

4. Montelukast Sodium Salt

5. Montelukast Sodium [usan]

6. Montelukast (sodium)

7. Mk-476

8. Mk-0476

9. Montelukast Na

10. Montelukast (as Sodium)

11. Montelukast Monosodium Salt

12. U1o3j18sfl

13. Chebi:6993

14. Sodium (r,e)-2-(1-(((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)thio)methyl)cyclopropyl)acetate

15. 151767-02-1 (sodium)

16. Singular

17. Nsc-759107

18. Dsstox_cid_26450

19. Dsstox_rid_81624

20. Dsstox_gsid_46450

21. Cyclopropaneacetic Acid, 1-(((1-(3-(2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)-, Sodium Salt, (r-(e))-

22. Kokast

23. Mls001304727

24. Sodium (r,e)-2-(1-((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propylthio)methyl)cyclopropyl)acetate

25. Cas-151767-02-1

26. Cyclopropaneacetic Acid, 1-[[[(1r)-1-[3-[(1e)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-, Sodium Salt (1:1)

27. Smr000469188

28. Sodium;2-[1-[[(1r)-1-[3-[(e)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanylmethyl]cyclopropyl]acetate

29. Mk 476

30. Unii-u1o3j18sfl

31. Mk 0476

32. Kipres

33. Lukasm

34. Mfcd00931431

35. Singulair (tn)

36. Cpd000469188

37. Ncgc00164568-01

38. Montelukast Sodium- Bio-x

39. Schembl9414

40. Schembl9415

41. Mls001424198

42. Sodium 1-((((r)-m-((e)-2-(7-chloro-2-quinolyl)vinyl)-alpha-(o-(1-hydroxy-1-methylethyl)phenethyl)benzyl)thio)methyl)cyclopropaneacetate

43. Chembl1200681

44. Dtxsid8046450

45. Montelukast Sodium [jan]

46. Montelukast Sodium (jp17/usp)

47. Hms2051f18

48. Hms2235h19

49. Hms3885d11

50. Montelukast Sodium [vandf]

51. Montelukast Sodium [mart.]

52. Act06295

53. Montelukast Sodium [usp-rs]

54. Montelukast Sodium [who-dd]

55. Tox21_112197

56. Mk0476

57. S4211

58. Akos015833416

59. Akos032949734

60. Tox21_112197_1

61. Am62787

62. Bcp9000959

63. Ccg-101049

64. Cs-0548

65. Ks-1087

66. Nc00299

67. Nsc 759107

68. Montelukast Monosodium Salt [mi]

69. Montelukast Sodium [orange Book]

70. Montelukast Sodium [ep Monograph]

71. Ncgc00164568-04

72. Bm164606

73. Cyclopropaneacetic Acid, 1-((((1r)-1-(3-((1e)-2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)-, Monosodium Salt

74. Hy-13315

75. Montelukast Sodium [usp Monograph]

76. M2340

77. Sw197679-2

78. 2-[1-[[[1-[3-[2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]thio]methyl]cyclopropyl]acetate; Sodium

79. D00529

80. J-008841

81. J-522711

82. L-706631

83. Q27107384

84. 1-((((1r)-1-(3-((1e)-2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic Acid Monosodium Salt

85. 1-[[[(1r)-1-[3-[(1e)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetic Acid Sodium Salt

86. 1-[[[(r)-1-[3-[2-(7-chloro-2-quinolyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-1-cyclopropaneacetic Acid Sodium Salt

87. Cyclopropaneacetic Acid,1-[[[(1r)-1-[3-[(1e)-2-(7-chloro-2-quinolinyl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]-,sodium Salt

88. Sodium {1-[({(1r)-1-{3-[(e)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl}-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl}sulfanyl)methyl]cyclopropyl}acetate

89. Sodium 1-((((r)-m -((e)-2-(7-chloro-2-quinolyl)vinyl)-alpha-(o-(1-hydroxy-1-methylethyl)phenethyl)benzyl)thio)methyl)cyclopropaneacetate

90. Sodium 1-((((r)-m-((e)-2-(7-chloro-2-quinolyl)vinyl)-.alpha.-(o-(1-hydroxy-1-methylethyl)phenethyl)benzyl)thio)methyl)cyclopropaneacetate

91. Sodium 1-[[[(1r)-1-[3-[(1e)-2-(7-chloroquinoline-2-yl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]thio]methyl]cyclopropaneacetate

92. Sodium 2-(1-((((r)-1-(3-((e)-2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)sulfanyl)methyl)cyclopropyl)acetate

93. Sodium(r,e)-2-(1-(((1-(3-(2-(7-chloroquinolin-2-yl)vinyl)phenyl)-3-(2-(2-hydroxypropan-2-yl)phenyl)propyl)thio)methyl)cyclopropyl)acetate

2.4 Create Date
2008-02-05
3 Chemical and Physical Properties
Molecular Weight 608.2 g/mol
Molecular Formula C35H35ClNNaO3S
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count5
Rotatable Bond Count12
Exact Mass607.1923871 g/mol
Monoisotopic Mass607.1923871 g/mol
Topological Polar Surface Area98.6 Ų
Heavy Atom Count42
Formal Charge0
Complexity898
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameMontelukast sodium
PubMed HealthMontelukast (By mouth)
Drug ClassesAnti-Inflammatory
Drug LabelMontelukast sodium, the active ingredient in montelukast sodium tablets and montelukast sodium chewable tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.Montelukast sodi...
Active IngredientMontelukast sodium
Dosage FormTablet; Granule; Tablet, chewable
RouteOral
Strengtheq 4mg base; eq 5mg base; eq 4mg base/packet; eq 10mg base
Market StatusPrescription
CompanyVintage Pharms; Mylan Pharms; Hetero Labs Ltd V; Apotex; Accord Hlthcare; Aurobindo Pharma; Torrent Pharms; Sandoz; Roxane; Glenmark Generics; Teva Pharms; Macleods Pharms; Kudco Ireland; Dr Reddys Labs

2 of 4  
Drug NameSingulair
Drug LabelMontelukast sodium, the active ingredient in SINGULAIRRegistered trademark of MERCK & CO., Inc.COPYRIGHT 1998-2009 MERCK & CO., Inc.All rights reserved, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl
Active IngredientMontelukast sodium
Dosage FormTablet; Granule; Tablet, chewable
RouteOral
Strengtheq 4mg base; eq 5mg base; eq 4mg base/packet; eq 10mg base
Market StatusPrescription
CompanyMerck

3 of 4  
Drug NameMontelukast sodium
PubMed HealthMontelukast (By mouth)
Drug ClassesAnti-Inflammatory
Drug LabelMontelukast sodium, the active ingredient in montelukast sodium tablets and montelukast sodium chewable tablets, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene CysLT1 receptor.Montelukast sodi...
Active IngredientMontelukast sodium
Dosage FormTablet; Granule; Tablet, chewable
RouteOral
Strengtheq 4mg base; eq 5mg base; eq 4mg base/packet; eq 10mg base
Market StatusPrescription
CompanyVintage Pharms; Mylan Pharms; Hetero Labs Ltd V; Apotex; Accord Hlthcare; Aurobindo Pharma; Torrent Pharms; Sandoz; Roxane; Glenmark Generics; Teva Pharms; Macleods Pharms; Kudco Ireland; Dr Reddys Labs

4 of 4  
Drug NameSingulair
Drug LabelMontelukast sodium, the active ingredient in SINGULAIRRegistered trademark of MERCK & CO., Inc.COPYRIGHT 1998-2009 MERCK & CO., Inc.All rights reserved, is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl
Active IngredientMontelukast sodium
Dosage FormTablet; Granule; Tablet, chewable
RouteOral
Strengtheq 4mg base; eq 5mg base; eq 4mg base/packet; eq 10mg base
Market StatusPrescription
CompanyMerck

4.2 Drug Indication

Asthma


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Asthmatic Agents

Drugs that are used to treat asthma. (See all compounds classified as Anti-Asthmatic Agents.)


Cytochrome P-450 CYP1A2 Inducers

Drugs and compounds that induce the synthesis of CYTOCHROME P-450 CYP1A2. (See all compounds classified as Cytochrome P-450 CYP1A2 Inducers.)


Leukotriene Antagonists

A class of drugs designed to prevent leukotriene synthesis or activity by blocking binding at the receptor level. (See all compounds classified as Leukotriene Antagonists.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Leukotriene Receptor Antagonists [MoA]; Leukotriene Receptor Antagonist [EPC]

API Reference Price

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V. ROAD","city":"MUMBAI,MAHARASHTRA.","supplier":"LINHAI TIANYU PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"UNICHEM LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"460.00","actualQuantity":"460","unit":"KGS","unitRateFc":"570","totalValueFC":"264699.2","currency":"USD","unitRateINR":"48222","date":"21-Sep-2024","totalValueINR":"22182120","totalValueInUsd":"264699.2","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"5722758","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.15, DONGHAI 5TH AVENUE, ZHEJIANG PROVINCIAL CHEMICAL AND MEDICAL RA W MATERIALS BASE TAIZHOU CITY, ZHEJ China","customerAddress":"UNICHEM BHAVAN, S. V. ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730226600,"product":"MONTELUKAST SODIUM","address":"UNICHEM BHAVAN, S. V. ROAD","city":"MUMBAI,MAHARASHTRA.","supplier":"LINHAI TIANYU PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"UNICHEM LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"540.00","actualQuantity":"540","unit":"KGS","unitRateFc":"570","totalValueFC":"311182.7","currency":"USD","unitRateINR":"48421.5","date":"30-Oct-2024","totalValueINR":"26147610","totalValueInUsd":"311182.7","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"6425262","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.15, DONGHAI 5TH AVENUE, ZHEJIANG PROVINCIAL CHEMICAL AND MEDICAL RA W MATERIALS BASE TAIZHOU CITY, ZHEJ China","customerAddress":"UNICHEM BHAVAN, S. V. ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730226600,"product":"MONTELUKAST SODIUM USP","address":"UNICHEM BHAVAN, S. V. ROAD","city":"MUMBAI,MAHARASHTRA.","supplier":"LINHAI TIANYU PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"UNICHEM LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"570","totalValueFC":"86439.6","currency":"USD","unitRateINR":"48421.5","date":"30-Oct-2024","totalValueINR":"7263225","totalValueInUsd":"86439.6","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"6425534","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.15, DONGHAI 5TH AVENUE, ZHEJIANG PROVINCIAL CHEMICAL AND MEDICAL RA W MATERIALS BASE TAIZHOU CITY, ZHEJ China","customerAddress":"UNICHEM BHAVAN, S. V. ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737570600,"product":"MONTELUKAST SODIUM USP MONTELUKAST SODIUM USP","address":"UNICHEM BHAVAN, S. V. ROAD","city":"MUMBAI,MAHARASHTRA.","supplier":"LINHAI TIANYU PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"UNICHEM LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"1100.00","actualQuantity":"1100","unit":"KGS","unitRateFc":"570","totalValueFC":"633331.9","currency":"USD","unitRateINR":"49647","date":"23-Jan-2025","totalValueINR":"54611700","totalValueInUsd":"633331.9","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"7941541","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.15, DONGHAI 5TH AVENUE, ZHEJIANG PROVINCIAL CHEMICAL AND MEDICAL RA W MATERIALS BASE TAIZHOU CITY, ZHEJ","customerAddress":"UNICHEM BHAVAN, S. V. ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737916200,"product":"MONTELUKAST SODIUM USP,LOT NO.MSBP23001R,MFG.DT:JUNE 2023,RETEST-MAY 2026(RE-IMPORT CASE)MONTELUKAST SODIUM USP-RE-IMPORT CASE","address":"SC0-99-100, SECTOR 17-B,","city":"CHANDIGARH.","supplier":"ZAFA PHARMACEUTICALS LABORATORIES","supplierCountry":"INDIA","foreign_port":"KARACHI -","customer":"AKUMS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"440","totalValueFC":"11111.1","currency":"USD","unitRateINR":"38324","date":"27-Jan-2025","totalValueINR":"958100","totalValueInUsd":"11111.1","indian_port":"Delhi Air","hs_no":"29420090","bill_no":"8028782","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"KARACHI -","supplierAddress":"PVT.LTD.,L-1\/B FEDERAL B INDUSTRIAL AREA,KARACHI 75950,PAKISTAN ,","customerAddress":"SC0-99-100, SECTOR 17-B,"}]
03-Jan-2022
30-Apr-2025
KGS
overview
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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

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API Imports and Exports

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

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FDA Orange Book

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01

BRECKENRIDGE

U.S.A

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2020-10-30

Application Number : 205319

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Breckenridge Pharmaceutical

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

RLD : No

TE Code :

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2012-08-03

Application Number : 91576

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

RLD : No

TE Code :

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : EQ 4MG BASE

Approval Date : 2012-08-03

Application Number : 91588

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Flag India
Digital Content Digital Content

RLD : No

TE Code :

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2012-08-03

Application Number : 91588

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

05

FCE Pharma
Not Confirmed
arrow
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FCE Pharma
Not Confirmed

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2015-09-04

Application Number : 204604

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

FCE Pharma
Not Confirmed
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FCE Pharma
Not Confirmed

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2014-09-11

Application Number : 203366

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

RISING

U.S.A
FCE Pharma
Not Confirmed
arrow

RISING

U.S.A
arrow
FCE Pharma
Not Confirmed

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 10MG BASE

Approval Date : 2017-04-24

Application Number : 209012

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

blank

08

SANDOZ INC

Switzerland
FCE Pharma
Not Confirmed
arrow

SANDOZ INC

Switzerland
arrow
FCE Pharma
Not Confirmed

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : EQ 4MG BASE

Approval Date : 2012-08-03

Application Number : 91414

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

blank

09

SANDOZ INC

Switzerland
FCE Pharma
Not Confirmed
arrow

SANDOZ INC

Switzerland
arrow
FCE Pharma
Not Confirmed

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2012-08-03

Application Number : 91414

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

blank

10

FCE Pharma
Not Confirmed
arrow
arrow
FCE Pharma
Not Confirmed

MONTELUKAST SODIUM

Brand Name : MONTELUKAST SODIUM

Dosage Form : TABLET, CHEWABLE;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2012-08-06

Application Number : 201581

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Europe

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01

Helvepharm AG

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Montelukast

Brand Name : Montelukast Helvepharm

Dosage Form : Film-Coated Tablets

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

02

Helvepharm AG

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Montelukast

Brand Name : Montelukast Helvepharm

Dosage Form : Film-Coated Tablets

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

03

Helvepharm AG

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Montelukast

Brand Name : Montelukast Zentiva

Dosage Form : Filmtabl

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

04

Helvepharm AG

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : Switzerland

Montelukast

Brand Name : Montelukast Zentiva

Dosage Form : Filmtabl

Dosage Strength : 10mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

Sanofi Company Banner

05

montelukastnatrium

Brand Name : Montelukast Orion

Dosage Form : TUGGTABLETT

Dosage Strength : 5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

06

montelukastnatrium

Brand Name : Montelukast Orion

Dosage Form : TABLETT

Dosage Strength : 10 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

07

montelukastnatrium

Brand Name : Montelukast Orion

Dosage Form : TUGGTABLETT

Dosage Strength : 4 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Fermion Orion Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

MONTELUKAST SODIUM

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 4MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

MONTELUKAST SODIUM

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner

10

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

Flag Germany
Digital Content Digital Content

Regulatory Info : Registered in EU

Registration Country : Germany

MONTELUKAST SODIUM

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Registered in EU

Registration Country : Germany

Tiefenbacher Compnay Banner
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Listed Dossiers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Flag Iran
Digital Content Digital Content

Regulatory Info :

Registration Country : Iran

Montelukast

Brand Name :

Dosage Form : Chewable Tablet

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

Faran Shimi Pharmaceutical

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Flag Iran
Digital Content Digital Content

Packaging :

Regulatory Info :

Montelukast

Dosage : Chewable Tablet

Dosage Strength : 5MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Iran

Faran Shimi Pharmaceutical

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Flag Iran
Digital Content Digital Content

Regulatory Info :

Registration Country : Iran

Montelukast

Brand Name :

Dosage Form : Film Coated Tablet

Dosage Strength : 10MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Iran

Faran Shimi Pharmaceutical

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Flag Iran
Digital Content Digital Content

Packaging :

Regulatory Info :

Montelukast

Dosage : Film Coated Tablet

Dosage Strength : 10MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Iran

Faran Shimi Pharmaceutical

03

  • fda
  • EDQM
  • WHO-GMP

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 10MG BASE

USFDA APPLICATION NUMBER - 20829

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DOSAGE - TABLET, CHEWABLE;ORAL - EQ 4MG BASE

USFDA APPLICATION NUMBER - 20830

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DOSAGE - TABLET, CHEWABLE;ORAL - EQ 5MG BASE

USFDA APPLICATION NUMBER - 20830

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DOSAGE - GRANULE;ORAL - EQ 4MG BASE/PACKET

USFDA APPLICATION NUMBER - 21409

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ABOUT THIS PAGE

Looking for 151767-02-1 / Montelukast Sodium API manufacturers, exporters & distributors?

Montelukast Sodium manufacturers, exporters & distributors 1

22

PharmaCompass offers a list of Montelukast Sodium 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 Montelukast Sodium manufacturer or Montelukast Sodium supplier for your needs.

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

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

API | Excipient name

Montelukast Sodium

Synonyms

151767-02-1, Singulair, Montair, Montelukast sodium salt, Montelukast sodium [usan], Montelukast (sodium)

Cas Number

151767-02-1

Unique Ingredient Identifier (UNII)

U1O3J18SFL

About Montelukast Sodium

Montelukast Sodium is the orally bioavailable monosodium salt of montelukast, a selective cysteinyl leukotriene receptor antagonist with anti-inflammatory and bronchodilating activities. Montelukast selectively and competitively blocks the cysteinyl leukotriene 1 (CysLT1) receptor, preventing binding of the inflammatory mediator leukotriene D4 (LTD4). Inhibition of LTD4 activity results in inhibition of leukotriene-mediated inflammatory events including: migration of eosinophils and neutrophils; adhesion of leukocytes to vascular endothelium, monocyte and neutrophil aggregation; increased airway edema; increased capillary permeability; and bronchoconstriction. The CysLT1 receptor is found in a number of tissues including spleen, lung, placenta, small intestine, and nasal mucosa, and in a variety of cell types including monocyte/macrophages, mast cells, eosinophils, CD34-positive hemopoietic progenitor cells, neutrophils and endothelial cells.

Montelukast Manufacturers

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

Montelukast Suppliers

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

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

Montelukast USDMF

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

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

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

Montelukast JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Montelukast Drug Master File in Japan (Montelukast JDMF) empowers Montelukast API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Montelukast JDMF during the approval evaluation for pharmaceutical products. At the time of Montelukast JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Montelukast suppliers with JDMF on PharmaCompass.

Montelukast KDMF

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

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

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

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

Montelukast CEP

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

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

Montelukast WC

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

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

Montelukast 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 Montelukast as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Montelukast GMP

Montelukast 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 Montelukast 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 Montelukast GMP manufacturer or Montelukast GMP API supplier for your needs.

Montelukast CoA

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

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

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