Msn Laboratories | Montelukast | Suppliers | APIs

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73 FDA Orange Book
368 Europe
48 Canada
11 Australia
73 South Africa
130 Listed Dossiers

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TABLET;ORAL - EQ 10MG BASE, TABLET, CHEWABLE;ORAL - EQ 4MG BASE, TABLET, CHEWABLE;ORAL - EQ 5MG BASE, GRANULE;ORAL - EQ 4MG BASE/PACKET

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TABLET;ORAL - EQ 10MG BASE
TABLET, CHEWABLE;ORAL - EQ 4MG BASE
TABLET, CHEWABLE;ORAL - EQ 5MG BASE
GRANULE;ORAL - EQ 4MG BASE/PACKET

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1 Minakem
4 Rochem International Inc
18 SPI Pharma
2 Seqens
11 DKSH
2 Jai Radhe Sales
1 Pharm-RX Chemical
2 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
14 Gangwal Healthcare
7 Nanjing Well Pharmaceutical
2 Pfanstiehl
1 ACG Worldwide
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10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
20 BASF
1 Bioplus Life Sciences
1 Clariant
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5 Ingredion Pharma Solutions
39 Kerry
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2 Nomisma Healthcare
3 Novo Excipients
3 Pharmatrans-Sanaq
8 Pluviaendo
5 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
25 Roquette
7 Seppic
6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
12 Sigachi Industries
2 The Dow Chemical Company
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334 Finished Drug Prices
10 Annual Reports

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3 BioAnalytical Methods

Synopsis

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703

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368

Europe

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South Africa

130

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12DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

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EDQM

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US Patents

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Health Canada Patents

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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 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 Formula	C₃₅H₃₅ClNNaO₃S
Molecular Weight	608.2 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	12
Exact Mass	607.1923871 g/mol
Monoisotopic Mass	607.1923871 g/mol
Topological Polar Surface Area	98.6 Å²
Heavy Atom Count	42
Formal Charge	0
Complexity	898
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Montelukast sodium
PubMed Health	Montelukast (By mouth)
Drug Classes	Anti-Inflammatory
Drug Label	Montelukast 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 Ingredient	Montelukast sodium
Dosage Form	Tablet; Granule; Tablet, chewable
Route	Oral
Strength	eq 4mg base; eq 5mg base; eq 4mg base/packet; eq 10mg base
Market Status	Prescription
Company	Vintage 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 Name	Singulair
Drug Label	Montelukast 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 Ingredient	Montelukast sodium
Dosage Form	Tablet; Granule; Tablet, chewable
Route	Oral
Strength	eq 4mg base; eq 5mg base; eq 4mg base/packet; eq 10mg base
Market Status	Prescription
Company	Merck

3 of 4
Drug Name	Montelukast sodium
PubMed Health	Montelukast (By mouth)
Drug Classes	Anti-Inflammatory
Drug Label	Montelukast 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 Ingredient	Montelukast sodium
Dosage Form	Tablet; Granule; Tablet, chewable
Route	Oral
Strength	eq 4mg base; eq 5mg base; eq 4mg base/packet; eq 10mg base
Market Status	Prescription
Company	Vintage 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 Name	Singulair
Drug Label	Montelukast 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 Ingredient	Montelukast sodium
Dosage Form	Tablet; Granule; Tablet, chewable
Route	Oral
Strength	eq 4mg base; eq 5mg base; eq 4mg base/packet; eq 10mg base
Market Status	Prescription
Company	Merck

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]

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Montelukast Sodium Thiol Acid

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16243

Submission : 2002-11-15

Status : Active

Type : II

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Dr Reddys Laboratories Ltd

India

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Montelukast Sodium [process-2]

GDUFA

DMF Review : Complete

Rev. Date : 2015-02-18

Pay. Date : 2012-12-31

DMF Number : 24516

Submission : 2010-12-31

Status : Active

Type : II

03

Apotex Pharmachem Inc

Canada

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Not Confirmed

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Tianish Laboratories Private Ltd

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API Reference Price

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LIMITED","customerCountry":"INDIA","quantity":"478.00","actualQuantity":"478","unit":"KGS","unitRateFc":"679.5","totalValueFC":"327579.2","currency":"USD","unitRateINR":"57286","date":"02-Jul-2024","totalValueINR":"27382700","totalValueInUsd":"327579.2","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29334900","bill_no":"1002142","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANNING WUXU INTERNATIONAL APT, 45","supplierAddress":"NO.1 NORTH OUTER RING ROAD FEIXIAN COUNTRY SHANDONG CHINA CN","customerAddress":"PLOT NO.2, MAITRIVIHAR,"}]

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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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 10MG BASE

USFDA APPLICATION NUMBER - 20829

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

USFDA APPLICATION NUMBER - 20830

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

USFDA APPLICATION NUMBER - 20830

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

USFDA APPLICATION NUMBER - 21409

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Excipients by Applications

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Fillers, Diluents & Binders

Coating Systems & Additives

Direct Compression

Disintegrants & Superdisintegrants

Controlled & Modified Release

01

Gangwal Healthcare

India

CPhI Worldwide, Milan

Booth #6F24

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Co-Processed Excipients, Controlled & Modified Release, Direct Compression

Brand Name : DiCOM-DC® SR300

Application : Co-Processed Excipients, Controlled & Modified Release, Direct Compression

Excipient Details : DiCOM-DC SR300 is used as a directly compressible, rate-controlling, and co-processed excipient in sustained-release tablets and capsules.

Pharmacopoeia Ref : In-house

Technical Specs : NA

Ingredient(s) : EthylCellulose

02

Nanjing Well Pharmaceutical

China

CPhI Worldwide, Milan

Booth #4A116

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgel Capsule, Softgels

Grade : Parenteral, Topical, Oral

Category : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Brand Name : Polyethylene Glycol 400

Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical

Excipient Details : PEG 400 is used as a suspending agent, stabilizer, plasticizer and filler in OSDs, liquids & semi-solids and as a solvent for parenteral formulations.

Pharmacopoeia Ref : ChP/USP/EP

Technical Specs : NA

Ingredient(s) : Polyethylene Glycol 400

03

Gangwal Healthcare

India

CPhI Worldwide, Milan

Booth #6F24

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Granule / Pellet, Tablet

Grade : Oral

Category : Controlled & Modified Release

Brand Name : Gellets-P®

Application : Controlled & Modified Release

Excipient Details : Gellets-P are Microcrystalline Cellulose based spheres for the manufacturing of pellets and modified release products.

Pharmacopoeia Ref : In-house

Technical Specs : NA

Ingredient(s) : Microcrystalline Cellulose

Excipients Web Link

India

ASC 2024

Not Confirmed

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

Granulation

Taste Masking

Thickeners and Stabilizers

Lubricants & Glidants

Chewable & Orodispersible Aids

Co-Processed Excipients

Film Formers & Plasticizers

Topical

Parenteral

Solubilizers

API Stability Enhancers

Coloring Agents

Emulsifying Agents

Empty Capsules

Vegetarian Capsules

Rheology Modifiers

Surfactant & Foaming Agents

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Global Sales Information

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US Medicaid Prescriptions

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USP

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ANALYTICAL

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BioAnalytical Methods

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ABOUT THIS PAGE

Montelukast Manufacturers | Traders | Suppliers

We have 71 companies offering Montelukast

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List of API Suppliers of Montelukast API listed on PharmaCompass.com

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

87 API Suppliers

33 USDMF

19 CEP/COS

19 JDMF

17 EU WC

23 KDMF

20 NDC API

49 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

INTERMEDIATES

25 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

703 FDF Dossiers

73 FDA Orange Book

368 Europe

48 Canada

11 Australia

73 South Africa

130 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE

TABLET, CHEWABLE;ORAL - EQ 4MG BASE

TABLET, CHEWABLE;ORAL - EQ 5MG BASE

GRANULE;ORAL - EQ 4MG BASE/PACKET

RELATED EXCIPIENT COMPANIES

1 Minakem

4 Rochem International Inc

18 SPI Pharma

2 Seqens

11 DKSH

2 Jai Radhe Sales

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14 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 ACG Worldwide

6 Actylis

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20 BASF

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10 Corel Pharma Chem

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2 Finar

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7 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

39 Kerry

3 Kima Chemical

6 Lonza Capsugel

14 Microlex e.U

1 NEWEDGE Overseas

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

8 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

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25 Roquette

7 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

12 Sigachi Industries

2 The Dow Chemical Company

4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS