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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]

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ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737743400,"product":"MONTELUKAST SODIUM USP","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"SHANDONG NEW TIME PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"ZHENGZHOU","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"495.00","actualQuantity":"495","unit":"KGS","unitRateFc":"630","totalValueFC":"314999.3","currency":"USD","unitRateINR":"54873","date":"25-Jan-2025","totalValueINR":"27162135","totalValueInUsd":"314999.3","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29334900","bill_no":"7988141","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZHENGZHOU","supplierAddress":"NO 1 NORTH OUTER RING ROAD FEI COUNTY SHANDONG SDNF","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"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 LTD","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,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747420200,"product":"MONTELUKAST SODIUM USP MONTELUKAST SODIUM USP","address":"UNICHEM BHAVAN, S. 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ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749580200,"product":"MONTELUKAST SODIUM USP (QTY:400 KGS) ASPER INV","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CHINA PHARMA SHANGHAI CO LTD","supplierCountry":"CHINA","foreign_port":"SHENZHEN","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"400.00","actualQuantity":"400","unit":"KGS","unitRateFc":"577","totalValueFC":"233014.9","currency":"USD","unitRateINR":"50054.8","date":"11-Jun-2025","totalValueINR":"20021900","totalValueInUsd":"233014.9","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29333990","bill_no":"2579287","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHENZHEN","supplierAddress":"OFFICE 402, NO. 110, ZHAOHUA ROAD CHANGNING DISTRICT, SHANGHAI, CHINA SDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1753295400,"product":"MONTELUKAST SODIUM USP (QTY:450 KGS)","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CHINA PHARMA SHANGHAI CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AUROBINDO PHARMA LTD","customerCountry":"INDIA","quantity":"450.00","actualQuantity":"450","unit":"KGS","unitRateFc":"577","totalValueFC":"261864.6","currency":"USD","unitRateINR":"50083.6","date":"24-Jul-2025","totalValueINR":"22537620","totalValueInUsd":"261864.6","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29333990","bill_no":"3457968","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE 402, NO. 110, ZHAOHUA ROAD CHANGNING DISTRICT, SHANGHAI, CHINA SDNF China","customerAddress":"PLOT NO.2, MAITRIVIHAR,"}]
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    29-Jul-2025
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    ABOUT THIS PAGE

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

    Montelukast Sodium manufacturers, exporters & distributors 1

    88

    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 Sodium Manufacturers

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

    Montelukast Sodium Suppliers

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

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

    Montelukast Sodium USDMF

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

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

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

    Montelukast Sodium 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 Sodium Drug Master File in Japan (Montelukast Sodium JDMF) empowers Montelukast Sodium 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 Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Montelukast Sodium 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 Sodium suppliers with JDMF on PharmaCompass.

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

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

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

    Montelukast Sodium CEP

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

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

    Montelukast Sodium WC

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

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

    Montelukast Sodium 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 Sodium as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Montelukast Sodium GMP

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

    Montelukast Sodium CoA

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

    Montelukast Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Montelukast Sodium 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 Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Montelukast Sodium EP), Montelukast Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Montelukast Sodium 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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