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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
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
| Molecular Weight | 608.2 g/mol |
|---|---|
| Molecular Formula | C35H35ClNNaO3S |
| 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 Ų |
| 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 |
| 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 |
Asthma
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.)
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USDMF
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : N/A
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DMF Number : 16243
Submission : 2002-11-15
Status : Active
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2017-10-20
Pay. Date : 2017-02-22
DMF Number : 31413
Submission : 2017-05-09
Status : Active
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
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DMF Number : 19829
Submission : 2006-10-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-22
Pay. Date : 2012-12-03
DMF Number : 21702
Submission : 2008-06-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-04
Pay. Date : 2015-04-29
DMF Number : 20580
Submission : 2007-06-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-22
Pay. Date : 2013-11-12
DMF Number : 22484
Submission : 2009-02-05
Status : Active
Type : II
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DMF Review : N/A
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DMF Number : 21893
Submission : 2008-08-14
Status : Inactive
Type : II
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DMF Review : N/A
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DMF Number : 20564
Submission : 2007-05-31
Status : Inactive
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DMF Review : Complete
Rev. Date : 2013-07-11
Pay. Date : 2013-06-26
DMF Number : 20425
Submission : 2007-03-26
Status : Active
Type : II
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Drugs in Development
Details:
Montelukast VersaFilm (montelukast) is a small molecule CysLT1 receptor inhibitor, given in the form of buccal film, is currently being ivestigated for patients with alzheimer's disease.
Lead Product(s): Montelukast Sodium
Therapeutic Area: Neurology Brand Name: Montelukast VersaFilm
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 03, 2024
Lead Product(s) : Montelukast Sodium
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
IntelGenx Reports Preliminary Results for Montelukast VersaFilm® in Alzheimer’s Disease
Details : Montelukast VersaFilm (montelukast) is a small molecule CysLT1 receptor inhibitor, given in the form of buccal film, is currently being ivestigated for patients with alzheimer's disease.
Brand Name : Montelukast VersaFilm
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 03, 2024
Details:
Montelukast VersaFilm (montelukast) is a leukotriene receptor antagonist, which is being evaluated in patients with Parkinson’s Disease, the second most common neurodegenerative disease.
Lead Product(s): Montelukast Sodium
Therapeutic Area: Neurology Brand Name: Montelukast VersaFilm
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2024
Lead Product(s) : Montelukast Sodium
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
IntelGenx Doses First Parkinson’s Patients with Montelukast VersaFilm in Phase 2 Trial
Details : Montelukast VersaFilm (montelukast) is a leukotriene receptor antagonist, which is being evaluated in patients with Parkinson’s Disease, the second most common neurodegenerative disease.
Brand Name : Montelukast VersaFilm
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 08, 2024
Details:
VersaFilm® (montelukast) is a leukotriene receptor antagonist, which is completed patient enrollment in the ongoing Phase 2a clinical trial in patients with mild to moderate Alzheimer’s Disease.
Lead Product(s): Montelukast Sodium
Therapeutic Area: Neurology Brand Name: Montelukast VersaFilm
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2023
Lead Product(s) : Montelukast Sodium
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
IntelGenx Receives Approval to Conduct MONTPARK™ Montelukast VersaFilm® Phase 2 Clinical Trial ...
Details : VersaFilm® (montelukast) is a leukotriene receptor antagonist, which is completed patient enrollment in the ongoing Phase 2a clinical trial in patients with mild to moderate Alzheimer’s Disease.
Brand Name : Montelukast VersaFilm
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 14, 2023
Details:
The agreement aims for the co-development and commercialization of cannabinoid-infused VersaFilm® products, including CBD VersaFilm (cannabinoid), a unique drug opportunity for the treatment of neurodegenerative diseases of the brain.
Lead Product(s): Montelukast Sodium
Therapeutic Area: Neurology Brand Name: CBD VersaFilm
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Tilray
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement November 06, 2023
Lead Product(s) : Montelukast Sodium
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Tilray
Deal Size : Undisclosed
Deal Type : Licensing Agreement
IntelGenx Announces Co-development and Commercialization of Cannabinoid-Infused VersaFilm® Produc...
Details : The agreement aims for the co-development and commercialization of cannabinoid-infused VersaFilm® products, including CBD VersaFilm (cannabinoid), a unique drug opportunity for the treatment of neurodegenerative diseases of the brain.
Brand Name : CBD VersaFilm
Molecule Type : Small molecule
Upfront Cash : Undisclosed
November 06, 2023
Details:
VersaFilm® (montelukast) is a leukotriene receptor antagonist, which is completed patient enrollment in the ongoing Phase 2a clinical trial in patients with mild to moderate Alzheimer’s Disease.
Lead Product(s): Montelukast Sodium
Therapeutic Area: Neurology Brand Name: Montelukast VersaFilm
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 01, 2023
Lead Product(s) : Montelukast Sodium
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
IntelGenx Completes Enrollment for ‘BUENA’ Montelukast VersaFilm® Phase 2a Clinical Trial in ...
Details : VersaFilm® (montelukast) is a leukotriene receptor antagonist, which is completed patient enrollment in the ongoing Phase 2a clinical trial in patients with mild to moderate Alzheimer’s Disease.
Brand Name : Montelukast VersaFilm
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 01, 2023
Details:
The agreement aims to investigate the use of IntelGenx’s Montelukast VersaFilm, a leukotriene receptor antagonist, for the treatment of Parkinson’s Disease.
Lead Product(s): Montelukast Sodium
Therapeutic Area: Neurology Brand Name: Montelukast VersaFilm
Study Phase: IND EnablingProduct Type: Small molecule
Sponsor: Karolinska University Hospital
Deal Size: $2.0 million Upfront Cash: Undisclosed
Deal Type: Agreement July 25, 2023
Lead Product(s) : Montelukast Sodium
Therapeutic Area : Neurology
Highest Development Status : IND Enabling
Partner/Sponsor/Collaborator : Karolinska University Hospital
Deal Size : $2.0 million
Deal Type : Agreement
IntelGenx Provides Update on Research Collaboration Evaluating Montelukast VersaFilm® for the Tre...
Details : The agreement aims to investigate the use of IntelGenx’s Montelukast VersaFilm, a leukotriene receptor antagonist, for the treatment of Parkinson’s Disease.
Brand Name : Montelukast VersaFilm
Molecule Type : Small molecule
Upfront Cash : Undisclosed
July 25, 2023
Details:
Upon completion of the Study, IntelGenx will retain the intellectual property rights and use the findings to further develop its Montelukast VersaFilm® program for Parkinson's disease treatment.
Lead Product(s): Montelukast Sodium
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Karolinska Institute
Deal Size: $2.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration February 09, 2023
Lead Product(s) : Montelukast Sodium
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Karolinska Institute
Deal Size : $2.0 million
Deal Type : Collaboration
Details : Upon completion of the Study, IntelGenx will retain the intellectual property rights and use the findings to further develop its Montelukast VersaFilm® program for Parkinson's disease treatment.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Undisclosed
February 09, 2023
Details:
Resumption of patient dosing in the ongoing Phase 2a (BUENA) clinical trial of Montelukast VersaFilm, a leukotriene receptor antagonist on the basis of Phase 1 study data that reduces the first-pass-effect and has a 52% higher bioavailability.
Lead Product(s): Montelukast Sodium
Therapeutic Area: Neurology Brand Name: Montelukast-Generic
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 20, 2022
Lead Product(s) : Montelukast Sodium
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
First Patient Dosed in IntelGenx’s Resumed ‘BUENA’ Montelukast VersaFilm® Phase 2a Clinical...
Details : Resumption of patient dosing in the ongoing Phase 2a (BUENA) clinical trial of Montelukast VersaFilm, a leukotriene receptor antagonist on the basis of Phase 1 study data that reduces the first-pass-effect and has a 52% higher bioavailability.
Brand Name : Montelukast-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 20, 2022
Details:
In Phase 1 studies, an oral film formulation of Montelukast is safe and tolerable in healthy subjects, reduces the first-pass-effect and has a 52% higher bioavailability compared to the Montelukast tablet, demonstrating a clear advantage of delivering Montelukast via film.
Lead Product(s): Montelukast Sodium
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2021
Lead Product(s) : Montelukast Sodium
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Patient Screening to Resume in IntelGenx’s ‘BUENA’ Montelukast VersaFilm® Phase 2a Clinical...
Details : In Phase 1 studies, an oral film formulation of Montelukast is safe and tolerable in healthy subjects, reduces the first-pass-effect and has a 52% higher bioavailability compared to the Montelukast tablet, demonstrating a clear advantage of delivering Mo...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 12, 2021
Details:
Data suggest Montelukast may inhibit mental decline, higher doses optimal for clinical trials assessing impact on neurological disease.
Lead Product(s): Montelukast Sodium
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2020
Lead Product(s) : Montelukast Sodium
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
IntelGenx Announces Publication of a Study Evaluating Montelukast’s Effect on Neurological Aging
Details : Data suggest Montelukast may inhibit mental decline, higher doses optimal for clinical trials assessing impact on neurological disease.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 09, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
2-[2-[3(S)-3[2-(7-chloro-2-quinolinyl) ethenyl] ph...
CAS Number : 142569-70-8
End Use API : Montelukast Sodium
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
2-(2-[3(S)-[2-(7-Chloro 2quiolinyl ethnyl)Phenyl}3...
CAS Number : 287930-77-2
End Use API : Montelukast Sodium
About The Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API...
4-Methoxy benzene sulfonyl chloride
CAS Number : 98-68-0
End Use API : Montelukast Sodium
About The Company : Our journey began in 1969, with our first manufacturing facility Jet Chemicals Pvt. Ltd (JCPL), a pioneer in manufacturing Pharmaceutical Excipients (Saccharin ...
4 - Methoxy benzene sulfonyl chloride
CAS Number : CAS-98-68-0
End Use API : Montelukast Sodium
About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...
1-(Mercaptomethyl)cyclopropane acetic acid
CAS Number : 162515-68-6
End Use API : Montelukast Sodium
About The Company : Ceyone Life Sciences specializes in providing research-oriented chemistry services and manufacturing niche chemicals, intermediates, and APIs. The company is fo...
(S)-1-(3-(2-(7-Chloroquinolin-2-yl)vinyl) phenyl)-...
CAS Number : 142569-70-8
End Use API : Montelukast Sodium
About The Company : Ceyone Life Sciences specializes in providing research-oriented chemistry services and manufacturing niche chemicals, intermediates, and APIs. The company is fo...
2-(2-[3(S)-[2-(7-Chloro 2Quiolinyl Ethnyl)Phenyl}3...
CAS Number :
End Use API : Montelukast Sodium
About The Company : Hoventa Pharma is in the business of manufacturing APIs for over three decades.We offer various kinds of services in addition to supplies of APIs, we undertake ...
Methyl2-(3-(3-(2-(7-Chloro 2 Quinolinyl) Ethenyl )...
CAS Number :
End Use API : Montelukast Sodium
About The Company : Hoventa Pharma is in the business of manufacturing APIs for over three decades.We offer various kinds of services in addition to supplies of APIs, we undertake ...
1-(Thiomethyl)-Cyclopropane Acetic Acid
CAS Number :
End Use API : Montelukast Sodium
About The Company : Hoventa Pharma is in the business of manufacturing APIs for over three decades.We offer various kinds of services in addition to supplies of APIs, we undertake ...
2-(2-(3(S)-(3-(2-(7-chloro-2-quinolinyl) ethenyl)p...
CAS Number : 142569-70-8
End Use API : Montelukast Sodium
About The Company : Kopalle Pharma is a trusted manufacturer of Active Pharma Ingredients (API’s) & Intermediates. Kopalle Pharma Chemicals Pvt Ltd is an ISO 9001:2015 Certified ...
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Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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Registration Country : Iran
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Dosage Form : Chewable Tablet
Dosage Strength : 5MG
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Registration Country : Iran
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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Dosage : Chewable Tablet
Dosage Strength : 5MG
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Registration Country : Iran
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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Registration Country : Iran
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Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
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Registration Country : Iran
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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Dosage : Film Coated Tablet
Dosage Strength : 10MG
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Registration Country : Iran
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
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Dosage Form : Chewable Tablet
Dosage Strength : 4MG
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Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
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Regulatory Info : Registered in EU
Dosage : Chewable Tablet
Dosage Strength : 4MG
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Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
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Dosage Form : Chewable Tablet
Dosage Strength : 5MG
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Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
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Regulatory Info : Registered in EU
Dosage : Chewable Tablet
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Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
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Dosage Form : Film Coated Tablet
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Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
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Regulatory Info : Registered in EU
Dosage : Film Coated Tablet
Dosage Strength : 10MG
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Registration Country : Germany
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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Registration Country : India
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Dosage Form : Chewable Tablet
Dosage Strength : 4MG
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Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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Dosage : Chewable Tablet
Dosage Strength : 4MG
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Registration Country : India
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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Dosage Form : Chewable Tablet
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Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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Dosage : Tablet
Dosage Strength : 10MG
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Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
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Dosage Form : Film Coated Tablet
Dosage Strength : 10MG
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Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : EU Approved
Dosage : Film Coated Tablet
Dosage Strength : 10MG
Brand Name :
Approval Date :
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Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info : EU Approved
Registration Country : Greece
Brand Name :
Dosage Form : Chewable Tablet
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : EU Approved
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info : EU Approved
Dosage : Chewable Tablet
Dosage Strength : 4MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Greece
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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ANALYTICAL
ABOUT THIS PAGE
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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 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.
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).
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