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ACTIVE PHARMA INGREDIENTS

13 API Suppliers, 3 USDMF, 4 JDMF, 1 KDMF, 2 NDC API, 7 Listed Suppliers, $ API Reference Price

13 API Suppliers
3 USDMF
4 JDMF
1 KDMF
2 NDC API
7 Listed Suppliers
$ API Reference Price

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

8 FDF Dossiers, 5 FDA Orange Book, 3 Listed Dossiers

8 FDF Dossiers
5 FDA Orange Book
3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;TOPICAL - 1%, CREAM;TOPICAL - 1%

drugProductComposition
CREAM;TOPICAL - 1%
CREAM;TOPICAL - 1%

RELATED EXCIPIENT COMPANIES

2 DKSH, 2 Nanjing Well Pharmaceutical, 4 Actylis, 5 BASF, 2 Finar, 1 Gangwal Chemicals, 6 Kerry, 2 Microlex e.U, 1 Pluviaendo, 4 Roquette, 1 Valens Pharmachem

relatedExcipients
2 DKSH
2 Nanjing Well Pharmaceutical
4 Actylis
5 BASF
2 Finar
1 Gangwal Chemicals
6 Kerry
2 Microlex e.U
1 Pluviaendo
4 Roquette
1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

12 Topical, 8 Film Formers & Plasticizers, 7 Coating Systems & Additives, 5 Solubilizers, 5 Parenteral, 5 Co-Processed Excipients, 3 Thickeners and Stabilizers, 3 Lubricants & Glidants, 2 Fillers, Diluents & Binders, 1 Controlled & Modified Release, 1 Granulation, 1 Direct Compression, 1 Emulsifying Agents

excipientsByApplications
12 Topical
8 Film Formers & Plasticizers
7 Coating Systems & Additives
5 Solubilizers
5 Parenteral
5 Co-Processed Excipients
3 Thickeners and Stabilizers
3 Lubricants & Glidants
2 Fillers, Diluents & Binders
1 Controlled & Modified Release
1 Granulation
1 Direct Compression
1 Emulsifying Agents

DIGITAL CONTENT

1 NEWS #PharmaBuzz

media
1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

globalSalesInformation
1 US Medicaid Prescriptions

MARKET PLACE

4 APIs

marketPlace
4 APIs

REF. STANDARDS & IMPURITIES

1 Others

otherSolutions
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 463

MARKET PLACE

API

FDF

2INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

104,858

Annual Reports (USD Million)

Finished Drug Prices

30 RELATED EXCIPIENT COMPANIES

54EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 101827-46-7, Butenafine hcl, Mentax, Kp-363, Butenafine (hydrochloride), Volley

Molecular Formula

C₂₃H₂₈ClN

Molecular Weight

353.9 g/mol

InChI Key

LJBSAUIFGPSHCN-UHFFFAOYSA-N

FDA UNII

R8XA2029ZI

Butenafine Hydrochloride is the hydrochloride salt form of butenafine, a synthetic benzylamine derivative with fungicidal properties. Butenafine hydrochloride interferes with the biosynthesis of ergosterol, an important component of fungal cell membranes, by inhibiting the epoxidation of squalene. This alters fungal membrane permeability and causes growth inhibition. Butenafine hydrochloride is active against a number of dermatophytes, including Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis, Sporothrix schenckii, and yeasts, including Candida albicans and C. parapsilosis.

1 2D Structure

Butenafine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

1-(4-tert-butylphenyl)-N-methyl-N-(naphthalen-1-ylmethyl)methanamine;hydrochloride

2.1.2 InChI

InChI=1S/C23H27N.ClH/c1-23(2,3)21-14-12-18(13-15-21)16-24(4)17-20-10-7-9-19-8-5-6-11-22(19)20;/h5-15H,16-17H2,1-4H3;1H

2.1.3 InChI Key

LJBSAUIFGPSHCN-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC(C)(C)C1=CC=C(C=C1)CN(C)CC2=CC=CC3=CC=CC=C32.Cl

2.2 Other Identifiers

2.2.1 UNII

R8XA2029ZI

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Butenafine

2. Butenafine Hcl

3. Kp 363

4. Kp-363

5. Mentax

6. N-(p-tert-butylbenzyl)-n-methyl-1-naphthalenemethylamine

7. N-4-tert-butylbenzyl-n-methyl-1-naphthalene Methylamine Hydrochloride

2.3.2 Depositor-Supplied Synonyms

1. 101827-46-7

2. Butenafine Hcl

3. Mentax

4. Kp-363

5. Butenafine (hydrochloride)

6. Volley

7. N-(p-tert-butylbenzyl)-n-methyl-1-naphthalenemethylamine Hydrochloride

8. Chebi:31325

9. R8xa2029zi

10. N-(4-(tert-butyl)benzyl)-n-methyl-1-(naphthalen-1-yl)methanamine Hydrochloride

11. 1-(4-tert-butylphenyl)-n-methyl-n-(naphthalen-1-ylmethyl)methanamine Hydrochloride

12. 1-(4-tert-butylphenyl)-n-methyl-n-(naphthalen-1-ylmethyl)methanamine;hydrochloride

13. N-(4-tert-butylbenzyl)-n-methyl-1-(naphthalen-1-yl)methanamine Hydrochloride

14. 1-naphthalenemethanamine, N-((4-(1,1-dimethylethyl)phenyl)methyl)-n-methyl-, Hydrochloride

15. N-(4-t-butylbenzyl)-n-methyl-1-naphthalenemethylamine Hydrochloride;n-(4-t-butylbenzyl)-n-methyl-1-naphthalenemethylamine Hydrochloride

16. Butenafine Hydrochloide

17. Unii-r8xa2029zi

18. Butenafine Hydrochloride [usan]

19. 1-(4-tert-butylphenyl)-n-methyl-n-(1-naphthalenylmethyl)methanamine Hydrochloride

20. Butenafine Hydrochloride [usan:jan]

21. Mentax (tn)

22. Mfcd00917064

23. Volley (tn)

24. 1-(4-tert-butylphenyl)-n-methyl-n-(1-naphthylmethyl)methanamine

25. Kp363 (hydrochloride)

26. N-4-tert-butylbenzyl-n-methyl-1-naphthalenemethylamine Hydrochloride

27. Surecn1648813

28. Dsstox_cid_28515

29. Dsstox_rid_82787

30. Dsstox_gsid_48589

31. Mls003899213

32. Schembl262301

33. Chembl1200397

34. Dtxsid2048589

35. Kp363

36. Bcp22699

37. Tox21_112918

38. Butenafine Hydrochloride [mi]

39. S3154

40. Butenafine Hydrochloride [jan]

41. Akos015895328

42. Ab07686

43. Ac-2116

44. Bcp9000464

45. Butenafine Hydrochloride (jp17/usan)

46. Ccg-220604

47. Cs-1124

48. Ks-1035

49. Sb83656

50. Butenafine Hydrochloride [mart.]

51. Butenafine Hydrochloride [vandf]

52. N-((4-(1,1-dimethylethyl)phenyl)methyl)-n-methyl-1-naphthalenemethanamine Hydrochloride

53. Butenafine Hydrochloride [who-dd]

54. 1-naphthalenemethanamine, N-[[4-(1,1-dimethylethyl)phenyl]methyl]-n-methyl-, Hydrochloride (1:1)

55. Hy-17396

56. Smr002204106

57. Butenafine Hydrochloride, >=98% (hplc)

58. Cas-101827-46-7

59. Ft-0631017

60. Ft-0699734

61. Sw199070-2

62. Butenafine Hydrochloride [orange Book]

63. D01093

64. 827b467

65. A800463

66. A800464

67. J-000499

68. Q27114276

69. 4-tert-butylbenzyl(methyl)(1-naphthalenemethyl)amine Hydrochloride

70. N-(4-tert-butylbenzyl)-n-methyl-1-naphthylmethylamine Hydrochloride

71. N-4-t-butylbenzyl-n-methyl-1-naphthalenemethylamine Hydrochloride

72. (4-tert-butylphenyl)-n-methyl-n-(naphthalen-1-ylmethyl)methanaminium Chloride

73. 1-(4-tert-butylphenyl)-n-methyl-n-(naphthalen-1-ylmethyl)methanamine,hydrochloride

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₂₃H₂₈ClN
Molecular Weight	353.9 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	1
Rotatable Bond Count	5
Exact Mass	353.1910276 g/mol
Monoisotopic Mass	353.1910276 g/mol
Topological Polar Surface Area	3.2 Å²
Heavy Atom Count	25
Formal Charge	0
Complexity	374
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Lotrimin ultra
PubMed Health	Butenafine (On the skin)
Drug Classes	Antifungal
Active Ingredient	Butenafine hydrochloride
Dosage Form	Cream
Route	Topical
Strength	1%
Market Status	Over the Counter
Company	Schering Plough

2 of 4
Drug Name	Mentax
PubMed Health	Butenafine (On the skin)
Drug Classes	Antifungal
Drug Label	Mentax Cream, 1%, contains the synthetic antifungal agent, butenafine hydrochloride. Butenafine is a member of the class of antifungal compounds known as benzylamines which are structurally related to the allylamines.Butenafine HCl is designated ch...
Active Ingredient	Butenafine hydrochloride
Dosage Form	Cream
Route	topical; Topical
Strength	1%
Market Status	Prescription
Company	Mylan Bertek; Mylan

3 of 4
Drug Name	Lotrimin ultra
PubMed Health	Butenafine (On the skin)
Drug Classes	Antifungal
Active Ingredient	Butenafine hydrochloride
Dosage Form	Cream
Route	Topical
Strength	1%
Market Status	Over the Counter
Company	Schering Plough

4 of 4
Drug Name	Mentax
PubMed Health	Butenafine (On the skin)
Drug Classes	Antifungal
Drug Label	Mentax Cream, 1%, contains the synthetic antifungal agent, butenafine hydrochloride. Butenafine is a member of the class of antifungal compounds known as benzylamines which are structurally related to the allylamines.Butenafine HCl is designated ch...
Active Ingredient	Butenafine hydrochloride
Dosage Form	Cream
Route	topical; Topical
Strength	1%
Market Status	Prescription
Company	Mylan Bertek; Mylan

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antifungal Agents

Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Benzylamines [CS]; Benzylamine Antifungal [EPC]

API SUPPLIERS

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USDMF

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JDMF

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"850","totalValueFC":"8.7","currency":"USD","unitRateINR":"71315","date":"29-Oct-2022","totalValueINR":"713.15","totalValueInUsd":"8.7","indian_port":"BOMBAY AIR","hs_no":"29214990","bill_no":"3078682","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678300200,"product":"BUTENAFINE HYDROCHLORIDE BATCH A230002 (BUTENAFINE HYDROCHLORIDE (API)","address":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:","city":"MUMBAI","supplier":"ERREGIERRE SPA","supplierCountry":"ITALY","foreign_port":"NA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"900","totalValueFC":"1827.3","currency":"USD","unitRateINR":"75150","date":"09-Mar-2023","totalValueINR":"150300","totalValueInUsd":"1827.3","indian_port":"BOMBAY AIR","hs_no":"29214990","bill_no":"4971476","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"B\/2 MAHALAXMI CHAMBERS 22 BHULABHAI DESAI ROAD Contact No:"}]

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API Imports and Exports

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

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CREAM;TOPICAL - 1%

USFDA APPLICATION NUMBER - 20524

DOSAGE - CREAM;TOPICAL - 1%

USFDA APPLICATION NUMBER - 21307

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Butenafine Hydrochloride

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

13 API Suppliers

3 USDMF

4 JDMF

1 KDMF

2 NDC API

7 Listed Suppliers

$ API Reference Price

INTERMEDIATES

2 Intermediates Suppliers

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5 FDA Orange Book

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CREAM;TOPICAL - 1%

CREAM;TOPICAL - 1%

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EXCIPIENTS BY APPLICATIONS

12 Topical

8 Film Formers & Plasticizers

7 Coating Systems & Additives

5 Solubilizers

5 Parenteral

5 Co-Processed Excipients

3 Thickeners and Stabilizers

3 Lubricants & Glidants

2 Fillers, Diluents & Binders

1 Controlled & Modified Release

1 Granulation

1 Direct Compression

1 Emulsifying Agents

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1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

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API REF. PRICE (USD/KG)

$ 463

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