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ACTIVE PHARMA INGREDIENTS

13 API Suppliers, 1 USDMF, 2 CEP/COS, 1 EU WC, 1 KDMF, 3 NDC API, 11 Listed Suppliers, $ API Reference Price

13 API Suppliers
1 USDMF
2 CEP/COS
1 EU WC
1 KDMF
3 NDC API
11 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

14 FDF Dossiers, 1 FDA Orange Book, 10 Europe, 3 Listed Dossiers

14 FDF Dossiers
1 FDA Orange Book
10 Europe
3 Listed Dossiers

RELATED EXCIPIENT COMPANIES

2 Seqens, 3 Actylis, 8 BASF, 1 Finar, 1 Gangwal Chemicals, 2 Nomisma Healthcare

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2 Seqens
3 Actylis
8 BASF
1 Finar
1 Gangwal Chemicals
2 Nomisma Healthcare

EXCIPIENTS BY APPLICATIONS

7 Topical, 4 Solubilizers, 4 Thickeners and Stabilizers, 4 Controlled & Modified Release, 2 Parenteral, 1 Coating Systems & Additives, 1 Film Formers & Plasticizers, 1 Granulation

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4 Solubilizers
4 Thickeners and Stabilizers
4 Controlled & Modified Release
2 Parenteral
1 Coating Systems & Additives
1 Film Formers & Plasticizers
1 Granulation

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1 DATA COMPILATION #PharmaFlow

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1 DATA COMPILATION #PharmaFlow

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 11 Finished Drug Prices

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1 US Medicaid Prescriptions
11 Finished Drug Prices

MARKET PLACE

11 APIs

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11 APIs

REF. STANDARDS & IMPURITIES

1 EDQM

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1 EDQM

Inabata Sertaconazole Nitrate

Synopsis

ACTIVE PHARMA INGREDIENTS

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EU WC

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VMF

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API REF. PRICE (USD/KG)

$ 809

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FDF

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FDF Dossiers

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Europe

Canada

Australia

South Africa

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DRUG PRODUCT COMPOSITIONS

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EDQM

USP

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PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

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News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

301,496

Annual Reports (USD Million)

Finished Drug Prices

17 RELATED EXCIPIENT COMPANIES

24EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 99592-39-9, Dermofix, Ertaczo, Zalain, Sertaconazole mononitrate, Ginedermofix

Molecular Formula

C₂₀H₁₆Cl₃N₃O₄S

Molecular Weight

500.8 g/mol

InChI Key

HAAITRDZHUANGT-UHFFFAOYSA-N

FDA UNII

1DV05410M5

Sertaconazole Nitrate is the nitrate salt form of sertaconazole, a synthetic imidazole derivative with antifungal property. Sertaconazole nitrate inhibits fungal cytochrome P-450 sterol C-14 alpha-demethylation, resulting in the accumulation of fungal 14 alpha-methyl sterols and the inhibition of ergosterol synthesis, an essential component of the cell membrane of fungi. This leads to a disruption of cell membrane permeability and leakage of adenine triphosphate (ATP) and other constituents from fugal cells.

1 2D Structure

Sertaconazole Nitrate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

1-[2-[(7-chloro-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole;nitric acid

2.1.2 InChI

InChI=1S/C20H15Cl3N2OS.HNO3/c21-14-4-5-16(18(23)8-14)19(9-25-7-6-24-12-25)26-10-13-11-27-20-15(13)2-1-3-17(20)22;2-1(3)4/h1-8,11-12,19H,9-10H2;(H,2,3,4)

2.1.3 InChI Key

HAAITRDZHUANGT-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1=CC2=C(C(=C1)Cl)SC=C2COC(CN3C=CN=C3)C4=C(C=C(C=C4)Cl)Cl.[N+](=O)(O)[O-]

2.2 Other Identifiers

2.2.1 UNII

1DV05410M5

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Dermofix

2. Dermoseptic

3. Ginedermofix

4. Mykosert

5. Sertaconazole

6. Sertaconazole Mononitrate

7. Zalain

2.3.2 Depositor-Supplied Synonyms

1. 99592-39-9

2. Dermofix

3. Ertaczo

4. Zalain

5. Sertaconazole Mononitrate

6. Ginedermofix

7. Dermovit

8. Fi 7056

9. Sertaconazole (nitrate)

10. Fi-7045

11. 99592-39-9 (nitrate)

12. 1-[2-[(7-chloro-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole;nitric Acid

13. 1dv05410m5

14. Fi-7056

15. 1-[2-[(7-chloro-1-benzothien-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-1h-imidazole Nitrate

16. 1h-imidazole, 1-(2-((7-chlorobenzo(b)thien-3-yl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-, Mononitrate

17. Dermoseptic

18. 1-{2-[(7-chloro-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl}-1h-imidazole; Nitric Acid

19. Fisderm

20. Extens

21. Onabet

22. Sr-05000001439

23. Unii-1dv05410m5

24. Sertaconazolenitrate

25. Ertaczo (tn)

26. Zalain (tn)

27. 1-(2-((7-chlorobenzo[b]thiophen-3-yl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-1h-imidazole Nitrate

28. 1h-imidazole, 1-(2-((7-chlorobenzo(b)thien-3-yl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-, Nitrate (1:1)

29. Ncgc00016966-01

30. Cas-99592-39-9

31. Dsstox_cid_25529

32. Dsstox_rid_80932

33. Dsstox_gsid_45529

34. Mls002154122

35. Schembl261807

36. Chembl1200725

37. Dtxsid2045529

38. Hy-b0736a

39. Hms1571a12

40. Hms2098a12

41. Hms2231n14

42. Hms3372h01

43. Hms3715a12

44. Sertaconazole Nitrate [mi]

45. Amy32537

46. Bcp09311

47. Tox21_110718

48. Ac-739

49. Fi7056

50. Mfcd00918063

51. S3161

52. Sertaconazole Nitrate [mart.]

53. Akos015888158

54. Akos015964610

55. Sertaconazole Nitrate [who-dd]

56. Ccg-221045

57. 1-[2-[(7-chloro-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole; Nitric Acid

58. As-14332

59. Smr001233429

60. Sertaconazole Nitrate [orange Book]

61. Sertaconazole Nitrate [ep Monograph]

62. Ft-0674558

63. D08510

64. F20635

65. A846049

66. A851341

67. Sr-05000001439-3

68. Q27252298

69. 1-(2-((7-chlorobenzo(b)thien-3-yl)methoxy)-2-(2,4-dichlorophenyl)ethyl)-1h-imidazole Mononitrate

70. 1-[2-[(7-chloranyl-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole; Nitric Acid

71. 1-[2-[(7-chloro-1-benzothiophen-3-yl)methoxy]-2-(2,4-dichlorophenyl)ethyl]imidazole,nitric Acid

2.3.3 Other Synonyms

1. Sertaconazole

2. Sertaconazol

3. Demofix

2.4 Create Date

2005-08-09

3 Chemical and Physical Properties

Molecular Formula	C₂₀H₁₆Cl₃N₃O₄S
Molecular Weight	500.8 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	6
Exact Mass	498.992710 g/mol
Monoisotopic Mass	498.992710 g/mol
Topological Polar Surface Area	121 Å²
Heavy Atom Count	31
Formal Charge	0
Complexity	513
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
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 2
Drug Name	Ertaczo
PubMed Health	Sertaconazole (On the skin)
Drug Classes	Antifungal
Drug Label	ERTACZO (sertaconazole nitrate) Cream, 2%, contains the imidazole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers.Sertaconazole nit...
Active Ingredient	Sertaconazole nitrate
Dosage Form	Cream
Route	Topical
Strength	2%
Market Status	Prescription
Company	Valeant Luxembourg

2 of 2
Drug Name	Ertaczo
PubMed Health	Sertaconazole (On the skin)
Drug Classes	Antifungal
Drug Label	ERTACZO (sertaconazole nitrate) Cream, 2%, contains the imidazole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers.Sertaconazole nit...
Active Ingredient	Sertaconazole nitrate
Dosage Form	Cream
Route	Topical
Strength	2%
Market Status	Prescription
Company	Valeant Luxembourg

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

Azoles [CS]; Azole Antifungal [EPC]

API SUPPLIERS

01

Inabata France S.A.S

France

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HRV Global Life Sciences

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Aspen Biopharma Labs

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Optimus Pharma

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Interquim Sa

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Sertaconazole Nitrate

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 11808

Submission : 1996-01-09

Status : Active

Type : II

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PHARMASYNTHESE Saint Pierre Les Elb...

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Sertaconazole nitrate, Micronised

Certificate Number : R1-CEP 2015-066 - Rev 00

Status : Valid

Issue Date : 2022-06-23

Type : Chemical

Substance Number : 1148

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Sertaconazole nitrate

Certificate Number : R2-CEP 1995-011 - Rev 03

Status : Valid

Issue Date : 2022-04-05

Type : Chemical

Substance Number : 1148

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API Reference Price

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