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Chemistry

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Also known as: 22916-47-8, Monistat, Monistat iv, Daktarin iv, Miconazol, Miconazolo
Molecular Formula
C18H14Cl4N2O
Molecular Weight
416.1  g/mol
InChI Key
BYBLEWFAAKGYCD-UHFFFAOYSA-N
FDA UNII
7NNO0D7S5M

Miconazole
An imidazole antifungal agent that is used topically and by intravenous infusion.
Miconazole is an Azole Antifungal.
1 2D Structure

Miconazole

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]imidazole
2.1.2 InChI
InChI=1S/C18H14Cl4N2O/c19-13-2-1-12(16(21)7-13)10-25-18(9-24-6-5-23-11-24)15-4-3-14(20)8-17(15)22/h1-8,11,18H,9-10H2
2.1.3 InChI Key
BYBLEWFAAKGYCD-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC(=C(C=C1Cl)Cl)COC(CN2C=CN=C2)C3=C(C=C(C=C3)Cl)Cl
2.2 Other Identifiers
2.2.1 UNII
7NNO0D7S5M
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Brentan

2. Dactarin

3. Miconasil Nitrate

4. Miconazole Nitrate

5. Monistat

6. Nitrate, Miconasil

7. Nitrate, Miconazole

8. R 14,889

9. R-14,889

10. R14,889

2.3.2 Depositor-Supplied Synonyms

1. 22916-47-8

2. Monistat

3. Monistat Iv

4. Daktarin Iv

5. Miconazol

6. Miconazolo

7. Miconazolum

8. Minostate

9. Monistat-derm

10. 1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-1h-imidazole

11. Mjr 1762

12. Miconazolum [inn-latin]

13. Vusion

14. Florid(nitrate)

15. 1-(2-((2,4-dichlorobenzyl)oxy)-2-(2,4-dichlorophenyl)ethyl)-1h-imidazole

16. Brentan

17. R 18134

18. 1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]imidazole

19. Miconazole 3

20. Nsc 170986

21. Daktarin

22. Miconazole (monistat)

23. Miconazole 7

24. Monistat 3

25. Monistat 5

26. Monistat 7

27. Monistat 1 Combination Pack

28. Chembl91

29. Monistat (tn)

30. Mfcd00216019

31. Miconazole 7 Combination Pack

32. 1-(2,4-dichloro-beta-((2,4-dichlorobenzyl)oxy)phenethyl)imidazole

33. 7nno0d7s5m

34. R18134 Nitrate

35. 1h-imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl)methoxy)ethyl)-

36. 1h-imidazole, 1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-

37. Mcz

38. Dactarin

39. Chebi:82892

40. Monistat 3 Combination Pack

41. 22916-47-8 (free)

42. Nsc-170986

43. Miconazolo [dcit]

44. Ncgc00016770-01

45. Micozole

46. Zimycan

47. 1-(2,4-dichloro-beta-((2,4-dichlorobenzyl)oxy)phenethyl) Imidazole

48. Imidazole, 1-(2,4-dichloro-beta-((2,4-dichlorobenzyl)oxy)phenethyl)-

49. Femizol-m

50. Miconazole-7

51. Imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl)methoxy)ethyl)-

52. Monazole 7

53. 1-[2-(2,4-dichlorophenyl)-2-{[(2,4-dichlorophenyl)methyl]oxy}ethyl]-1h-imidazole

54. Miconazol [inn-spanish]

55. Oravig

56. Aflorix(nitrate)

57. 1-[2-(2,4-dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]-1h-imidazole

58. 1-{2-[(2,4-dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl}-1h-imidazole

59. Imidazole, 1-(2,4-dichloro-beta-((2,4-dichlorobenzyl)oxy) Phenethyl)-

60. Albistat(nitrate)

61. Andergin(nitrate)

62. Conofite(nitrate)

63. (+/-)-miconazole Nitrate Salt

64. 1h-imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl) Methoxy)ethyl)-

65. Imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl) Methoxy)ethyl)- (9ci)

66. Monista (nitrate)

67. Micantin (nitrate)

68. Novo-miconazole Vaginal Ovules

69. Ccris 7924

70. Gyno-daktar(nitrate)

71. Lotrimin Af(nitrate)

72. Nsc169434

73. Epi-monistat(nitrate)

74. Monistat 7 Vaginal Suppositories

75. Miconazole Nitrate Salt

76. Einecs 245-324-5

77. Unii-7nno0d7s5m

78. Brn 0965511

79. Zimybase

80. Miconazole Base

81. 1-(2,4-dichloro-beta-[(2,4-dichlorobenzyl)oxy]phenethyl)imidazole

82. Sr-01000000271

83. 1-(2-(2,4-dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl)-1h-imidazole

84. 1-[2-[(2,4-dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1h-imidazole

85. 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl)methoxy)ethyl)-1h-imidazole

86. Miconazole [usp:inn:ban:jan]

87. Prestwick_335

88. Oravig (tn)

89. Spectrum_000965

90. Miconazole [mi]

91. Miconazole [inn]

92. Miconazole [jan]

93. Prestwick0_000067

94. Prestwick1_000067

95. Prestwick2_000067

96. Prestwick3_000067

97. Spectrum2_001048

98. Spectrum3_000507

99. Spectrum4_000061

100. Spectrum5_001297

101. Dsstox_cid_3319

102. Miconazole [vandf]

103. Bmse000924

104. (+-)-1-(2,4-dichloro-beta-((2,4-dichlorobenzyl)oxy)phenethyl)imidazole

105. Cid_4189

106. Miconazole [mart.]

107. Schembl2866

108. Dsstox_rid_76975

109. Miconazole [who-dd]

110. Dsstox_gsid_23319

111. Oprea1_091955

112. Bspbio_000253

113. Bspbio_002033

114. Kbiogr_000581

115. Kbioss_001445

116. Mls002222203

117. Divk1c_000156

118. Spbio_000976

119. Spbio_002174

120. Bpbio1_000279

121. Gtpl2449

122. Miconazole (jp17/usp/inn)

123. Dtxsid6023319

124. Miconazole [ep Impurity]

125. Miconazole [orange Book]

126. Schembl13934598

127. Bdbm31772

128. Kbio1_000156

129. Kbio2_001445

130. Kbio2_004013

131. Kbio2_006581

132. Kbio3_001533

133. Miconazole [ep Monograph]

134. Miconazole [usp Impurity]

135. Ninds_000156

136. Hms1568m15

137. Hms2090b21

138. Hms2095m15

139. Hms2232b14

140. Hms3374j10

141. Hms3656e14

142. Hms3712m15

143. Miconazole [usp Monograph]

144. Hy-b0454

145. Tox21_110601

146. Dl-448

147. Nsc170986

148. S2536

149. Stk834405

150. 1-(2,4-dichlorophenyl)-1-[(2,4-dichlorophenyl)methoxy]-2-imidazolylethane

151. Akos001574474

152. Akos016842489

153. Ccg-220067

154. Db01110

155. Ds-1881

156. 1h-imidazole, 1-2-((2,4-dichlorophenyl)-2-((2,4-dichlorophenyl))methoxy)ethyl)-, (+-)-

157. Idi1_000156

158. Ncgc00018294-02

159. Ncgc00018294-04

160. Ncgc00018294-06

161. Ncgc00018294-08

162. 75319-47-0

163. Miconazole 100 Microg/ml In Acetonitrile

164. Nci60_001353

165. Nci60_001380

166. Smr001307249

167. Sbi-0051448.p003

168. Cas-22916-47-8

169. Db-046018

170. Ab00053500

171. Ft-0628942

172. Sw196614-4

173. D00416

174. R18134

175. Ab00053500-23

176. Ab00053500-24

177. Ab00053500-25

178. Ab00053500_26

179. Ab00053500_27

180. Ab00053500_28

181. 216m019

182. A878389

183. Ae-641/01941016

184. Q410534

185. J-014898

186. Sr-01000000271-5

187. Brd-a82396632-001-03-0

188. Brd-a82396632-008-02-7

189. 1-[2,4dichloro-beta-(2,4-dichlorobenzyloxy)phenethyl]imidazole

190. 1-[2,4-dichloro-beta-([2,4-dichlorobenzyl]oxy)-phenethyl]imidazole

191. 1-[2,4-dichloro-beta-(2,4-dichlorobenzyloxy)-phenethyl]imidazole

192. 1-[2,4-dichloro-beta-(2,4-dichlorobenzyloxy)phenethyl]-imidazole

193. 1-[2,4-dichloro-beta-(2,4-dichlorobenzyloxy)phenethyl]imidazole

194. Imidazole,4-dichloro-.beta.-[(2,4-dichlorobenzyl)oxy]phenethyl]-

195. 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl)methoxy)ethyl)-imidazol

196. 1-[2,4-dichloro-.beta.-[(2,4-dichlorobenzyl)oxy]phenethyl]imidazole

197. 1-[2,4-dichloro-beta-([2,4-dichlorobenzyl]oxy)-phenethyl] Imidazole

198. 1-[2-(2,4-dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]imidazole

199. 1h-imidazole,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-

200. Imidazole, 1-(2,4-dichloro-.beta.-((2,4-dichlorobenzyl)oxy)phenethyl)-

201. (+/-)-1-(2,4-dichloro-b-((2,4-dichlorobenzyl)oxy)phenethyl)imidazole

202. 1-[2-(2,4-dichloro-benzyloxy)-2-(2,4-dichloro-phenyl)-ethyl]-1h-imidazole

203. 1-[2-(2,4-dichlorobenzyl)oxy-2-(2,4-dichlorophenyl)ethyl]imidazole;nitric Acid

204. 1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)-methoxy]ethyl]-1h-imidazole

205. 1-[2-[(2,4-dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1h-imidazole #

206. Imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl)methoxy)ethyl)- (9ci)

207. 1h-imidazole, 1-2-((2,4-dichlorophenyl)-2-((2,4-dichlorophenyl))methoxy)ethyl)-, (+/-)-

208. Monistat, Daktarin Iv, Miconazolo, Miconazolum, Dactarin, Miconazol, Minostate, Brentan, Florid(nitrate)

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 416.1 g/mol
Molecular Formula C18H14Cl4N2O
XLogP35.3
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count2
Rotatable Bond Count6
Exact Mass415.983074 g/mol
Monoisotopic Mass413.986024 g/mol
Topological Polar Surface Area27 Ų
Heavy Atom Count25
Formal Charge0
Complexity417
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 22  
Drug NameMiconazole 3
PubMed HealthMiconazole/Zinc Oxide/White Petrolatum (On the skin)
Drug ClassesAntifungal
Active IngredientMiconazole nitrate
Dosage FormCream
RouteVaginal
Strength4%
Market StatusOver the Counter
CompanyTaro

2 of 22  
Drug NameMiconazole 3 combination pack
Active IngredientMiconazole nitrate
Dosage FormCream
RouteTopical, vaginal
Strength2%,4%
Market StatusOver the Counter
CompanyPerrigo

3 of 22  
Drug NameMiconazole 7
Active IngredientMiconazole nitrate
Dosage FormCream
RouteVaginal
Strength2%
Market StatusOver the Counter
CompanyActavis Mid Atlantic

4 of 22  
Drug NameMiconazole 7 combination pack
Active IngredientMiconazole nitrate
Dosage FormCream, suppository
RouteTopical, vaginal
Strength2%,100mg
Market StatusOver the Counter
CompanyG And W Labs

5 of 22  
Drug NameMonistat 1 combination pack
Drug LabelMONISTAT 3 Vaginal Suppositories are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, 1-[2,4-Dichloro--[(2,4-dichlorobenzyl)oxy]phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable oil bas...
Active IngredientMiconazole nitrate
Dosage FormCream, suppository
RouteTopical, vaginal
Strength2%,1.2gm
Market StatusOver the Counter
CompanyInsight Pharms

6 of 22  
Drug NameMonistat 3
Active IngredientMiconazole nitrate
Dosage FormCream; Suppository
RouteVaginal
Strength200mg; 4%
Market StatusOver the Counter; Prescription
CompanyInsight Pharms

7 of 22  
Drug NameMonistat 3 combination pack
Active IngredientMiconazole nitrate
Dosage FormCream
RouteTopical, vaginal
Strength2%,4%
Market StatusOver the Counter
CompanyInsight Pharms

8 of 22  
Drug NameMonistat 7
Drug LabelORAVIG (miconazole) buccal tablets are applied topically to the gum once daily and release miconazole as the buccal tablet gradually dissolves [ see Clinical Pharmacology (12.3)].Miconazole is an imidazole antifungal agent and is described chemically...
Active IngredientMiconazole nitrate
Dosage FormCream; Suppository
RouteVaginal
Strength100mg; 2%
Market StatusOver the Counter
CompanyInsight Pharms

9 of 22  
Drug NameM-zole 3 combination pack
PubMed HealthMiconazole
Drug ClassesAntifungal, Imidazole
Active IngredientMiconazole nitrate
Dosage FormCream, suppository
RouteTopical, vaginal
Strength2%,200mg
Market StatusOver the Counter
CompanyActavis Mid Atlantic

10 of 22  
Drug NameOravig
Active IngredientMiconazole
Dosage FormTablet
RouteBuccal
Strength50mg
Market StatusPrescription
CompanyBioalliance Pharma

11 of 22  
Drug NameVusion
Active Ingredientpetrolatum, white; Miconazole nitrate; zinc oxide
Dosage FormOintment
RouteTopical
Strength15%; 81.35%; 0.25%
Market StatusPrescription
CompanyDelcor Asset

12 of 22  
Drug NameMiconazole 3
PubMed HealthMiconazole/Zinc Oxide/White Petrolatum (On the skin)
Drug ClassesAntifungal
Active IngredientMiconazole nitrate
Dosage FormCream
RouteVaginal
Strength4%
Market StatusOver the Counter
CompanyTaro

13 of 22  
Drug NameMiconazole 3 combination pack
Active IngredientMiconazole nitrate
Dosage FormCream
RouteTopical, vaginal
Strength2%,4%
Market StatusOver the Counter
CompanyPerrigo

14 of 22  
Drug NameMiconazole 7
Active IngredientMiconazole nitrate
Dosage FormCream
RouteVaginal
Strength2%
Market StatusOver the Counter
CompanyActavis Mid Atlantic

15 of 22  
Drug NameMiconazole 7 combination pack
Active IngredientMiconazole nitrate
Dosage FormCream, suppository
RouteTopical, vaginal
Strength2%,100mg
Market StatusOver the Counter
CompanyG And W Labs

16 of 22  
Drug NameMonistat 1 combination pack
Drug LabelMONISTAT 3 Vaginal Suppositories are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, 1-[2,4-Dichloro--[(2,4-dichlorobenzyl)oxy]phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable oil bas...
Active IngredientMiconazole nitrate
Dosage FormCream, suppository
RouteTopical, vaginal
Strength2%,1.2gm
Market StatusOver the Counter
CompanyInsight Pharms

17 of 22  
Drug NameMonistat 3
Active IngredientMiconazole nitrate
Dosage FormCream; Suppository
RouteVaginal
Strength200mg; 4%
Market StatusOver the Counter; Prescription
CompanyInsight Pharms

18 of 22  
Drug NameMonistat 3 combination pack
Active IngredientMiconazole nitrate
Dosage FormCream
RouteTopical, vaginal
Strength2%,4%
Market StatusOver the Counter
CompanyInsight Pharms

19 of 22  
Drug NameMonistat 7
Drug LabelORAVIG (miconazole) buccal tablets are applied topically to the gum once daily and release miconazole as the buccal tablet gradually dissolves [ see Clinical Pharmacology (12.3)].Miconazole is an imidazole antifungal agent and is described chemically...
Active IngredientMiconazole nitrate
Dosage FormCream; Suppository
RouteVaginal
Strength100mg; 2%
Market StatusOver the Counter
CompanyInsight Pharms

20 of 22  
Drug NameM-zole 3 combination pack
PubMed HealthMiconazole
Drug ClassesAntifungal, Imidazole
Active IngredientMiconazole nitrate
Dosage FormCream, suppository
RouteTopical, vaginal
Strength2%,200mg
Market StatusOver the Counter
CompanyActavis Mid Atlantic

21 of 22  
Drug NameOravig
Active IngredientMiconazole
Dosage FormTablet
RouteBuccal
Strength50mg
Market StatusPrescription
CompanyBioalliance Pharma

22 of 22  
Drug NameVusion
Active Ingredientpetrolatum, white; Miconazole nitrate; zinc oxide
Dosage FormOintment
RouteTopical
Strength15%; 81.35%; 0.25%
Market StatusPrescription
CompanyDelcor Asset

4.2 Drug Indication

Miconazole is indicated for the local treatment of oropharyngeal candidiasis in adult patients and for the adjunctive treatment of diaper dermatitis complicated by candidiasis in immunocompetent patients aged four weeks and older. Miconazole is available as both a suppository and cream for the treatment of vaginal yeast infections and the relief of associated vulvar itching and irritation. Lastly, miconazole cream is effective in treating athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm infections (tinea corporis), pityriasis (formerly tinea) versicolor, and cutaneous candidiasis.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Miconazole is an azole antifungal that functions primarily through inhibition of a specific demethylase within the CYP450 complex. As miconazole is typically applied topically and is minimally absorbed into the systemic circulation following application, the majority of patient reactions are limited to hypersensitivity and cases of anaphylaxis. Patients using intravaginal miconazole products are advised not to rely on contraceptives to prevent pregnancy and sexually transmitted infections, as well as not to use tampons concurrently.


5.2 MeSH Pharmacological Classification

Cytochrome P-450 CYP3A Inhibitors

Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP3A. (See all compounds classified as Cytochrome P-450 CYP3A Inhibitors.)


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.)


14-alpha Demethylase Inhibitors

Compounds that specifically inhibit STEROL 14-DEMETHYLASE. A variety of azole-derived ANTIFUNGAL AGENTS act through this mechanism. (See all compounds classified as 14-alpha Demethylase Inhibitors.)


Cytochrome P-450 CYP2C9 Inhibitors

Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP2C9. (See all compounds classified as Cytochrome P-450 CYP2C9 Inhibitors.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
MICONAZOLE
5.3.2 FDA UNII
7NNO0D7S5M
5.3.3 Pharmacological Classes
Azoles [CS]; Azole Antifungal [EPC]
5.4 ATC Code

D01AC02

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


A - Alimentary tract and metabolism

A01 - Stomatological preparations

A01A - Stomatological preparations

A01AB - Antiinfectives and antiseptics for local oral treatment

A01AB09 - Miconazole


A - Alimentary tract and metabolism

A07 - Antidiarrheals, intestinal antiinflammatory/antiinfective agents

A07A - Intestinal antiinfectives

A07AC - Imidazole derivatives

A07AC01 - Miconazole


D - Dermatologicals

D01 - Antifungals for dermatological use

D01A - Antifungals for topical use

D01AC - Imidazole and triazole derivatives

D01AC02 - Miconazole


G - Genito urinary system and sex hormones

G01 - Gynecological antiinfectives and antiseptics

G01A - Antiinfectives and antiseptics, excl. combinations with corticosteroids

G01AF - Imidazole derivatives

G01AF04 - Miconazole


J - Antiinfectives for systemic use

J02 - Antimycotics for systemic use

J02A - Antimycotics for systemic use

J02AB - Imidazole derivatives

J02AB01 - Miconazole


S - Sensory organs

S02 - Otologicals

S02A - Antiinfectives

S02AA - Antiinfectives

S02AA13 - Miconazole


5.5 Absorption, Distribution and Excretion

Absorption

Miconazole given to healthy volunteers as a single 50 mg oral tablet produced a mean Cmax of 15.1 16.2 mcg/mL, a mean AUC0-24 of 55.2 35.1 mcg\*h/mL, and a median Tmax of 7 hours (range 2.0-24.1). In these patients measurable plasma concentrations ranged from 0.5 to 0.83 mcg/mL. Topical miconazole is absorbed poorly into the systemic circulation. In pediatric patients aged 1-21 months given multiple topical applications of miconazole ointment for seven days, the plasma miconazole concentration was less than 0.5 ng/mL in 88% of the patients, with the remaining patients having a concentration of 0.57 and 0.58 ng/mL, respectively. Similarly, patients. administered with a vaginal 1200 mg ovule had a mean Cmax of 10.71 ng/mL, mean Tmax of 18.4 hours, and mean AUC0-96 of 477.3 ng\*h/mL.


Route of Elimination

Miconazole is excreted through both urine and feces; less than 1% of unchanged miconazole is recovered in urine.


Volume of Distribution

A 1200 mg miconazole vaginal suppository resulted in a calculated apparent volume of distribution of 95 546 L while a 100 mg vaginal cream yielded an apparent volume of distribution of 10 911L.


5.6 Metabolism/Metabolites

Miconazole is metabolized in the liver and does not give rise to any active metabolites.


5.7 Biological Half-Life

Miconazole has a terminal half-life of 24 hours.


5.8 Mechanism of Action

Miconazole is an azole antifungal used to treat a variety of conditions, including those caused by _Candida_ overgrowth. Unique among the azoles, miconazole is thought to act through three main mechanisms. The primary mechanism of action is through inhibition of the CYP450 14-lanosterol demethylase enzyme, which results in altered ergosterol production and impaired cell membrane composition and permeability, which in turn leads to cation, phosphate, and low molecular weight protein leakage. In addition, miconazole inhibits fungal peroxidase and catalase while not affecting NADH oxidase activity, leading to increased production of reactive oxygen species (ROS). Increased intracellular ROS leads to downstream pleiotropic effects and eventual apoptosis. Lastly, likely as a result of lanosterol demethylation inhibition, miconazole causes a rise in intracellular levels of farnesol. This molecule participates in quorum sensing in _Candida_, preventing the transition from yeast to mycelial forms and thereby the formation of biofilms, which are more resistant to antibiotics. In addition, farnesol is an inhibitor of drug efflux ABC transporters, namely _Candida_ CaCdr1p and CaCdr2p, which may additionally contribute to increased effectiveness of azole drugs.


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MICONAZOLE NITRATE, PLASTIC JAR 8005 (R014889) (FORTESTING PURPOSE ONLY)(N.C.V.) MICONAZOLE NITRATE, PLASTIC JAR 8005 (R014889) (FOR","address":"30 FORJETT STREET","city":"MUMBAI, MAHARASHTRA.","supplier":"JANSSEN PHARMACEUTICA NV","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"JOHNSON & JOHNSON PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.24","actualQuantity":"241","unit":"GMS","unitRateFc":"2.7","totalValueFC":"662.8","currency":"EURO","unitRateINR":"238.2","date":"28-Mar-2025","totalValueINR":"57407.16","totalValueInUsd":"662.8","indian_port":"Bombay Air","hs_no":"29332990","bill_no":"9157983","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG 30 B-2340 Beerse, , B elgium SDNF Belgium","customerAddress":"30 FORJETT STREET"}]
03-Jan-2022
30-Apr-2025
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ABOUT THIS PAGE

Looking for 22916-47-8 / Miconazole API manufacturers, exporters & distributors?

Miconazole manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Miconazole 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 Miconazole manufacturer or Miconazole supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Miconazole manufacturer or Miconazole supplier.

PharmaCompass also assists you with knowing the Miconazole API Price utilized in the formulation of products. Miconazole API Price is not always fixed or binding as the Miconazole Price is obtained through a variety of data sources. The Miconazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Miconazole

Synonyms

22916-47-8, Monistat, Monistat iv, Daktarin iv, Miconazol, Miconazolo

Cas Number

22916-47-8

Unique Ingredient Identifier (UNII)

7NNO0D7S5M

About Miconazole

An imidazole antifungal agent that is used topically and by intravenous infusion.

Miconazol Manufacturers

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

Miconazol Suppliers

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

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

Miconazol USDMF

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

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

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

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

Miconazol CEP

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

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

Miconazol WC

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

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

Miconazol 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 Miconazol as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Miconazol GMP

Miconazol 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 Miconazol 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 Miconazol GMP manufacturer or Miconazol GMP API supplier for your needs.

Miconazol CoA

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

Miconazol CoA mostly includes findings from lab analyses of a specific batch. For each Miconazol 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.

Miconazol may be tested according to a variety of international standards, such as European Pharmacopoeia (Miconazol EP), Miconazol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Miconazol 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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