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Chemistry

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Also known as: 126-07-8, (+)-griseofulvin, Amudane, Grisactin, Grisefuline, Griseofulvinum
Molecular Formula
C17H17ClO6
Molecular Weight
352.8  g/mol
InChI Key
DDUHZTYCFQRHIY-RBHXEPJQSA-N
FDA UNII
32HRV3E3D5

Griseofulvin
An antifungal agent used in the treatment of TINEA infections.
Griseofulvin is a Tubulin Inhibiting Agent. The physiologic effect of griseofulvin is by means of Decreased Mitosis, and Microtubule Inhibition.
1 2D Structure

Griseofulvin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S,5'R)-7-chloro-3',4,6-trimethoxy-5'-methylspiro[1-benzofuran-2,4'-cyclohex-2-ene]-1',3-dione
2.1.2 InChI
InChI=1S/C17H17ClO6/c1-8-5-9(19)6-12(23-4)17(8)16(20)13-10(21-2)7-11(22-3)14(18)15(13)24-17/h6-8H,5H2,1-4H3/t8-,17+/m1/s1
2.1.3 InChI Key
DDUHZTYCFQRHIY-RBHXEPJQSA-N
2.1.4 Canonical SMILES
CC1CC(=O)C=C(C12C(=O)C3=C(O2)C(=C(C=C3OC)OC)Cl)OC
2.1.5 Isomeric SMILES
C[C@@H]1CC(=O)C=C([C@]12C(=O)C3=C(O2)C(=C(C=C3OC)OC)Cl)OC
2.2 Other Identifiers
2.2.1 UNII
32HRV3E3D5
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Fulvicin U F

2. Fulvicin-u-f

3. Fulvicinuf

4. Grifulvin V

5. Gris Peg

6. Gris-peg

7. Grisactin

8. Grisefuline

9. Grispeg

2.3.2 Depositor-Supplied Synonyms

1. 126-07-8

2. (+)-griseofulvin

3. Amudane

4. Grisactin

5. Grisefuline

6. Griseofulvinum

7. Griseofulvina

8. Grizeofulvin

9. Grifulvin

10. Grisofulvin

11. Spirofulvin

12. Fulcin

13. Grysio

14. Lamoryl

15. Likuden

16. Fulvicin

17. Griseofulvine

18. Poncyl

19. Curling Factor

20. Grisovin

21. Grisactin V

22. Griseofulvine [inn-french]

23. Griseofulvinum [inn-latin]

24. Griseofulvina [inn-spanish]

25. Griseofulvin, Microcrystalline

26. Delmofulvina

27. Fulvistatin

28. Griscofulvin

29. Fulcine

30. Fulvina

31. Fulvinil

32. Fungivin

33. Greosin

34. Gresfeed

35. Grifulin

36. Grisetin

37. Guservin

38. Murfulvin

39. Neo-fulcin

40. Biogrisin-fp

41. Fulvican Grisactin

42. Griseofulvin-forte

43. Fulvicin-p/g

44. Fulvicin-u/f

45. Griseofulvin, Ultramicrocrystalline

46. Griseofulvin Microsize

47. Xuanjing

48. Mfcd00082343

49. Griseofulvin, Ultramicrosize

50. Usaf Sc-2

51. Griseomix

52. Grisactin Ultra

53. Nsc-755822

54. Griseofulvin Forte

55. Fulvicin P/g

56. 32hrv3e3d5

57. Chebi:27779

58. Griseofulvin Permeability Diameter

59. Nsc-34533

60. (2s,5'r)-7-chloro-3',4,6-trimethoxy-5'-methylspiro[1-benzofuran-2,4'-cyclohex-2-ene]-1',3-dione

61. Ncgc00091120-01

62. Dsstox_cid_674

63. Nsc 34533

64. Dsstox_rid_75725

65. Dsstox_gsid_20674

66. (1's,6'r)-7-chloro-2',4,6-trimethoxy-6'-methylspiro(benzofuran-2(3h),1'-(2)cyclohexene)-3,4'-dione

67. (1's-trans)- 7-chloro-2',4,6-trimethoxy-6'-methylspiro(benzofuran-2(3h),1'-cyclohex-2'-ene)-3,4'-dione

68. (2s,6'r)-7-chloro-2',4,6-trimethoxy-6'-methyl-3h,4'h-spiro[1-benzofuran-2,1'-cyclohex[2]ene]-3,4'-dione

69. (2s,6'r)-7-chloro-2',4,6-trimethoxy-6'-methyl-3h-spiro[benzofuran-2,1'-cyclohexan]-2'-ene-3,4'-dione

70. Ultragris-165

71. Ultragris-330

72. Fulvicin Bolus

73. Fulvicin-u/f (veterinary)

74. Fulvicin Bolus (veterinary)

75. Fulvicin P/g 165

76. Fulvicin P/g 330

77. Spiro(benzofuran-2(3h),1'-(2)cyclohexene)-3,4'-dione, 7-chloro-2',4,6-trimethoxy-6'-methyl-, (1's-trans)-

78. 7-chloro-4,6,2'-trimethoxy-6'-methylgris-2'-en-3,4'-dione

79. Caswell No. 471b

80. Fulvidex

81. (2s,6'r)-7-chloro-2',4,6-trimethoxy-6'-methyl-3h-spiro[1-benzofuran-2,1'-cyclohexan]-2'-ene-3,4'-dione

82. (1's,6'r)-7-chloro-2',4,6-trimethoxy-6'-methyl-3h-spiro[benzofuran-2,1'-cyclohex[2]ene]-3,4'-dione

83. Smr000718755

84. Ccris 320

85. Hsdb 1722

86. Sr-05000001535

87. Einecs 204-767-4

88. Epa Pesticide Chemical Code 471400

89. Griseofulvin And Alpha-ifn

90. Brn 0095226

91. Unii-32hrv3e3d5

92. Griseoflulvin

93. Griseofulvin, Microsize

94. Ai3-51015

95. Fulvicin Uf

96. Griseofulvin,(s)

97. Griseofulvin [usp:inn:ban:jan]

98. (2s,5'r)-7-chloro-3',4,6-trimethoxy-5'-methyl-spiro[benzofuran-2,4'-cyclohex-2-ene]-1',3-dione

99. Prestwick_247

100. Grisactin V (tn)

101. Gris-peg (tn)

102. Griseofulvin,microsize

103. Spectrum_000816

104. Cpd000718755

105. Specplus_000336

106. Prestwick3_000226

107. Spectrum2_000213

108. Spectrum3_000161

109. Spectrum4_000927

110. Spectrum5_000648

111. Griseofulvin [mi]

112. Griseofulvin [usp:inn]

113. Griseofulvin [inn]

114. Griseofulvin [jan]

115. Chembl562

116. Griseofulvin [hsdb]

117. Griseofulvin [iarc]

118. 7-chloro-2',4,6-trimethoxy-6'beta-methylspiro(benzofuran-2(3h),1'-(2)cyclohexene)-3,4'-dione

119. 7-chloro-4,6-dimethoxycoumaran-3-one-2-spiro-1'-(2'-methoxy-6'-methylcyclohex-2'-en-4'-one)

120. Griseofulvin [vandf]

121. Schembl21988

122. Bspbio_000271

123. Bspbio_001621

124. Griseofulvin [mart.]

125. Kbiogr_001454

126. Kbioss_001296

127. Spectrum200046

128. (2s-trans)-7-chloro-2',4,6-trimethoxy-6'-methylspiro(benzofuran-2(3h),1'-(2)cyclohexene)-3,4'-dione

129. 5-18-05-00150 (beilstein Handbook Reference)

130. Mls001304062

131. Mls002152905

132. Mls002154239

133. Spiro(benzofuran-2(3h),1'-(2)cyclohexene)-3,4'-dione, 7-chloro-2',4,6-trimethoxy-6'-methyl-, (2s-trans)-

134. Bidd:gt0024

135. Divk1c_000154

136. Divk1c_006432

137. Griseofulvin [usp-rs]

138. Griseofulvin [who-dd]

139. Griseofulvin [who-ip]

140. Griseofulvin (jan/usp/inn)

141. Spbio_000225

142. Bpbio1_000299

143. Megxm0_000184

144. Dtxsid8020674

145. Acon0_000953

146. Acon1_001843

147. Bdbm31775

148. Fulvicin-u/f Powder And Tablets

149. Hms500h16

150. Kbio1_000154

151. Kbio1_001376

152. Kbio2_001296

153. Kbio2_003864

154. Kbio2_006432

155. Kbio3_001121

156. Griseofulvin [green Book]

157. Ninds_000154

158. Griseofulvin [orange Book]

159. Hms1923e09

160. Hms2091a03

161. Hms2095n13

162. Hms2235f13

163. Hms3259d05

164. Hms3712n13

165. Interacts With Polymerized Microtubules And Associated Proteins

166. Pharmakon1600-00200046

167. Zinc622123

168. Griseofulvin [ep Monograph]

169. 7-chloro-2',4,6-trimethoxy-6'.beta.-methylspiro(benzofuran-2(3h),1'-(2)cyclohexene)-3,4'-dione

170. Spiro(benzofuran-2(3h),1'-(2)cyclohexene)-3,4'-dione, 7-chloro-2',4,6-trimethoxy-6'-methyl-, (1's,6'r)-

171. Griseofulvin [usp Monograph]

172. Tox21_111087

173. Tox21_202235

174. Tox21_303005

175. Ccg-38416

176. Lmpk13060001

177. Nsc755822

178. S4071

179. Griseofulvinum [who-ip Latin]

180. Akos015896380

181. Tox21_111087_1

182. Cs-3426

183. Db00400

184. Nc00616

185. Sdccgmls-0066450.p001

186. Griseofulvin 100 Microg/ml In Methanol

187. Idi1_000154

188. Ncgc00091120-02

189. Ncgc00091120-03

190. Ncgc00091120-04

191. Ncgc00091120-05

192. Ncgc00091120-06

193. Ncgc00091120-07

194. Ncgc00091120-08

195. Ncgc00091120-09

196. Ncgc00091120-13

197. Ncgc00256353-01

198. Ncgc00259784-01

199. As-13736

200. Bt164513

201. Hy-17583

202. Griseofulvin 100 Microg/ml In Acetonitrile

203. G0384

204. En300-52615

205. Bim-0051396.0001

206. C06686

207. D00209

208. Ab00052005_07

209. Griseofulvin, Vetranal(tm), Analytical Standard

210. Griseofulvin Permeability Diameter [usp-rs]

211. Q416096

212. Sr-01000837512

213. Griseofulvin, Antibiotic For Culture Media Use Only

214. Q-201178

215. Sr-01000837512-2

216. Sr-05000001535-1

217. Sr-05000001535-3

218. Sr-05000001535-4

219. Brd-k08273968-001-05-9

220. Brd-k08273968-001-09-1

221. Brd-k08273968-001-19-0

222. Z1258578352

223. Griseofulvin, British Pharmacopoeia (bp) Reference Standard

224. Griseofulvin, From Penicillium Griseofulvum, 97.0-102.0%

225. Griseofulvin, European Pharmacopoeia (ep) Reference Standard

226. Griseofulvin, United States Pharmacopeia (usp) Reference Standard

227. Griseofulvin Permeability Diameter, United States Pharmacopeia (usp) Reference Standard

228. Griseofulvin, Pharmaceutical Secondary Standard; Certified Reference Material

229. 107912-37-8

230. 7-chloro-2',4,6-trimethoxy-6'-methylspiro[benzofuran-2(3h),1',- [2]cyclohexene]-3,4'-dione

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 352.8 g/mol
Molecular Formula C17H17ClO6
XLogP32.2
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count6
Rotatable Bond Count3
Exact Mass352.0713660 g/mol
Monoisotopic Mass352.0713660 g/mol
Topological Polar Surface Area71.1 Ų
Heavy Atom Count24
Formal Charge0
Complexity575
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 8  
Drug NameGrifulvin v
Active IngredientGriseofulvin, microsize
Dosage FormTablet; Suspension
RouteOral
Strength500mg; 125mg/5ml
Market StatusPrescription
CompanyValeant Luxembourg

2 of 8  
Drug NameGriseofulvin
PubMed HealthGriseofulvin (By mouth)
Drug ClassesAntifungal
Drug LabelGriseofulvin microsize contains griseofulvin microsize for oral administration. The active ingredient, griseofulvin, is a fungistatic antibiotic, derived from a species of Penicillium. The chemical name of griseofulvin is 7-chloro-2', 4,6-trimethoxy-
Active IngredientGriseofulvin, microsize
Dosage FormTablet; Suspension
RouteOral
Strength250mg; 500mg; 125mg/5ml
Market StatusPrescription
CompanyVintage Pharms; Perrigo Co Tennessee; Sandoz; Ivax Sub Teva Pharms; Actavis Mid Atlantic; Sigmapharm Labs

3 of 8  
Drug NameGriseofulvin, ultramicrosize
Active IngredientGriseofulvin, ultramicrosize
Dosage FormTablet
RouteOral
Strength250mg; 125mg
Market StatusPrescription
CompanyRiconpharma

4 of 8  
Drug NameGris-peg
Drug LabelGris-PEG Tablets contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium.Each Gris-PEG tablet contains:Active Ingredient: griseofulvin ultramicrosize .... 125 mgInactive Ingredients: colloidal silicon...
Active IngredientGriseofulvin, ultramicrosize
Dosage FormTablet
RouteOral
Strength250mg; 125mg
Market StatusPrescription
CompanyPedinol

5 of 8  
Drug NameGrifulvin v
Active IngredientGriseofulvin, microsize
Dosage FormTablet; Suspension
RouteOral
Strength500mg; 125mg/5ml
Market StatusPrescription
CompanyValeant Luxembourg

6 of 8  
Drug NameGriseofulvin
PubMed HealthGriseofulvin (By mouth)
Drug ClassesAntifungal
Drug LabelGriseofulvin microsize contains griseofulvin microsize for oral administration. The active ingredient, griseofulvin, is a fungistatic antibiotic, derived from a species of Penicillium. The chemical name of griseofulvin is 7-chloro-2', 4,6-trimethoxy-
Active IngredientGriseofulvin, microsize
Dosage FormTablet; Suspension
RouteOral
Strength250mg; 500mg; 125mg/5ml
Market StatusPrescription
CompanyVintage Pharms; Perrigo Co Tennessee; Sandoz; Ivax Sub Teva Pharms; Actavis Mid Atlantic; Sigmapharm Labs

7 of 8  
Drug NameGriseofulvin, ultramicrosize
Active IngredientGriseofulvin, ultramicrosize
Dosage FormTablet
RouteOral
Strength250mg; 125mg
Market StatusPrescription
CompanyRiconpharma

8 of 8  
Drug NameGris-peg
Drug LabelGris-PEG Tablets contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium.Each Gris-PEG tablet contains:Active Ingredient: griseofulvin ultramicrosize .... 125 mgInactive Ingredients: colloidal silicon...
Active IngredientGriseofulvin, ultramicrosize
Dosage FormTablet
RouteOral
Strength250mg; 125mg
Market StatusPrescription
CompanyPedinol

4.2 Therapeutic Uses

Antibiotics, Antifungal

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


GRISEOFULVIN IS USED IN THE TREATMENT OF TINEAS (RINGWORM INFECTIONS) OF THE SKIN, HAIR & NAILS--TINEA CORPORIS, TINEA PEDIS, TINEA CRURIS, TINEA BARBAE, TINEA CAPITIS & TINEA UNGUIUM (ONYCHOMYCOSIS) CAUSED BY SUSCEPTIBLE SPECIES OF TRICHOPHYTON, MICROSPORUM, OR EPIDERMOPHYTON.

McEvoy, G.K. (ed.). American Hospital Formulary Service--Drug Information 94. Bethesda, MD: American Society of Hospital Pharmacists, Inc. 1994 (Plus Supplements)., p. 83


MEDICATION (VET): DRUG IS USEFUL IN TREATMENT OF SUPERFICIAL FUNGUS INFECTIONS CAUSED BY TRICHOPHYTON MENTAGROPHYTES, RUBRUM, INTERDIGITALE, SCHOENLEINI, SULPHUREUM AND VERRUCOSUM, AND MICROSPORUM AND OVINI, CANIS, AND GYPSEUM...

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1166


MEDICATION (VET): TO TREAT RINGWORM OF SKIN OR NAILS ESPECIALLY THOSE AREAS DIFFICULT TO TREAT LOCALLY (EYE, MOUTH, NAIL AREAS), OR THOSE REFRACTORY TO OTHER THERAPY.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 247


For more Therapeutic Uses (Complete) data for GRISEOFULVIN (14 total), please visit the HSDB record page.


4.3 Drug Warning

ORAL THRUSH DUE TO CANDIDAL OVERGROWTH HAS...OCCURRED.

McEvoy, G.K. (ed.). American Hospital Formulary Service--Drug Information 94. Bethesda, MD: American Society of Hospital Pharmacists, Inc. 1994 (Plus Supplements)., p. 84


GRISEOFULVIN...IS CONTRAINDICATED IN PATIENTS WITH ACUTE INTERMITTENT PORPHYRIA OR A HISTORY OF.../IT/, HEPATOCELLULAR FAILURE, AND HYPERSENSITIVITY TO THE DRUG. ... SAFE USE...DURING PREGNANCY HAS NOT BEEN ESTABLISHED.

American Medical Association, Council on Drugs. AMA Drug Evaluations Annual 1994. Chicago, IL: American Medical Association, 1994., p. 1593


RARELY, TRANSIENT DIMINUTION OF HEARING HAS OCCURRED...PARESTHESIAS OF HANDS AND FEET HAS FOLLOWED EXTENDED THERAPY... OCCASIONALLY, LARGE DOSES HAVE PRODUCED...PSYCHOTIC SYMPTOMS.

McEvoy, G.K. (ed.). American Hospital Formulary Service--Drug Information 94. Bethesda, MD: American Society of Hospital Pharmacists, Inc. 1994 (Plus Supplements)., p. 84


GRISEOFULVIN HAS BEEN REPORTED TO CAUSE TACHYCARDIA AND FLUSHING...

McEvoy, G.K. (ed.). American Hospital Formulary Service--Drug Information 94. Bethesda, MD: American Society of Hospital Pharmacists, Inc. 1994 (Plus Supplements)., p. 84


For more Drug Warnings (Complete) data for GRISEOFULVIN (17 total), please visit the HSDB record page.


4.4 Drug Indication

For the treatment of ringworm infections of the skin, hair, and nails, namely: tinea corporis, tinea pedis, tinea cruris, tinea barbae, cradle cap or other conditions caused by Trichophyton or Microsporum fungi.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

Griseofulvin is a mycotoxic metabolic product of Penicillium spp. It was the first available oral agent for the treatment of dermatophytoses and has now been used for more than forty years. Griseofulvin is fungistatic with in vitro activity against various species of Microsporum Epidermophyton, and Trichophyton. It has no effect on bacteria or on other genera of fungi. Following oral administration, griseofulvin is deposited in the keratin precursor cells and has a greater affinity for diseased tissue. The drug is tightly bound to the new keratin which becomes highly resistant to fungal invasions. Once the keratin-Griseofulvin complex reaches the skin site of action, it binds to fungal microtubules (tubulin) thus altering fungal mitosis.


5.2 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.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
GRISEOFULVIN
5.3.2 FDA UNII
32HRV3E3D5
5.3.3 Pharmacological Classes
Microtubule Inhibition [PE]; Tubulin Inhibiting Agent [EPC]; Decreased Mitosis [PE]
5.4 ATC Code

D - Dermatologicals

D01 - Antifungals for dermatological use

D01A - Antifungals for topical use

D01AA - Antibiotics

D01AA08 - Griseofulvin


D - Dermatologicals

D01 - Antifungals for dermatological use

D01B - Antifungals for systemic use

D01BA - Antifungals for systemic use

D01BA01 - Griseofulvin


5.5 Absorption, Distribution and Excretion

Absorption

Poorly absorbed from GI ranging from 25 to 70% of an oral dose. Absorption is significantly enhanced by administration with or after a fatty meal.


IN RATS GIVEN ORAL DOSES OF 100 MG/KG BODY WT (36)CL-GRISEOFULVIN, 10% OF ACTIVITY WAS FOUND IN URINE AFTER 24 HR & 4% DURING 24-48 HR. ...IN ANOTHER STUDY, WITHIN 24-HR PERIOD ONLY 0.14% OF SIMILAR ORAL DOSES IN RATS WAS FOUND IN URINE, & 16% WAS RECOVERED IN FECES. FOLLOWING ITS IV INJECTION GRISEOFULVIN WAS DISTRIBUTED EVENLY THROUGHOUT TISSUES, ALTHOUGH HIGHER LEVELS WERE FOUND IN SKIN & LUNG.

IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Humans. Geneva: World Health Organization, International Agency for Research on Cancer, 1972-PRESENT. (Multivolume work). Available at: https://monographs.iarc.fr/ENG/Classification/index.php, p. V10 157 (1976)


Microsize - variable, ranging from 25 to 70% of an oral dose. Ultramicrosize - Almost completely absorbed. Absorption is significantly enhanced by administration with or after a fatty meal.

USP Convention. USPDI-Drug Information for the Health Care Professional. 14th ed. Volume I. Rockville, MD: United States Pharmacopeial Convention, Inc., 1994. (Plus Updates)., p. 1457


Griseofulvin is deposited in varying concentrations in the keratin layer of the skin, hair, and nails. It can be detected in the stratum corneum of the skin within a few hours following administration. Only a very small fraction of an oral dose is distributed in the body fluids and tissues.

USP Convention. USPDI-Drug Information for the Health Care Professional. 14th ed. Volume I. Rockville, MD: United States Pharmacopeial Convention, Inc., 1994. (Plus Updates)., p. 1457


Elimination: Renal. less than 1% of a dose is excreted as unchanged drug in the urine. Approximately 36% of griseofulvin is excreted unchanged in the feces.

USP Convention. USPDI-Drug Information for the Health Care Professional. 14th ed. Volume I. Rockville, MD: United States Pharmacopeial Convention, Inc., 1994. (Plus Updates)., p. 1457


GRISEOFULVIN IS PROBABLY DEPOSITED IN BASAL CELLS AND IS CARRIED OUTWARDS INTO EPIDERMIS AS NORMAL SKIN GROWTH PROCEEDS. THIS...MAKES FOR LONG LATENCY FROM TIME MEDICATION IS BEGUN UNTIL EVIDENCE OF IMPROVEMENT OCCURS.

Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 1166


5.6 Metabolism/Metabolites

Primarily hepatic with major metabolites being 6-methyl-griseofulvin and its glucuronide conjugate.


Griseofulvin is mainly metabolized to 6-dimethylgriseofulvin and its glucuronide.

Booth, N.H., L.E. McDonald (eds.). Veterinary Pharmacology and Therapeutics. 5th ed. Ames, Iowa: Iowa State University Press, 1982., p. 776


...IT HAS BEEN REPORTED THAT 6-DEMETHYLGRISEOFULVIN IS THE MAJOR URINARY METABOLITE...IN MAN, THE PREVIOUSLY REPORTED 4-DEMETHYL-GRISEOFULVIN WAS ABSENT. GRISEOFULVIC ACID (7-CHLORO-4,6-DIMETHOXY-6'-METHYLGRISAN-2',3,4'-TRIONE) WAS IDENTIFIED...

The Royal Society of Chemistry. Foreign Compound Metabolism in Mammals. Volume 6: A Review of the Literature Published during 1978 and 1979. London: The Royal Society of Chemistry, 1981., p. 275


5.7 Biological Half-Life

9-21 hours


DRUG HAS A HALF-LIFE IN PLASMA OF ABOUT 1 DAY, & APPROX 50% OF ORAL DOSE CAN BE DETECTED IN THE URINE WITHIN 5 DAYS, MOSTLY IN THE FORM OF METABOLITES /SRP: 36% IN THE FECES WITHIN 5 DAYS/.

Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1173


The half-life of griseofulvin in canine plasma was found to be 47 minutes ... .

Booth, N.H., L.E. McDonald (eds.). Veterinary Pharmacology and Therapeutics. 5th ed. Ames, Iowa: Iowa State University Press, 1982., p. 775


5.8 Mechanism of Action

Griseofulvin is fungistatic, however the exact mechanism by which it inhibits the growth of dermatophytes is not clear. It is thought to inhibit fungal cell mitosis and nuclear acid synthesis. It also binds to and interferes with the function of spindle and cytoplasmic microtubules by binding to alpha and beta tubulin. It binds to keratin in human cells, then once it reaches the fungal site of action, it binds to fungal microtubes thus altering the fungal process of mitosis.


Fungistatic; griseofulvin inhibits fungal cell mitosis by causing disruption of the mitotic spindle structure, thereby arresting the metaphase of cell division. It is deposited in varying concentrations in the keratin precursor cells of skin, hair, and nails, rendering the keratin resistant to fungal invasion. As the infected keratin is shed, it is replaced with healthy tissue.

USP Convention. USPDI-Drug Information for the Health Care Professional. 14th ed. Volume I. Rockville, MD: United States Pharmacopeial Convention, Inc., 1994. (Plus Updates)., p. 1457


API SUPPLIERS

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Shanghai Hegno Pharmaceutical

China

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China

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GSK

United Kingdom

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GSK

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Shanghai Pharmaceuticals Holding C...

China

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Shanghai Zhonghua Pharmaceutical

China

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China

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Nippon Kayaku

Japan

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Wyeth Pharmaceuticals Inc

U.S.A

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Wyeth Pharmaceuticals Inc

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Sinobright Pharmaceutical Company ...

China

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Arudavis Labs

India

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India

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Asia Pioneer Pharmaceuticals

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Glaxosmithkline Llc

United Kingdom

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Glaxosmithkline Llc

United Kingdom
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GDUFA

DMF Review : N/A

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DMF Number : 13338

Submission : 1998-09-01

Status : Inactive

Type : II

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Nippon Kayaku Co Ltd

Japan

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GDUFA

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Biotech Showcase
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GDUFA

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Biotech Showcase
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Glaxo Wellcome London GB

United Kingdom
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United Kingdom
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Certificate Number : R0-CEP 2000-374 - Rev 01

Status : Withdrawn by Holder

Issue Date : 2001-11-21

Type : TSE

Substance Number : 182

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Certificate Number : R1-CEP 2002-143 - Rev 02

Status : Valid

Issue Date : 2022-11-07

Type : Chemical

Substance Number : 182

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NDC API

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GRISEOFULVIN

NDC Package Code : 71052-109

Start Marketing Date : 2022-10-18

End Marketing Date : 2025-12-31

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Marketing Category : BULK INGREDIENT

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GRISEOFULVIN

NDC Package Code : 60592-306

Start Marketing Date : 2019-11-29

End Marketing Date : 2025-12-31

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GRISEOFULVIN

NDC Package Code : 60264-310

Start Marketing Date : 2007-05-01

End Marketing Date : 2025-12-31

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Marketing Category : BULK INGREDIENT

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GRISEOFULVIN

NDC Package Code : 49452-3363

Start Marketing Date : 2000-08-01

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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Griseofulvin

About the Company : Arudavis Labs is in the business of manufacturing and trading of Active Pharmaceutical Ingredients and Formulations. We have been serving the Pharmaceutical and Biotechnology Indus...

Arudavis Labs is in the business of manufacturing and trading of Active Pharmaceutical Ingredients and Formulations. We have been serving the Pharmaceutical and Biotechnology Industries all over the world for the past 10 years with good track regard of keeping our customers happy. We are specialized in the area of Vitamins, Nutraceuticals and Excipients. Our main products are N-Acetyl-L-Cysteine, Pyridoxine Hydrochloride, Thiamine Hydrochloride and Benfotiamine. The company growth is mainly driven by technology based research and development to meet customer demands.
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Griseofulvin

About the Company : Asia Pioneer Pharmaceuticals is a leading supplier of fine chemicals, pharmaceutical intermediates, active pharmaceutical ingredients and other compounds. It also offers finished p...

Asia Pioneer Pharmaceuticals is a leading supplier of fine chemicals, pharmaceutical intermediates, active pharmaceutical ingredients and other compounds. It also offers finished product licensing, custom manufacturing and outsourcing services. In partnership with state-of-the-art manufacturers in China, Asia Pioneer provides world-class quality products at excellent value, in full compliance with standards required by leading regulatory agencies in the USA and Europe.
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Biotechnica DWC

Algeria
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Griseofulvin

About the Company : BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies al...

BIOTECHNICA DWC LLC has carved a niche for itself in providing value added compliance, regulatory qualification, project management and GDP guidance services to pharma companies all over the world. Biotechnica is an integrated global solution provider from design to implementation of industrial projects in the areas of Pharmaceuticals,Agri-food ,Cosmetics and Nutrition. With more than 25 years of experience in the assembly of plants, particularly in the pharmaceutical sector, we accompany our customers in the various stages of their projects – E-CTD Dossieers – Raw Materiels – Equipements – Accessories – Packaging – Distribution.
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Griseofulvin

About the Company : Sinobright Pharmaceutical Co., Ltd. Founded in 2003, with ISO & GSP(Good Supply Practice) Certificate, which is specialized in sourcing for APIs,Intermediates,Chemicals and other r...

Sinobright Pharmaceutical Co., Ltd. Founded in 2003, with ISO & GSP(Good Supply Practice) Certificate, which is specialized in sourcing for APIs,Intermediates,Chemicals and other related products.Sinobright has accumulated large wide domestic partnership network to provide overseas customers with diverse of value-added services,including the plant auditing for the requirements of EDQM and FDA,introduce or recommend new APIs to regulated markets,custom synthesis service for lab scare to plant scare, regulatory affairs and consulting services.
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Griseofulvin

About the Company : Zhejiang Huida Biotech Co., Ltd. is located in Hangzhou, Zhejiang Province. It was established in 2020 and is a holding subsidiary of Huadong Medicine Co., Ltd. The company focu...

Zhejiang Huida Biotech Co., Ltd. is located in Hangzhou, Zhejiang Province. It was established in 2020 and is a holding subsidiary of Huadong Medicine Co., Ltd. The company focuses on the research and development of microbial active pharmaceutical substances (APIs), intermediates and large health products. It is a technologically innovative fermentation product research enterprise. With strong R&D strength, the company provides first-class technology, first-class service and first-class products to global customers by discovering and cultivating the most valuable microbial metabolites.
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API Reference Price

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PHARMACEUTICALS","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"72.3","totalValueFC":"2927.9","currency":"USD","unitRateINR":"6134","date":"06-Sep-2024","totalValueINR":"245361","totalValueInUsd":"2927.9","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"5458468","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"OFFICE F,32\/F, PLAZA 88 NO.88 YEUNG YEUNG UK ROAD TSEN WAN, NT,HONG KONG, CHINA CN CN","customerAddress":"LINCOLN HOUSE, B\/H SATYAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727461800,"product":"GRISEOFULVIN BP","address":"NO.54-55, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"TIANCHEN HANGZHOU TRADING ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SCOTT-EDIL PHARMACIA","customerCountry":"INDIA","quantity":"280.00","actualQuantity":"280","unit":"KGS","unitRateFc":"70","totalValueFC":"19786.8","currency":"USD","unitRateINR":"5922","date":"28-Sep-2024","totalValueINR":"1658160","totalValueInUsd":"19786.8","indian_port":"JNPT","hs_no":"29420090","bill_no":"5854291","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM 2409 NO.136 QINGCHUM ROAD GONG SHU DISTRICT, HANGZHOU CHINA CHINA SDNF CHINA","customerAddress":"NO.54-55, INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727634600,"product":"GRISEOFULVIN IP","address":"218\/219, 2ND FLOOR,KAILASH PLAZA,","city":"GHATKOPAR EAST,MUMBAI, MAHARASTHRA","supplier":"BRILLIANT PHARMACEUTICAL LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AQUATIC REMEDIES PVT LTD","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"70.5","totalValueFC":"142505.1","currency":"USD","unitRateINR":"5971.1","date":"30-Sep-2024","totalValueINR":"11942103.22","totalValueInUsd":"142505.1","indian_port":"JNPT","hs_no":"29419090","bill_no":"5877226","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO, 88 YEU NG UK ROAD TSUEN WAN, NT HONG KONG TSUEN, , HONG KONG HONG KONG","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728498600,"product":"GRISEOFULVIN BP2023\/EP11.0","address":"PLOT NO. 221, G.I.D.C.,","city":"GUJARAT","supplier":"AHARVEST LIMITED","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"AMOLI 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03-Jan-2021
29-Nov-2024
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DOSAGE - TABLET;ORAL - 125MG

USFDA APPLICATION NUMBER - 50475

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DOSAGE - TABLET;ORAL - 250MG

USFDA APPLICATION NUMBER - 50475

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ABOUT THIS PAGE

Griseofulvin Manufacturers

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

Griseofulvin Suppliers

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

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

Griseofulvin USDMF

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

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

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

Griseofulvin CEP

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

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

Griseofulvin 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 Griseofulvin as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Griseofulvin GMP

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

Griseofulvin CoA

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

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

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