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Chemistry

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Also known as: 84371-65-3, Mifegyne, Mifeprex, Ru-486, Korlym, Ru486
Molecular Formula
C29H35NO2
Molecular Weight
429.6  g/mol
InChI Key
VKHAHZOOUSRJNA-GCNJZUOMSA-N
FDA UNII
320T6RNW1F

Mifepristone
A progestational and glucocorticoid hormone antagonist. Its inhibition of progesterone induces bleeding during the luteal phase and in early pregnancy by releasing endogenous prostaglandins from the endometrium or decidua. As a glucocorticoid receptor antagonist, the drug has been used to treat hypercortisolism in patients with nonpituitary CUSHING SYNDROME.
Mifepristone is a Progestin Antagonist. The mechanism of action of mifepristone is as a Progestational Hormone Receptor Antagonist.
1 2D Structure

Mifepristone

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(8S,11R,13S,14S,17S)-11-[4-(dimethylamino)phenyl]-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one
2.1.2 InChI
InChI=1S/C29H35NO2/c1-5-15-29(32)16-14-26-24-12-8-20-17-22(31)11-13-23(20)27(24)25(18-28(26,29)2)19-6-9-21(10-7-19)30(3)4/h6-7,9-10,17,24-26,32H,8,11-14,16,18H2,1-4H3/t24-,25+,26-,28-,29-/m0/s1
2.1.3 InChI Key
VKHAHZOOUSRJNA-GCNJZUOMSA-N
2.1.4 Canonical SMILES
CC#CC1(CCC2C1(CC(C3=C4CCC(=O)C=C4CCC23)C5=CC=C(C=C5)N(C)C)C)O
2.1.5 Isomeric SMILES
CC#C[C@@]1(CC[C@@H]2[C@@]1(C[C@@H](C3=C4CCC(=O)C=C4CC[C@@H]23)C5=CC=C(C=C5)N(C)C)C)O
2.2 Other Identifiers
2.2.1 UNII
320T6RNW1F
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Mifgyne

2. Mifegyne

3. Mifeprex

4. R 38486

5. R-38486

6. R38486

7. Ru 38486

8. Ru 486

9. Ru-38486

10. Ru-486

11. Ru38486

12. Ru486

13. Zk 98296

14. Zk-98296

15. Zk98296

2.3.2 Depositor-Supplied Synonyms

1. 84371-65-3

2. Mifegyne

3. Mifeprex

4. Ru-486

5. Korlym

6. Ru486

7. Ru 486

8. Mifepriston

9. Corlux

10. Ru 38486

11. Ru-38486

12. Mls000069785

13. 320t6rnw1f

14. Vgx-410c

15. Chebi:50692

16. Vgx-410

17. Nsc-759862

18. Ncgc00025179-05

19. Smr000058481

20. Mifepristonum [latin]

21. Mifepristona [spanish]

22. Dsstox_cid_3322

23. C-1073

24. Dsstox_rid_76976

25. Dsstox_gsid_23322

26. (11beta,17beta)-11-[4-(dimethylamino)phenyl]-17-hydroxy-17-(1-propyn-1-yl)estra-4,9-dien-3-one

27. (8s,11r,13s,14s,17s)-11-(4-(dimethylamino)phenyl)-17-hydroxy-13-methyl-17-(prop-1-yn-1-yl)-1,2,6,7,8,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-3-one

28. (8s,11r,13s,14s,17s)-11-(4-dimethylaminophenyl)-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one

29. (8s,11r,13s,14s,17s)-11-[4-(dimethylamino)phenyl]-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one

30. 11-(4-dimethylamino-phenyl)-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,13,14,15,16,17-dodec Ahydro-cyclopenta[a]phenanthren-3-one

31. Mifepristona

32. Mifepristonum

33. (11beta,17beta)-11-[4-(dimethylamino)phenyl]-17-hydroxy-17-prop-1-yn-1-ylestra-4,9-dien-3-one

34. Ru486 (tetramethyl-rhodamine Conjugated)

35. Mifepristone [usan:inn:ban]

36. Hsdb 6841

37. Sr-01000076011

38. R 38486

39. Brn 5779404

40. Unii-320t6rnw1f

41. Pictovir

42. Ru 486-6

43. Ccris 9332

44. 1nhz

45. 11beta-(p-(dimethylamino)phenyl)-17beta-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one

46. Mifeprex (tn)

47. Pictovir (tm)

48. Prestwick_570

49. Cas-84371-65-3

50. Korlym (tn)

51. 2w8y

52. Mifepristone (mifeprex)

53. Opera_id_562

54. Mifepristone, >=98%

55. Prestwick0_000299

56. Prestwick1_000299

57. Prestwick2_000299

58. Prestwick3_000299

59. Spectrum5_002045

60. Mifepristone [mi]

61. Mifepristone [inn]

62. Mifepristone [jan]

63. Mifepristone [hsdb]

64. Mifepristone [usan]

65. 11beta-(4-(dimethylamino)phenyl)-17beta-hydroxy-17-(1-propynyl)estra-4,9-dien-3-on

66. 17-beta-hydroxy-11-beta-(4-dimethylaminophenyl-1)-17-alpha-(prop-1-ynyl)oestra-4,9-dien-3-one

67. Mifepristone [vandf]

68. Bidd:pxr0123

69. Lopac0_000801

70. Schembl16087

71. Bspbio_000238

72. Mifepristone [mart.]

73. 11beta-(4-(dimethylamino)phenyl)-17-hydroxy-21-methyl-19-nor-17alpha-pregna-4,9-dien-20-m-3-on

74. 11beta-(4-(n,n-dimethylamino)phenyl)-17alpha-(prop-1-ynyl)-delta4,9-estradiene-17beta-ol-3-one

75. Mls001074115

76. Mls001424271

77. (non-labelled)mifepristone-d3

78. Mifepristone [usp-rs]

79. Mifepristone [who-dd]

80. Spbio_002457

81. Ru-486; Mifepristone

82. Bpbio1_000262

83. Chembl438575

84. Gtpl2805

85. Mifepristone (jan/usan/inn)

86. Chembl1276308

87. Dtxsid5023322

88. Bdbm18627

89. Hms1568l20

90. Hms2052l05

91. Hms2090l22

92. Hms2095l20

93. Hms2230p21

94. Hms3262b03

95. Hms3412d17

96. Hms3649j08

97. Hms3676d17

98. Hms3712l20

99. Hms3884d12

100. Mifepristone [orange Book]

101. 11.beta.-(p-(dimethylamino)phenyl)-17.beta.-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one

102. Act02598

103. Bcp02145

104. Zinc3831128

105. Tox21_110952

106. Tox21_301841

107. Tox21_500801

108. Bdbm50072024

109. Hsci1_000369

110. S2606

111. Vx-410

112. Akos015895416

113. Tox21_110952_1

114. Ccg-101164

115. Ci-1073

116. Cs-1435

117. Db00834

118. Lp00801

119. Nc00414

120. Nsc 759862

121. Sdccgsbi-0050778.p002

122. Mifepristone 1.0 Mg/ml In Acetonitrile

123. Ncgc00025179-06

124. Ncgc00025179-07

125. Ncgc00025179-08

126. Ncgc00025179-09

127. Ncgc00025179-12

128. Ncgc00025179-13

129. Ncgc00025179-23

130. Ncgc00179632-01

131. Ncgc00255152-01

132. Ncgc00261486-01

133. (11beta,17beta)-11-(4-(dimethylamino)phenyl)-17-hydroxy-17-(1-propynyl)-estra-4,9-dien-3-one

134. As-13938

135. Cpd000058481

136. Estra-4,9-dien-3-one, 11-(4-(dimethylamino)phenyl)-17-hydroxy-17-(1-propynyl)-, (11-beta,17-beta)-

137. Hy-13683

138. Ru486;c-1073

139. Eu-0100801

140. C07652

141. D00585

142. M 8046

143. 371m653

144. A840767

145. Q411240

146. Sr-01000721888

147. Q-201405

148. Sr-01000076011-1

149. Sr-01000076011-3

150. Sr-01000076011-5

151. Sr-01000076011-9

152. Sr-01000721888-4

153. Brd-k37270826-001-04-5

154. Brd-k37270826-001-31-8

155. Mifepristone, United States Pharmacopeia (usp) Reference Standard

156. (11?,17?)-11-[4-(dimethylamino)phenyl]-17-hydroxy-17-(1-propynyl)-estra-4,9-dien-3-one

157. 11.beta.-[4-(dimethylamino)phenyl]-17.beta.-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one

158. 11beta-(4-dimethylamino)phenyl-17beta-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one

159. 11ss-[p-(dimethylamino)fenyl]-17ss-hydroxy- 17-(1-propynyl)estra-4,9-dien-3-on

160. (10s,11s,14s,15s,17r)-17-[4-(dimethylamino)phenyl]-14-hydroxy-15-methyl-14-(prop-1-yn-1-yl)tetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadeca-1,6-dien-5-one

161. (10s,11s,14s,15s,17r)-17-[4-(dimethylamino)phenyl]-14-hydroxy-15-methyl-14-(prop-1-yn-1-yl)tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-1,6-dien-5-one

162. (11.beta.,17.beta.)-11-(4-(dimethylamino)phenyl)-17-hydroxy-17-(1-propynyl)-estra-4,9-dien-3-one

163. (11r,13s,14s,17s)-11-(4-dimethylamino-phenyl)-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,13,14,15,16,17-dodecahydro-cyclopenta[a]phenanthren-3-one

164. (8s,11r,13s,14s,17s)-11-[4-(dimethylamino)phenyl]-13-methyl-17-oxidanyl-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one

165. 122742-25-0

166. 83203-42-3

167. Estra-4,9-dien-3-one, 11-[4-(dimethylamino)phenyl]-17-hydroxy-17-(1-propyn-1-yl)-, (11.beta.,17.beta.)-

168. Estra-4,9-dien-3-one, 11-[4-(dimethylamino)phenyl]-17-hydroxy-17-(1-propynyl)-, (11b,17b)-

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 429.6 g/mol
Molecular Formula C29H35NO2
XLogP33.8
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count3
Rotatable Bond Count3
Exact Mass429.266779359 g/mol
Monoisotopic Mass429.266779359 g/mol
Topological Polar Surface Area40.5 Ų
Heavy Atom Count32
Formal Charge0
Complexity921
Isotope Atom Count0
Defined Atom Stereocenter Count5
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 4  
Drug NameKorlym
PubMed HealthMifepristone (By mouth)
Drug ClassesAntiglucocorticoid, Antiprogesterone
Drug LabelKorlym (mifepristone) is a cortisol receptor blocker for oral administration. The chemical name of mifepristone is 11-(4-dimethylaminophenyl)-17-hydroxy-17-(1-propynyl)-estra-4, 9-dien-3-one. The chemical formula is C29H35NO2; the molecular wei...
Active IngredientMifepristone
Dosage FormTablet
RouteOral
Strength300mg
Market StatusPrescription
CompanyCorcept Therap

2 of 4  
Drug NameMifeprex
Active IngredientMifepristone
Dosage FormTablet
RouteOral
Strength200mg
Market StatusPrescription
CompanyDanco Labs

3 of 4  
Drug NameKorlym
PubMed HealthMifepristone (By mouth)
Drug ClassesAntiglucocorticoid, Antiprogesterone
Drug LabelKorlym (mifepristone) is a cortisol receptor blocker for oral administration. The chemical name of mifepristone is 11-(4-dimethylaminophenyl)-17-hydroxy-17-(1-propynyl)-estra-4, 9-dien-3-one. The chemical formula is C29H35NO2; the molecular wei...
Active IngredientMifepristone
Dosage FormTablet
RouteOral
Strength300mg
Market StatusPrescription
CompanyCorcept Therap

4 of 4  
Drug NameMifeprex
Active IngredientMifepristone
Dosage FormTablet
RouteOral
Strength200mg
Market StatusPrescription
CompanyDanco Labs

4.2 Therapeutic Uses

Abortifacient Agents, Steroidal; Contraceptives, Oral, Synthetic; Contraceptives, Postcoital, Synthetic; Hormone Antagonists; Luteolytic Agents; Menstruation-Inducing Agents

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


Mifepristone is indicated in combination with misoprostol for the medical termination of intrauterine pregnancy of 49 days duration or less. /Included in US product labeling/

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


4.3 Drug Warning

Confirmed or suspected ectopic pregnancy, undiagnosed adnexal mass, or IUD currently in place. Chronic adrenal failure or concurrent long-term corticosteroid therapy. Known hypersensitivity to mifepristone, misoprostol, or other prostaglandins. Hemorrhagic disorders, inherited porphyrias, or concurrent anticoagulant therapy.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3148


Vaginal bleeding that is heavier than associated with a normal menses occurs in almost all women receiving mifepristone and misoprostol. Based on clinical studies, bleeding or spotting should be expected for an average of 9-16 days. ... Excessive bleeding may require treatment with vasoconstrictors, saline infusions, and/or blood transfusions or curettage.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3148


Severe vaginal bleeding may occur following spontaneous, surgical, or medical abortion (including following mifepristone administration). Prolonged heavy vaginal bleeding (i.e. soaking through 2 thick full-size sanitary pads per hour for 2 consecutive hours) may be a sign of incomplete abortion or other complications, and prompt medical or surgical intervention maybe required to prevent the development of hypovolemic shock. Patients should be advised to seek immediate medical attention if prolonged heavy vaginal bleeding or syncope occurs following mifepristone administration.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3148


Serious bacterial infections (including very rare cases of fatal septic shock) have been reported following mifepristone administration; a causal relationship to the mifepristone-misoprostol regimen has not been established. Clinicians should consider the possibility of infection if sustained fever (temperature of 38 degrees C or higher persisting for more than 4 hours), severe abdominal pain, or pelvic tenderness occurs within several days of medical abortion. Atypical presentations of serious infection and sepsis (i.e., presence of significant leukocytosis, tachycardia, or hemoconcentration without fever, severe abdominal pain, pelvic tenderness) may also occur.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3148


For more Drug Warnings (Complete) data for MIFEPRISTONE (14 total), please visit the HSDB record page.


4.4 Drug Indication

For the medical termination of intrauterine pregnancy through 49 days' pregnancy. Also indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and are not candidates for surgery or have had unsuccessful surgery.


FDA Label


Treatment of endometriosis


Treatment of hypercortisolism (Cushing's syndrome) of endogenous origin


Treatment of leiomyoma of uterus


5 Pharmacology and Biochemistry
5.1 Pharmacology

Mifepristone is a synthetic steroid with antiprogestational effects indicated for the medical termination of intrauterine pregnancy through 49 days' pregnancy. Doses of 1 mg/kg or greater of mifepristone have been shown to antagonize the endometrial and myometrial effects of progesterone in women. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins. Mifepristone also exhibits antiglucocorticoid and weak antiandrogenic activity. The activity of the glucocorticoid dexamethasone in rats was inhibited following doses of 10 to 25 mg/kg of mifepristone. Doses of 4.5 mg/kg or greater in human beings resulted in a compensatory elevation of adrenocorticotropic hormone (ACTH) and cortisol.


5.2 MeSH Pharmacological Classification

Contraceptives, Oral, Synthetic

Oral contraceptives which owe their effectiveness to synthetic preparations. (See all compounds classified as Contraceptives, Oral, Synthetic.)


Luteolytic Agents

Chemical compounds that cause LUTEOLYSIS or degeneration of the CORPUS LUTEUM. (See all compounds classified as Luteolytic Agents.)


Contraceptives, Postcoital, Synthetic

Postcoital contraceptives which owe their effectiveness to synthetic preparations. (See all compounds classified as Contraceptives, Postcoital, Synthetic.)


Abortifacient Agents, Steroidal

Steroidal compounds with abortifacient activity. (See all compounds classified as Abortifacient Agents, Steroidal.)


Menstruation-Inducing Agents

Chemical compounds that induce menstruation either through direct action on the reproductive organs or through indirect action by relieving another condition of which amenorrhea is a secondary result. (From Dorland, 27th ed) (See all compounds classified as Menstruation-Inducing Agents.)


Hormone Antagonists

Chemical substances which inhibit the function of the endocrine glands, the biosynthesis of their secreted hormones, or the action of hormones upon their specific sites. (See all compounds classified as Hormone Antagonists.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
MIFEPRISTONE
5.3.2 FDA UNII
320T6RNW1F
5.3.3 Pharmacological Classes
Progestin Antagonist [EPC]; Progestational Hormone Receptor Antagonists [MoA]
5.4 ATC Code

G03XB01

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


G - Genito urinary system and sex hormones

G03 - Sex hormones and modulators of the genital system

G03X - Other sex hormones and modulators of the genital system

G03XB - Progesterone receptor modulators

G03XB01 - Mifepristone


5.5 Absorption, Distribution and Excretion

Absorption

The absolute bioavailability of a 20 mg oral dose is 69%


Route of Elimination

Fecal: 83%; Renal: 9%.


The absolute bioavailability of oral mifepristone is 69%.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


Protein binding: Very high (98%); predominantly to albumin and alpha1- acid glycoprotein.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


Time to peak concentration: 90 minutes after a 600 mg oral dose.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


Peak plasma concentration: 1.98 mg/L following a single 600 mg oral dose.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


Fecal; 83% of a 600 mg dose over 11 days. Renal; 9% of a 600 mg dose over 11 days.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


5.6 Metabolism/Metabolites

Hepatic. Hepatic, by Cytochrome P450 3A4 isoenzyme to the N-monodemethylated metabolite (RU 42 633); RU 42 698, which results from the loss of two methyl groups from position 11 beta; and RU 42 698, which results from terminal hydroxylation of the 17–propynyl chain.


Hepatic, by Cytochrome P450 3A4 isoenzyme to the N-monodemethylated metabolite (RU 42 633); RU 42 698, which results from terminal hydroxylation of the 17-propynyl chain.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


Mifepristone has known human metabolites that include 17alpha-hydroxymifepristone and Monodemethylated mifepristone.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.7 Biological Half-Life

18 hours


Terminal: 18 hours; begins slowly and becomes more rapid with time.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


5.8 Mechanism of Action

The anti-progestational activity of mifepristone results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species (mouse, rat, rabbit and monkey), the compound inhibits the activity of endogenous or exogenous progesterone. The termination of pregnancy results. In the treatment of Cushing's syndrome, Mifepristone blocks the binding of cortisol to its receptor. It does not decrease cortisol production but reduces the effects of excess cortisol, such as high blood sugar levels.


Mifepristone competitively inhibits the actions of progesterone at progesterone-receptor sites, resulting in termination of pregnancy.The combination of mifepristone and misoprostol causes expulsion of the products of conception through decidual necrosis, myometrial contractions, and cervical softening.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


When administered in the early stages of pregnancy, mifepristone causes decidual breakdown by blockade of uterine progesterone receptors. This leads to detachment of the blastocyte, which decreases hCG production. This in turn causes a decrease in progesterone secretion from the corpus luteum, which further accentuates decidual breakdown. Decreased endogenous progesterone coupled with blockade of progesterone receptors in the uterus increases prostaglandin levels and sensitizes the myometrium to the contractile actions of prostaglandins.

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1622


In addition, mifepristone promotes uterine contractions and softening of the cervix and sensitizes the myometrium to effects of prostaglandins (e.g., misoprostol) that stimulate uterine contraction and expulsion of the products of conception. In the absence of progesterone, mifepristone acts as a partial progestin agonist. At dosages higher than those used for termination of pregnancy, mifepristone also exhibits antiglucocorticoid activity. The drug also has been shown to have weak antiandrogenic activity.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3148


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Submission : 2011-01-30

Status : Active

Type : II

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05

Pharma, Lab & Chemical Expo
Not Confirmed

05

Pharma, Lab & Chemical Expo
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 21944

Submission : 2008-09-08

Status : Inactive

Type : II

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06

Pharma, Lab & Chemical Expo
Not Confirmed
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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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Mifepristone

About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...

Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncology products. The company's core strength lies in its dedicated team, and its promoters bring over 25 years of experience in manufacturing, promoting products, and managing audits for regulated markets such as the EU, Mexico, China, Korea, and Russia. GONANE PHARMA is actively engaged in discussions with Japanese customers and anticipates further expansion into additional markets.
Gonane Pharma

02

LGM Pharma

U.S.A
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Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Digital Content Digital Content

Mifepristone

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

03

Seqens

France
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Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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Digital Content Digital Content

Mifepristone

About the Company : Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling ...

Since its inception in 2003, Seqens has grown to become a global leader in pharmaceutical solutions and specialty ingredients. Seqens supports its customers in developing, scaling up and manufacturing drug substances from the pre-clinical phase to the commercial phase. It offers a large portfolio of APIs and proprietary products. Seqens also develops custom solutions and ingredients for the most demanding industries, such as healthcare, electronics and cosmetics. Its unique range of technologies enables it to manufacture complex molecules for small- and large-scale demands. It operates 24 industrial plants and 10 R&D centres across the globe.
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04

ASG Biochem

India
PharmaVenue
Not Confirmed
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ASG Biochem

India
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Not Confirmed

Mifepristone

About the Company : ASG Biochem Private Limited at Ganganagar near Kolkata, West Bengal, India, is a bulk API manufacturing company of the New Delhi based diversified APEEJAY STYA GROUP. The unit acqu...

ASG Biochem Private Limited at Ganganagar near Kolkata, West Bengal, India, is a bulk API manufacturing company of the New Delhi based diversified APEEJAY STYA GROUP. The unit acquired from AKZO NOBEL N.V., the Netherlands in 2004 is engaged in the synthesis of specialized APIs, in particular, hormones and intermediates.The unit has global exports including intermediates / penultimates to the European Union apart from supply to internal Group companies. In addition, the plant also holds ISO 9001-2008 and ISO 14001:2004 certification from DNV, the Netherlands.The unit has Japan accreditation for manufacturing APIs.
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Mifepristone

About the Company : Aspen Biopharma Labs is a multifaceted company that was established in 2014. Aspen Bio Pharma defines development and novelty as a challenge for competitive markets to provide impr...

Aspen Biopharma Labs is a multifaceted company that was established in 2014. Aspen Bio Pharma defines development and novelty as a challenge for competitive markets to provide improved health services to people, through pioneering Research & Development in agreement with the latest principles to ensure safe and secured wellness. The Company is established in bringing the benefit of high quality APIs & Finished Formulations, yet reasonably priced, to patients in India and other emerging markets.
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06

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Mifepristone

About the Company : Balaji corporation was established in 2006, the group have two branch in india.To play a key role as innovative and delenadable service provided.The company was quick to envisage t...

Balaji corporation was established in 2006, the group have two branch in india.To play a key role as innovative and delenadable service provided.The company was quick to envisage the challenges which the repidly growing pharmaceuticals industry in india . To meet high qulity requirement means for high calliber of expertise to understand cutting edge technology and provide suitable products Today balaji corporation is a name well-known with pharamceuticals player in healthcare idustries .Our principal have undoubtedly played a key role in our success. We strive to provide best quality pharmaceutical products.
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07

Curia

U.S.A
PharmaVenue
Not Confirmed
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Curia

U.S.A
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PharmaVenue
Not Confirmed

Mifepristone

About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners tur...

Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners turn their ideas into real-world impact. We partner closely with pharmaceutical and biotechnology companies to boost business performance and improve patients’ lives. From early discovery and development through manufacturing and commercialization, our suite of custom solutions allows us to tailor every engagement to your precise needs, whether that’s an independent project or an opportunity that cuts across the drug continuum.
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08

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Mifepristone

About the Company : Dalian Richon Chem. Co., Ltd is a high-tech enterprise professionally involved in research and development, manufacturing process and sales service of pharmaceutical intermediates ...

Dalian Richon Chem. Co., Ltd is a high-tech enterprise professionally involved in research and development, manufacturing process and sales service of pharmaceutical intermediates and APIs. It has passed ISO9001:2000 international quality management system certificate. Its business scope includes development and manufacturing of APIs and pharmaceutical intermediates, contract development and manufacturing for domestic and international pharmaceutical companies, technical consultation, service and transfer.
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09

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Mifepristone

About the Company : Hanways Chempharm Co., Limited, the former one is Hubei Hanways Pharchem CO.,Limited, set up in 2009 in Wuhan, China. We are engaged in supplying APIs, pharmaceutical intermediate...

Hanways Chempharm Co., Limited, the former one is Hubei Hanways Pharchem CO.,Limited, set up in 2009 in Wuhan, China. We are engaged in supplying APIs, pharmaceutical intermediates, and fine chemicals for worldwide markets. With decades of development, now we grow to a leading and outstanding company. We are not just a trading company, but a comprehensive solutions supplier. With our sound knowledge of pharmaceutical business, our advantage is to integrate resources and adapt to all different demands of markets. We are a young but dynamic and energetic company with high efficient and high flexible decision making system.
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10

Naari

India
PharmaVenue
Not Confirmed
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Naari

India
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Not Confirmed

Mifepristone

About the Company : NAARI, meaning woman in Sanskrit, embodies the philosophy and objectives of our Organization. NAARI is a Swiss Pharmaceuticals company focused on female health with an emphasis on...

NAARI, meaning woman in Sanskrit, embodies the philosophy and objectives of our Organization. NAARI is a Swiss Pharmaceuticals company focused on female health with an emphasis on hormones and complex generics. We are an integrated player producing Biotech intermediates, Active Pharmaceutical Ingredients and Finished Dosage Forms supported by in house R&D in each domain. The company's current portfolio consists of generics and a robust innovative pipeline.
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API Reference Price

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RE IMPORT DUE TO PARTICLE SIZE OF MATERIAL IS OUT OF SPECIFICATI","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"HALO PHARMACEUTICAL INC","supplierCountry":"INDIA","foreign_port":"MONTREAL-DORAVAL APT","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"37.55","actualQuantity":"37.55","unit":"KGS","unitRateFc":"50","totalValueFC":"2671.8","currency":"USD","unitRateINR":"5978.7","date":"23-Oct-2024","totalValueINR":"224499.28","totalValueInUsd":"2671.8","indian_port":"Ahmedabad Air","hs_no":"29372900","bill_no":"6296979","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MONTREAL-DORAVAL APT","supplierAddress":"17800 LAPOINTE STREET MIRABEL QC J7 J 0W8 SDNF CANADA","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731954600,"product":"MIFEPRISTONE IH\/IP","address":"VILL.GHOGADWAL (CHOKIWALA),","city":"","supplier":"SHANGHAI YOKACHEM TECHNOLOGY CO. LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"ACME FORMULATION PVT LTD","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"930","totalValueFC":"28201.5","currency":"USD","unitRateINR":"79329","date":"19-Nov-2024","totalValueINR":"2379870","totalValueInUsd":"28201.5","indian_port":"Delhi Air","hs_no":"29372900","bill_no":"6750833","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"ROOM 607, 610 BUILDING 2 NO 1295 CH UANQIAO ROAD CHINA (SHANGHAI) Pudon g\/Shanghai, , CHINA CHINA","customerAddress":"VILL.GHOGADWAL (CHOKIWALA),"}]
27-Jan-2021
19-Nov-2024
KGS
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Average Price (USD/KGS)

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Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
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(USD/KGS)
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ABOUT THIS PAGE

Mifepristone Manufacturers

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

Mifepristone Suppliers

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

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

Mifepristone USDMF

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

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

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

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

Mifepristone WC

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

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

Mifepristone 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 Mifepristone as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Mifepristone GMP

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

Mifepristone CoA

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

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

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