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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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CHINA CHINA","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1762885800,"product":"MIFEPRISTONE IP MIFEPRISTONE IP","address":"218\/219, 2ND FLOOR,KAILASH PLAZA,","city":"GHATKOPAR EAST,MUMBAI, MAHARASTHRA","supplier":"SHRIYA PHARMA SURGICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"AQUATIC REMEDIES LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"638.2","totalValueFC":"64268.9","currency":"USD","unitRateINR":"57122.8","date":"12-Nov-2025","totalValueINR":"5712280","totalValueInUsd":"64268.9","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29372900","bill_no":"91","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"43 HANIFABAI MANZIL ROOM NO 18,GRO UND FLOOR KAPAD BAZAR MAHIM WEST,MA HARASHTRA , MAHARASHTRA, INDIA INDIA","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1763749800,"product":"MIFEPRISTONE IP MIFEPRISTONE IP","address":"304,MOHAN PLACE,L.S.C.BLOCK-C","city":"DELHI","supplier":"ZHEJIANG XIANJU PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"AKUMS DRUGS AND PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"630","totalValueFC":"126877.5","currency":"USD","unitRateINR":"56385","date":"22-Nov-2025","totalValueINR":"11277000","totalValueInUsd":"126877.5","indian_port":"Delhi Air","hs_no":"29372900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.1 XIANYAO ROAD,XIANJU ZHEJIANG C HINA , , CHINA SDNF CHINA","customerAddress":"304,MOHAN PLACE,L.S.C.BLOCK-C"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1765564200,"product":"MIFEPRISTONE IP MIFEPRISTONE IP","address":"43 HANIFABAI MANZIL ROOM NO 18,GRO","city":"MAHIM WEST,MAHARASHTRA","supplier":"GREEN PARROT (WUHAN) TRADING LIMITED","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"SHRIYA PHARMA SURGICAL","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"644","totalValueFC":"326647.8","currency":"USD","unitRateINR":"58797.2","date":"13-Dec-2025","totalValueINR":"29398600","totalValueInUsd":"326647.8","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29372900","bill_no":"2e38","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"15-5, UNIT 6, R&D BUILDING 6, ZONE II, NO. 3 GUANGGU AVENUE, EAST LAKE NEW TECHNOLOGY DEVELOPMENT ZONE, W CHINA","customerAddress":"43 HANIFABAI MANZIL ROOM NO 18,GRO"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1765909800,"product":"MIFEPRISTONE IP MIFEPRISTONE IP","address":"43 HANIFABAI MANZIL ROOM NO 18,GRO","city":"MAHIM WEST,MAHARASHTRA","supplier":"GREEN PARROT (WUHAN) TRADING LIMITED","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"SHRIYA PHARMA SURGICAL","customerCountry":"INDIA","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"644","totalValueFC":"326647.8","currency":"USD","unitRateINR":"58797.2","date":"17-Dec-2025","totalValueINR":"29398600","totalValueInUsd":"326647.8","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29372900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"15-5, UNIT 6, R&D BUILDING 6, ZONE II, NO. 3 GUANGGU AVENUE, EAST LAKE NEW TECHNOLOGY DEVELOPMENT ZONE, W CHINA","customerAddress":"43 HANIFABAI MANZIL ROOM NO 18,GRO"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1766169000,"product":"MIFEPRISTONE IP MIFEPRISTONE IP","address":"304,MOHAN PLACE,L.S.C.BLOCK-C","city":"DELHI","supplier":"ZHEJIANG XIANJU PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"AKUMS DRUGS AND PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"225.00","actualQuantity":"225","unit":"KGS","unitRateFc":"630","totalValueFC":"143717.3","currency":"USD","unitRateINR":"57487.5","date":"20-Dec-2025","totalValueINR":"12934687.5","totalValueInUsd":"143717.3","indian_port":"Delhi Air","hs_no":"29372900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"NO.1 XIANYAO ROAD,XIANJU ZHEJIANG C HINA , , CHINA SDNF CHINA","customerAddress":"304,MOHAN PLACE,L.S.C.BLOCK-C"}]
    08-Jan-2022
    20-Dec-2025
    KGS
    overview
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

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

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    API Imports and Exports

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

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    INTERMEDIATE SUPPLIERS

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    01

    Ningbo Inno Pharmchem Co., Ltd.

    China
    ASCO GU
    Not Confirmed
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    Ningbo Inno Pharmchem Co., Ltd.

    China
    ASCO GU
    Not Confirmed
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    Pyridinium tribromide

    CAS Number : 39416-48-3

    End Use API : Mifepristone

    About The Company : NINGBO INNO PHARMCHEM CO.,LTD. develop, pilot and commercial produce organic chemicals, pharmaceutical intermediates and nutraceuticals. We also offer custom sy...

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    02

    Zhejiang Xianju Pharmaceutical Co. ...

    China
    ASCO GU
    Not Confirmed
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    Zhejiang Xianju Pharmaceutical Co. ...

    China
    ASCO GU
    Not Confirmed
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    19-nor-5(10)-androstene-3,17-dione

    CAS Number : 3962-66-1

    End Use API : Mifepristone

    About The Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedic...

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    03

    Zhejiang Xianju Pharmaceutical Co. ...

    China
    ASCO GU
    Not Confirmed
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    Zhejiang Xianju Pharmaceutical Co. ...

    China
    ASCO GU
    Not Confirmed
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    3-ethylene dioxy-17-oxo-13ß-methyl-estra-5(10),9(...

    CAS Number : 24916-90-3

    End Use API : Mifepristone

    About The Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedic...

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    04

    Zhejiang Xianju Pharmaceutical Co. ...

    China
    ASCO GU
    Not Confirmed
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    Zhejiang Xianju Pharmaceutical Co. ...

    China
    ASCO GU
    Not Confirmed
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    5a,10a-epoxy-3,3-ethylenedioxy-17a-propynyl-estra-...

    CAS Number : 84371-57-3

    End Use API : Mifepristone

    About The Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedic...

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    05

    Zhejiang Xianju Pharmaceutical Co. ...

    China
    ASCO GU
    Not Confirmed
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    Zhejiang Xianju Pharmaceutical Co. ...

    China
    ASCO GU
    Not Confirmed
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    3-(1,2-ethanediyl-bosoxy)-11a-(4-(n,n- dimethylami...

    CAS Number : 84371-64-2

    End Use API : Mifepristone

    About The Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedic...

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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    FDA Orange Book

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    01

    CORCEPT THERAP

    U.S.A
    BIO CEO & Investor
    Not Confirmed
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    CORCEPT THERAP

    U.S.A
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    BIO CEO & Investor
    Not Confirmed
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    RLD : Yes

    TE Code : AB

    MIFEPRISTONE

    Brand Name : KORLYM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 300MG

    Approval Date : 2012-02-17

    Application Number : 202107

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    02

    DANCO LABS LLC

    U.S.A
    BIO CEO & Investor
    Not Confirmed
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    DANCO LABS LLC

    U.S.A
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    BIO CEO & Investor
    Not Confirmed
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    RLD : Yes

    TE Code : AB

    MIFEPRISTONE

    Brand Name : MIFEPREX

    Dosage Form : TABLET;ORAL

    Dosage Strength : 200MG

    Approval Date : 2000-09-28

    Application Number : 20687

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AB

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    03

    GENBIOPRO

    U.S.A
    BIO CEO & Investor
    Not Confirmed
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    GENBIOPRO

    U.S.A
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    RLD : No

    TE Code : AB

    MIFEPRISTONE

    Brand Name : MIFEPRISTONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 200MG

    Approval Date : 2019-04-11

    Application Number : 91178

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    04

    TEVA PHARMS USA INC

    Israel
    euroPLX 90 Lisbon
    Not Confirmed
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    TEVA PHARMS USA INC

    Israel
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    euroPLX 90 Lisbon
    Not Confirmed
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    Flag Israel
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    RLD : No

    TE Code : AB

    MIFEPRISTONE

    Brand Name : MIFEPRISTONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 300MG

    Approval Date : 2020-08-03

    Application Number : 211436

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    05

    EVITA SOLUTIONS

    Country
    BIO CEO & Investor
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    EVITA SOLUTIONS

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    RLD : No

    TE Code : AB

    MIFEPRISTONE

    Brand Name : MIFEPRISTONE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 200MG

    Approval Date : 2025-09-30

    Application Number : 216616

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Europe

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    01

    2Care4 Aps

    Denmark
    euroPLX 90 Lisbon
    Not Confirmed
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    2Care4 Aps

    Denmark
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    euroPLX 90 Lisbon
    Not Confirmed
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    Regulatory Info : Prescription

    Registration Country : Denmark

    Mifepriston

    Brand Name : Mifegyne

    Dosage Form : Tablet

    Dosage Strength : 200mg

    Packaging :

    Approval Date : 10-09-2021

    Application Number : 28106631821

    Regulatory Info : Prescription

    Registration Country : Denmark

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    Exelgyn

    France
    euroPLX 90 Lisbon
    Not Confirmed
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    Exelgyn

    France
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    euroPLX 90 Lisbon
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    Flag France
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    Regulatory Info : Marketed

    Registration Country : Norway

    Mifepriston

    Brand Name : Mifegyne

    Dosage Form : Tablet

    Dosage Strength : 200mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info : Marketed

    Registration Country : Norway

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    Exelgyn

    France
    euroPLX 90 Lisbon
    Not Confirmed
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    Exelgyn

    France
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    euroPLX 90 Lisbon
    Not Confirmed
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    Regulatory Info : Authorized

    Registration Country : Spain

    Mifepristone

    Brand Name : Mifegyne

    Dosage Form : Tablet

    Dosage Strength : 600MG

    Packaging :

    Approval Date : 11-06-2019

    Application Number : 84219

    Regulatory Info : Authorized

    Registration Country : Spain

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    04

    Exelgyn, Paris

    France
    euroPLX 90 Lisbon
    Not Confirmed
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    Exelgyn, Paris

    France
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    euroPLX 90 Lisbon
    Not Confirmed
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    Regulatory Info : Approved

    Registration Country : Sweden

    Mifepristone

    Brand Name : Mifegyne

    Dosage Form : Tablet

    Dosage Strength : 200mg

    Packaging :

    Approval Date : 04-09-1992

    Application Number : 1.99E+13

    Regulatory Info : Approved

    Registration Country : Sweden

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    Linepharma

    United Kingdom
    euroPLX 90 Lisbon
    Not Confirmed
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    Linepharma

    United Kingdom
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    euroPLX 90 Lisbon
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    Regulatory Info : Authorized

    Registration Country : Spain

    Mifepristone

    Brand Name : Mifepriston Linepharma

    Dosage Form : Tablet

    Dosage Strength : 200MG

    Packaging :

    Approval Date : 13-11-2013

    Application Number : 77617

    Regulatory Info : Authorized

    Registration Country : Spain

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    Nordic Pharma Gmbh

    France
    euroPLX 90 Lisbon
    Not Confirmed
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    Nordic Pharma Gmbh

    France
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    euroPLX 90 Lisbon
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    Regulatory Info : Allowed

    Registration Country : Switzerland

    My Firstborn

    Brand Name : Mifegyne

    Dosage Form : Tablet

    Dosage Strength : 200mg

    Packaging :

    Approval Date : 14/07/1999

    Application Number : 55205

    Regulatory Info : Allowed

    Registration Country : Switzerland

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    07

    Orifarm A/S

    Denmark
    euroPLX 90 Lisbon
    Not Confirmed
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    Orifarm A/S

    Denmark
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    euroPLX 90 Lisbon
    Not Confirmed
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    Regulatory Info : Prescription

    Registration Country : Denmark

    Mifepriston

    Brand Name : Mifegyne

    Dosage Form : Tablet

    Dosage Strength : 200mg

    Packaging :

    Approval Date : 12-06-2020

    Application Number : 28106414820

    Regulatory Info : Prescription

    Registration Country : Denmark

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    08

    Sun Pharmaceutical Industries, Ltd

    India
    euroPLX 90 Lisbon
    Not Confirmed
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    Sun Pharmaceutical Industries, Ltd

    India
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    euroPLX 90 Lisbon
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    Regulatory Info :

    Registration Country : Moldova

    Mifepristone; Misoprostol

    Brand Name : Medabon

    Dosage Form : Vaginal Tablets

    Dosage Strength : 200mg; 0.2mg

    Packaging :

    Approval Date : 09-04-2020

    Application Number :

    Regulatory Info :

    Registration Country : Moldova

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    Sun Pharmaceutical Industries Europe Bv

    India
    euroPLX 90 Lisbon
    Not Confirmed
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    Sun Pharmaceutical Industries Europe Bv

    India
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    Regulatory Info : Deregistered

    Registration Country : Sweden

    Mifepristone; Misoprostol

    Brand Name : Meda Subscriber

    Dosage Form : Vaginal Tablet

    Dosage Strength : 200mg;(4x0.2mg)

    Packaging :

    Approval Date : 02-08-2012

    Application Number : 2.01E+13

    Regulatory Info : Deregistered

    Registration Country : Sweden

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    EXELGYN

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    EXELGYN

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    Regulatory Info :

    Registration Country : Italy

    Mifepristone

    Brand Name : Mifegyne

    Dosage Form : Mifepristone 200Mg 1 Combined Oral Use

    Dosage Strength : 1 CPR 200 mg

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    Approval Date :

    Application Number :

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    Registration Country : Italy

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    LINEPHARMA INTERNATIONAL LIMITED

    United Kingdom
    euroPLX 90 Lisbon
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    LINEPHARMA INTERNATIONAL LIMITED

    United Kingdom
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    Regulatory Info : Prescription

    Registration Country : Canada

    MIFEPRISTONE

    Brand Name : MIFEGYMISO

    Dosage Form : TABLET

    Dosage Strength : 200MG

    Packaging : 1 MIFEPRISTONE AND 4 MISOPROSTOL PER PACK

    Approval Date :

    Application Number : 2444038

    Regulatory Info : Prescription

    Registration Country : Canada

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    MS Health Pty Ltd

    Australia
    euroPLX 90 Lisbon
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    Regulatory Info :

    Registration Country : Australia

    mifepristone (&) misoprostol

    Brand Name : MS-2 Step

    Dosage Form : tablet

    Dosage Strength : 200 mg

    Packaging : 1

    Approval Date :

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    Registration Country : Australia

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    Adcock Ingram Limited

    South Africa
    euroPLX 90 Lisbon
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    South Africa
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    Regulatory Info : Generic

    Registration Country : South Africa

    Mifepristone

    Brand Name : Mediprist 200 mg

    Dosage Form : TAB

    Dosage Strength : 200mg

    Packaging : 1X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Medi Challenge

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    euroPLX 90 Lisbon
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    Regulatory Info : Originator

    Registration Country : South Africa

    Mifepristone

    Brand Name : Mifegyne

    Dosage Form : TAB

    Dosage Strength : 200mg

    Packaging : 3X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    euroPLX 90 Lisbon
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    Mifepristone

    Brand Name : MEDABON CO

    Dosage Form : KIT

    Dosage Strength : 200mg

    Packaging : 5X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Application : Coating Systems & Additives, Controlled & Modified Release

    Excipient Details : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.

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    ABOUT THIS PAGE

    Looking for 84371-65-3 / Mifepristone API manufacturers, exporters & distributors?

    Mifepristone manufacturers, exporters & distributors 1

    13

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

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

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

    API | Excipient name

    Mifepristone

    Synonyms

    84371-65-3, Mifegyne, Mifeprex, Ru-486, Korlym, Ru486

    Cas Number

    84371-65-3

    Unique Ingredient Identifier (UNII)

    320T6RNW1F

    About 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.

    RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex Manufacturers

    A RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex, including repackagers and relabelers. The FDA regulates RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex 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 RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex Suppliers

    A RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex supplier is an individual or a company that provides RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex active pharmaceutical ingredient (API) or RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex finished formulations upon request. The RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex suppliers may include RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex API manufacturers, exporters, distributors and traders.

    click here to find a list of RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex USDMF

    A RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex DMF (Drug Master File) is a document detailing the whole manufacturing process of RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex active pharmaceutical ingredient (API) in detail. Different forms of RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex DMFs exist exist since differing nations have different regulations, such as RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex DMF submitted to regulatory agencies in the US is known as a USDMF. RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex USDMF includes data on RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex suppliers with USDMF on PharmaCompass.

    RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex 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 RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex Drug Master File in Japan (RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex JDMF) empowers RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex 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 RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex JDMF during the approval evaluation for pharmaceutical products. At the time of RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex 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 RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex suppliers with JDMF on PharmaCompass.

    RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex WC

    A RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex written confirmation (RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex WC) is an official document issued by a regulatory agency to a RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex manufacturer, verifying that the manufacturing facility of a RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex APIs or RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex finished pharmaceutical products to another nation, regulatory agencies frequently require a RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex WC (written confirmation) as part of the regulatory process.

    click here to find a list of RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex suppliers with Written Confirmation (WC) on PharmaCompass.

    RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex 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 RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex 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 RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex 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 RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex suppliers with NDC on PharmaCompass.

    RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex GMP

    RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex 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 RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex 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 RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex GMP manufacturer or RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex GMP API supplier for your needs.

    RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex CoA

    A RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex CoA (Certificate of Analysis) is a formal document that attests to RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex's compliance with RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex specifications and serves as a tool for batch-level quality control.

    RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex CoA mostly includes findings from lab analyses of a specific batch. For each RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex 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.

    RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex may be tested according to a variety of international standards, such as European Pharmacopoeia (RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex EP), RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (RU-486;RU-38486;Mifegyne;Mifeprex;Mifeprex 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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