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    Chemistry

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    Also known as: 59122-46-2, Cytotec, Isprelor, Sc-29333, Misoprostolum [inn-latin], Misodel
    Molecular Formula
    C22H38O5
    Molecular Weight
    382.5  g/mol
    InChI Key
    OJLOPKGSLYJEMD-URPKTTJQSA-N
    FDA UNII
    0E43V0BB57
    Misoprostol
    A synthetic analog of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion, and enhances mucosal resistance to injury. It is an effective anti-ulcer agent and also has oxytocic properties.
    Misoprostol is a Prostaglandin E1 Analog.
    1 2D Structure

    Misoprostol

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    methyl 7-[(1R,2R,3R)-3-hydroxy-2-[(E)-4-hydroxy-4-methyloct-1-enyl]-5-oxocyclopentyl]heptanoate
    2.1.2 InChI
    InChI=1S/C22H38O5/c1-4-5-14-22(2,26)15-10-12-18-17(19(23)16-20(18)24)11-8-6-7-9-13-21(25)27-3/h10,12,17-18,20,24,26H,4-9,11,13-16H2,1-3H3/b12-10+/t17-,18-,20-,22?/m1/s1
    2.1.3 InChI Key
    OJLOPKGSLYJEMD-URPKTTJQSA-N
    2.1.4 Canonical SMILES
    CCCCC(C)(CC=CC1C(CC(=O)C1CCCCCCC(=O)OC)O)O
    2.1.5 Isomeric SMILES
    CCCCC(C)(C/C=C/[C@H]1[C@@H](CC(=O)[C@@H]1CCCCCCC(=O)OC)O)O
    2.2 Other Identifiers
    2.2.1 UNII
    0E43V0BB57
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Apo Misoprostol

    2. Apo-misoprostol

    3. Cytotec

    4. Glefos

    5. Misoprostol, (11alpha,13e)-isomer

    6. Misoprostol, (11alpha,13e,16r)-isomer

    7. Misoprostol, (11alpha,13z)-(+-)-isomer

    8. Misoprostol, (11alpha.13e,16s)-isomer

    9. Misoprostol, (11beta,13e)-(+-)-isomer

    10. Misoprostol, (11beta,13e,16r)-isomer

    11. Misoprostol, (11beta,13e,16s)-isomer

    12. Novo Misoprostol

    13. Novo-misoprostol

    14. Sc 29333

    15. Sc 30249

    16. Sc-29333

    17. Sc-30249

    18. Sc29333

    19. Sc30249

    2.3.2 Depositor-Supplied Synonyms

    1. 59122-46-2

    2. Cytotec

    3. Isprelor

    4. Sc-29333

    5. Misoprostolum [inn-latin]

    6. Misodel

    7. Sc 29333

    8. Ccris 6859

    9. Hsdb 3573

    10. Methyl 7-[(1r,2r,3r)-3-hydroxy-2-[(e)-4-hydroxy-4-methyloct-1-enyl]-5-oxocyclopentyl]heptanoate

    11. Brn 4155643

    12. 103601-27-0

    13. 0e43v0bb57

    14. Prost-13-en-1-oic Acid, 11,16-dihydroxy-16-methyl-9-oxo-, Methyl Ester,(11a,13e)-

    15. Ncgc00162445-02

    16. Misoprostolum

    17. Misoprost

    18. Misotol

    19. Misogon

    20. Misopess

    21. Misotac

    22. Gymiso

    23. Methyl (11alpha,13e)-11,16-dihydroxy-16-methyl-9-oxoprost-13-en-1-oate

    24. 7-[(1r,2r,3r)-3-hydroxy-2-[(e)-4-hydroxy-4-methyloct-1-enyl]-5-oxocyclopentyl]heptanoic Acid Methyl Ester

    25. Cytotec (tn)

    26. Misoprostol (methyl Ester)

    27. Sr-01000695425

    28. Unii-0e43v0bb57

    29. Xp-16j

    30. Mvi 200

    31. Methyl 7-((1r,2r,3r)-3-hydroxy-2-((e)-4-hydroxy-4-methyloct-1-enyl)-5-oxocyclopentyl)heptanoate

    32. 11

    33. A-misoprostol

    34. Cas_59122-46-2

    35. Misoprostol [usan:usp:inn:ban:jan]

    36. Misoprostol [mi]

    37. Dsstox_cid_897

    38. Misoprostol [inn]

    39. Misoprostol [jan]

    40. Methyl (+-)-11-alpha,16-dihydroxy-16-methyl-9-oxoprost-13-en-1-oate

    41. Misoprostol [hsdb]

    42. Misoprostol [usan]

    43. Chembl606

    44. Misoprostol [vandf]

    45. Schembl7787

    46. (11-alpha,13e)-(+-)-11,16-dihydroxy-16-methyl-9-oxoprost-13-en-1-oic Acid Methyl Ester

    47. Dsstox_rid_75852

    48. Misoprostol [mart.]

    49. Dsstox_gsid_20897

    50. Misoprostol [usp-rs]

    51. Misoprostol [who-dd]

    52. Mls000028863

    53. Misoprostol (jan/usp/inn)

    54. Misoprostol, 1% In Cellulose

    55. Gtpl1936

    56. Dtxsid7020897

    57. Bdbm85606

    58. Chebi:94387

    59. Misoprostol, >=99% (hplc)

    60. Misoprostol [orange Book]

    61. Regid_for_cid_5282381

    62. Hms2090l10

    63. Hms3648f03

    64. Hms3715k08

    65. Misoprostol [ep Monograph]

    66. Misoprostol [usp Monograph]

    67. Ex-a1774

    68. Hy-b0610

    69. Tox21_112010

    70. Arthrotec Component Misoprostol

    71. Akos015899652

    72. Ccg-221093

    73. Db00929

    74. Prost-13-en-1-oic Acid, 11,16-dihydroxy-16-methyl-9-oxo-, Methyl Ester, (11alpha,13e)-

    75. Smp1_000193

    76. Misoprostol Component Of Arthrotec

    77. Ncgc00162445-01

    78. Ncgc00162445-03

    79. (+-)-methyl (1r,2r,3r)-3-hydroxy-2-((e)-(4rs)-4-hydroxy-4-methyl-1-octenyl)-5-oxocyclopentaneheptanoate

    80. 62015-39-8

    81. As-83017

    82. Smr000058558

    83. Cas-59122-46-2

    84. D00419

    85. Ab00513745-05

    86. 122m462

    87. A832173

    88. Q416025

    89. Q-201409

    90. Sr-01000695425-2

    91. Sr-01000695425-4

    92. Brd-a50310035-001-01-6

    93. Misoprostol, European Pharmacopoeia (ep) Reference Standard

    94. Misoprostol, United States Pharmacopeia (usp) Reference Standard

    95. (+/-) Methyl 11alpha, 16-dihydroxy-16-methyl-9-oxoprost-13e-en-1-oate

    96. (+/-) Methyl 11alpha,16-dihydroxy-16-methyl-9-oxoprost-13e-en-1-oate

    97. (+/-) Methyl-11alpha,16-dihydroxy-16-methyl-9-oxoprost-13e-en-1-oate

    98. (+/-) Methyl-11alpha,16-dihydroxy-16-methyl-9-oxoprost13e-en-1-oate

    99. (+/-)-(11a,13e)-11,16-dihydroxy-16-methyl-9-oxo-prost-13-en-1-oic Acid Methyl Ester

    100. (11alpha,13e)-11,16-dihydroxy-16-methyl-9-oxoprosta-13-ene-1-oic Acid Methyl Ester

    101. 9-oxo-11alpha,16-dihydroxy-16-methyl-prost-13e-en-1-oic Acid, Methyl Ester

    102. Misoprostol For System Suitability, European Pharmacopoeia (ep) Reference Standard

    103. (+/-)-methyl (1r,2r,3r)-3-hydroxy-2-((e)-(4rs)-4-hydroxy-4-methyl-1-octenyl)-5-oxocyclopentaneheptanoate

    104. Methyl 7-[(1r,2r,3r)-2-[(e)-4-methyl-4-oxidanyl-oct-1-enyl]-3-oxidanyl-5-oxidanylidene-cyclopentyl]heptanoate

    105. Methyl 7-[(1r,2r,3r)-3-hydroxy-2-[(1e)-4-hydroxy-4-methyloct-1-en-1-yl]-5-oxocyclopentyl]heptanoate

    106. Prost-13-en-1-oic Acid, 11,16-dihydroxy-16-methyl-9-oxo-, Methyl Ester, (11.alpha.,13e)-(+/-)-

    107. Prost-13-en-1-oic Acid, 11,16-dihydroxy-16-methyl-9-oxo-, Methyl Ester, (11alpha,13e)-(+-)-

    108. Rel-methyl 7-((1r,2r,3r)-3-hydroxy-2-((e)-4-hydroxy-4-methyloct-1-en-1-yl)-5-oxocyclopentyl)heptanoate

    2.4 Create Date
    2005-10-11
    3 Chemical and Physical Properties
    Molecular Weight 382.5 g/mol
    Molecular Formula C22H38O5
    XLogP33.7
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count14
    Exact Mass382.27192431 g/mol
    Monoisotopic Mass382.27192431 g/mol
    Topological Polar Surface Area83.8 Ų
    Heavy Atom Count27
    Formal Charge0
    Complexity487
    Isotope Atom Count0
    Defined Atom Stereocenter Count3
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameCytotec
    PubMed HealthMisoprostol (By mouth)
    Drug ClassesAntiulcer, Protectant, Endocrine-Metabolic Agent
    Drug LabelMisoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog.Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by ():Misopros...
    Active IngredientMisoprostol
    Dosage FormTablet
    RouteOral
    Strength0.2mg; 0.1mg
    Market StatusPrescription
    CompanyGd Searle

    2 of 4  
    Drug NameMisoprostol
    PubMed HealthMisoprostol (By mouth)
    Drug ClassesAntiulcer, Protectant, Endocrine-Metabolic Agent
    Drug LabelMisoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog.Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by ():Misopros...
    Active IngredientMisoprostol
    Dosage FormTablet
    RouteOral
    Strength0.1mg; 0.2mg
    Market StatusPrescription
    CompanyNovel Labs; Ivax Sub Teva Pharms

    3 of 4  
    Drug NameCytotec
    PubMed HealthMisoprostol (By mouth)
    Drug ClassesAntiulcer, Protectant, Endocrine-Metabolic Agent
    Drug LabelMisoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog.Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by ():Misopros...
    Active IngredientMisoprostol
    Dosage FormTablet
    RouteOral
    Strength0.2mg; 0.1mg
    Market StatusPrescription
    CompanyGd Searle

    4 of 4  
    Drug NameMisoprostol
    PubMed HealthMisoprostol (By mouth)
    Drug ClassesAntiulcer, Protectant, Endocrine-Metabolic Agent
    Drug LabelMisoprostol oral tablets contain either 100 mcg or 200 mcg of misoprostol, a synthetic prostaglandin E1 analog.Misoprostol contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by ():Misopros...
    Active IngredientMisoprostol
    Dosage FormTablet
    RouteOral
    Strength0.1mg; 0.2mg
    Market StatusPrescription
    CompanyNovel Labs; Ivax Sub Teva Pharms

    4.2 Therapeutic Uses

    Abortifacient Agents, Nonsteroidal; Anti-Ulcer Agents; Oxytocics

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

    Misoprostol is indicated for the prevention of gastric ulcer associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, in patients at high risk of complications from gastric ulcer, such as the elderly, and in patients with concomitant disease or patients at high risk of developing gastric ulceration, such as those with a history of ulcer. /Included in US product labeling/

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2085

    Misoprostol is indicated in the short-term treatment of duodenal ulcer. /NOT included in US product labeling/

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2085

    The efficacy and tolerability of mifepristone in combo with misoprostol for termination of early pregnancy (up to 49 days of amenorrhea) are established.

    PMID:8574255 Aub'eny E et al; Int J Fertil Menopausal Stud 40 (Suppl 2): 85-91 (1995)

    For more Therapeutic Uses (Complete) data for MISOPROSTOL (8 total), please visit the HSDB record page.

    4.3 Drug Warning

    Misoprostol is contraindicated during pregnancy. Studies in humans have shown that misoprostol causes an increase in the frequency and intensity of uterine contractions. Misoprostol administration has also been associated with a higher incidence of uterine bleeding and expulsion of uterine contents. Miscarriages caused by misoprostol are likely to be incomplete, resulting in very serious medical complications, sometimes requiring hospitalization and surgery, and possibly causing infertility.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2086

    Patients of childbearing potential may use misoprostol if nonsteroidal anti-inflammatory drug (NSAID) therapy is required and patient is at high risk of complications from gastric ulcers associated with the use of NSAIDs, or is at high risk of developing gastric ulceration. Such patients must comply with effective contraceptive measures, must have had a negative serum pregnancy test within 2 weeks prior to initiation of therapy and must start misoprostol therapy only on the second or third day of the next normal menstrual period.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2086

    It is unlikely that misoprostol is distributed into breast milk since it is rapidly metabolized throughout the body. however, it is not known if the active metabolite, misoprostol acid, is distributed into breast milk. Therefore, administration of misoprostol to nursing women is not recommended because of the potential distribution of misoprostol acid, which could cause significant diarrhea in the nursing infant.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2086

    Misoprostol generally is well tolerated. The frequency of adverse effects does not appear to be affected by patient age in adults. The most frequent adverse effects associated with misoprostol therapy involve the GI tract (e.g., diarrhea, nausea, abdominal pain).

    McEvoy G.K. (ed.). American Hospital Formulary Service-Drug Information 96. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 1996 (Plus Supplements)., p. 2169

    For more Drug Warnings (Complete) data for MISOPROSTOL (8 total), please visit the HSDB record page.

    4.4 Drug Indication

    Misoprostol is indicated as a tablet to reduce the risk of NSAID induced gastric ulcers but not duodenal ulcers in high risk patients. Misoprostol is also formulated in combination with diclofenac to treat symptoms of osteoarthritis or rheumatoid arthritis in patients with a high risk of developing gastric ulcers. Misoprostol is used off label for the management of miscarriages, prevention of post partum hemorrhage, and is also used alone or in combination with mifepristone in other countries for first trimester abortions.

    FDA Label

    Induction of labour

    Induction of labour

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Misoprostol is a prostaglandin E1 analog used to reduce the risk of NSAID induced gastric ulcers by reducing secretion of gastric acid from parietal cells. Misoprostol is also used to manage miscarriages and used alone or in combination with mifepristone for first trimester abortions. An oral dose of misoprostol has an 8 minute onset of action and a duration of action of approximately 2 hours, a sublingual dose has an 11 minute onset of action and a duration of action of approximately 3 hours, a vaginal dose has a 20 minute onset of action and a duration of action of approximately 4 hours, and a rectal dose has a 100 minute onset of action and a duration of action of approximately 4 hours.

    5.2 MeSH Pharmacological Classification

    Oxytocics

    Drugs that stimulate contraction of the myometrium. They are used to induce LABOR, OBSTETRIC at term, to prevent or control postpartum or postabortion hemorrhage, and to assess fetal status in high risk pregnancies. They may also be used alone or with other drugs to induce abortions (ABORTIFACIENTS). Oxytocics used clinically include the neurohypophyseal hormone OXYTOCIN and certain prostaglandins and ergot alkaloids. (From AMA Drug Evaluations, 1994, p1157) (See all compounds classified as Oxytocics.)

    Abortifacient Agents, Nonsteroidal

    Non-steroidal chemical compounds with abortifacient activity. (See all compounds classified as Abortifacient Agents, Nonsteroidal.)

    Anti-Ulcer Agents

    Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    MISOPROSTOL
    5.3.2 FDA UNII
    0E43V0BB57
    5.3.3 Pharmacological Classes
    Prostaglandins E, Synthetic [CS]; Prostaglandin E1 Analog [EPC]
    5.4 ATC Code

    A - Alimentary tract and metabolism

    A02 - Drugs for acid related disorders

    A02B - Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)

    A02BB - Prostaglandins

    A02BB01 - Misoprostol

    G - Genito urinary system and sex hormones

    G02 - Other gynecologicals

    G02A - Uterotonics

    G02AD - Prostaglandins

    G02AD06 - Misoprostol

    5.5 Absorption, Distribution and Excretion

    Absorption

    For an 800g oral dose of misoprostol, the AUC was 2.01920.8032h\*ng/mL, the Cmax was 2.68301.2161ng/mL, and a tmax of 0.3450.186h. For a 800g sublingual dose of misoprostol, the AUC was 3.20941.0417h\*ng/mL, the Cmax was 2.43911.1567ng/mL, and a tmax of 0.7120.415h. For a 800g buccal dose of misoprostol, the AUC was 2.07260.3578h\*ng/mL, the Cmax was 1.36110.3436ng/mL, and a tmax of 1.3080.624h.

    Route of Elimination

    As much as 73.24.6% of a radiolabelled oral dose of misoprostol is recovered in the urine.

    Volume of Distribution

    Data regarding the volume of distribution of misoprostol is scarce. The apparent volume of distribution of the active metabolite of misoprostol was in subjects with normal renal function was 13.68.0L/kg, with mild renal impairment was 17.323.0L/kg, with moderate renal impairment was 14.36.8L/kg, and with end stage renal disease was 11.09.6L/kg.

    Clearance

    Because of the rapid de-esterification of misoprostol before or during absorption, it is usually undetectable in plasma. Misoprostol's active metabolite, misoprostol acid, has a total body clearance of 0.286L/kg/min. Subjects with mild renal impairment had a total body clearance of 0.2260.073L/kg/min, subjects with moderate renal impairment had a total body clearance of 0.2700.103L/kg/min, and subjects with end stage renal disease had a total body clearance of 0.1050.052L/kg/min.

    Rapidly absorbed following oral administration.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2085

    Elimination: Renal (64 to 73% of the oral dose excreted within the first 24 hours). Fecal (15% of the oral dose).

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2086

    5.6 Metabolism/Metabolites

    Misoprostol is de-esterified to its active metabolite, misoprostol acid, also known as SC-30695. This metabolite is further reduced to dinor and tetranor metabolites (SC-41411), a prostaglandin F1 (PGF1) analog of SC-41411, and a -16-carboxylic acid derivative. However, the majority of these metabolites are not well described in the literature.

    Rapidly de-esterified to misoprostol acid (primary biologically active metabolite). The de-esterified metabolite undergoes further metabolism by beta and omega oxidation, which can take place in various tissues in the body.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2085

    5.7 Biological Half-Life

    The half life of an 800g oral dose is 1.04010.5090h, for a sublingual dose is 0.85420.1170h, and for a buccal dose is 0.83650.1346h.

    Terminal - 20-40 minutes

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2085

    5.8 Mechanism of Action

    Misoprostol is a synthetic prostaglandin E1 analog that stimulates prostaglandin E1 receptors on parietal cells in the stomach to reduce gastric acid secretion. Mucus and bicarbonate secretion are also increased along with thickening of the mucosal bilayer so the mucosa can generate new cells. Misoprostol binds to smooth muscle cells in the uterine lining to increase the strength and frequency of contractions as well as degrade collagen and reduce cervical tone.

    Misoprostol enhances natural gastromucosal defense mechanisms and healing in acid-related disorders, probably by increasing production of gastric mucus and mucosal secretion of bicarbonate.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2085

    Misoprostol inhibits basal and nocturnal gastric acid secretion by direct action on the parietal cells; also inhibits gastric acid secretion stimulated by food, histamine, and pentagastrin. It decreases pepsin secretion under basal, but not histamine stimulation. Misoprostol has no significant effect on fasting or postprandial gastrin or intrinsic factor output.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 16th ed. Volume I. Rockville, MD: U.S. Pharmaceutical Convention, Inc. 1996 (Plus updates)., p. 2085

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HEATHROW","supplierAddress":"WHALTON ROAD, MORPETH,NORTHUMBERLANDNE61 3YA, ENGLAND UNITED KINGDOM","customerAddress":"NO 31, RACE COURSE ROAD,BANGALORE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726597800,"product":"MISOPROSTOL DISPERSION","address":"C-3\/199, JANAK PURI,","city":"NEW DELHI","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"NAARI","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"950","totalValueFC":"48122.8","currency":"USD","unitRateINR":"80655","date":"18-Sep-2024","totalValueINR":"4032750","totalValueInUsd":"48122.8","indian_port":"Delhi Air","hs_no":"29375000","bill_no":"5669036","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"WHALTON ROAD MORPETH NORTHUMBERLAND NE61 3YA SDNF GB","customerAddress":"C-3\/199, JANAK PURI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733337000,"product":"MISOPROSTOL DISPERSION USP MISOPROSTOL DISPERSION USP","address":"NO.27,RACE COURSE ROAD,","city":"KARNATAKA","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"MICRO LABS LIMITED","customerCountry":"INDIA","quantity":"57.71","actualQuantity":"57.71","unit":"KGS","unitRateFc":"2376","totalValueFC":"137733.8","currency":"USD","unitRateINR":"202791.6","date":"05-Dec-2024","totalValueINR":"11703103.24","totalValueInUsd":"137733.8","indian_port":"Madras Air","hs_no":"29375000","bill_no":"7069455","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"WHALTON ROAD, MORPETH, NORTHUMBERLAND NE61 3YA, ENGLAND UNITED KINGDOM","customerAddress":"NO.27,RACE COURSE ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1733337000,"product":"MISOPROSTOL DISPERSION USP MISOPROSTOL DISPERSION USP","address":"NO.27,RACE COURSE ROAD,","city":"KARNATAKA","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"MICRO LABS LIMITED","customerCountry":"INDIA","quantity":"142.29","actualQuantity":"142.29","unit":"KGS","unitRateFc":"2376","totalValueFC":"339597","currency":"USD","unitRateINR":"202791.6","date":"05-Dec-2024","totalValueINR":"28855216.76","totalValueInUsd":"339597","indian_port":"Madras Air","hs_no":"29375000","bill_no":"7069455","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"WHALTON ROAD, MORPETH, NORTHUMBERLAND NE61 3YA, ENGLAND UNITED KINGDOM","customerAddress":"NO.27,RACE COURSE ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737657000,"product":"MISOPROSTOL-HPMC 1% DISPERSION MISOPROSTOL-HPMC 1% DISPERSION","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"EVERLIGHT CHEMICAL","supplierCountry":"TAIWAN","foreign_port":"TAIYUAN","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"1660","totalValueFC":"25151.5","currency":"USD","unitRateINR":"144586","date":"24-Jan-2025","totalValueINR":"2168790","totalValueInUsd":"25151.5","indian_port":"Bombay Air","hs_no":"29375000","bill_no":"7984141","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIYUAN","supplierAddress":"12, INDUSTRIAL THIRD RD,KUANYIN DISTRICT, TAOYUAN CITY, TAIWAN SDNF","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738780200,"product":"MISOPROSTOL DISPERSION (UQUIFA) USP MISOPROSTOL DISPERSION (UQUIFA) USP","address":"218\/219, 2ND FLOOR,KAILASH PLAZA,","city":"GHATKOPAR EAST,MUMBAI, MAHARASTHRA","supplier":"PIRAMAL HEALTH CARE UK LTD","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"AQUATIC REMEDIES PVT LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"700","totalValueFC":"70109.4","currency":"USD","unitRateINR":"60970","date":"06-Feb-2025","totalValueINR":"6097000","totalValueInUsd":"70109.4","indian_port":"Bombay Air","hs_no":"29375000","bill_no":"8204072","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"WHALTON ROAD, MORPETH,NORTHUMBERLAN D, NE61 3YA,UNITED KINGDOM(UK) UK, , UNITED KINGDOM UNITED KINGDOM","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"}]
    02-Jan-2021
    06-Feb-2025
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    API Imports and Exports

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    (USD/KGS)    		 Number of Transactions

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    Europe

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    01

    Ferring Pharmaceuticals AS

    Switzerland
    MAGHREB PHARMA
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Misoprostol

    Brand Name : Misodel

    Dosage Form : Vaginal Posts

    Dosage Strength : 200 mcg

    Packaging : Foil Bag

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    02

    Pfizer AS

    U.S.A
    World Vaccine Conference
    Not Confirmed
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    Pfizer AS

    U.S.A
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    World Vaccine Conference
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    Regulatory Info :

    Registration Country : Norway

    Misoprostol

    Brand Name : Cytotec

    Dosage Form : Antic-calc Tablet

    Dosage Strength : 0.2 mg

    Packaging : Blister

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    03

    Pfizer AS

    U.S.A
    World Vaccine Conference
    Not Confirmed
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    Pfizer AS

    U.S.A
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    Regulatory Info :

    Registration Country : Norway

    Misoprostol

    Brand Name : Cytotec

    Dosage Form : Tablet

    Dosage Strength : 0.2 mg

    Packaging : Blisterpakning 100item

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    04

    Pfizer AG

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Diclofenacum natricum; Misoprostolum

    Brand Name : Arthrotec 50

    Dosage Form : Bitabs

    Dosage Strength : 50mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    05

    Pfizer AG

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Diclofenacum natricum; Misoprostolum

    Brand Name : Arthrotec 75

    Dosage Form : Bitabs

    Dosage Strength : 75mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    06

    Pfizer AG

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Diclofenacum natricum; Misoprostolum

    Brand Name : Arthrotec 75

    Dosage Form : Bitabs

    Dosage Strength : 75mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    07

    Pfizer AG

    U.S.A
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    Pfizer AG

    U.S.A
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    World Vaccine Conference
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    Regulatory Info :

    Registration Country : Switzerland

    Misoprostol

    Brand Name : Cytotec

    Dosage Form : Tabl

    Dosage Strength : 200mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    08

    Pfizer AG

    U.S.A
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    Regulatory Info :

    Registration Country : Switzerland

    Misoprostol

    Brand Name : Cytotec

    Dosage Form : Tabl

    Dosage Strength : 200mcg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    09

    Ferring Läkemedel AB

    Country
    MAGHREB PHARMA
    Not Confirmed
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    Regulatory Info :

    Registration Country : Sweden

    misoprostol

    Brand Name : Misodel

    Dosage Form : VAGINALINLÄGG

    Dosage Strength : 200 MIKROGRAM

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    Exelgyn, Paris

    Country
    MAGHREB PHARMA
    Not Confirmed
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    Exelgyn, Paris

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    MAGHREB PHARMA
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    Regulatory Info :

    Registration Country : Sweden

    misoprostol

    Brand Name : Topogyne

    Dosage Form : TABLET

    Dosage Strength : 400 MICROGRAM

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 0.1MG

    USFDA APPLICATION NUMBER - 19268

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    DOSAGE - TABLET;ORAL - 0.2MG

    USFDA APPLICATION NUMBER - 19268

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    DOSAGE - TABLET, DELAYED RELEASE;ORAL - 50MG;...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG

    USFDA APPLICATION NUMBER - 20607

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    DOSAGE - TABLET, DELAYED RELEASE;ORAL - 75MG;...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG

    USFDA APPLICATION NUMBER - 20607

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    ABOUT THIS PAGE

    Looking for 59122-46-2 / Misoprostol API manufacturers, exporters & distributors?

    Misoprostol manufacturers, exporters & distributors 1

    17

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

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

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

    API | Excipient name

    Misoprostol

    Synonyms

    59122-46-2, Cytotec, Isprelor, Sc-29333, Misoprostolum [inn-latin], Misodel

    Cas Number

    59122-46-2

    Unique Ingredient Identifier (UNII)

    0E43V0BB57

    About Misoprostol

    A synthetic analog of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion, and enhances mucosal resistance to injury. It is an effective anti-ulcer agent and also has oxytocic properties.

    Misoprostol Manufacturers

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

    Misoprostol Suppliers

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

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

    Misoprostol USDMF

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

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

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

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

    Misoprostol KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Misoprostol Drug Master File in Korea (Misoprostol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Misoprostol. The MFDS reviews the Misoprostol KDMF as part of the drug registration process and uses the information provided in the Misoprostol KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Misoprostol KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Misoprostol API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Misoprostol suppliers with KDMF on PharmaCompass.

    Misoprostol CEP

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

    A Misoprostol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Misoprostol CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Misoprostol suppliers with CEP (COS) on PharmaCompass.

    Misoprostol 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 Misoprostol as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Misoprostol GMP

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

    Misoprostol CoA

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

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

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