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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

    USDMF

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-01-31

    Pay. Date : 2013-01-10

    DMF Number : 17076

    Submission : 2003-11-25

    Status : Active

    Type : II

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    02

    Asia Pharma Expo
    Not Confirmed

    02

    Everlight Chemical Industrial Corp

    Taiwan
    arrow
    Asia Pharma Expo
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-01-30

    Pay. Date : 2013-01-10

    DMF Number : 15017

    Submission : 2000-08-17

    Status : Active

    Type : II

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    03

    Asia Pharma Expo
    Not Confirmed

    03

    Everlight Chemical Industrial Corp

    Taiwan
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    Asia Pharma Expo
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14500

    Submission : 1999-10-21

    Status : Inactive

    Type : II

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    04

    Asia Pharma Expo
    Not Confirmed

    04

    Daiichi Fine Chemical Co Ltd

    Japan
    arrow
    Asia Pharma Expo
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15068

    Submission : 2000-09-28

    Status : Inactive

    Type : II

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    05

    Asia Pharma Expo
    Not Confirmed

    05

    Daiichi Fine Chemical Co Ltd

    Japan
    arrow
    Asia Pharma Expo
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15044

    Submission : 2000-09-13

    Status : Inactive

    Type : II

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    06

    Pharmatech International Inc

    United Kingdom

    USDMF

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    Asia Pharma Expo
    Not Confirmed

    06

    Pharmatech International Inc

    United Kingdom
    arrow
    Asia Pharma Expo
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 12729

    Submission : 1997-11-07

    Status : Inactive

    Type : II

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    07

    Asia Pharma Expo
    Not Confirmed

    07

    Piramal Healthcare Uk Ltd

    U.S.A
    arrow
    Asia Pharma Expo
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-02-07

    Pay. Date : 2013-01-18

    DMF Number : 21188

    Submission : 2007-12-12

    Status : Active

    Type : II

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    08

    Yonsung Fine Chemicals Co Ltd

    South Korea

    USDMF

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    Asia Pharma Expo
    Not Confirmed

    08

    Yonsung Fine Chemicals Co Ltd

    South Korea
    arrow
    Asia Pharma Expo
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23041

    Submission : 2009-08-14

    Status : Inactive

    Type : II

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

    Listed Suppliers

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    01

    Chirogate International

    Taiwan
    arrow
    Asia Pharma Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothChirogate is a professional Prostaglandin manufacturer.

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    Misoprostol

    About the Company : Chirogate, established in 1999, is a leading supplier of niche-market molecules, specializing in prostaglandins. Focused on quality and compliance, it offers competitively priced p...

    Chirogate, established in 1999, is a leading supplier of niche-market molecules, specializing in prostaglandins. Focused on quality and compliance, it offers competitively priced prostaglandin APIs to regulated and unregulated markets worldwide. Using proprietary processes and advanced technology, Chirogate adheres to cGMP and international manufacturing standards, ensuring product safety and quality. The company has passed successful regulatory inspections, including by the USFDA. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Chirogate CB

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    02

    HRV Pharma

    India
    arrow
    Asia Pharma Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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    Misoprostol

    About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

    HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    HRV Global Life Sciences

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    03

    EUROAPI

    France
    arrow
    CPhI Japan
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Flag France
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    Digital Content Digital Content

    Misoprostol

    About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...

    EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio of around 200 products, covering a wide range of technologies and innovative molecules through CDMO activities. Supported by 3,650 employees, strong R&D capabilities, and six manufacturing sites in Europe, EUROAPI delivers high-quality API manufacturing to customers in more than 80 countries. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    EUROAPI Compnay Banner

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    04

    LGM Pharma

    U.S.A
    arrow
    Interphex
    Booth #2158
    • fda
    • EDQM
    • WHO-GMP

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

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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Misoprostol

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

    LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulation, analytical method development and testing, custom API synthesis, regulatory support, and commercial manufacturing. Supported by a network of over 300 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    LGM Pharma CB

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    05

    Century Pharmaceuticals

    India
    arrow
    Vietnam Medi-Pharm Expo
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothCentury has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.

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    Flag India
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    Misoprostol

    About the Company : Century Pharmaceuticals, established in 1982, has 40 years of experience manufacturing APIs for major pharma companies in India and abroad. Its products are made in compliance with...

    Century Pharmaceuticals, established in 1982, has 40 years of experience manufacturing APIs for major pharma companies in India and abroad. Its products are made in compliance with cGMP, 21 CFR, and ICH guidelines, and it also produces intermediates and develops new APIs as per client requirements. The company conducts biotechnological research on human therapeutic proteins, including treatments for asthma, mastocytosis, and basophilic leukemia, and supplies research-grade biotech and animal health products. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Century Company Banner

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    06

    Tenatra Exports

    India
    arrow
    Asia Pharma Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Misoprostol

    About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

    Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Exports Private Limited was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Tenatra

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    07

    Willow Birch Pharma

    U.S.A
    arrow
    Asia Pharma Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothWillow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.

    Contact Supplier Contact Supplier
    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Misoprostol

    About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...

    Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 states as a drug wholesaler and NABP accreditation since 2007, Willow Birch Pharma delivers top-quality products at competitive prices with unparalleled service and regulatory support nationwide. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Company Banner

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    08

    Dr Pradeep Reddy’s Laboratories P...

    India
    Asia Pharma Expo
    Not Confirmed
    arrow

    Dr Pradeep Reddy’s Laboratories P...

    India
    arrow
    Asia Pharma Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    Post an Enquiry Post an Enquiry
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Misoprostol

    About the Company : Dr Pradeep Reddy’s Laboratories involved in APIs and Intermediates Research and Development of APIs and facilitating Manufacture of Prostaglandin analogues. We set up Dr Pradee...

    Dr Pradeep Reddy’s Laboratories involved in APIs and Intermediates Research and Development of APIs and facilitating Manufacture of Prostaglandin analogues. We set up Dr Pradeep Reddy’s Laboratories to create a high quality medical drug Research and manufacturing low volume (APIs & Intermediates) using cost effective methods and provide pharmaceutical drugs and vitamins at an affordable price. Behind the scenes, our dedicated team of highly experienced scientists and chemists with over 18 years experience in specialty API drug development are working really, really hard to meet the highest international standards.
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    09

    Pharma Noble Chem

    India
    Asia Pharma Expo
    Not Confirmed
    arrow

    Pharma Noble Chem

    India
    arrow
    Asia Pharma Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    Post an Enquiry Post an Enquiry
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Misoprostol Acid

    About the Company : Pharma Noble Chem Ltd, a subsidiary of Noble Group, is a leading manufacturer of APIs, API intermediates, and specialty chemicals. Committed to quality and innovation, we offer hig...

    Pharma Noble Chem Ltd, a subsidiary of Noble Group, is a leading manufacturer of APIs, API intermediates, and specialty chemicals. Committed to quality and innovation, we offer high-quality products and reliable CRAMS for the pharmaceutical industry. Founded in 1984 by Mohammed Akhtar, Noble Group has expanded globally, with a strong presence in India, Saudi Arabia, UAE, Oman, China, Singapore, Myanmar, Laos, Azerbaijan, and Qatar. Our reputation is built on excellence, innovation, and impact across multiple sectors worldwide.
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    10

    Piramal Pharma Solutions

    U.S.A
    Asia Pharma Expo
    Not Confirmed
    arrow

    Piramal Pharma Solutions

    U.S.A
    arrow
    Asia Pharma Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
    Post an Enquiry Post an Enquiry
    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Misoprostol

    About the Company : Piramal Pharma Solutions (PPS) is a CDMO that provides end-to-end solutions for drug development and manufacturing across the drug life cycle to its clients in North America, Europ...

    Piramal Pharma Solutions (PPS) is a CDMO that provides end-to-end solutions for drug development and manufacturing across the drug life cycle to its clients in North America, Europe and Asia through a globally integrated network of facilities. It offers a range of services from drug discovery to commercial supply of APIs and finished dosage forms, along with specialized services like HPAPIs, antibody drug conjugations, sterile fill/finish, peptide products and services and potent solid oral drug products. PPS also provides services for biologics, including vaccines, gene therapies and monoclonal antibodies through its subsidiary Yapan Bio.
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    Only 10 entries up to this point, click to access all click full view read-more
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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1642530600,"product":"MISOPROSTOL HPMC 1% DISPERSION","address":"1 W 109 S V S S NIVAS STREET NO 1 ,CZECH COLONY SANATHNAGAR","city":"HYDERABAD,TELANGANA","supplier":"LUCENT DRUGS PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"EL RAZY PHARMACEUTICALS CO","customerCountry":"EGYPT","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"630","totalValueFC":"2376","currency":"USD","unitRateINR":44250,"date":"19-Jan-2022","totalValueINR":"177000","totalValueInUsd":"2376","indian_port":"HYDERABAD AIR","hs_no":"29375000","bill_no":"7570018","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"1 W 109 S V S S NIVAS STREET NO 1 ,CZECH COLONY SANATHNAGAR, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1642703400,"product":"MISOPROSTOL (1%W\/W DISPERSION IN HPMC)","address":"AVRA HOUSE, 7-102\/54, SAI ENCLAVE, HABSIGUDA","city":"HYDERABAD,TELANGANA","supplier":"AVRA LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"NEW YORK","customer":"RIA INTERNATIONAL LLC","customerCountry":"UNITED STATES","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"618","totalValueFC":"2832.5","currency":"USD","unitRateINR":42200,"date":"21-Jan-2022","totalValueINR":"211000","totalValueInUsd":"2832.5","indian_port":"HYDERABAD AIR","hs_no":"29420090","bill_no":"7650812","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"AVRA HOUSE, 7-102\/54, SAI ENCLAVE, HABSIGUDA, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643394600,"product":"MISOPROSTOL 1% HPMC MAKE LUCENT DRUGS","address":"Shop No.L-9, Durvas CHS,Yashwant Vi Opp .D-Mart, Vasai-Nalasopara Link","city":"Vasai (East)","supplier":"SYMBOLIFE PHARMA","supplierCountry":"INDIA","foreign_port":"ISLAMABAD - ISLAMABA","customer":"UNDISCLOSED","customerCountry":"PAKISTAN","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"340","totalValueFC":"6685.2","currency":"USD","unitRateINR":24900,"date":"29-Jan-2022","totalValueINR":"498000","totalValueInUsd":"6685.2","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"7834701","productDescription":"API","marketType":"","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"Shop No.L-9, Durvas CHS,Yashwant Vi Opp .D-Mart, Vasai-Nalasopara Link, Vasai (East)","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1647628200,"product":"MISOPROSTOL (1%W\/W DISPERSION IN HPMC)","address":"AVRA HOUSE, 7-102\/54, SAI ENCLAVE, HABSIGUDA","city":"HYDERABAD,TELANGANA","supplier":"AVRA LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"NEWARK, NJ","customer":"RIA INTERNATIONAL LLC","customerCountry":"UNITED STATES","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"618","totalValueFC":"2820.8","currency":"USD","unitRateINR":43000,"date":"19-Mar-2022","totalValueINR":"215000","totalValueInUsd":"2820.8","indian_port":"HYDERABAD AIR","hs_no":"29420090","bill_no":"9059960","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"AVRA HOUSE, 7-102\/54, SAI ENCLAVE, HABSIGUDA, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649269800,"product":"MISOPROSTOL 1% HPMC","address":"Shop No.L-9, Durvas CHS,Yashwant Vi Opp .D-Mart, Vasai-Nalasopara Link","city":"Vasai (East)","supplier":"SYMBOLIFE PHARMA","supplierCountry":"INDIA","foreign_port":"LAHORE","customer":"BANK AL HABIB","customerCountry":"PAKISTAN","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"280","totalValueFC":"11146.6","currency":"USD","unitRateINR":21025,"date":"07-Apr-2022","totalValueINR":"841000","totalValueInUsd":"11146.6","indian_port":"BOMBAY AIR","hs_no":"29375000","bill_no":"9533535","productDescription":"API","marketType":"","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"Shop No.L-9, Durvas CHS,Yashwant Vi Opp .D-Mart, Vasai-Nalasopara Link, Vasai (East)","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1649788200,"product":"MISOPROSTOL (1% W\/W DISPERSION IN HPMC)","address":"AVRA HOUSE, 7-102\/54, SAI ENCLAVE, HABSIGUDA","city":"HYDERABAD,TELANGANA","supplier":"AVRA LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"KARACHI -","customer":"BANK AL HABIB LTD","customerCountry":"PAKISTAN","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"485","totalValueFC":"47754.2","currency":"USD","unitRateINR":36030,"date":"13-Apr-2022","totalValueINR":"3603000","totalValueInUsd":"47754.2","indian_port":"HYDERABAD AIR","hs_no":"29420090","bill_no":"9680688","productDescription":"API","marketType":"","country":"PAKISTAN","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"AVRA HOUSE, 7-102\/54, SAI ENCLAVE, HABSIGUDA, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1651689000,"product":"1% MISOPROSTOL HPMC DISPERSION","address":"BIOTECH PARK, PHASE-II,LALGADI,MAL AKPET VILLAGE,TURKAPALLI, SHAMEERPE","city":"HYDERABAD,TELANGANA","supplier":"ASPEN BIOPHARMA LABS PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"FUTURE PHARMACEUTICAL","customerCountry":"EGYPT","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"400","totalValueFC":"582.3","currency":"USD","unitRateINR":30000,"date":"05-May-2022","totalValueINR":"45000","totalValueInUsd":"582.3","indian_port":"HYDERABAD AIR","hs_no":"29375000","bill_no":"1182838","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"BIOTECH PARK, PHASE-II,LALGADI,MAL AKPET VILLAGE,TURKAPALLI, SHAMEERPE, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q2","strtotime":1653244200,"product":"1% MISOPROSTOL HPMC DISPERSION","address":"BIOTECH PARK, PHASE-II,LALGADI,MAL AKPET VILLAGE,TURKAPALLI, SHAMEERPE","city":"HYDERABAD,TELANGANA","supplier":"ASPEN BIOPHARMA LABS PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"SINGAPORE","customer":"AIR MARKET LOGISTICS S PTE LTD","customerCountry":"SINGAPORE","quantity":"11.00","actualQuantity":"11","unit":"KGS","unitRateFc":"380","totalValueFC":"4153.4","currency":"USD","unitRateINR":29181.81818181818,"date":"23-May-2022","totalValueINR":"321000","totalValueInUsd":"4153.4","indian_port":"HYDERABAD AIR","hs_no":"29375000","bill_no":"1578604","productDescription":"API","marketType":"","country":"SINGAPORE","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"BIOTECH PARK, PHASE-II,LALGADI,MAL AKPET VILLAGE,TURKAPALLI, SHAMEERPE, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API 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HEATHROW","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"92.06","actualQuantity":"92.06","unit":"KGS","unitRateFc":"750","totalValueFC":"70003.3","currency":"USD","unitRateINR":"68437.5","date":"19-Dec-2025","totalValueINR":"6300356.25","totalValueInUsd":"70003.3","indian_port":"Bombay Air","hs_no":"29375000","bill_no":"5","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"WHALTON ROAD, MORPETH, NORTHUMBERLAND, NE61 3YA , SDNF UNITED KINGDOM","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1766687400,"product":"MISOPROSTOL DISPERSION USPBATCH NO.B35052C)","address":"Plot No.564\/A\/22 ,\u00a0 Road No.92,Jubilee Hills ,\u00a0 Hyderabad , \u00a0HYDERABAD ,\u00a0 TELANGANA,\u00a0 500096","city":"","supplier":"PIRAMAL HEALTHCARE UK LTD","supplierCountry":"UNITED KINGDOM","foreign_port":"HEATHROW APT\/LONDON","customer":"SENADOR LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"36.14","actualQuantity":"36.14","unit":"KGS","unitRateFc":"985","totalValueFC":"36092","currency":"USD","unitRateINR":"89881.3","date":"26-Dec-2025","totalValueINR":"3248308.38","totalValueInUsd":"36092","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29375000","bill_no":"6794981","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"HEATHROW APT\/LONDON","supplierAddress":"WHALTON ROAD,MORPETH NORTHUMBERLAND SDNF United Kingdom","customerAddress":"Plot No.564\/A\/22 ,\u00a0 Road No.92,Jubilee Hills ,\u00a0 Hyderabad , \u00a0HYDERABAD ,\u00a0 TELANGANA,\u00a0 500096"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1766773800,"product":"MISOPROSTOL-HPMC 1% DISPERSION U.S.P MISOPROSTOL-HPMC 1% DISPERSION U.S.P","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"EVERLIGHT CHEMICAL INDUSTRIAL CORP","supplierCountry":"TAIWAN","foreign_port":"TAIYUAN","customer":"SUN PHARMACEUTICAL INDUSTRIES LTD","customerCountry":"INDIA","quantity":"8.00","actualQuantity":"8","unit":"KGS","unitRateFc":"1660","totalValueFC":"13464.3","currency":"USD","unitRateINR":"151475","date":"27-Dec-2025","totalValueINR":"1211800","totalValueInUsd":"13464.3","indian_port":"Bombay Air","hs_no":"29375000","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIYUAN","supplierAddress":"5-6 FLOOR CHUNG TING BUILDING NO.77 SECTION 2, TUN HUA SOUTH ROAD TAIPEI TAIWAN TW","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1767119400,"product":"MISOPROSTOL DISPERSION USP MISOPROSTOL DISPERSION USP","address":"NO 31, RACE COURSE ROAD,BANGALORE","city":"BENGALURU,KARNATAKA","supplier":"PIRAMAL HEALTHCARE UK LTD","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"MICRO LABS LTD","customerCountry":"INDIA","quantity":"299.34","actualQuantity":"299.34","unit":"KGS","unitRateFc":"2376","totalValueFC":"721102.8","currency":"USD","unitRateINR":"216810","date":"31-Dec-2025","totalValueINR":"64899905.4","totalValueInUsd":"721102.8","indian_port":"Madras Air","hs_no":"29375000","bill_no":"24962232","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 31, RACE COURSE ROAD,BANGALORE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1767119400,"product":"MISOPROSTOL DISPERSION USP MISOPROSTOL DISPERSION","address":"VILL.GHOGADWAL (CHOKIWALA),","city":"","supplier":"PIRAMAL HEALTHCARE UK LTD","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"ACME FORMULATION PRIVATE LTD","customerCountry":"INDIA","quantity":"96.24","actualQuantity":"96.24","unit":"KGS","unitRateFc":"985","totalValueFC":"96112.1","currency":"USD","unitRateINR":"89881.3","date":"31-Dec-2025","totalValueINR":"8650171.5","totalValueInUsd":"96112.1","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"4","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"WHALTON ROAD MORPETH NORTHUMBERLAND NE61 3YA ENGLAND , , UNITED KINGDO M UNITED KINGDOM","customerAddress":"VILL.GHOGADWAL (CHOKIWALA),"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1769711400,"product":"MISOPROSTOL HPMC 1% DISPERSION USP MISOPROSTOL HPMC 1% DISPERSION USP","address":"C-3\/199, JANAK PURI,","city":"NEW DELHI","supplier":"EVERLIGHT CHEMICAL INDUSTRIAL CORP","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"NAARI PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"18.50","actualQuantity":"18.5","unit":"KGS","unitRateFc":"900","totalValueFC":"16735.2","currency":"N\/A","unitRateINR":"82080","date":"30-Jan-2026","totalValueINR":"1518480","totalValueInUsd":"16735.2","indian_port":"Delhi Air","hs_no":"29375000","bill_no":"808296","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"5-6 FLOOR CHUNG TING BUILDING NO.77 SECTION 2 TUN HUA SOUTH ROAD TAIPEI SDNF TW","customerAddress":"C-3\/199, JANAK PURI,"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1771007400,"product":"MISOPROSTOL DISPERSION(UQUIFA)USP (BATCH NO.B35178C)","address":"Plot No.564\/A\/22 ,\u00a0 Road No.92,Jubilee Hills ,\u00a0 Hyderabad , \u00a0HYDERABAD ,\u00a0 TELANGANA,\u00a0 500096","city":"","supplier":"PIRAMAL HEALTHCARE UK LTD","supplierCountry":"UNITED KINGDOM","foreign_port":"HEATHROW APT\/LONDON","customer":"SENADOR LABORATORIES PRIVATE LTD","customerCountry":"INDIA","quantity":"34.82","actualQuantity":"34.82","unit":"KGS","unitRateFc":"985","totalValueFC":"34517.3","currency":"USD","unitRateINR":"89979.8","date":"14-Feb-2026","totalValueINR":"3133094.9","totalValueInUsd":"34517.3","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29375000","bill_no":"5","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"HEATHROW APT\/LONDON","supplierAddress":"WHALTON ROAD,MORPETH NORTHUMBERLAND NE61 3YA United Kingdom","customerAddress":"Plot No.564\/A\/22 ,\u00a0 Road No.92,Jubilee Hills ,\u00a0 Hyderabad , \u00a0HYDERABAD ,\u00a0 TELANGANA,\u00a0 500096"}]
    18-Jan-2022
    14-Feb-2026
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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

    59

    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.

    APL-202 Manufacturers

    A APL-202 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of APL-202, including repackagers and relabelers. The FDA regulates APL-202 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. APL-202 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 APL-202 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    APL-202 Suppliers

    A APL-202 supplier is an individual or a company that provides APL-202 active pharmaceutical ingredient (API) or APL-202 finished formulations upon request. The APL-202 suppliers may include APL-202 API manufacturers, exporters, distributors and traders.

    click here to find a list of APL-202 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    APL-202 USDMF

    A APL-202 DMF (Drug Master File) is a document detailing the whole manufacturing process of APL-202 active pharmaceutical ingredient (API) in detail. Different forms of APL-202 DMFs exist exist since differing nations have different regulations, such as APL-202 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A APL-202 DMF submitted to regulatory agencies in the US is known as a USDMF. APL-202 USDMF includes data on APL-202's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The APL-202 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of APL-202 suppliers with USDMF on PharmaCompass.

    APL-202 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 APL-202 Drug Master File in Japan (APL-202 JDMF) empowers APL-202 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 APL-202 JDMF during the approval evaluation for pharmaceutical products. At the time of APL-202 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 APL-202 suppliers with JDMF on PharmaCompass.

    APL-202 KDMF

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

    Pharmaceutical companies submit a APL-202 Drug Master File in Korea (APL-202 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of APL-202. The MFDS reviews the APL-202 KDMF as part of the drug registration process and uses the information provided in the APL-202 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a APL-202 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 APL-202 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of APL-202 suppliers with KDMF on PharmaCompass.

    APL-202 CEP

    A APL-202 CEP of the European Pharmacopoeia monograph is often referred to as a APL-202 Certificate of Suitability (COS). The purpose of a APL-202 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of APL-202 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of APL-202 to their clients by showing that a APL-202 CEP has been issued for it. The manufacturer submits a APL-202 CEP (COS) as part of the market authorization procedure, and it takes on the role of a APL-202 CEP holder for the record. Additionally, the data presented in the APL-202 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the APL-202 DMF.

    A APL-202 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. APL-202 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 APL-202 suppliers with CEP (COS) on PharmaCompass.

    APL-202 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 APL-202 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for APL-202 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 APL-202 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 APL-202 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a APL-202 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of APL-202 suppliers with NDC on PharmaCompass.

    APL-202 GMP

    APL-202 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 APL-202 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 APL-202 GMP manufacturer or APL-202 GMP API supplier for your needs.

    APL-202 CoA

    A APL-202 CoA (Certificate of Analysis) is a formal document that attests to APL-202's compliance with APL-202 specifications and serves as a tool for batch-level quality control.

    APL-202 CoA mostly includes findings from lab analyses of a specific batch. For each APL-202 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.

    APL-202 may be tested according to a variety of international standards, such as European Pharmacopoeia (APL-202 EP), APL-202 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (APL-202 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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