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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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    CPhI Korea
    Attending
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    Virtual BoothChirogate is a professional Prostaglandin manufacturer.

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    USDMF CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 68245-0006

    Start Marketing Date : 2005-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF arrow-down
    ✖

    Registrant Name : Shin Poong Pharmaceutical Co., Ltd.

    Registration Date : 2022-01-14

    Registration Number : 20220114-209-J-1214

    Manufacturer Name : Chirogate International Inc.

    Manufacturer Address : No.41, Lane 298, Gong 2nd Rd., and No.22, Alley 39, Lane 298, Gong 2nd Rd., Longtan Dist., Taoyuan City 32559, Taiwan

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    02

    EUROAPI

    France

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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

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    EUROAPI Compnay Banner

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    03

    LGM Pharma

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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

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    LGM Pharma CB

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    04

    Century Pharmaceuticals

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    iPHEX India
    Attending
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    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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    Century Company Banner

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    05

    Tenatra Chemie

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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

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    Tenatra

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    06

    TAPI Technology & API Services

    Israel

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI Korea
    Attending
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    Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14390

    Submission : 1999-09-07

    Status : Inactive

    Type : II

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    07

    Chirogate International

    Taiwan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothChirogate is a professional Prostaglandin manufacturer.

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    ✖

    Registrant Name : Unimed Pharmaceutical Co., Ltd.

    Registration Date : 2021-10-05

    Registration Number : 20211005-209-J-1115

    Manufacturer Name : Chirogate International Inc. Wulin Plant

    Manufacturer Address : No. 41, Sec. 1, Gong 2nd Rd., and No. 22, Alley 39, Sec.1, Gong 2nd Rd., Longtan Dist., Taoyuan City 325019, Taiwan.

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    08

    TAPI Technology & API Services

    Israel

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI Korea
    Attending
    • fda
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    Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14391

    Submission : 1999-09-07

    Status : Inactive

    Type : II

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    TAPI Company Banner

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    09

    Piramal Pharma Solutions

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    CRS
    Not Confirmed
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    Piramal Pharma Solutions

    U.S.A

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CRS
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-02-07

    Pay. Date : 2013-01-18

    DMF Number : 21188

    Submission : 2007-12-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-121 - Rev 01

    Issue Date : 2017-01-20

    Type : Chemical

    Substance Number : 1731

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Kyowa Pharma Chemical Co Ltd

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    CRS
    Not Confirmed
    arrow

    Kyowa Pharma Chemical Co Ltd

    Japan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CRS
    Not Confirmed
    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15044

    Submission : 2000-09-13

    Status : Inactive

    Type : II

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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]

    NDC API

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    read-moreread-more

    01

    Chirogate International Inc

    Taiwan
    arrow
    CPhI Korea
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothChirogate is a professional Prostaglandin manufacturer.

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    Digital Content Digital Content

    MISOPROSTOL

    NDC Package Code : 68245-0006

    Start Marketing Date : 2005-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    Chirogate CB

    Portfolio PDF

    Product Web Link

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    Digital Content

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    02

    Everlight Chemical Industrial Corpo...

    Taiwan
    CRS
    Not Confirmed
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    Everlight Chemical Industrial Corpo...

    Taiwan
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    CRS
    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.
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    Digital Content Digital Content

    MISOPROSTOL

    NDC Package Code : 65035-127

    Start Marketing Date : 2021-11-24

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (10g/kg)

    Marketing Category : DRUG FOR FURTHER PROCESSING

    blank

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    03

    Kalchem International inc

    U.S.A
    CRS
    Not Confirmed
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    Kalchem International inc

    U.S.A
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    CRS
    Not Confirmed
    • fda
    • EDQM
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    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.
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    MISOPROSTOL

    NDC Package Code : 60592-234

    Start Marketing Date : 2020-07-29

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    04

    LETCO MEDICAL, LLC

    U.S.A
    CRS
    Not Confirmed
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    LETCO MEDICAL, LLC

    U.S.A
    arrow
    CRS
    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.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    MISOPROSTOL

    NDC Package Code : 62991-3178

    Start Marketing Date : 2023-04-04

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR HUMAN P...

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    05

    Medisca Inc.

    U.S.A
    CRS
    Not Confirmed
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    Medisca Inc.

    U.S.A
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    CRS
    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.
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    MISOPROSTOL

    NDC Package Code : 38779-2778

    Start Marketing Date : 2014-09-02

    End Marketing Date : 2026-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    Professional Compounding Centers of...

    United Kingdom
    CRS
    Not Confirmed
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    Professional Compounding Centers of...

    United Kingdom
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    CRS
    Not Confirmed
    • fda
    • EDQM
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    MISOPROSTOL

    NDC Package Code : 51927-0255

    Start Marketing Date : 2013-06-24

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT FOR HUMAN P...

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    07

    YS Life Science Co., Ltd.

    South Korea
    CRS
    Not Confirmed
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    YS Life Science Co., Ltd.

    South Korea
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    CRS
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    MISOPROSTOL

    NDC Package Code : 40016-003

    Start Marketing Date : 2010-02-10

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1642357800,"product":"11 EPIMISOPROSTOL DSK-RD 2205 1121 32220","address":"HOTEL DREAMZ PARK OFFICE COMPLEX\\r\\nUNIT G, 571\/2, ANNA SALAI,\\r\\nTEYNAMPET, CHENNAI, TAMIL NADU.","city":"CHENNAI,","supplier":"PFIZER HEALTHCARE INDIA PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"SINGAPORE","customer":"LEONG PEAK CHUEN","customerCountry":"SINGAPORE","quantity":"11.50","actualQuantity":"11.5","unit":"KGS","unitRateFc":"488.7","totalValueFC":"5544.1","currency":"USD","unitRateINR":35913.043478260872,"date":"17-Jan-2022","totalValueINR":"413000","totalValueInUsd":"5544.1","indian_port":"BANGALORE AIR","hs_no":"29062990","bill_no":"7521072","productDescription":"API","marketType":"","country":"SINGAPORE","selfForZScoreResived":"Pharma Grade","supplierPort":"BANGALORE AIR","supplierAddress":"HOTEL DREAMZ PARK OFFICE COMPLEX\\r\\nUNIT G, 571\/2, ANNA SALAI,\\r\\nTEYNAMPET, CHENNAI, TAMIL NADU., CHENNAI,","customerAddress":""},{"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 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HEATHROW","customer":"ACME FORMULATION PRIVATE LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"985","totalValueFC":"99844.6","currency":"USD","unitRateINR":"86483","date":"13-Mar-2025","totalValueINR":"8648300","totalValueInUsd":"99844.6","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"8867462","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":"2025","qtr":"Q1","strtotime":1742927400,"product":"MISOPROSTOL DISPERSION USP MISOPROSTOL DISPERSION USP","address":"218\/219, 2ND FLOOR,KAILASH PLAZA,","city":"GHATKOPAR EAST,MUMBAI, MAHARASTHRA","supplier":"PIRAMAL HEALTHCARE UK LTD","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"AQUATIC REMEDIES LTD","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"700","totalValueFC":"141103","currency":"USD","unitRateINR":"61110","date":"26-Mar-2025","totalValueINR":"12222000","totalValueInUsd":"141103","indian_port":"Bombay Air","hs_no":"29375000","bill_no":"9115367","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":"218\/219, 2ND FLOOR,KAILASH PLAZA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743013800,"product":"MISOPROSTOL DISPERSION MISOPROSTOL DISPERSION","address":"C-3\/199, JANAK PURI,","city":"NEW DELHI","supplier":"PIRAMAL HEALTHCARE UK LTD","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"NAARI PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"950","totalValueFC":"47874.2","currency":"USD","unitRateINR":"82935","date":"27-Mar-2025","totalValueINR":"4146750","totalValueInUsd":"47874.2","indian_port":"Delhi Air","hs_no":"29375000","bill_no":"9144613","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":"2025","qtr":"Q2","strtotime":1747161000,"product":"MISOPROSTOL DISPERSION MISOPROSTOL DISPERSION","address":"C-3\/199, JANAK PURI,","city":"NEW DELHI","supplier":"PIRAMAL HEALTHCARE UK LTD","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"NAARI PHARMA PRIVATE LTD","customerCountry":"INDIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"950","totalValueFC":"38155.8","currency":"USD","unitRateINR":"81272.5","date":"14-May-2025","totalValueINR":"3250900","totalValueInUsd":"38155.8","indian_port":"Delhi Air","hs_no":"29375000","bill_no":"2056663","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,"}]
    17-Jan-2022
    14-May-2025
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

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

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    API Imports and Exports

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

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    INTERMEDIATE SUPPLIERS

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    01

    Valsynthese

    Switzerland
    EPS
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    Valsynthese

    Switzerland
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    Suberic acid

    CAS Number : 505-48-6

    End Use API : Misoprostol

    About The Company : Valsynthese, a privately held CDMO, is a member of the SSE Group. Headquartered in Brig, Switzerland, it has a broad international reach. With over a century of...

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    Europe

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    01

    BIOINDUSTRIA FARMACEUTICI Srl

    Italy
    CRS
    Not Confirmed
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    BIOINDUSTRIA FARMACEUTICI Srl

    Italy
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    Flag Italy
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    Regulatory Info :

    Registration Country : Italy

    Diclofenac Sodium; Misoprostol

    Brand Name : Misofenac

    Dosage Form :

    Dosage Strength : 10 Cpr 75 Mg + 200 Mcg  

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    02

    Pfizer AS

    U.S.A
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    U.S.A
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    Flag U.S.A
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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
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    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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    Pfizer AG

    U.S.A
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    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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    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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    06

    Pfizer AG

    U.S.A
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    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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    Pfizer AG

    U.S.A
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    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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    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 :

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    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Ferring Läkemedel AB

    Country
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    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

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    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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    Canada

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    01

    AA PHARMA INC

    U.S.A
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    U.S.A
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    Registration Country : Canada

    MISOPROSTOL

    Brand Name : MISOPROSTOL

    Dosage Form : TABLET

    Dosage Strength : 100MCG

    Packaging : 100/250/500

    Approval Date :

    Application Number : 2244022

    Regulatory Info :

    Registration Country : Canada

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    AA PHARMA INC

    U.S.A
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    Registration Country : Canada

    MISOPROSTOL

    Brand Name : MISOPROSTOL

    Dosage Form : TABLET

    Dosage Strength : 200MCG

    Packaging : 100/500

    Approval Date :

    Application Number : 2244023

    Regulatory Info :

    Registration Country : Canada

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    GENMED A DIVISION OF PFIZER CANADA ULC

    Canada
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    GENMED A DIVISION OF PFIZER CANADA ULC

    Canada
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    Registration Country : Canada

    MISOPROSTOL

    Brand Name : GD-DICLOFENAC/MISOPROSTOL 50

    Dosage Form : TABLET (DELAYED-RELEASE)

    Dosage Strength : 200MCG

    Packaging : 250

    Approval Date :

    Application Number : 2341689

    Regulatory Info :

    Registration Country : Canada

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    GENMED A DIVISION OF PFIZER CANADA ULC

    Canada
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    GENMED A DIVISION OF PFIZER CANADA ULC

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    Registration Country : Canada

    MISOPROSTOL

    Brand Name : GD-DICLOFENAC/MISOPROSTOL 75

    Dosage Form : TABLET (DELAYED-RELEASE)

    Dosage Strength : 200MCG

    Packaging : 250

    Approval Date :

    Application Number : 2341697

    Regulatory Info :

    Registration Country : Canada

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    LINEPHARMA INTERNATIONAL LIMITED

    United Kingdom
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    LINEPHARMA INTERNATIONAL LIMITED

    United Kingdom
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    Registration Country : Canada

    MISOPROSTOL

    Brand Name : MIFEGYMISO

    Dosage Form : KIT

    Dosage Strength : 200MCG

    Packaging : 1 MIFEPRISTONE AND 4 MISOPROSTOL PER PACK

    Approval Date :

    Application Number : 2444038

    Regulatory Info :

    Registration Country : Canada

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    PFIZER CANADA ULC

    U.S.A
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    Registration Country : Canada

    MISOPROSTOL

    Brand Name : ARTHROTEC 50

    Dosage Form : TABLET (DELAYED-RELEASE)

    Dosage Strength : 200MCG

    Packaging : 250

    Approval Date :

    Application Number : 1917056

    Regulatory Info :

    Registration Country : Canada

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    PFIZER CANADA ULC

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    Registration Country : Canada

    MISOPROSTOL

    Brand Name : ARTHROTEC 75

    Dosage Form : TABLET (DELAYED-RELEASE)

    Dosage Strength : 200MCG

    Packaging : 250

    Approval Date :

    Application Number : 2229837

    Regulatory Info :

    Registration Country : Canada

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    Pharmascience Inc.

    Canada
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    Pharmascience Inc.

    Canada
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    Regulatory Info : Prescription

    Registration Country : Canada

    Misoprostol

    Brand Name : PMS-MISOPROSTOL (0.1MG)

    Dosage Form : TABLET

    Dosage Strength : 0.1MG

    Packaging : 100

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    Application Number :

    Regulatory Info : Prescription

    Registration Country : Canada

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    Pharmascience Inc.

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    Misoprostol

    Brand Name : PMS-MISOPROSTOL (0.2MG)

    Dosage Form : TABLET

    Dosage Strength : 0.2MG

    Packaging : 100/500

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    Registration Country : Canada

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    PHARMASCIENCE INC

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    Registration Country : Canada

    MISOPROSTOL

    Brand Name : PMS-DICLOFENAC-MISOPROSTOL

    Dosage Form : TABLET (DELAYED-RELEASE)

    Dosage Strength : 200MCG

    Packaging :

    Approval Date :

    Application Number : 2413469

    Regulatory Info :

    Registration Country : Canada

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    Australia

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    mifepristone (&) misoprostol

    Brand Name : MS-2 Step

    Dosage Form : tablet

    Dosage Strength : 200 mg

    Packaging : 1

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    Pfizer Laboratories (Pty) Ltd

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    Regulatory Info : Generic

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    Misoprostol

    Brand Name : Misoprostol Pfizer

    Dosage Form : TAB

    Dosage Strength : 200mcg

    Packaging : 60X1mcg

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    Brand Name : Misoprostol Pfizer

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    Dosage Strength : 200mcg

    Packaging : 120X1mcg

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    Registration Country : South Africa

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    Regulatory Info : Originator

    Registration Country : South Africa

    Misoprostol

    Brand Name : Arthrotec 50

    Dosage Form : TAB

    Dosage Strength : 200mcg

    Packaging : 20X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Misoprostol

    Brand Name : Arthrotec 50

    Dosage Form : TAB

    Dosage Strength : 200mcg

    Packaging : 60X1mg

    Approval Date :

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    Regulatory Info : Originator

    Registration Country : South Africa

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    Regulatory Info : Originator

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    Misoprostol

    Brand Name : Arthrotec 75

    Dosage Form : TAB

    Dosage Strength : 200mcg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Regulatory Info : Generic

    Registration Country : South Africa

    Misoprostol

    Brand Name : MEDABON CO

    Dosage Form : KIT

    Dosage Strength : 0,2mg

    Packaging : 5X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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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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    Company : Pharmacia-Upjhn

    Diclofenac Sodium/Misoprostol

    Drug Cost (USD) : 213,568

    Year : 2023

    Prescribers : 54

    Prescriptions : 233

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    Company : Pharmacia-Upjhn

    Diclofenac Sodium/Misoprostol

    Drug Cost (USD) : 593,413

    Year : 2023

    Prescribers : 146

    Prescriptions : 662

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    Brand Name : Cytotec

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    Company : Pharmacia-Upjhn

    Misoprostol

    Drug Cost (USD) : 33,330

    Year : 2023

    Prescribers : 22

    Prescriptions : 45

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    Company : Actavis/Teva

    Diclofenac Sodium/Misoprostol

    Drug Cost (USD) : 1,454,458

    Year : 2023

    Prescribers : 2953

    Prescriptions : 7378

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    Company : Amneal Pharmace

    Diclofenac Sodium/Misoprostol

    Drug Cost (USD) : 2,199,194

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    Prescribers : 3302

    Prescriptions : 8763

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    Company : Bluepoint Labor

    Diclofenac Sodium/Misoprostol

    Drug Cost (USD) : 258,621

    Year : 2023

    Prescribers : 509

    Prescriptions : 1700

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    Company : Eagle Pharmaceu

    Diclofenac Sodium/Misoprostol

    Drug Cost (USD) : 1,110

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    Company : Greenstone LLC.

    Diclofenac Sodium/Misoprostol

    Drug Cost (USD) : 1,723,840

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    Company : Micro Labs USA,

    Diclofenac Sodium/Misoprostol

    Drug Cost (USD) : 1,618,670

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    Company : Nivagen Pharmac

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    Drug Cost (USD) : 17,908

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    Prescriptions : 85

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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.

    Pfizer Brand of Misoprostol Manufacturers

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

    Pfizer Brand of Misoprostol Suppliers

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

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

    Pfizer Brand of Misoprostol USDMF

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

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

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

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

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

    After submitting a Pfizer Brand of 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 Pfizer Brand of Misoprostol API can apply through the Korea Drug Master File (KDMF).

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

    Pfizer Brand of Misoprostol CEP

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

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

    Pfizer Brand of 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 Pfizer Brand of Misoprostol as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Pfizer Brand of Misoprostol GMP

    Pfizer Brand of 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 Pfizer Brand 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 Pfizer Brand of Misoprostol GMP manufacturer or Pfizer Brand of Misoprostol GMP API supplier for your needs.

    Pfizer Brand of Misoprostol CoA

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

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

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