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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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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 Chemie Private Limited (TCPL) 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.
Tenatra

06

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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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07

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Misoprostol

About the Company : Founded in 1972, and public listed in Taiwan Stock Exchange in 1988, Everlight Chemical focuses on the development of chemical synthesis technology, which gradually became its core...

Founded in 1972, and public listed in Taiwan Stock Exchange in 1988, Everlight Chemical focuses on the development of chemical synthesis technology, which gradually became its core competency. Today the company’s main product lines include: Color Chemicals, Specialty Chemicals, Toner, Electronic Chemicals, Pharmaceutical Chemicals, and Nano-Materials. Having a total of 17 operating locations and 6 production bases around the world, it employs approximately 1,900 employees. In 2017, its revenue approximately was USD300M (NT 9.2 billion).
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08

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Misoprostol

About the Company : Fleming Laboratories Limited is in the business of manufacturing and supply of high-quality generic Active Pharmaceutical Ingredients (APIs) to the global Pharmaceutical Industry. ...

Fleming Laboratories Limited is in the business of manufacturing and supply of high-quality generic Active Pharmaceutical Ingredients (APIs) to the global Pharmaceutical Industry. The facilities are audited & approved by /accredited with various Regulatory agencies including EUGMP, EDQM, WHO GMP, PMDA (Japan), COFEPRIS (Mexico), Korea FDA.
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09

Monvi Labs

India
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Monvi Labs

India
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Misoprostol

About the Company : Monvi Laboratories PVT LTD, is a Research and Development Organization, headquartered in Hyderabad, India. We aspire to emerge as a global player in delivering high quality, innova...

Monvi Laboratories PVT LTD, is a Research and Development Organization, headquartered in Hyderabad, India. We aspire to emerge as a global player in delivering high quality, innovative products to global pharmaceutical industries. Infrastructure includes Process Development and Scale-up Labs to handle various developmental challenges
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10

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Misoprostol

About the Company : Founded in 2000, YONSUNG fine chemicals co., Ltd. is a top quality, fast growing manufacturer of APIs, especially, PROSTAGLANDINS and related products for pharmaceutical applicatio...

Founded in 2000, YONSUNG fine chemicals co., Ltd. is a top quality, fast growing manufacturer of APIs, especially, PROSTAGLANDINS and related products for pharmaceutical applications. YONSUNG prides itself on the quality of its products, which gives the company an important competitive edge. The site manufactures API,s for the US, EU and other regulated markets and complies with the cGMP guidelines established by ICH (Q7A). The relevance of new requirements from the FDA, ICH, EMEA and EDQM is continuously monitored.Stringent controls are built-in to ensure that every single product meets the specification of most known pharmacopeias.
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HEATHROW","customer":"NAARI","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"950","totalValueFC":"48122.8","currency":"USD","unitRateINR":"80655","date":"18-Sep-2024","totalValueINR":"4032750","totalValueInUsd":"48122.8","indian_port":"Delhi Air","hs_no":"29375000","bill_no":"5669036","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"WHALTON ROAD MORPETH NORTHUMBERLAND NE61 3YA SDNF GB","customerAddress":"C-3\/199, JANAK PURI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727375400,"product":"MISOPROSTOL DISPERSION USP","address":"218\/219, 2ND FLOOR,KAILASH PLAZA,","city":"GHATKOPAR EAST,MUMBAI, MAHARASTHRA","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"AQUATIC REMEDIES PVT LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"700","totalValueFC":"35333.6","currency":"USD","unitRateINR":"59220","date":"27-Sep-2024","totalValueINR":"2961000","totalValueInUsd":"35333.6","indian_port":"Bombay Air","hs_no":"29375000","bill_no":"5833916","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"WHALTON ROAD, MORPETH , NORTHUMBERL AND NE61 3YA , UNITED KINGDOM (UK) SDNF UNITED KINGDOM","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727461800,"product":"MISOPROSTOL DISPERSION USP","address":"VILL.GHOGADWAL (CHOKIWALA),","city":"","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"ACME FORMULATION PVT LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"985","totalValueFC":"99438.9","currency":"USD","unitRateINR":"83331","date":"28-Sep-2024","totalValueINR":"8333100","totalValueInUsd":"99438.9","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"5857286","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":"2024","qtr":"Q4","strtotime":1728585000,"product":"MISOPROSTOL DISPERSION","address":"C-3\/199, JANAK PURI,","city":"NEW DELHI","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"NAARI","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"950","totalValueFC":"95931","currency":"USD","unitRateINR":"80607.5","date":"11-Oct-2024","totalValueINR":"8060750","totalValueInUsd":"95931","indian_port":"Delhi Air","hs_no":"29375000","bill_no":"6080148","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"WHALTON ROAD MORPETH NORTHUMBERLAND NE61 3YA SDNF GB","customerAddress":"C-3\/199, JANAK PURI,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731868200,"product":"MISOPROSTOL DISPERSION USP","address":"VILL.GHOGADWAL (CHOKIWALA),","city":"","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"ACME FORMULATION PVT LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"985","totalValueFC":"99564.3","currency":"USD","unitRateINR":"84020.5","date":"18-Nov-2024","totalValueINR":"8402050","totalValueInUsd":"99564.3","indian_port":"Delhi Air","hs_no":"29379090","bill_no":"6743102","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":"2024","qtr":"Q4","strtotime":1733337000,"product":"MISOPROSTOL DISPERSION USP MISOPROSTOL DISPERSION USP","address":"NO.27,RACE COURSE ROAD,","city":"KARNATAKA","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"MICRO LABS LIMITED","customerCountry":"INDIA","quantity":"142.29","actualQuantity":"142.29","unit":"KGS","unitRateFc":"2376","totalValueFC":"339597","currency":"USD","unitRateINR":"202791.6","date":"05-Dec-2024","totalValueINR":"28855216.76","totalValueInUsd":"339597","indian_port":"Madras Air","hs_no":"29375000","bill_no":"7069455","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"WHALTON ROAD, MORPETH, NORTHUMBERLAND NE61 3YA, ENGLAND UNITED KINGDOM","customerAddress":"NO.27,RACE COURSE ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737397800,"product":"MISOPROSTOL DISPERSION USP MISOPROSTOL DISPERSION USP","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"PIRAMAL PHARMA SOLUTIONS","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"CIPLA","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"750","totalValueFC":"75757.4","currency":"USD","unitRateINR":"65325","date":"21-Jan-2025","totalValueINR":"6532500","totalValueInUsd":"75757.4","indian_port":"Bombay Air","hs_no":"29375000","bill_no":"7903490","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"WHALTON ROAD, MORPETH, NORTHUMBERLAND, NE61 3YA , SDNF","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737657000,"product":"MISOPROSTOL-HPMC 1% DISPERSION MISOPROSTOL-HPMC 1% DISPERSION","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"M\/S EVERLIGHT CHEMICAL INDUSTRIAL CORPORATION","supplierCountry":"TAIWAN","foreign_port":"TAIYUAN","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"1660","totalValueFC":"25151.5","currency":"USD","unitRateINR":"144586","date":"24-Jan-2025","totalValueINR":"2168790","totalValueInUsd":"25151.5","indian_port":"Bombay Air","hs_no":"29375000","bill_no":"7984141","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIYUAN","supplierAddress":"12, INDUSTRIAL THIRD RD,KUANYIN DISTRICT, TAOYUAN CITY, TAIWAN SDNF","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738780200,"product":"MISOPROSTOL DISPERSION (UQUIFA) USP MISOPROSTOL DISPERSION (UQUIFA) USP","address":"218\/219, 2ND FLOOR,KAILASH PLAZA,","city":"GHATKOPAR EAST,MUMBAI, MAHARASTHRA","supplier":"PIRAMAL HEALTH CARE UK LTD","supplierCountry":"UNITED KINGDOM","foreign_port":"LONDON - HEATHROW","customer":"AQUATIC REMEDIES PVT LTD","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"700","totalValueFC":"70109.4","currency":"USD","unitRateINR":"60970","date":"06-Feb-2025","totalValueINR":"6097000","totalValueInUsd":"70109.4","indian_port":"Bombay Air","hs_no":"29375000","bill_no":"8204072","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"LONDON - HEATHROW","supplierAddress":"WHALTON ROAD, MORPETH,NORTHUMBERLAN D, NE61 3YA,UNITED KINGDOM(UK) UK, , UNITED KINGDOM UNITED KINGDOM","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"}]
11-Jan-2021
06-Feb-2025
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API/FDF Prices: Book a Demo to explore the features and consider upgrading later

API Imports and Exports

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

Upgrade, download data, analyse, strategize, subscribe with us contact

FDF Dossiers

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01

Actavis Inc

Ireland
ELCC
Not Confirmed
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Actavis Inc

Ireland
arrow
ELCC
Not Confirmed

DICLOFENAC SODIUM; MISOPROSTOL

Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 75MG;0.2MG

Packaging :

Approval Date : 2012-07-09

Application Number : 201089

Regulatory Info : RX

Registration Country : USA

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02

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

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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03

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

Misoprostol

Brand Name :

Dosage Form : Tablet

Dosage Strength : 200MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

04

Pfizer Inc

U.S.A
ELCC
Not Confirmed
arrow

Pfizer Inc

U.S.A
arrow
ELCC
Not Confirmed

DICLOFENAC SODIUM; MISOPROSTOL

Brand Name : ARTHROTEC

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 75MG;0.2MG

Packaging :

Approval Date : 1997-12-24

Application Number : 20607

Regulatory Info : RX

Registration Country : USA

blank

05

Pfizer Inc

U.S.A
ELCC
Not Confirmed
arrow

Pfizer Inc

U.S.A
arrow
ELCC
Not Confirmed

Misoprostol

Brand Name : Cytotec

Dosage Form : Tablet

Dosage Strength : 0.2 mg

Packaging : Blisterpakning 100item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

06

Pfizer Inc

U.S.A
ELCC
Not Confirmed
arrow

Pfizer Inc

U.S.A
arrow
ELCC
Not Confirmed

Diclofenacum natricum; Misoprostolum

Brand Name : Arthrotec 75

Dosage Form : Bitabs

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

07

Pfizer Inc

U.S.A
ELCC
Not Confirmed
arrow

Pfizer Inc

U.S.A
arrow
ELCC
Not Confirmed

Misoprostol

Brand Name : Misoprostol Pfizer

Dosage Form : TAB

Dosage Strength : 200mcg

Packaging : 60X1mcg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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08

Pfizer Inc

U.S.A
ELCC
Not Confirmed
arrow

Pfizer Inc

U.S.A
arrow
ELCC
Not Confirmed

Misoprostol

Brand Name : Arthrotec 50

Dosage Form : TAB

Dosage Strength : 200mcg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

blank

09

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

Misoprostol

Brand Name : PMS-MISOPROSTOL (0.2MG)

Dosage Form : TABLET

Dosage Strength : 0.2MG

Packaging : 100/500

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Canada

blank

10

Sandoz B2B

Switzerland
ELCC
Not Confirmed
arrow

Sandoz B2B

Switzerland
arrow
ELCC
Not Confirmed

DICLOFENAC SODIUM; MISOPROSTOL

Brand Name : DICLOFENAC SODIUM AND MISOPROSTOL

Dosage Form : TABLET, DELAYED RELEASE;ORAL

Dosage Strength : 50MG;0.2MG

Packaging :

Approval Date : 2013-05-09

Application Number : 200158

Regulatory Info : DISCN

Registration Country : USA

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Europe

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01

Pfizer

U.S.A
ELCC
Not Confirmed
arrow

Pfizer

U.S.A
arrow
ELCC
Not Confirmed

misoprostol

Brand Name : Cytotec

Dosage Form : TABLET

Dosage Strength : 0.2 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

blank

02

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

Diclofenac Sodium; Misoprostol

Brand Name : Artrotec

Dosage Form :

Dosage Strength : 10 Cpr 75 Mg + 200 Mcg  

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

blank

03

Pfizer AS

U.S.A
ELCC
Not Confirmed
arrow

Pfizer AS

U.S.A
arrow
ELCC
Not Confirmed

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

blank

04

Pfizer AS

U.S.A
ELCC
Not Confirmed
arrow

Pfizer AS

U.S.A
arrow
ELCC
Not Confirmed

Misoprostol

Brand Name : Cytotec

Dosage Form : Tablet

Dosage Strength : 0.2 mg

Packaging : Blisterpakning 100item

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

05

Pfizer AG

U.S.A
ELCC
Not Confirmed
arrow

Pfizer AG

U.S.A
arrow
ELCC
Not Confirmed

Diclofenacum natricum; Misoprostolum

Brand Name : Arthrotec 50

Dosage Form : Bitabs

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

06

Pfizer AG

U.S.A
ELCC
Not Confirmed
arrow

Pfizer AG

U.S.A
arrow
ELCC
Not Confirmed

Diclofenacum natricum; Misoprostolum

Brand Name : Arthrotec 50

Dosage Form : Bitabs

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

07

Pfizer AG

U.S.A
ELCC
Not Confirmed
arrow

Pfizer AG

U.S.A
arrow
ELCC
Not Confirmed

Diclofenacum natricum; Misoprostolum

Brand Name : Arthrotec 50

Dosage Form : Bitabs

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

08

Pfizer AG

U.S.A
ELCC
Not Confirmed
arrow

Pfizer AG

U.S.A
arrow
ELCC
Not Confirmed

Diclofenacum natricum; Misoprostolum

Brand Name : Arthrotec 75

Dosage Form : Bitabs

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

09

Pfizer AG

U.S.A
ELCC
Not Confirmed
arrow

Pfizer AG

U.S.A
arrow
ELCC
Not Confirmed

Diclofenacum natricum; Misoprostolum

Brand Name : Arthrotec 75

Dosage Form : Bitabs

Dosage Strength : 75mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

10

Ferring Läkemedel AB

Country
ELCC
Not Confirmed
arrow

Ferring Läkemedel AB

Country
arrow
ELCC
Not Confirmed

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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Canada

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01

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

MISOPROSTOL

Brand Name : MISOPROSTOL

Dosage Form : TABLET

Dosage Strength : 100MCG

Packaging : 100/250/500

Approval Date :

Application Number : 2244022

Regulatory Info : Prescription

Registration Country : Canada

blank

02

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

MISOPROSTOL

Brand Name : MISOPROSTOL

Dosage Form : TABLET

Dosage Strength : 200MCG

Packaging : 100/500

Approval Date :

Application Number : 2244023

Regulatory Info : Prescription

Registration Country : Canada

blank

03

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

MISOPROSTOL

Brand Name : GD-DICLOFENAC/MISOPROSTOL 50

Dosage Form : TABLET (DELAYED-RELEASE)

Dosage Strength : 200MCG

Packaging : 250

Approval Date :

Application Number : 2341689

Regulatory Info : Prescription

Registration Country : Canada

blank

04

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

MISOPROSTOL

Brand Name : GD-DICLOFENAC/MISOPROSTOL 75

Dosage Form : TABLET (DELAYED-RELEASE)

Dosage Strength : 200MCG

Packaging : 250

Approval Date :

Application Number : 2341697

Regulatory Info : Prescription

Registration Country : Canada

blank

05

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

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 : Prescription

Registration Country : Canada

blank

06

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

MISOPROSTOL

Brand Name : ARTHROTEC 50

Dosage Form : TABLET (DELAYED-RELEASE)

Dosage Strength : 200MCG

Packaging : 250

Approval Date :

Application Number : 1917056

Regulatory Info : Prescription

Registration Country : Canada

blank

07

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

MISOPROSTOL

Brand Name : ARTHROTEC 75

Dosage Form : TABLET (DELAYED-RELEASE)

Dosage Strength : 200MCG

Packaging : 250

Approval Date :

Application Number : 2229837

Regulatory Info : Prescription

Registration Country : Canada

blank

08

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

Misoprostol

Brand Name : PMS-MISOPROSTOL (0.1MG)

Dosage Form : TABLET

Dosage Strength : 0.1MG

Packaging : 100

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Canada

blank

09

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

Misoprostol

Brand Name : PMS-MISOPROSTOL (0.2MG)

Dosage Form : TABLET

Dosage Strength : 0.2MG

Packaging : 100/500

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Canada

blank

10

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

MISOPROSTOL

Brand Name : PMS-DICLOFENAC-MISOPROSTOL

Dosage Form : TABLET (DELAYED-RELEASE)

Dosage Strength : 200MCG

Packaging :

Approval Date :

Application Number : 2413469

Regulatory Info : Prescription

Registration Country : Canada

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Listed Dossiers

read-more
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01

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

Misoprostol

Brand Name :

Dosage Form : Tablet

Dosage Strength : 200MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

01

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

Misoprostol

Dosage : Tablet

Dosage Strength : 200MCG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

blank

02

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

Diclofenac Sodium; Misoprostol

Brand Name :

Dosage Form : Tablet

Dosage Strength : 50MG; 200MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

blank

02

ELCC
Not Confirmed
arrow

03

ELCC
Not Confirmed
arrow
arrow
ELCC
Not Confirmed

Diclofenac Sodium; Misoprostol

Brand Name :

Dosage Form : Tablet

Dosage Strength : 75MG; 200MCG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Misoprostol

Brand Name : Noprostol

Dosage Form : Tablet

Dosage Strength : 200mcg

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Regulatory Info :

Registration Country : Indonesia

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Dosage : Tablet

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Brand Name : Noprostol

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Registration Country : Indonesia

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Misoprostol

Brand Name :

Dosage Form : Tablet

Dosage Strength : 25MCG

Packaging : 10x10 Tablets in a Blister Pack

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Registration Country : India

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Dosage Strength : 25MCG

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Registration Country : India

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Misoprostol

Brand Name :

Dosage Form : Tablet

Dosage Strength : 200MCG

Packaging : 10x10 Tablets in a Blister Pack

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Registration Country : India

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Misoprostol

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Dosage Form : Tablet

Dosage Strength : 0.2MG

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Registration Country : China

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Registration Country : China

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 0.1MG

USFDA APPLICATION NUMBER - 19268

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DOSAGE - TABLET;ORAL - 0.2MG

USFDA APPLICATION NUMBER - 19268

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

USFDA APPLICATION NUMBER - 20607

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

USFDA APPLICATION NUMBER - 20607

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ABOUT THIS PAGE

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

Misoprostol manufacturers, exporters & distributors 1

17

PharmaCompass offers a list of Misoprostol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Misoprostol manufacturer or Misoprostol supplier for your needs.

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

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

API | Excipient name

Misoprostol

Synonyms

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

Cas Number

59122-46-2

Unique Ingredient Identifier (UNII)

0E43V0BB57

About Misoprostol

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

Misoprostol Manufacturers

A Misoprostol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Misoprostol, including repackagers and relabelers. The FDA regulates Misoprostol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Misoprostol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

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

Misoprostol Suppliers

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

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

Misoprostol USDMF

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

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

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

Misoprostol JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Misoprostol Drug Master File in Japan (Misoprostol JDMF) empowers Misoprostol API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Misoprostol JDMF during the approval evaluation for pharmaceutical products. At the time of Misoprostol JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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

Misoprostol KDMF

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

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

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

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

Misoprostol CEP

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

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

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

Misoprostol NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Misoprostol as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Misoprostol API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Misoprostol as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Misoprostol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Misoprostol NDC to their finished compounded human drug products, they may choose to do so.

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

Misoprostol GMP

Misoprostol Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Misoprostol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Misoprostol GMP manufacturer or Misoprostol GMP API supplier for your needs.

Misoprostol CoA

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

Misoprostol CoA mostly includes findings from lab analyses of a specific batch. For each Misoprostol CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

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

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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