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ACTIVE PHARMA INGREDIENTS

9 API Suppliers, 5 USDMF, 2 EU WC, 4 NDC API, 6 Listed Suppliers, $ API Reference Price

9 API Suppliers
5 USDMF
2 EU WC
4 NDC API
6 Listed Suppliers
$ API Reference Price

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

48 FDF Dossiers, 34 FDA Orange Book, 7 Europe, 1 Canada, 1 South Africa, 5 Listed Dossiers

48 FDF Dossiers
34 FDA Orange Book
7 Europe
1 Canada
1 South Africa
5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;ORAL, RECTAL - 66%;10%, SOLUTION;INTRAUTERINE - 52.7%;26.8%, INJECTABLE;INJECTION - 66%;10%

drugProductComposition
SOLUTION;ORAL, RECTAL - 66%;10%
SOLUTION;INTRAUTERINE - 52.7%;26.8%
INJECTABLE;INJECTION - 66%;10%

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 DKSH, 1 Actylis

relatedExcipients
1 Rochem International Inc
1 DKSH
1 Actylis

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 1 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 Finished Drug Prices

globalSalesInformation
4 Finished Drug Prices

MARKET PLACE

7 APIs, 1 FDF Dossiers

marketPlace
7 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM , 2 USP , 2 Others

otherSolutions
2 EDQM
2 USP
2 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

MARKET PLACE

API

FDF

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

2EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Meglumine diatrizoate, 131-49-7, Meglumine amidotrizoate, Renografin, Cardiografin, Cystografin

Molecular Formula

C₁₈H₂₆I₃N₃O₉

Molecular Weight

809.1 g/mol

InChI Key

MIKKOBKEXMRYFQ-WZTVWXICSA-N

FDA UNII

3X9MR4N98U

A versatile contrast medium used for DIAGNOSTIC X-RAY RADIOLOGY.

1 2D Structure

Diatrizoate Meglumine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

3,5-diacetamido-2,4,6-triiodobenzoic acid;(2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol

2.1.2 InChI

InChI=1S/C11H9I3N2O4.C7H17NO5/c1-3(17)15-9-6(12)5(11(19)20)7(13)10(8(9)14)16-4(2)18;1-8-2-4(10)6(12)7(13)5(11)3-9/h1-2H3,(H,15,17)(H,16,18)(H,19,20);4-13H,2-3H2,1H3/t;4-,5+,6+,7+/m.0/s1

2.1.3 InChI Key

MIKKOBKEXMRYFQ-WZTVWXICSA-N

2.1.4 Canonical SMILES

CC(=O)NC1=C(C(=C(C(=C1I)C(=O)O)I)NC(=O)C)I.CNCC(C(C(C(CO)O)O)O)O

2.1.5 Isomeric SMILES

CC(=O)NC1=C(C(=C(C(=C1I)C(=O)O)I)NC(=O)C)I.CNC[C@@H]([C@H]([C@@H]([C@@H](CO)O)O)O)O

2.2 Other Identifiers

2.2.1 UNII

3X9MR4N98U

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Amidotricoic Acid

2. Amidotrizoate, Meglumine

3. Angiografin

4. Diatrizoate Methylglucamine

5. Diatrizoate, Meglumine

6. Diatrizoate, Methylglucamine

7. Diatrizoic Acid Methylglucamine

8. Gastrograffin

9. Gastrografin

10. Gastrographin

11. Ioxeol

12. Meglumine Amidotrizoate

13. Meglumine Diatrizoate

14. Meglumine, Diatrizoate

15. Methylglucamine Diatrizoate

16. Methylglucamine, Diatrizoate

17. Methylglucamine, Diatrizoic Acid

18. Reno 60

19. Reno M Dip

20. Reno M-dip

21. Reno Mdip

22. Renograffin

23. Renografin

24. Renografin M 76

25. Renografin M-76

26. Renografin M76

27. Sinografin

28. Triombrast

29. Triombrin

30. Urografin

31. Urografin 76

32. Urovist

33. Verografin

2.3.2 Depositor-Supplied Synonyms

1. Meglumine Diatrizoate

2. 131-49-7

3. Meglumine Amidotrizoate

4. Renografin

5. Cardiografin

6. Cystografin

7. Renovist

8. Renocal

9. Angiovist 282

10. Diatrizoate Methylglucamine

11. Reno

12. Urovist Cysto

13. Urovist Cysto Pediatric

14. Urovist Meglumine Diu/ct

15. Meglumine Amidotrizoate Injection

16. Diatrizoate Meglumine [usp]

17. 131-49-7 (meglumine)

18. Diatrizoic Acid Meglumine Salt

19. 3x9mr4n98u

20. Angiografin

21. Urovist

22. 1-deoxy-1-(methylamino)-d-glucitol 3,5-diacetamido-2,4,6-triiodobenzoate (salt)

23. Renurix

24. Unipaque

25. Hypaque Meglumine

26. (2r,3r,4r,5s)-6-(methylamino)hexane-1,2,3,4,5-pentaol 3,5-diacetamido-2,4,6-triiodobenzoate

27. Cystographin Dilute

28. Diatrizoate Meglumine (usp)

29. Reno-m

30. Reno-m-dip

31. Benzoic Acid, 3,5-bis(acetylamino)-2,4,6-triiodo-, Compd. With 1-deoxy-1-(methylamino)-d-glucitol (1:1)

32. Hypaque 60

33. Renograffin M-76

34. Hypaque M 30

35. Hypaque 13.4

36. Reno-30

37. Hypaque-cysto

38. Reno-dip

39. Cystografin Dilute

40. Reno M 60

41. Gastrografin Oral (veterinary)

42. Reno-60

43. Md 60

44. Einecs 205-024-7

45. Unii-3x9mr4n98u

46. Hypaque (tn)

47. Urovist (tn)

48. Reno (tn)

49. 3,5-bis(acetamido)-2,4,6-triiodbenzoesaeure, 1-desoxy-1-methylamino-d-glucit-salz

50. Benzoic Acid, 3,5-diacetamido-2,4,6-triiodo-, Compd. With 1-deoxy-1-(methylamino)-d-glucitol

51. Schembl107036

52. Chembl1200839

53. Dtxsid20897171

54. Hms2234f23

55. Diatrizoate Meglumine [vandf]

56. Meglumine Amidotrizoate [mart.]

57. Glucitol, 1-deoxy-1-(methylamino)-, 3,5-diacetamido-2,4,6-triiodobenzoate (salt), D-

58. Meglumine Amidotrizoate [who-dd]

59. Diatrizoate Meglumine [green Book]

60. Diatrizoate Meglumine [orange Book]

61. Diatrizoic Acid Meglumine Salt [mi]

62. Diatrizoate Meglumine [usp Monograph]

63. Renocal Component Diatrizoate Meglumine

64. Angiovist Component Diatrizoate Meglumine

65. D02015

66. Meglumine Amidotrizoate Injection [jan]

67. Renovist Component Diatrizoate Meglumine

68. Diatrizoate Meglumine Component Of Renocal

69. Gastrovist Component Diatrizoate Meglumine

70. Renografin Component Diatrizoate Meglumine

71. Sinografin Component Diatrizoate Meglumine

72. Diatrizoate Meglumine Component Of Angiovist

73. Diatrizoate Meglumine Component Of Renovist

74. Gastrografin Component Diatrizoate Meglumine

75. Diatrizoate Meglumine Component Of Gastrovist

76. Diatrizoate Meglumine Component Of Renografin

77. Diatrizoate Meglumine Component Of Sinografin

78. Md-gastroview Component Diatrizoate Meglumine

79. Diatrizoate Meglumine Component Of Gastrografin

80. Q27114690

81. Diatrizoate Meglumine Component Of Md-gastroview

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₈H₂₆I₃N₃O₉
Molecular Weight	809.1 g/mol
Hydrogen Bond Donor Count	9
Hydrogen Bond Acceptor Count	10
Rotatable Bond Count	9
Exact Mass	808.8803 g/mol
Monoisotopic Mass	808.8803 g/mol
Topological Polar Surface Area	209 Å²
Heavy Atom Count	33
Formal Charge	0
Complexity	525
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 6
Drug Name	Cystografin
Drug Label	Cystografin is a radiopaque contrast agent supplied as a sterile, clear, colorless to pale yellow, mobile or slightly viscous solution. Each mL provides 300 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of sol...
Active Ingredient	Diatrizoate meglumine
Dosage Form	Solution
Route	Urethral
Strength	30%
Market Status	Prescription
Company	Bracco

2 of 6
Drug Name	Cystografin dilute
Drug Label	Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is a radiopaque contrast agent supplied as a sterile, aqueous solution. Each mL provides 180 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of soluti...
Active Ingredient	Diatrizoate meglumine
Dosage Form	Solution
Route	Urethral
Strength	18%
Market Status	Prescription
Company	Bracco

3 of 6
Drug Name	Sinografin
Drug Label	Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is a sterile, nonpyrogenic, essentially colorless to pale yellow, aqueous radiopaque contrast medium for intrauterine instillation. Each mL provides 527 mg diatrizoate meglumine an...
Active Ingredient	Diatrizoate meglumine; iodipamide meglumine
Dosage Form	Solution
Route	Intrauterine
Strength	26.8%; 52.7%
Market Status	Prescription
Company	Bracco

4 of 6
Drug Name	Cystografin
Drug Label	Cystografin is a radiopaque contrast agent supplied as a sterile, clear, colorless to pale yellow, mobile or slightly viscous solution. Each mL provides 300 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of sol...
Active Ingredient	Diatrizoate meglumine
Dosage Form	Solution
Route	Urethral
Strength	30%
Market Status	Prescription
Company	Bracco

5 of 6
Drug Name	Cystografin dilute
Drug Label	Cystografin Dilute (Diatrizoate Meglumine Injection USP 18%) is a radiopaque contrast agent supplied as a sterile, aqueous solution. Each mL provides 180 mg diatrizoate meglumine with 0.4 mg edetate disodium as a sequestering agent. Each mL of soluti...
Active Ingredient	Diatrizoate meglumine
Dosage Form	Solution
Route	Urethral
Strength	18%
Market Status	Prescription
Company	Bracco

6 of 6
Drug Name	Sinografin
Drug Label	Sinografin (Diatrizoate Meglumine and lodipamide Meglumine Injection) is a sterile, nonpyrogenic, essentially colorless to pale yellow, aqueous radiopaque contrast medium for intrauterine instillation. Each mL provides 527 mg diatrizoate meglumine an...
Active Ingredient	Diatrizoate meglumine; iodipamide meglumine
Dosage Form	Solution
Route	Intrauterine
Strength	26.8%; 52.7%
Market Status	Prescription
Company	Bracco

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Contrast Media

Substances used to allow enhanced visualization of tissues. (See all compounds classified as Contrast Media.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

X-Ray Contrast Activity [MoA]; Radiographic Contrast Agent [EPC]

API SUPPLIERS

01

Biophore India Pharmaceuticals Pvt...

India

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

Medlab Asia & Asia Health

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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India

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CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

HRV Global Life Sciences

India

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

CPHI Middle east

Attending

HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF AU

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03

HONOUR LAB LTD

India

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

Medlab Asia & Asia Health

Not Confirmed

04

Curia

U.S.A

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

Medlab Asia & Asia Health

Not Confirmed

05

Vasudha Pharma Chem

India

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

Medlab Asia & Asia Health

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06

ORGANICA Feinchemie GmbH Wolfen

Germany

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

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07

Hetero Drugs

India

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

Medlab Asia & Asia Health

Not Confirmed

08

Vasudha Pharma Chem

India

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

Medlab Asia & Asia Health

Not Confirmed

09

Sionc Pharmaceuticals

India

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

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Listed Suppliers

01

Biophore India Pharmaceuticals Pvt ...

India

iPHEX India

Attending

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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India

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Diatrizoate Meglumine

About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.

02

HRV Global Life Sciences

India

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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Diatrizoate Meglumine

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.