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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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JDMF

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NDC API

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VMF

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Chemistry

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Also known as: 78649-41-9, Iomeprolum, Iomeron, Imeron, Iomeron 300, N,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(n-methylglycolamido)isophthalamide
Molecular Formula
C17H22I3N3O8
Molecular Weight
777.1  g/mol
InChI Key
NJKDOADNQSYQEV-UHFFFAOYSA-N
FDA UNII
17E17JBP8L

Iomeprol
Iomeprol has been investigated for the diagnostic of Coronary Artery Disease.
1 2D Structure

Iomeprol

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-N,3-N-bis(2,3-dihydroxypropyl)-5-[(2-hydroxyacetyl)-methylamino]-2,4,6-triiodobenzene-1,3-dicarboxamide
2.1.2 InChI
InChI=1S/C17H22I3N3O8/c1-23(9(29)6-26)15-13(19)10(16(30)21-2-7(27)4-24)12(18)11(14(15)20)17(31)22-3-8(28)5-25/h7-8,24-28H,2-6H2,1H3,(H,21,30)(H,22,31)
2.1.3 InChI Key
NJKDOADNQSYQEV-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN(C1=C(C(=C(C(=C1I)C(=O)NCC(CO)O)I)C(=O)NCC(CO)O)I)C(=O)CO
2.2 Other Identifiers
2.2.1 UNII
17E17JBP8L
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Imeron

2. Iomeprol 350

3. Iomeprol 400

4. Iomeron

2.3.2 Depositor-Supplied Synonyms

1. 78649-41-9

2. Iomeprolum

3. Iomeron

4. Imeron

5. Iomeron 300

6. N,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(n-methylglycolamido)isophthalamide

7. N1,n3-bis(2,3-dihydroxypropyl)-5-(2-hydroxy-n-methylacetamido)-2,4,6-triiodoisophthalamide

8. E-7337

9. 1-n,3-n-bis(2,3-dihydroxypropyl)-5-[(2-hydroxyacetyl)-methylamino]-2,4,6-triiodobenzene-1,3-dicarboxamide

10. 17e17jbp8l

11. 1185146-41-1

12. Chebi:31710

13. N,n'-bis(2,3-dihydroxypropyl)-5-[glycoloyl(methyl)amino]-2,4,6-triiodoisophthalamide

14. Ncgc00183283-01

15. Iomeprolo

16. E7337

17. 1,3-benzenedicarboxamide, N,n'-bis(2,3-dihydroxypropyl)-5-((hydroxyacetyl)methylamino)-2,4,6-triiodo-

18. Iomeprolum [inn-latin]

19. Unii-17e17jbp8l

20. Iomeprol [usan:inn:ban:jan]

21. Iomeprol [usan]

22. Iomeprol [inn]

23. Iomeprol [jan]

24. Iomeprol [mi]

25. Iomeron 300 (tn)

26. Iomeprol [mart.]

27. Iomeprol [who-dd]

28. Dsstox_cid_28987

29. Dsstox_rid_83252

30. Dsstox_gsid_49061

31. Schembl26981

32. Iomeprol (jan/usan/inn)

33. Chembl2107214

34. Dtxsid1049061

35. Bcp34386

36. Tox21_113611

37. Akos030255901

38. Db11705

39. Ac-30722

40. Cas-78649-41-9

41. Db-056324

42. Ft-0627277

43. Ft-0670399

44. Methylacetamido)-2,4,6-triiodoisophthalamide

45. D01719

46. Iomeprol 100 Microg/ml In Acetonitrile/methanol

47. Iomeprol 100 Microg/ml In Acetonitrile:methanol

48. A839467

49. B-16880

50. N1,n3-bis(2,3-dihydroxypropyl)-5-(2-hydroxy-n-

51. Q6062808

52. 1,3-benzenedicarboxamide, N1,n3-bis(2,3-dihydroxypropyl)-5-[(2-hydroxyacetyl)methylamino]-2,4,6-triiodo-

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 777.1 g/mol
Molecular Formula C17H22I3N3O8
XLogP3-2.3
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count8
Rotatable Bond Count10
Exact Mass776.8541 g/mol
Monoisotopic Mass776.8541 g/mol
Topological Polar Surface Area180 Ų
Heavy Atom Count31
Formal Charge0
Complexity591
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count2
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Contrast Media

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


4.2 ATC Code

V08AB10

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


V - Various

V08 - Contrast media

V08A - X-ray contrast media, iodinated

V08AB - Watersoluble, nephrotropic, low osmolar x-ray contrast media

V08AB10 - Iomeprol


USDMF

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World Health Expo
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01

World Health Expo
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10299

Submission : 1993-06-15

Status : Inactive

Type : II

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Arab Health
Not Confirmed

02

Arab Health
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 42428

Submission : 2025-08-15

Status : Active

Type : II

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KDMF

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Chemical Corporation

United Kingdom
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Chemical Corporation

United Kingdom
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Iomeprol

Registrant Name : UK Chemical Pharm Co., Ltd.

Registration Date : 2018-05-08

Registration Number : 20180508-210-J-214

Manufacturer Name : UK Chemical Pharm Co., Ltd.

Manufacturer Address : 7, Block 3, Banwol Industrial Complex, 11, Moknae-ro 122beongil, Danwon-gu, Ansan-si,...

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MFC

South Korea
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MFC

South Korea
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Iomeprol

Registrant Name : MFC Co., Ltd.

Registration Date : 2020-01-07

Registration Number : 20200107-210-J-521

Manufacturer Name : MFC Co., Ltd.

Manufacturer Address : 35 Cheongwon Industrial Complex 7-gil, Mado-myeon, Hwaseong-si, Gyeonggi-do

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Iomeprol

Registrant Name : Sangjin Trading Co., Ltd.

Registration Date : 2024-05-09

Registration Number : 20240509-210-J-1638

Manufacturer Name : Zhejiang Starry Pharmaceutic...

Manufacturer Address : No.1 Starry Road, Xianju Modern Industrial Centralization Zone, Xianju County, Zhejia...

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Listed Suppliers

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Arab Health
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Iomeprol

About the Company : BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special gener...

BrightGene Bio-Medical Technology Co., Ltd. is a research driven biopharmaceutical company that engages in the R&D and manufacturing of innovative medicine as well as special generic APIs and FDFs with primary strategic focus on the regulated market. We have an exciting and very promising innovative pipeline including immuno-oncological therapeutic agents, orally available GLP-1RA peptides for type 2 diabetes, antibody drug conjugates for solid tumor, novel non-antibody dependent tumor targeting conjugates for brain cancer and solid tumor brain-metastasis.
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Iomeprol

About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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API Reference Price

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[{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1693247400,"product":"IOMEPROL","address":"PLOT NO 55 AND 45 TSIIC,BIOTECH PH ASE-III KARAKAPATLA","city":"MEDAK","supplier":"HANGZHOU ROYALL","supplierCountry":"CHINA","foreign_port":"NA","customer":"JODAS EXPOIM PRIVATE LTD","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"1200","totalValueFC":"1213","currency":"USD","unitRateINR":"99473.9","date":"29-Aug-2023","totalValueINR":"100478.64","totalValueInUsd":"1213","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO 55 AND 45 TSIIC,BIOTECH PH ASE-III KARAKAPATLA"}]
29-Aug-2023
29-Aug-2023
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Average Price (USD/KGS)

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

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FDF Dossiers

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01

Bracco

Italy
Arab Health
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IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 25GM IODINE/100ML (250MG IODINE/ML)

Packaging :

Approval Date : 2024-11-27

Application Number : 216016

Regulatory Info : DISCN

Registration Country : USA

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Bracco

Italy
Arab Health
Not Confirmed
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Bracco

Italy
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Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 15GM IODINE/50ML (300MG IODINE/ML)

Packaging :

Approval Date : 2024-11-27

Application Number : 216016

Regulatory Info : DISCN

Registration Country : USA

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Bracco

Italy
Arab Health
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Italy
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IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 30GM IODINE/100ML (300MG IODINE/ML)

Packaging :

Approval Date : 2024-11-27

Application Number : 216016

Regulatory Info : DISCN

Registration Country : USA

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Bracco

Italy
Arab Health
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Bracco

Italy
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IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 45GM IODINE/150ML (300MG IODINE/ML)

Packaging :

Approval Date : 2024-11-27

Application Number : 216016

Regulatory Info : DISCN

Registration Country : USA

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Bracco

Italy
Arab Health
Not Confirmed
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Bracco

Italy
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Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 60GM IODINE/200ML (300MG IODINE/ML)

Packaging :

Approval Date : 2024-11-27

Application Number : 216016

Regulatory Info : DISCN

Registration Country : USA

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Bracco

Italy
Arab Health
Not Confirmed
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Bracco

Italy
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Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 17.5GM IODINE/50ML (350MG IODINE/ML)

Packaging :

Approval Date : 2024-11-27

Application Number : 216016

Regulatory Info : DISCN

Registration Country : USA

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Bracco

Italy
Arab Health
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Italy
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IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 35GM IODINE/100ML (350MG IODINE/ML)

Packaging :

Approval Date : 2024-11-27

Application Number : 216016

Regulatory Info : DISCN

Registration Country : USA

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Bracco

Italy
Arab Health
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Bracco

Italy
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IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 52.5GM IODINE/150ML (350MG IODINE/ML

Packaging :

Approval Date : 2024-11-27

Application Number : 216016

Regulatory Info : DISCN

Registration Country : USA

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Bracco

Italy
Arab Health
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Bracco

Italy
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Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 70GM IODINE/200ML (350MG IODINE/ML)

Packaging :

Approval Date : 2024-11-27

Application Number : 216016

Regulatory Info : DISCN

Registration Country : USA

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Bracco

Italy
Arab Health
Not Confirmed
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Bracco

Italy
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Arab Health
Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 20GM IODINE/50ML (400MG IODINE/ML)

Packaging :

Approval Date : 2024-11-27

Application Number : 216016

Regulatory Info : DISCN

Registration Country : USA

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FDA Orange Book

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BRACCO

Italy
Arab Health
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Italy
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IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 25GM IODINE/100ML (250MG IODINE/ML)

Approval Date : 2024-11-27

Application Number : 216016

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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BRACCO

Italy
Arab Health
Not Confirmed
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BRACCO

Italy
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Arab Health
Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 15GM IODINE/50ML (300MG IODINE/ML)

Approval Date : 2024-11-27

Application Number : 216016

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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BRACCO

Italy
Arab Health
Not Confirmed
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BRACCO

Italy
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Arab Health
Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 52.5GM IODINE/150ML (350MG IODINE/ML

Approval Date : 2024-11-27

Application Number : 216016

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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BRACCO

Italy
Arab Health
Not Confirmed
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BRACCO

Italy
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Arab Health
Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 70GM IODINE/200ML (350MG IODINE/ML)

Approval Date : 2024-11-27

Application Number : 216016

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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BRACCO

Italy
Arab Health
Not Confirmed
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BRACCO

Italy
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Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRA-ARTERIAL

Dosage Strength : 20GM IODINE/50ML (400MG IODINE/ML)

Approval Date : 2024-11-27

Application Number : 216016

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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BRACCO

Italy
Arab Health
Not Confirmed
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BRACCO

Italy
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Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 15GM IODINE/50ML (300MG IODINE/ML)

Approval Date : 2024-11-27

Application Number : 216017

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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BRACCO

Italy
Arab Health
Not Confirmed
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BRACCO

Italy
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Arab Health
Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 30GM IODINE/100ML (300MG IODINE/ML)

Approval Date : 2024-11-27

Application Number : 216017

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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BRACCO

Italy
Arab Health
Not Confirmed
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BRACCO

Italy
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Arab Health
Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 45GM IODINE/150ML (300MG IODINE/ML)

Approval Date : 2024-11-27

Application Number : 216017

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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BRACCO

Italy
Arab Health
Not Confirmed
arrow

BRACCO

Italy
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Arab Health
Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 60GM IODINE/200ML (300MG IODINE/ML)

Approval Date : 2024-11-27

Application Number : 216017

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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BRACCO

Italy
Arab Health
Not Confirmed
arrow

BRACCO

Italy
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Arab Health
Not Confirmed

IOMEPROL

Brand Name : IOMERVU

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 60GM IODINE/150ML (400MG IODINE/ML)

Approval Date : 2024-11-27

Application Number : 216017

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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Europe

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01

World Health Expo
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Iomeprol

Brand Name : Iomeron 400

Dosage Form : Iomeprol 100.000Mg 250Ml 1 Units Parenteral Use

Dosage Strength : 1 bottle EV 250 ml 400 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Iomeprol

Brand Name : Iomeron 350

Dosage Form : Iomeprol 17.500Mg 50Ml 1 Units Parenteral Use

Dosage Strength : 1 bottle EV 50 ml 350 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Iomeprol

Brand Name : Iomeron 400

Dosage Form : Iomeprol 20,000Mg 50Ml 1 Units Parenteral Use

Dosage Strength : 1 bottle EV 50 ml 400 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Iomeprol

Brand Name : Iomeron 400

Dosage Form : Iomeprol 30,000Mg 75Ml 1 Units Parenteral Use

Dosage Strength : 1 bottle EV 75 ml 400 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Iomeprol

Brand Name : Iomeron 250

Dosage Form : Iomeprol 37.500Mg 150Ml 1 Units Parenteral Use

Dosage Strength : 1 bottle EV 150 ml 250 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Iomeprol

Brand Name : Iomeron 300

Dosage Form : Iomeprol 60.000Mg 200Ml 1 Units Parenteral Use

Dosage Strength : 1 bottle EV 200 ml 300 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Iomeprol

Brand Name : Iomeron

Dosage Form : Injectable Solution

Dosage Strength : 150mgI/ml

Packaging :

Approval Date : 17/10/1997

Application Number : 19971017000056

Regulatory Info : Approved

Registration Country : Sweden

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Iomeprol

Brand Name : Iomeron

Dosage Form : Injectable Solution

Dosage Strength : 400mgI/ml

Packaging :

Approval Date : 17/10/1997

Application Number : 19971017000100

Regulatory Info : Approved

Registration Country : Sweden

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Iomeprol

Brand Name : Iomeron

Dosage Form : Injectable Solution

Dosage Strength : 300MG

Packaging :

Approval Date : 01-02-1996

Application Number : 60809

Regulatory Info : Authorized

Registration Country : Spain

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Iomeprol

Brand Name : Iomeron

Dosage Form : Injection Solution

Dosage Strength : 150mg Iodine/ml

Packaging :

Approval Date : 11-07-1994

Application Number : 28101556893

Regulatory Info : Prescription

Registration Country : Denmark

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DATA COMPILATION #PharmaFlow

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DMF filings rise 4.5% in Q3 2025; China holds lead, India records 20% growth in submissions
The third quarter (Q3) of 2025 witnessed a steady rise in Drug Master File (DMF) submissions to the US Food and Drug Administration (FDA). DMFs are used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug productsA total of 323 Type II DMFs were submitted during this period, as opposed to 309 submissions in Q3 2024, marking an increase of 4.53 percent. This is the second highest number since 2018. In Q1 2025, 339 Type II filings were recorded.Across all DMF types (II, III, IV, and V), 479 DMFs were filed in Q3 2025, compared to 394 in Q3 2024, representing a 21.57 percent increase. Out of the 323 Type II DMFs submitted in Q3 2025, 40 had completed their review by the end of Q3, reflecting a processing lag between submission and review completion. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available)China maintains its lead while India posts double-digit growth in DMF submissions China and India continued to dominate DMF submissions in Q3 2025. China retained the top spot with 153 Type II DMFs, matching its submission count from Q3 2024. India recorded 131 DMFs, marking a 20.18 percent increase over 109 filings during the corresponding period last year.The United States stood a distant third with 17 filings, compared to 13 in Q3 2024. Among European nations, Italy recorded eight DMFs, doubling its 2024 tally. The Netherlands filed four, up from three. Spain submitted only one DMF, as against seven submitted in Q3 2024. Taiwan made three filings, up from one submitted in Q3 2024. Together, India, China and Taiwan accounted for about 88.9 percent of all Type II DMFs filed during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) China’s Suzhou Ryway Biotech tops corporate tally; India’s Hetero, Biophore followChina’s Suzhou Ryway Biotech led the company-wise tally with 12 DMF submissions in Q3 2025. The company had not filed any DMFs in Q3 2024.India’s Hetero Group followed with nine DMFs, maintaining the same number of filings as Q3 2024. Biophore India Pharmaceuticals ranked third with six DMFs, doubling its count from three last year.Other notable contributors include Sai Sreyas Pharmaceuticals (India) and Shanghai Haoyuan Chemexpress (China), with five DMFs each. Companies such as SNJ Group, Lunan Pharmaceutical, Allsino Pharmaceutical, Shankus Pharma, Jiangxi Xinganjiang Pharmaceutical, Sunpure Extracts, Lee Pharma, Umedica Laboratories, Linhai Tianyu Pharmaceutical and Maithri Drugs filed four DMFs each. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) Olaparib, semaglutide lead molecular filings; Dr. Reddy’s files DMF for edoxaban & tucatinibDr. Reddy’s Laboratories also featured among key DMF filers in Q3 2025, submitting two DMFs — for edoxaban tosylate monohydrate and tucatinib copovidone. Edoxaban tosylate monohydrate (marketed as Savaysa by Daiichi Sankyo) is a prescription anticoagulant used to reduce the risk of stroke and to treat deep vein thrombosis and pulmonary embolism. Patent exclusivity for Savaysa extends until October 2026 in the United States, with no generic currently available.In terms of molecules, the highest number of DMFs were filed for olaparib, semaglutide, ruxolitinib phosphate, ferric carboxymaltose, and vismodegib, with three DMFs each in Q3 2025.Olaparib, sold by AstraZeneca under the brand name Lynparza, saw DMFs being filed by BDR Lifesciences and Intas Pharmaceuticals from India, and by ScinoPharm Taiwan during the quarter.Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk, continued to draw strong interest from API manufacturers. DMFs for semaglutide were filed by three Chinese companies: Yangzhou Aurisco Pharmaceutical, Zhejiang Peptites Biotech, and Fujian Genohope Biotech.Ruxolitinib phosphate, marketed by Incyte as Jakafi, saw three DMFs. Three Indian companies — Alembic Pharmaceuticals, Valary Labs, and Devi Pharmatech — filed DMFs for this API in Q3 2025. Other molecules that received multiple DMF submissions include ferric carboxymaltose (used to treat iron-deficiency anemia) and vismodegib (an oral therapy for basal-cell carcinoma). View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) First-time DMF filings span 17 companies; India leads with nine first-time DMFs The quarter saw first-time DMF filings from 17 companies. India took a lead here with nine first-time DMF filings, followed by China (six), and the US (two).The DMF filings in this quarter included inclisiran sodium (filed by Aurisco Pharmaceutical of China), pacritinib citrate (by TAPI Nl B.V. of the Netherlands), and vosoritide (by Apicore LLC of the US).Out of the 19 first-time DMFs filed in Q3 2025, four completed their Generic Drug User Fee Amendments (GDUFA) review process during the quarter. View FDA DMF Filings in Q3 2025 (Power BI Dashboard, Free Excel Available) GDUFA fee for FY 2026: The FDA Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry.Fee rates for fiscal year 2026 were published on July 30, 2025. FDA has revised fees under GDUFA III across all categories. While there is a slight increase in the DMF fee from US$ 95,084 in 2025 to US$ 102,584 in 2026, the ANDA fee has seen a sharp rise: from US$ 321,920 in 2025 to US$ 358,247 in 2026.FY 2025 and FY 2026 User Fee Rates Generic drug fee category Fees rates for FY 2025 Fees rates for FY 2026 Applications:     Abbreviated New Drug Application (ANDA) US$ 3,21,920 US$ 3,58,247 Drug Master File (DMF) US$ 95,084 US$ 1,02,584 Facilities:     Active Pharmaceutical Ingredient (API)—Domestic US$ 41,580 US$ 43,549 API—Foreign US$ 56,580 US$ 58,549 Finished Dosage Form (FDF)—Domestic US$ 2,31,952 US$ 2,38,943 FDF—Foreign US$ 2,46,952 US$ 2,53,943 Contract Manufacturing Organization (CMO)—Domestic US$ 55,668 US$ 57,346 CMO—Foreign US$ 70,668 US$ 72,346 GDUFA Program:     Large size operation generic drug applicant US$ 18,91,664 US$ 19,18,377 Medium size operation generic drug applicant US$ 7,56,666 US$ 7,67,351 Small business generic drug applicant US$ 1,89,166 US$ 1,91,838 Our viewFor several years prior to the pandemic, India had a lead in Type II DMF submissions. In recent years, China has surpassed India in DMF filings. But Q3 2025 numbers indicate that Indian drugmakers are fast catching up. Since DMFs establish trust in APIs from across the world, we feel this healthy competition between drugmakers from the two countries is good for the global pharmaceutical industry. 

Impressions: 3363

https://www.pharmacompass.com/radio-compass-blog/dmf-filings-rise-4-5-in-q3-2025-china-holds-lead-india-records-20-growth-in-submissions

#PharmaFlow by PHARMACOMPASS
13 Nov 2025

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Iomeprol

Dosage Form : Iomeprol 100.000Mg 250Ml 1 Units...

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Dosage Form : Iomeprol 150.000Mg 500Ml 1 Units...

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Dosage Form : Iomeprol 175.000Mg 500Ml 1 Units...

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Dosage Form : Iomeprol 200.000Mg 500Ml 1 Units...

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ABOUT THIS PAGE

Looking for 78649-41-9 / Iomeprol API manufacturers, exporters & distributors?

Iomeprol manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Iomeprol

Synonyms

78649-41-9, Iomeprolum, Iomeron, Imeron, Iomeron 300, N,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(n-methylglycolamido)isophthalamide

Cas Number

78649-41-9

Unique Ingredient Identifier (UNII)

17E17JBP8L

About Iomeprol

Iomeprol has been investigated for the diagnostic of Coronary Artery Disease.

iomeprol 400 Manufacturers

A iomeprol 400 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of iomeprol 400, including repackagers and relabelers. The FDA regulates iomeprol 400 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. iomeprol 400 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 iomeprol 400 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

iomeprol 400 Suppliers

A iomeprol 400 supplier is an individual or a company that provides iomeprol 400 active pharmaceutical ingredient (API) or iomeprol 400 finished formulations upon request. The iomeprol 400 suppliers may include iomeprol 400 API manufacturers, exporters, distributors and traders.

click here to find a list of iomeprol 400 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

iomeprol 400 USDMF

A iomeprol 400 DMF (Drug Master File) is a document detailing the whole manufacturing process of iomeprol 400 active pharmaceutical ingredient (API) in detail. Different forms of iomeprol 400 DMFs exist exist since differing nations have different regulations, such as iomeprol 400 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A iomeprol 400 DMF submitted to regulatory agencies in the US is known as a USDMF. iomeprol 400 USDMF includes data on iomeprol 400's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The iomeprol 400 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of iomeprol 400 suppliers with USDMF on PharmaCompass.

iomeprol 400 KDMF

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

Pharmaceutical companies submit a iomeprol 400 Drug Master File in Korea (iomeprol 400 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of iomeprol 400. The MFDS reviews the iomeprol 400 KDMF as part of the drug registration process and uses the information provided in the iomeprol 400 KDMF to evaluate the safety and efficacy of the drug.

After submitting a iomeprol 400 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 iomeprol 400 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of iomeprol 400 suppliers with KDMF on PharmaCompass.

iomeprol 400 GMP

iomeprol 400 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 iomeprol 400 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 iomeprol 400 GMP manufacturer or iomeprol 400 GMP API supplier for your needs.

iomeprol 400 CoA

A iomeprol 400 CoA (Certificate of Analysis) is a formal document that attests to iomeprol 400's compliance with iomeprol 400 specifications and serves as a tool for batch-level quality control.

iomeprol 400 CoA mostly includes findings from lab analyses of a specific batch. For each iomeprol 400 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.

iomeprol 400 may be tested according to a variety of international standards, such as European Pharmacopoeia (iomeprol 400 EP), iomeprol 400 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (iomeprol 400 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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