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Chemistry

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Also known as: 73334-07-3, Ultravist, Iopromidum, Iopromida, Proscope, N1,n3-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(2-methoxyacetamido)-n1-methylisophthalamide
Molecular Formula
C18H24I3N3O8
Molecular Weight
791.1  g/mol
InChI Key
DGAIEPBNLOQYER-UHFFFAOYSA-N
FDA UNII
712BAC33MZ

Iopromide
Iopromide is a contrast medium.
Iopromide is a Radiographic Contrast Agent. The mechanism of action of iopromide is as a X-Ray Contrast Activity.
1 2D Structure

Iopromide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-N,3-N-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(2-methoxyacetyl)amino]-3-N-methylbenzene-1,3-dicarboxamide
2.1.2 InChI
InChI=1S/C18H24I3N3O8/c1-24(4-9(28)6-26)18(31)12-13(19)11(17(30)22-3-8(27)5-25)14(20)16(15(12)21)23-10(29)7-32-2/h8-9,25-28H,3-7H2,1-2H3,(H,22,30)(H,23,29)
2.1.3 InChI Key
DGAIEPBNLOQYER-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN(CC(CO)O)C(=O)C1=C(C(=C(C(=C1I)C(=O)NCC(CO)O)I)NC(=O)COC)I
2.2 Other Identifiers
2.2.1 UNII
712BAC33MZ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Clarograf

2. Iopromid

3. Lopromid

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

5. Ultravist

6. Ultravist 300

2.3.2 Depositor-Supplied Synonyms

1. 73334-07-3

2. Ultravist

3. Iopromidum

4. Iopromida

5. Proscope

6. N1,n3-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(2-methoxyacetamido)-n1-methylisophthalamide

7. Zk 35760

8. 1-n,3-n-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(2-methoxyacetyl)amino]-3-n-methylbenzene-1,3-dicarboxamide

9. Zk-35760

10. Magnesium Methanide Propan-1-ide(1:1:1)

11. N,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(2-methoxyacetamido)-n-methylisophthalamide

12. 712bac33mz

13. Ultravist 300

14. Chebi:63578

15. N,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(methoxyacetyl)amino]-n-methylisophthalamide

16. Ultravist 370

17. Iopromid

18. Dsstox_cid_3163

19. Dsstox_rid_76898

20. Dsstox_gsid_23163

21. 1,3-benzenedicarboxamide, N,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-((methoxyacetyl)amino)-n-methyl-

22. Shl 414c

23. Iopromidum [inn-latin]

24. Iopromida [inn-spanish]

25. Ultravist 150

26. Ultravist 240

27. Einecs 277-385-9

28. Ultravist (pharmacy Bulk)

29. Brn 7085608

30. Unii-712bac33mz

31. Iopromide [usan:usp:inn:ban]

32. Ultravist (tn)

33. Ncgc00016923-01

34. Proscope (tn)

35. Cas-73334-07-3

36. Bay86-4877

37. Bay 86-4877

38. Iopromide [inn]

39. Iopromide [jan]

40. Iopromide [mi]

41. Iopromide [usan]

42. Prestwick0_000872

43. Prestwick1_000872

44. Prestwick2_000872

45. Prestwick3_000872

46. Iopromide [vandf]

47. Iopromide [mart.]

48. Iopromide [usp-rs]

49. Iopromide [who-dd]

50. Chembl1725

51. Iopromide (jan/usp/inn)

52. Schembl24546

53. Bspbio_000943

54. Mls002154045

55. Iopromide, Analytical Standard

56. Spbio_002864

57. Bpbio1_001039

58. Iopromide [ep Impurity]

59. Iopromide [orange Book]

60. Dtxsid0023163

61. Iopromide [ep Monograph]

62. Iopromide [usp Monograph]

63. Hms1570p05

64. Hms2097p05

65. Hms2233o23

66. Hms3370m05

67. Hms3714p05

68. Bcp08449

69. Hy-b1362

70. Tox21_110684

71. Ultravist 300 In Plastic Container

72. Ac-535

73. Mfcd00867924

74. S3207

75. Akos025402129

76. Tox21_110684_1

77. Ccg-220872

78. Db09156

79. Iopromid 100 Microg/ml In Acetonitrile

80. Ncgc00179367-01

81. Ncgc00179367-03

82. 1,3-benzenedicarboxamide, N,n'-bis(2,3-dihydroxypropyl)-5-((methoxyacetyl)amino)-n-methyl-2,4,6-triiodo-

83. Bs-17441

84. Smr001233368

85. Ab00513942

86. Cs-0013103

87. Ft-0627283

88. D01893

89. 334i073

90. Sr-01000841262

91. Q4202805

92. Sr-01000841262-2

93. Iopromide, European Pharmacopoeia (ep) Reference Standard

94. Iopromide, United States Pharmacopeia (usp) Reference Standard

95. Iopromide For System Suitability 1, European Pharmacopoeia (ep) Reference Standard

96. Iopromide For System Suitability 2, European Pharmacopoeia (ep) Reference Standard

97. 1,3-benzenedicarboxamide, N1,n3-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-[(2-methoxyacetyl)amino]-n1-methyl-

98. N,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-n-methyl-5-{[(methyloxy)acetyl]amino}benzene-1,3-dicarboxamide

99. N-(2,3-dihydroxypropyl)-3-[(2,3-dihydroxypropyl)(methyl)carbamoyl]-5-[(1-hydroxy-2-methoxyethylidene)amino]-2,4,6-triiodobenzene-1-carboximidic Acid

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 791.1 g/mol
Molecular Formula C18H24I3N3O8
XLogP3-2.1
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count8
Rotatable Bond Count11
Exact Mass790.8698 g/mol
Monoisotopic Mass790.8698 g/mol
Topological Polar Surface Area169 Ų
Heavy Atom Count32
Formal Charge0
Complexity647
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count2
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 10  
Drug NameUltravist
Active IngredientIopromide
Dosage FormInjectable
RouteInjection
Strength62.3%; 49.9%; 76.9%
Market StatusPrescription
CompanyBayer Hlthcare

2 of 10  
Drug NameUltravist 150
Active IngredientIopromide
Dosage FormInjectable
RouteInjection
Strength31.2%
Market StatusPrescription
CompanyBayer Hlthcare

3 of 10  
Drug NameUltravist 240
Active IngredientIopromide
Dosage FormInjectable
RouteInjection
Strength49.9%
Market StatusPrescription
CompanyBayer Hlthcare

4 of 10  
Drug NameUltravist 300
Active IngredientIopromide
Dosage FormInjectable
RouteInjection
Strength62.3%
Market StatusPrescription
CompanyBayer Hlthcare

5 of 10  
Drug NameUltravist 370
Active IngredientIopromide
Dosage FormInjectable
RouteInjection
Strength76.9%
Market StatusPrescription
CompanyBayer Hlthcare

6 of 10  
Drug NameUltravist
Active IngredientIopromide
Dosage FormInjectable
RouteInjection
Strength62.3%; 49.9%; 76.9%
Market StatusPrescription
CompanyBayer Hlthcare

7 of 10  
Drug NameUltravist 150
Active IngredientIopromide
Dosage FormInjectable
RouteInjection
Strength31.2%
Market StatusPrescription
CompanyBayer Hlthcare

8 of 10  
Drug NameUltravist 240
Active IngredientIopromide
Dosage FormInjectable
RouteInjection
Strength49.9%
Market StatusPrescription
CompanyBayer Hlthcare

9 of 10  
Drug NameUltravist 300
Active IngredientIopromide
Dosage FormInjectable
RouteInjection
Strength62.3%
Market StatusPrescription
CompanyBayer Hlthcare

10 of 10  
Drug NameUltravist 370
Active IngredientIopromide
Dosage FormInjectable
RouteInjection
Strength76.9%
Market StatusPrescription
CompanyBayer Hlthcare

4.2 Drug Indication

Iopromide, as the product Iovist, is indicated for use as an X-ray contrast agent in the following procedures: Intra-arterial digital subtraction angiography (IA-DSA) (150 mg I/mL) Cerebral arteriography and peripheral arteriography (300 mg I/mL) Coronary arteriography and left ventriculography, visceral angiography and aortography (370 mg I/mL) Peripheral venography (240 mg I/mL) Excretory urography (300 mg I/mL) Contrast computed tomography (CT) imaging of head and body (300 mg I/mL and 370 mg I/mL)


FDA Label


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 Active Moiety
IOPROMIDE
5.2.2 FDA UNII
712BAC33MZ
5.2.3 Pharmacological Classes
X-Ray Contrast Activity [MoA]; Radiographic Contrast Agent [EPC]
5.3 ATC Code

V08AB05

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

V08AB05 - Iopromide


5.4 Absorption, Distribution and Excretion

Absorption

Following administration, the degree of contrast enhancement is directly related to the iodine content in the administered dose; peak iodine plasma levels occur immediately following rapid intravenous injection. Iodine plasma levels fall rapidly within 5 to 10 minutes, which can be accounted for by the dilution in the vascular and extravascular fluid compartments. Contrast enhancement appears to be greatest immediately after bolus injections (15 seconds to 120 seconds). Thus, greatest enhancement may be detected by a series of consecutive two-to-three second scans performed within 30 to 90 seconds after injection (that is, dynamic computed tomographic imaging). Injection may be visualized in the renal parenchyma within 3060 seconds following rapid intravenous injection. Opacification of the calyces and pelves in patients with normal renal function becomes apparent within 13 minutes, with optimum contrast occurring within 515 minutes.


Route of Elimination

The amounts excreted unchanged in urine represent 97% of the dose in young healthy subjects. Only 2% of the dose is recovered in the feces. Similar recoveries in urine and feces are observed in middle-aged and elderly patients. This finding suggests that, compared to the renal route, biliary and/or gastrointestinal excretion is not important for iopromide. During the slower terminal phase only 3% of the dose is eliminated; 97% of the dose is disposed of during the earlier phases, the largest part of which occurs during the main elimination phase.


Volume of Distribution

16 L


Clearance

The mean total and renal clearances are 107 mL/min and 104 mL/min, respectively.


5.5 Metabolism/Metabolites

Iopromide is not metabolized.


5.6 Biological Half-Life

After intravenous administration to healthy young volunteers, plasma iopromide concentration time profile shows an initial distribution phase with a half-life of 0.24 hour; a main elimination phase with a half-life of 2 hours; and a terminal elimination phase with a half-life of 6.2 hours.


5.7 Mechanism of Action

Iopromide is a low osmolar, non-ionic X-ray contrast agent for intravascular administration. It functions as a contrast agent by opacifying blood vessels in the path of flow of the contrast agent, permitting radiographic visualization of the internal structures until significant hemodilution occurs.


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Date of Issue : 2022-06-16

Valid Till : 2025-06-16

Written Confirmation Number : WC-0031

Address of the Firm : Unit-Lingojigudem (V) Choutuppal (M) Nalgonda District Talangana State India

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Date of Issue : 2020-12-18

Valid Till : 2022-06-16

Written Confirmation Number : WC-0031A3

Address of the Firm : Unit-Lingojigudem (V) Choutuppal (M) Nalgonda District Talangana State India

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D6 D8, SY.NO. 234\/2,234\/3,","city":"TURKAPALLY(V),SHAMEERPET, HYDERABAD","supplier":"UNITED STATES PHARMACOPEIAL","supplierCountry":"INDIA","foreign_port":"WASHINGTON, DULLES I","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0001","unit":"KGS","unitRateFc":"17620000","totalValueFC":"1811.1","currency":"USD","unitRateINR":"1511887400","date":"21-Jun-2024","totalValueINR":"151188.74","totalValueInUsd":"1811.1","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"4117205","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"WASHINGTON, DULLES I","supplierAddress":"7135 ENGLISH MUFFIN WAY FREDERICK,MD, US 21704, UNITED STATES OF AMERICA United States","customerAddress":"P.NO. D6 D8, SY.NO. 234\/2,234\/3,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728930600,"product":"IOPROMIDE","address":"101, SITARAM MANSION,","city":"KAROL BAGH, NEW DELHI","supplier":"ZHEJIANG STARRY PHARMACEUTICAL CO., LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"252","totalValueFC":"7634.1","currency":"USD","unitRateINR":"21382.2","date":"15-Oct-2024","totalValueINR":"641466","totalValueInUsd":"7634.1","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"6131939","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.1 STARRY ROAD OF XIANJU MODERN I NDUSTRIAL CENTRALIZATION ZONE SDNF China","customerAddress":"101, SITARAM MANSION,"}]
09-Aug-2021
26-Mar-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

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API Imports and Exports

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

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Europe

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01

Bayer Pharma AG

Germany
AACR Annual meeting
Not Confirmed
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Bayer Pharma AG

Germany
arrow
AACR Annual meeting
Not Confirmed

iopromide

Brand Name : Ultra Vist

Dosage Form : INJECTION / INFUSION

Dosage Strength : 240 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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02

Bayer Pharma AG

Germany
AACR Annual meeting
Not Confirmed
arrow

Bayer Pharma AG

Germany
arrow
AACR Annual meeting
Not Confirmed

iopromide

Brand Name : Ultra Vist

Dosage Form : INJECTION / INFUSION

Dosage Strength : 150 MG I / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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03

BAYER PHARMA AG

Germany
AACR Annual meeting
Not Confirmed
arrow

BAYER PHARMA AG

Germany
arrow
AACR Annual meeting
Not Confirmed

Iopromide

Brand Name : Ultravist

Dosage Form : Iopromide 30,000Mg Iodine 100Ml 1 Units Parenteral Use

Dosage Strength : 1 bottle EV 100 ml 300 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

BAYER PHARMA AG

Germany
AACR Annual meeting
Not Confirmed
arrow

BAYER PHARMA AG

Germany
arrow
AACR Annual meeting
Not Confirmed

Iopromide

Brand Name : Ultravist

Dosage Form : Iopromide 37.000Mg Iodine 100Ml 1 Units Parenteral Use

Dosage Strength : 1 bottle EV 100 ml 370 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

Bayer Pharma AG

Germany
AACR Annual meeting
Not Confirmed
arrow

Bayer Pharma AG

Germany
arrow
AACR Annual meeting
Not Confirmed

Iopromide

Brand Name : Ultra Shown

Dosage Form : Injection/infusion fluid, resolution

Dosage Strength : 240 mg IN/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

06

Bayer Pharma AG

Germany
AACR Annual meeting
Not Confirmed
arrow

Bayer Pharma AG

Germany
arrow
AACR Annual meeting
Not Confirmed

Iopromide

Brand Name : Ultra Shown

Dosage Form : Injection/infusion fluid, resolution

Dosage Strength : 300 mg IN/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

07

Bayer Pharma AG

Germany
AACR Annual meeting
Not Confirmed
arrow

Bayer Pharma AG

Germany
arrow
AACR Annual meeting
Not Confirmed

Iopromide

Brand Name : Ultra Shown

Dosage Form : Injection/infusion fluid, resolution

Dosage Strength : 300 mg IN/ml

Packaging : Bottle of glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

08

Bayer Pharma AG

Germany
AACR Annual meeting
Not Confirmed
arrow

Bayer Pharma AG

Germany
arrow
AACR Annual meeting
Not Confirmed

Iopromide

Brand Name : Ultra Shown

Dosage Form : Injection/infusion fluid, resolution

Dosage Strength : 300 mg IN/ml

Packaging : Bottle of glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

09

Bayer Pharma AG

Germany
AACR Annual meeting
Not Confirmed
arrow

Bayer Pharma AG

Germany
arrow
AACR Annual meeting
Not Confirmed

Iopromide

Brand Name : Ultra Shown

Dosage Form : Injection/infusion fluid, resolution

Dosage Strength : 370 mg IN/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

10

Bayer Pharma AG

Germany
AACR Annual meeting
Not Confirmed
arrow

Bayer Pharma AG

Germany
arrow
AACR Annual meeting
Not Confirmed

Iopromide

Brand Name : Ultra Shown

Dosage Form : Injection/infusion fluid, resolution

Dosage Strength : 370 mg IN/ml

Packaging : Bottle of glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Parenteral

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01

Pfanstiehl

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Grade : Parenteral

Category : Parenteral

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ABOUT THIS PAGE

Looking for 73334-07-3 / Iopromide API manufacturers, exporters & distributors?

Iopromide manufacturers, exporters & distributors 1

55

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

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

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

API | Excipient name

Iopromide

Synonyms

73334-07-3, Ultravist, Iopromidum, Iopromida, Proscope, N1,n3-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-5-(2-methoxyacetamido)-n1-methylisophthalamide

Cas Number

73334-07-3

Unique Ingredient Identifier (UNII)

712BAC33MZ

About Iopromide

Iopromide is a contrast medium.

ULTRAVIST 300 IN PLASTIC CONTAINER Manufacturers

A ULTRAVIST 300 IN PLASTIC CONTAINER manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ULTRAVIST 300 IN PLASTIC CONTAINER, including repackagers and relabelers. The FDA regulates ULTRAVIST 300 IN PLASTIC CONTAINER manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ULTRAVIST 300 IN PLASTIC CONTAINER 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 ULTRAVIST 300 IN PLASTIC CONTAINER manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

ULTRAVIST 300 IN PLASTIC CONTAINER Suppliers

A ULTRAVIST 300 IN PLASTIC CONTAINER supplier is an individual or a company that provides ULTRAVIST 300 IN PLASTIC CONTAINER active pharmaceutical ingredient (API) or ULTRAVIST 300 IN PLASTIC CONTAINER finished formulations upon request. The ULTRAVIST 300 IN PLASTIC CONTAINER suppliers may include ULTRAVIST 300 IN PLASTIC CONTAINER API manufacturers, exporters, distributors and traders.

click here to find a list of ULTRAVIST 300 IN PLASTIC CONTAINER suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

ULTRAVIST 300 IN PLASTIC CONTAINER USDMF

A ULTRAVIST 300 IN PLASTIC CONTAINER DMF (Drug Master File) is a document detailing the whole manufacturing process of ULTRAVIST 300 IN PLASTIC CONTAINER active pharmaceutical ingredient (API) in detail. Different forms of ULTRAVIST 300 IN PLASTIC CONTAINER DMFs exist exist since differing nations have different regulations, such as ULTRAVIST 300 IN PLASTIC CONTAINER USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A ULTRAVIST 300 IN PLASTIC CONTAINER DMF submitted to regulatory agencies in the US is known as a USDMF. ULTRAVIST 300 IN PLASTIC CONTAINER USDMF includes data on ULTRAVIST 300 IN PLASTIC CONTAINER's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ULTRAVIST 300 IN PLASTIC CONTAINER USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of ULTRAVIST 300 IN PLASTIC CONTAINER suppliers with USDMF on PharmaCompass.

ULTRAVIST 300 IN PLASTIC CONTAINER KDMF

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

Pharmaceutical companies submit a ULTRAVIST 300 IN PLASTIC CONTAINER Drug Master File in Korea (ULTRAVIST 300 IN PLASTIC CONTAINER KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ULTRAVIST 300 IN PLASTIC CONTAINER. The MFDS reviews the ULTRAVIST 300 IN PLASTIC CONTAINER KDMF as part of the drug registration process and uses the information provided in the ULTRAVIST 300 IN PLASTIC CONTAINER KDMF to evaluate the safety and efficacy of the drug.

After submitting a ULTRAVIST 300 IN PLASTIC CONTAINER 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 ULTRAVIST 300 IN PLASTIC CONTAINER API can apply through the Korea Drug Master File (KDMF).

click here to find a list of ULTRAVIST 300 IN PLASTIC CONTAINER suppliers with KDMF on PharmaCompass.

ULTRAVIST 300 IN PLASTIC CONTAINER CEP

A ULTRAVIST 300 IN PLASTIC CONTAINER CEP of the European Pharmacopoeia monograph is often referred to as a ULTRAVIST 300 IN PLASTIC CONTAINER Certificate of Suitability (COS). The purpose of a ULTRAVIST 300 IN PLASTIC CONTAINER CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ULTRAVIST 300 IN PLASTIC CONTAINER EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ULTRAVIST 300 IN PLASTIC CONTAINER to their clients by showing that a ULTRAVIST 300 IN PLASTIC CONTAINER CEP has been issued for it. The manufacturer submits a ULTRAVIST 300 IN PLASTIC CONTAINER CEP (COS) as part of the market authorization procedure, and it takes on the role of a ULTRAVIST 300 IN PLASTIC CONTAINER CEP holder for the record. Additionally, the data presented in the ULTRAVIST 300 IN PLASTIC CONTAINER CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ULTRAVIST 300 IN PLASTIC CONTAINER DMF.

A ULTRAVIST 300 IN PLASTIC CONTAINER CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ULTRAVIST 300 IN PLASTIC CONTAINER 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 ULTRAVIST 300 IN PLASTIC CONTAINER suppliers with CEP (COS) on PharmaCompass.

ULTRAVIST 300 IN PLASTIC CONTAINER WC

A ULTRAVIST 300 IN PLASTIC CONTAINER written confirmation (ULTRAVIST 300 IN PLASTIC CONTAINER WC) is an official document issued by a regulatory agency to a ULTRAVIST 300 IN PLASTIC CONTAINER manufacturer, verifying that the manufacturing facility of a ULTRAVIST 300 IN PLASTIC CONTAINER active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ULTRAVIST 300 IN PLASTIC CONTAINER APIs or ULTRAVIST 300 IN PLASTIC CONTAINER finished pharmaceutical products to another nation, regulatory agencies frequently require a ULTRAVIST 300 IN PLASTIC CONTAINER WC (written confirmation) as part of the regulatory process.

click here to find a list of ULTRAVIST 300 IN PLASTIC CONTAINER suppliers with Written Confirmation (WC) on PharmaCompass.

ULTRAVIST 300 IN PLASTIC CONTAINER GMP

ULTRAVIST 300 IN PLASTIC CONTAINER 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 ULTRAVIST 300 IN PLASTIC CONTAINER 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 ULTRAVIST 300 IN PLASTIC CONTAINER GMP manufacturer or ULTRAVIST 300 IN PLASTIC CONTAINER GMP API supplier for your needs.

ULTRAVIST 300 IN PLASTIC CONTAINER CoA

A ULTRAVIST 300 IN PLASTIC CONTAINER CoA (Certificate of Analysis) is a formal document that attests to ULTRAVIST 300 IN PLASTIC CONTAINER's compliance with ULTRAVIST 300 IN PLASTIC CONTAINER specifications and serves as a tool for batch-level quality control.

ULTRAVIST 300 IN PLASTIC CONTAINER CoA mostly includes findings from lab analyses of a specific batch. For each ULTRAVIST 300 IN PLASTIC CONTAINER 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.

ULTRAVIST 300 IN PLASTIC CONTAINER may be tested according to a variety of international standards, such as European Pharmacopoeia (ULTRAVIST 300 IN PLASTIC CONTAINER EP), ULTRAVIST 300 IN PLASTIC CONTAINER JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ULTRAVIST 300 IN PLASTIC CONTAINER 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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