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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 11 USDMF, 8 CEP/COS, 6 JDMF, 1 EU WC, 13 KDMF, 3 NDC API, 12 Listed Suppliers, $ API Reference Price

26 API Suppliers
11 USDMF
8 CEP/COS
6 JDMF
1 EU WC
13 KDMF
3 NDC API
12 Listed Suppliers
$ API Reference Price

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

136 FDF Dossiers, 45 FDA Orange Book, 70 Europe, 5 Canada, 7 South Africa, 9 Listed Dossiers

136 FDF Dossiers
45 FDA Orange Book
70 Europe
5 Canada
7 South Africa
9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 41%, INJECTABLE;INJECTION - 51%, INJECTABLE;INJECTION - 61%, INJECTABLE;INJECTION - 76%, INJECTABLE;INJECTION - 51%, INJECTABLE;INJECTION - 61%, INJECTABLE;INJECTION - 76%

drugProductComposition
INJECTABLE;INJECTION - 41%
INJECTABLE;INJECTION - 51%
INJECTABLE;INJECTION - 61%
INJECTABLE;INJECTION - 76%
INJECTABLE;INJECTION - 51%
INJECTABLE;INJECTION - 61%
INJECTABLE;INJECTION - 76%

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1 Topical

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66 Finished Drug Prices

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66 Finished Drug Prices

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11 APIs, 8 FDF Dossiers

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11 APIs
8 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM , 4 USP , 4 Others

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4 USP
4 Others

Synopsis

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JDMF

EU WC

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0 DRUGS IN DEVELOPMENT

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3EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 60166-93-0, Iopamiron, Isovue, Iopamiro, Niopam, Solutrast

Molecular Formula

C₁₇H₂₂I₃N₃O₈

Molecular Weight

777.1 g/mol

InChI Key

XQZXYNRDCRIARQ-LURJTMIESA-N

FDA UNII

JR13W81H44

A non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiological procedures.

Iopamidol is a Radiographic Contrast Agent. The mechanism of action of iopamidol is as a X-Ray Contrast Activity.

1 2D Structure

Iopamidol

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

1-N,3-N-bis(1,3-dihydroxypropan-2-yl)-5-[[(2S)-2-hydroxypropanoyl]amino]-2,4,6-triiodobenzene-1,3-dicarboxamide

2.1.2 InChI

InChI=1S/C17H22I3N3O8/c1-6(28)15(29)23-14-12(19)9(16(30)21-7(2-24)3-25)11(18)10(13(14)20)17(31)22-8(4-26)5-27/h6-8,24-28H,2-5H2,1H3,(H,21,30)(H,22,31)(H,23,29)/t6-/m0/s1

2.1.3 InChI Key

XQZXYNRDCRIARQ-LURJTMIESA-N

2.1.4 Canonical SMILES

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

2.1.5 Isomeric SMILES

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

2.2 Other Identifiers

2.2.1 UNII

JR13W81H44

2.3 Synonyms

2.3.1 MeSH Synonyms

1. B 15,000

2. B 15000

3. B-15,000

4. B-15000

5. B15,000

6. B15000

7. Gastromiro

8. Iopamidol, (+-)-isomer

9. Iopamidol, (r)-isomer

10. Iopamidol, Sodium Salt, (s)-isomer

11. Iopamiro

12. Isovue

13. Isovue 370

14. Jopamidol

15. Niopam

16. Solutrast

17. Solutrast 370

18. Solutrast Gastro

19. Sq 13,396

2.3.2 Depositor-Supplied Synonyms

1. 60166-93-0

2. Iopamiron

3. Isovue

4. Iopamiro

5. Niopam

6. Solutrast

7. Iomapidol

8. Gastromiro

9. Iopamidolum

10. B-15000

11. Sq-13396

12. Sq 13,396

13. 62883-00-5

14. (s)-n,n'-bis(2-hydroxy-1-(hydroxymethyl)ethyl)-2,4,6-triiodo-5-lactamidoisophthalamide

15. L-(+)-n,n'-bis(2-hydroxy-1-hydroxymethylethyl)-2,4,6-triiodo-5-lactamide Isophthalamide

16. L-5alpha-hydroxypropionylamino-2,4,6-triiodoisophthalic Acid Di(1,3-dihydroxy-2-propylamide)

17. Chebi:31711

18. Jr13w81h44

19. (s)-n1,n3-bis(1,3-dihydroxypropan-2-yl)-5-(2-hydroxypropanamido)-2,4,6-triiodoisophthalamide

20. Iopamidol 300

21. Solutrast 370

22. Ncgc00016892-01

23. Oypalomin

24. Isovue 370

25. Cas-60166-93-0

26. Dsstox_cid_3158

27. Dsstox_rid_76896

28. Dsstox_gsid_23158

29. 1,3-benzenedicarboxamide, N,n'-bis(2-hydroxy-1-(hydroxymethyl)ethyl)-5-((2-hydroxy-1-oxopropyl)amino)-2,4,6-triiodo-, (s)-

30. 1-n,3-n-bis(1,3-dihydroxypropan-2-yl)-5-[[(2s)-2-hydroxypropanoyl]amino]-2,4,6-triiodobenzene-1,3-dicarboxamide

31. Iopamiron 300

32. Iopamiron 370

33. Jopamiron 200

34. Iopamiro 370

35. Isovue-370

36. Niopam 300

37. Iopamidolum [inn-latin]

38. N,n'-bis(1,3-dihydroxypropan-2-yl)-5-{[(2s)-2-hydroxypropanoyl]amino}-2,4,6-triiodobenzene-1,3-dicarboxamide

39. Iopamidol-200

40. Iopamidol-250

41. Iopamidol-300

42. Iopamidol-370

43. Scanlux-300

44. Scanlux-370

45. Isovue-128

46. Isovue-200

47. Isovue-250

48. Isovue-300

49. Isovue-m 200

50. Isovue-m 300

51. Einecs 262-093-6

52. B 15000

53. Brn 6250226

54. Iopamyron

55. Sq 13396

56. Unii-jr13w81h44

57. Hsdb 8075

58. Iopamiron (tn)

59. Iopamidol-200 In Plastic Container

60. Iopamidol-250 In Plastic Container

61. Iopamidol-300 In Plastic Container

62. Iopamidol-370 In Plastic Container

63. Isovue (tn)

64. Iopamidol [usan:usp:inn:ban:jan]

65. Iopamidol [inn]

66. Iopamidol [jan]

67. Iopamidol [mi]

68. Iopamidol [usan]

69. Prestwick0_000871

70. Prestwick1_000871

71. Prestwick2_000871

72. Prestwick3_000871

73. Iopamidol [vandf]

74. Iopamidol (jp17/usp)

75. Iopamidol [mart.]

76. Iopamidol [who-dd]

77. L-5alpha-idrossipropionilamino-2,4,6-triiodoisoftal-di(1,3-diidrossi-2-propilamide)

78. Schembl27781

79. Bspbio_000941

80. Spbio_002862

81. Bpbio1_001037

82. Iopamidol [ep Impurity]

83. Iopamidol [orange Book]

84. Chembl1200932

85. Dtxsid1023158

86. Iopamidol [ep Monograph]

87. Iopamidol [usp Monograph]

88. Hms1570p03

89. Hms2097p03

90. Hms3714p03

91. Pharmakon1600-01502304

92. Act03261

93. Hy-b0684

94. Zinc3830947

95. Tox21_110668

96. Nsc759636

97. S4532

98. Akos015891034

99. Tox21_110668_1

100. Ccg-213024

101. Db08947

102. Ks-1421

103. Ncgc00016892-02

104. Ncgc00016892-04

105. (s)-n,n Inverted Exclamation Marka-bis[2-hydroxy-1-(hydroxymethyl)ethyl]-2,4,6-triiodo-5-lactamidoisophthalamide

106. (s)-n,n'-bis(2-hydroxy-1-(hydroxymethyl)ethyl)-5-((2-hydroxy-1-oxopropyl)amino)-2,4,6-triiodoisophthaldiamide

107. 1,3-benzenedicarboxamide, N,n'-bis(2-hydroxy-1-(hydroxymethyl)ethyl)-5-(((2s)-2-hydroxy-1-oxopropyl)amino)-2,4,6-triiodo-

108. N1,n3-bis(1,3-dihydroxypropan-2-yl)-5-(2-hydroxypropanoylamino)-2,4,6-triiodo-benzene-1,3-dicarboxamide

109. Ab00513941

110. D01797

111. H11976

112. Hydroxypropanamido)-2,4,6-triiodoisophthalamide

113. Ab00513941_02

114. 166i930

115. A834067

116. Q424788

117. Q-201245

118. (s)-n1,n3-bis(1,3-dihydroxypropan-2-yl)-5-(2-

119. Brd-k75868704-001-01-2

120. (s)-n,n'-bis[2-hydroxy-1-(hydroxymethyl)ethyl]-5-[(2-hydroxy-1-oxopropyl)amino]-2,4,6-triiodo-1,3-benzenedicarboxamide

121. N,n'-bis[2-hydroxy-1-(hydroxymethyl)ethyl]-5-[[(2s)-2-hydroxy-1-oxopropyl]amino]-2,4,6-triiodo-1,3-benzenedicarboxamide

122. N,n'-bis[2-hydroxy-1-(hydroxymethyl)ethyl]-5-{[(2s)-2-hydroxypropanoyl]amino}-2,4,6-triiodobenzene-1,3-dicarboxamide

123. N1,n3-bis(1,3-dihydroxypropan-2-yl)-5-[(2s)-2-hydroxypropanamido]-2,4,6-triiodobenzene-1,3-dicarboxamide

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₇H₂₂I₃N₃O₈
Molecular Weight	777.1 g/mol
XLogP3	-2.4
Hydrogen Bond Donor Count	8
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	10
Exact Mass	776.8541 g/mol
Monoisotopic Mass	776.8541 g/mol
Topological Polar Surface Area	188 Å²
Heavy Atom Count	31
Formal Charge	0
Complexity	583
Isotope Atom Count	0
Defined Atom Stereocenter Count	1
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 22
Drug Name	Iopamidol-250
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	51%
Market Status	Prescription
Company	Fresenius Kabi Usa

2 of 22
Drug Name	Iopamidol-300
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	61%
Market Status	Prescription
Company	Fresenius Kabi Usa

3 of 22
Drug Name	Iopamidol-370
Drug Label	ISOVUE (Iopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intravascular administration. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a sui...
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	76%
Market Status	Prescription
Company	Fresenius Kabi Usa

4 of 22
Drug Name	Isovue-200
Drug Label	ISOVUE (Iopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intravascular administration. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a sui...
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	41%
Market Status	Prescription
Company	Bracco

5 of 22
Drug Name	Isovue-250
Drug Label	Diagnostic NONIONIC RADIOPAQUE CONTRAST MEDIAFor Intrathecal Administration in NeuroradiologyIncluding Myelography (Lumbar, Thoracic, Cervical, Total Columnar) Pediatric Myelography (Lumbar, Thoracic), and for Contrast Enhancement of Computed Tomogra...
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	51%
Market Status	Prescription
Company	Bracco

6 of 22
Drug Name	Isovue-300
Drug Label	ISOVUE (Iopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intravascular administration. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a sui...
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	61%
Market Status	Prescription
Company	Bracco

7 of 22
Drug Name	Isovue-370
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	76%
Market Status	Prescription
Company	Bracco

8 of 22
Drug Name	Isovue-m 200
Drug Label	ISOVUE (lopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intravascular administration.Each mL of ISOVUE-200 (lopamidol Injection 41%) provides 408 mg iopamidol with 1 mg tromethamine and 0.26 mg edetate c...
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	41%
Market Status	Prescription
Company	Bracco

9 of 22
Drug Name	Isovue-m 300
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	61%
Market Status	Prescription
Company	Bracco

10 of 22
Drug Name	Scanlux-300
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	61%
Market Status	Prescription
Company	Sanochemia Corp Usa

11 of 22
Drug Name	Scanlux-370
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	76%
Market Status	Prescription
Company	Sanochemia Corp Usa

12 of 22
Drug Name	Iopamidol-250
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	51%
Market Status	Prescription
Company	Fresenius Kabi Usa

13 of 22
Drug Name	Iopamidol-300
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	61%
Market Status	Prescription
Company	Fresenius Kabi Usa

14 of 22
Drug Name	Iopamidol-370
Drug Label	ISOVUE (Iopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intravascular administration. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a sui...
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	76%
Market Status	Prescription
Company	Fresenius Kabi Usa

15 of 22
Drug Name	Isovue-200
Drug Label	ISOVUE (Iopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intravascular administration. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a sui...
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	41%
Market Status	Prescription
Company	Bracco

16 of 22
Drug Name	Isovue-250
Drug Label	Diagnostic NONIONIC RADIOPAQUE CONTRAST MEDIAFor Intrathecal Administration in NeuroradiologyIncluding Myelography (Lumbar, Thoracic, Cervical, Total Columnar) Pediatric Myelography (Lumbar, Thoracic), and for Contrast Enhancement of Computed Tomogra...
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	51%
Market Status	Prescription
Company	Bracco

17 of 22
Drug Name	Isovue-300
Drug Label	ISOVUE (Iopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intravascular administration. Each bottle is to be used as a Pharmacy Bulk Package for dispensing multiple single dose preparations utilizing a sui...
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	61%
Market Status	Prescription
Company	Bracco

18 of 22
Drug Name	Isovue-370
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	76%
Market Status	Prescription
Company	Bracco

19 of 22
Drug Name	Isovue-m 200
Drug Label	ISOVUE (lopamidol Injection) formulations are stable, aqueous, sterile, and nonpyrogenic solutions for intravascular administration.Each mL of ISOVUE-200 (lopamidol Injection 41%) provides 408 mg iopamidol with 1 mg tromethamine and 0.26 mg edetate c...
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	41%
Market Status	Prescription
Company	Bracco

20 of 22
Drug Name	Isovue-m 300
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	61%
Market Status	Prescription
Company	Bracco

21 of 22
Drug Name	Scanlux-300
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	61%
Market Status	Prescription
Company	Sanochemia Corp Usa

22 of 22
Drug Name	Scanlux-370
Active Ingredient	Iopamidol
Dosage Form	Injectable
Route	Injection
Strength	76%
Market Status	Prescription
Company	Sanochemia Corp Usa

4.2 Therapeutic Uses

/EXPERIMENTAL THER:/ Meconium obstruction of prematurity (MO) often occurs in extremely low-birth weight (ELBW) infants, and its treatment is quite a challenge for neonatologists. /Investigators/ attempted to establish a method of primary treatment for MO of prematurity in ELBW infants. An iopamidol enema with 50 cm H2O static pressure was performed as the primary treatment. This procedure is safe and effective and /was recommended/ as the first treatment for MO in ELBW infants. The procedure was performed 50 times in 23 infants and no complications occurred. Out of 23 patients, 20 (88%) improved, but the other 3 did not. In the failure group, the procedure was performed on a significantly later date and the mortality rate was higher (12.5 vs. 67%). This procedure is safe and effective. /The authors/ recommend this as the first treatment for MO in ELBW infants.

PMID:19184049 Nakaoka T et al; Pediatr Surg Int 25 (3): 273-6 (2009)

/EXPERIMENTAL THER:/ ... Ninety mice used in this study were divided into three groups: lipiodol, iopamidol, and normal saline. The test compounds were given by submucosal injection to the gastric wall of anesthetized mice. The specimens were subjected to histopathological examination. The mean grades of acute inflammatory response after iopamidol and lipiodol injection were significantly higher than control group. However, there was no significant difference between iopamidol and lipiodol injection. The mean grade of chronic inflammatory response and fibrosis showed no differences between groups. The presence or absence of fibrinoid necrosis and mesothelial hyperplasia showed no statistical differences at each time point between groups. The foam cell, which is similar to human signet ring cell carcinoma, were not identified in normal saline and iopamidol group, but were detected by postoperative day 7 in lipiodol group. /It was concluded/ that iopamidol and lipiodol when used as a contrast media of CT lymphography is an available material for preoperative sentinel node navigation surgery for gastric cancer with an acceptable incidence of pathological alterations in a mouse model. /The/ results are potentially useful to clinical (human) application.

PMID:22347708 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278638 Hwang SH et al; J Korean Surg Soc 82 (2): 70-8 (2012)

Hematomas and intraparenchymal bleeders seldom demonstrate any contrast enhancement. However, in cases of intraparenchymal clot, for which there is no obvious clinical explanation, contrast media administration may be helpful in ruling out the possibility of associated arteriovenous malformation. /Included in US product label/

US Natl Inst Health; DailyMed. Current Medication Information for ISOVUE (iopamidol) injection, solution (January 2012). Available from, as of June 5, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=416ab996-a2e8-4fe1-a9c9-f10b86df3bb5

Arteriovenous malformations and aneurysms will show contrast enhancement. For these vascular lesions, the enhancement is probably dependent on the iodine content of the circulating blood pool. /Included in US product label/

For more Therapeutic Uses (Complete) data for Iopamidol (9 total), please visit the HSDB record page.

4.3 Drug Warning

Focal and generalized motor seizures have been reported after intrathecal use of water-soluble contrast agents including iopamidol. In several of those cases reported with iopamidol, higher than recommended doses were employed. Therefore avoid: deviations from recommended neuroradiologic procedure or patient management; use in patients with a history of epilepsy unless medically justified; overdosage; intracranial entry of a bolus or premature diffusion of a high concentration of the medium; failure to maintain elevation of the head during the procedure, on the stretcher, and in bed; excessive and particularly active patient movement or straining.[US Natl Inst Health; DailyMed. Current Medication Information for ISOVUE-M (iopamidol) injection, solution

Bracco Diagnostics Inc] (January 2012). Available from, as of June 5, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=11e893d2-0183-4581-b908-c8b7302c7edb

FDA Pregnancy risk category B: NO EVIDENCE OF RISK IN HUMANS. Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absents of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility.

Use of medications that may lower the seizure threshold (phenothiazine derivatives, including those used for their antihistaminic properties; tricyclic antidepressants; MAO inhibitors; CNS stimulants; analeptics; antipsychotic agents) should be carefully evaluated. While the contributory role of such medications has not been established, some physicians have discontinued these agents at least 48 hours before and for at least 24 hours following intrathecal use.[US Natl Inst Health; DailyMed. Current Medication Information for ISOVUE-M (iopamidol) injection, solution

Bracco Diagnostics Inc] (January 2012). Available from, as of June 5, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=11e893d2-0183-4581-b908-c8b7302c7edb

Direct intracisternal or ventricular administration for standard radiography (without computerized tomographic enhancement) is not recommended. Inadvertent intracranial entry of a large or concentrated bolus of the contrast medium, which increases the risk of neurotoxicity, can be prevented by careful patient management. Also, effort should be directed to avoid rapid dispersion of the medium causing inadvertent rise to intracranial levels (e.g., by active patient movement). If such intracranial entry of the medium occurs, prophylactic anticonvulsant treatment with diazepam or barbiturates orally for 24 to 48 hours should be considered.[US Natl Inst Health; DailyMed. Current Medication Information for ISOVUE-M (iopamidol) injection, solution

Bracco Diagnostics Inc] (January 2012). Available from, as of June 5, 2012: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=11e893d2-0183-4581-b908-c8b7302c7edb

For more Drug Warnings (Complete) data for Iopamidol (37 total), please visit the HSDB record page.

4.4 Drug Indication

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

IOPAMIDOL

5.2.2 FDA UNII

JR13W81H44

5.2.3 Pharmacological Classes

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

5.3 ATC Code

V - Various

V08 - Contrast media

V08A - X-ray contrast media, iodinated

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

V08AB04 - Iopamidol

5.4 Absorption, Distribution and Excretion

Radiographic contrast media (CM) induce renal vasoconstriction and may initiate induced nephropathy. Endothelin (ET), a vasoconstrictor, and nitric oxide (NO), a vasodilator, which are synthesized in the kidney by the vascular endothelium as well as by tubular epithelial and glomerular mesangial cells, are key modulators of renal circulation after CM administration. Intravascular CM, in addition, induces pronounced diuresis and natriuresis. The aim of the present study was to evaluate and compare changes in endogenous vasoactive mediators and contrast-induced natriuresis after CM administration. Diagnostic angiographic procedures were performed in 14 patients (9 males and 5 females) using the non-ionic CM Iopamidol. Before and immediately after angiography, venous blood and urine samples were obtained. The urinary excretion of ET-1 and nitrates/nitrites (NOx), and the fractional excretion of sodium (FENa) were measured and analyzed. The urinary excretion of both ET-1 and NOx increased significantly (p < 0.05) after angiography, and urinary ET-1 and NOx excretion was correlated with an increase in FENa (p < 0.05). Exposure to CM in humans is associated with an increase in urinary ET and NOx. The excretion of sodium following CM administration is associated with an increase in urinary ET and NOx. ET and NO might be important in the renal change in humans after CM administration.

PMID:16015005 Murakami R et al; Nephron Clin Pract 101 (3): c150-4 (2005)

No iodinated compound other than Iopamidol was found in the urine of subjects who received intrathecal injection of 10 mL of Iopamiro "300". The compound was neither metabolized nor altered in its optical configuration and urinary iodide content was always in the normal range. Between 72 and 85% of injected Iopamidol was excreted within 72 h of injection.

PMID:6687926 Pitre D et al; Neuroradiology 25 (1): 37-8 (1983)

It is not known whether this drug is excreted in human milk.

The pharmacokinetics of iopamidol in both normal and abnormal tissue have been shown to be variable. Contrast enhancement appears to be greatest soon after administration of the contrast medium, and following intraarterial rather than intravenous administration. ...

For more Absorption, Distribution and Excretion (Complete) data for Iopamidol (8 total), please visit the HSDB record page.

5.5 Metabolism/Metabolites

No significant metabolism, deiodination, or biotransformation occurs.

5.6 Biological Half-Life

The pharmacokinetics of iopamidol 370 (Iopamiro), a non-ionic water soluble organic iodine compound, were studied in adults with different degrees of chronic renal failure and in healthy volunteers. After 50 mL were administered i.v., plasma and urine levels were determined. The main pharmacokinetic parameters were calculated on the basis of bi-compartmental open model. There were significant differences from healthy volunteers in half-life beta, which increased with the degree of renal failure as the clearance values decreased. Half-life beta was equal to 1.67 h in healthy volunteers, 4.24 h in patients with mild renal failure and 10.03 h in patients with severe renal failure. The clearance decreased as follows: 0.11 (L/h kg) in healthy volunteers, 0.06 (L/h kg) in patients with mild renal failure and 0.02 (L/h kg) in patients with severe renal failure. No significant differences were found in distribution volume values nor in half-life alpha.

PMID:2222559 Corradi A et al; Arzneimittelforschung 40 (7): 830-2 (1990)

The pharmacokinetics of intravenously administered iopamidol in normal subjects conform to an open two-compartment model with first order elimination (a rapid alpha phase for drug distribution and a slow beta phase for drug elimination). The elimination serum or plasma half-life is approximately two hours; the half-life is not dose dependent.

5.7 Mechanism of Action

To test the hypothesis that iodinated contrast media may induce an elevation in serum potassium level, /contrast media was administered to rabbits and tested in-vitro according to four protocols./ Protocol A: After intravenous infusion of contrast media into six rabbits, alterations of potassium ion concentrations were measured. Protocol B: Fresh rabbit blood was mixed in vitro with contrast media, and the fluctuations in potassium were monitored over a 30-minute period. Protocol C: Similar to protocol B, except that blood from humans with no reaction to contrast media was used. For protocol A, blood potassium levels increased above baseline levels. The elevations were statistically significant (P < .05). For protocol B, diatrizoate and ioxaglate caused a gradual increase in blood potassium levels, but iopamidol did not. In protocol C, all three contrast media caused statistically significant elevation in potassium levels. The release of potassium was statistically significant at 5 minutes (P < .05 for diatrizoate and ioxaglate, and P < .01 for iopamidol). The mean release rates (+/- standard deviation) by means of linear regression analysis were 0.0190 mmol/min +/- 0.0112 with diatrizoate, 0.0159 mmol/min +/- 0.0057 with iopamidol, and 0.0088 mmol/min +/- 0.0033 with ioxaglate. Iodinated contrast media increase blood potassium levels causing release of potassium into intravascular spaces. This potassium release may play some role in contrast medium-induced adverse reactions.

PMID:8685334 Hayakawa K, Shimizu Y; Radiology 200 (2): 407-11 (1996)

The synthesis of prostaglandins and other metabolic products of arachidonic acid (AA) was investigated in isolated perfused lungs of hamsters during the infusion of various concentrations of meglumine diatrizoate and iopamidol. Forty nmol of (14)C-AA was infused into the pulmonary circulation with radiographic contrast media (RCM), and prostaglandins, thromboxanes, and metabolites of lipoxygenases were analyzed from the nonrecirculating perfusion effluent. Arachidonate infusion increased the perfusion pressure. This pressor response was decreased by iopamidol ... The amount of radioactivity was decreased in the perfusion effluent and increased in lung lipids by iopamidol. ... Almost all arachidonate metabolites were decreased significantly by iopamidol when compared with hypertonic saline ...

PMID:6413449 Paajanen H et al; Invest Radiol 18 (4): 375-81 (1983)

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","customerCountry":"INDIA","quantity":"1350.00","actualQuantity":"1350","unit":"KGS","unitRateFc":"130","totalValueFC":"180420.9","currency":"USD","unitRateINR":"10907.1","date":"15-Nov-2022","totalValueINR":"14724631","totalValueInUsd":"180420.9","indian_port":"JNPT","hs_no":"29242990","bill_no":"3306783","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO 10 CHARTERED SQAURE,2ND FL OOR SIRASPETH PADOLE CORNER"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1673289000,"product":"IOPAMIDOL","address":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta","city":"MEDAK","supplier":"JIANGXI BROTHER PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"9.00","actualQuantity":"9","unit":"KGS","unitRateFc":"120","totalValueFC":"1105.6","currency":"USD","unitRateINR":"10044","date":"10-Jan-2023","totalValueINR":"90396","totalValueInUsd":"1105.6","indian_port":"HYDERABAD AIR","hs_no":"29242990","bill_no":"4119647","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1673289000,"product":"IOPAMIDOL","address":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta","city":"MEDAK","supplier":"JIANGXI BROTHER PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"289.00","actualQuantity":"289","unit":"KGS","unitRateFc":"120","totalValueFC":"35503.1","currency":"USD","unitRateINR":"10044","date":"10-Jan-2023","totalValueINR":"2902716","totalValueInUsd":"35503.1","indian_port":"HYDERABAD AIR","hs_no":"29242990","bill_no":"4119647","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1673289000,"product":"IOPAMIDOL","address":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta","city":"MEDAK","supplier":"JIANGXI BROTHER PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"JODAS EXPOIM PVT. LTD","customerCountry":"INDIA","quantity":"396.00","actualQuantity":"396","unit":"KGS","unitRateFc":"120","totalValueFC":"48647.9","currency":"USD","unitRateINR":"10044","date":"10-Jan-2023","totalValueINR":"3977424","totalValueInUsd":"48647.9","indian_port":"HYDERABAD AIR","hs_no":"29242990","bill_no":"4119647","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"Plot No 55 and 45 TSIIC BIOTECH Phase-III Karakapatla Conta"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1689877800,"product":"IOPAMIDOL (QTY:2 X 200 MG, VALUE: USD 265\/EACH) (FOC)","address":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,","city":"TURKAPALLY-V SHAMIRPET HYDERABAD,TE","supplier":"USP","supplierCountry":"INDIA","foreign_port":"NA","customer":"UNITED STATES PHARMACOPEIA - INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.0004","unit":"KGS","unitRateFc":"1325000","totalValueFC":"545.4","currency":"USD","unitRateINR":"112068549.6","date":"21-Jul-2023","totalValueINR":"44827.062","totalValueInUsd":"545.4","indian_port":"HYDERABAD AIR","hs_no":"29242990","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"P.NO. D6 & D8, SY.NO. 234\/2,234\/3, ,235\/2 & 542\/2, IKP KNOWLEDGE PARK,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692729000,"product":"IOPAMIDOL USP LIST-4, ITEM NO.- 54","address":"PLOT NO 10 CHARTERED SQAURE,2ND FL ,OOR SIRASPETH PADOLE CORNER ,,","city":"NAGPUR","supplier":"ZHEJIANG STARRY PHARMACEUTICAL CO LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"GENETEK LIFESCIENCES PRIVATE ","customerCountry":"INDIA","quantity":"3000.00","actualQuantity":"3000","unit":"KGS","unitRateFc":"125","totalValueFC":"380191.2","currency":"USD","unitRateINR":"10392.9","date":"23-Aug-2023","totalValueINR":"31493641.16","totalValueInUsd":"380191.2","indian_port":"JNPT\/ NHAVA SHEVA SEA","hs_no":"29242990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO 10 CHARTERED SQAURE,2ND FL ,OOR SIRASPETH PADOLE CORNER ,,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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INTERMEDIATES SUPPLIERS

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FDF Dossiers

01

AbbVie Inc

U.S.A

Antibody Engineering

Not Confirmed

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U.S.A

Virtual Booth

Digital Content

Regulatory Info : DISCN

Registration Country : USA

IOPAMIDOL

Brand Name : IOPAMIDOL-300

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 61%

Packaging :

Approval Date : 1997-04-30

Application Number : 74638

Regulatory Info : DISCN

Registration Country : USA

Product Web Link

Corporate PDF

02

AXIM

South Africa

Antibody Engineering

Not Confirmed

03

Bioindustria L.I.M. Spa

Italy

China

Austria

Antibody Engineering

Not Confirmed

Only 10 entries up to this point, click to access all

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FDA Orange Book

01

ABBVIE

U.S.A

Antibody Engineering

Not Confirmed

Contact Supplier

U.S.A

Virtual Booth

Digital Content

RLD : No

TE Code :

IOPAMIDOL

Brand Name : IOPAMIDOL-300

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 61%

Approval Date : 1997-04-30

Application Number : 74638

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Product Web Link

Corporate PDF

02

BAXTER HLTHCARE

U.S.A

U.S.A

U.S.A

Antibody Engineering

Not Confirmed

GALENICA SENESE Srl

Morocco

Antibody Engineering

Not Confirmed

Italy

Antibody Engineering

South Africa

Antibody Engineering

Not Confirmed

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Listed Dossiers

01

BIEM ILAC SANAYI VE TICARET A.S

Turkey

India

Antibody Engineering

Not Confirmed

08

Jodas Expoim Pvt. Ltd

India

Antibody Engineering

Not Confirmed

09

Jodas Expoim Pvt. Ltd

India

Antibody Engineering

Not Confirmed

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - 41%

USFDA APPLICATION NUMBER - 18735

DOSAGE - INJECTABLE;INJECTION - 51%

USFDA APPLICATION NUMBER - 18735

DOSAGE - INJECTABLE;INJECTION - 61%

USFDA APPLICATION NUMBER - 18735

DOSAGE - INJECTABLE;INJECTION - 76%

USFDA APPLICATION NUMBER - 18735

DOSAGE - INJECTABLE;INJECTION - 51%

USFDA APPLICATION NUMBER - 20327

DOSAGE - INJECTABLE;INJECTION - 61%

USFDA APPLICATION NUMBER - 20327

DOSAGE - INJECTABLE;INJECTION - 76%

USFDA APPLICATION NUMBER - 20327

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Parenteral

Topical

Global Sales Information

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Finished Drug Prices

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Market Place

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APIs

Injectable Grade Iopamidol API needed in Vietnam [ENA20149]

A company that focuses on manufacturing and distribution of pharmaceutical products, medicinal herbs and medical equipment is looking for suppliers of Injectable Grade Iopamidol API for commercial purposes. The required quantity is 100 kg, 200 kg & 500 kg. The suppliers must support this enquiry with DMF, GMP & CoA.

31 Jul 2024

Iopamidol (100 kg) API needed in Pakistan [ENA19187]

A pharmaceutical company that specializes in the formulation of parenteral is looking for suppliers of Iopamidol (100 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.

13 Mar 2024

Iopamidol (MOQ) API needed in India [ENA18026]

A company that focuses on research, development & manufacturing of medical devices is looking for suppliers of Iopamidol (MOQ) API for development purposes. The suppliers must support this enquiry with CoA.

13 Sep 2023

Iopamidol API needed in Tanzania [ENA17936]

A company that focuses on the commercialization of medical products and services is looking for suppliers of Iopamidol API for commercial purposes. The suppliers must support this enquiry with CoA.

01 Sep 2023

Iopamidol API needed in South Africa [ENA15309]

A company that deals in the export, import and distribution of various pharmaceutical products is looking for suppliers of Iopamidol API for commercial purpose. The suppliers must support this enquiry with USDMF.

14 Oct 2022

Various APIs needed in Vietnam [ENA13356]

A leading biopharmaceutical company that specializes in research, develop, manufacture and market a wide range of therapeutic injection products is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with GMP & CoA. 1. Injectable Grade Iopamidol (2 MT) API 2. Injectable Grade Netilmicin Sulfate (5 kg) API 3. Injectable Grade Linezolid (5 kg) API 4. Injectable Grade Meglumine Sodium Succinate (100 kg) API 5. Injectable Grade Midazolam (1 kg) API

19 Apr 2022

Iopamidol (100 kg) API needed in India [ENA12806]

A company that deals in import & export of various pharmaceutical products is looking for suppliers of Iopamidol (100 kg) API for commercial purpose. The suppliers must support this enquiry with CoA.

24 Feb 2022

Various APIs needed in Egypt [ENA11369]

A company that deals in the distribution of pharmaceuticals, medical devices and cosmetics is looking for suppliers of Various APIs for pilot batch & commercial purpose. The required quantity is 10 kg for each. The suppliers must support this enquiry with GMP. 1. Troxerutin API 2. Iopamidol API 3. Iopromide API 4. Nafcillin API

11 Sep 2021

Various APIs needed in Iran [ENA08450]

A pharmaceutical company based in Iran that deals in gastric products, contrast media & antifungal preparations is looking for suppliers of Various APIs. The suppliers must support this enquiry with GMP & DMF. 1. Iopamidol API 2. Iopromide API 3. Indocyanine Green API 4. Desmopressin Acetate API 5. Voriconazole API

04 Sep 2020

Pentaacetyl lopamidol API (50 kg) needed in Pakistan [ENA03908]

A major player in the healthcare and agriculture sectors in Pakistan is looking for Pentaacetyl lopamidol API (50 kg). Interested suppliers must provide COA & safety data sheets.

12 Apr 2019

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FDF DOSSIERS

Iopamidol (61% & 76%) Injections needed in India [ENA10763]

A company that works collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions is looking for suppliers of Iopamidol (61% & 76%) Injections for laboratory testing purposes. The required quantity is 500 ml of each.

01 Jul 2021

Tender// Various Finished Dosage Formulations needed in Bulgaria [ENA09837]

01 Mar 2021

Tender// Various Finished Dosage Formulations needed in Bulgaria [ENA09797]

23 Feb 2021

Various Finished Dosage Formulations needed in Sudan [ENA08609]

A pharmaceutical company that aims to deliver and offering availability of the highest pharmaceutical products, biological, biosimilars and medical devices is looking for suppliers of Various Finished Dosage Formulations for a tender. The suppliers must support this enquiry with GMP. 1. Iopamidol (300 mg/ml, 50 ml) Vials 2. Monoclonal anti Rho-D immunoglobulin (300 mg/ 2 ml) Prefilled Injections 3. Iron (iii) Hydroxide (50 mg/ 5 ml, 150 ml) Syrups 4. Dydrogesterone (10 mg) Tablets

22 Sep 2020

Various finished formulations needed in Turkey [ENA06069]

Tebin Group, a trading company is looking for suppliers of various finished formulations as mentioned below. The supplier must support this enquiry with CoA. Interested suppliers can contact them via Email: kamil@tebingroup.com. 1. Optiray 350 mg/ml (100 ml)- Qty: 2000 2. Scanlux 370 mg/ml (100 ml)- Qty: 1000 3. Omnipaque 350 mg/ml (100 ml)- Qty: 2000

14 Dec 2019

Iopamidol (100 ml) injections needed in Tanzania [ENA05141]

Indepth Scientific Company, one of the leading distributor company in Tanzania is looking for suppliers of Iopamidol (100 ml) injections per 100 ml bottle. The supplier must support this enquiry with FDA. The required yearly quantity is about 1000 bottles. Interested suppliers can contact then via Email: amnayram@gmail.com.

12 Sep 2019

Enquiry// Iohexol, Iopromide, Iopamidol, Iodixanol Injections needed in Yemen [ENA01054]

Al Jazerah, a company representing pharmaceutical manufacturers to be their exclusive agent in the Republic of Yemen is looking for suppliers of following finished formulations: 1. Iohexol Injections 2. Iopromide Injections 3. Iopamidol Injections 4. Iodixanol Injections Interested suppliers must contact Nasser Email: nassrmbrk@gmail.com or Tel: +967 771720200.

04 Jul 2018

Enquiry//Iopamidol-370 required in Rwanda [ENA00008]

The monthly requirements is about 300 bottles of 100ml (annual need is about 3500 bottles) at the CHUK/National Reference Hospital in Kigali, Rwanda. Interested suppliers should contact Mr EZECHIEL Niyotwizera Medical Imaging Technologist (MIT) CHUK +250788487228 National Commissioner / AMIR

08 Apr 2016

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REF. STANDARDS & IMPURITIES

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

26 API Suppliers

11 USDMF

8 CEP/COS

6 JDMF

1 EU WC

13 KDMF

3 NDC API

12 Listed Suppliers

$ API Reference Price

INTERMEDIATES

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

136 FDF Dossiers

45 FDA Orange Book

70 Europe

5 Canada

7 South Africa

9 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 41%

INJECTABLE;INJECTION - 51%

INJECTABLE;INJECTION - 61%

INJECTABLE;INJECTION - 76%

INJECTABLE;INJECTION - 51%

INJECTABLE;INJECTION - 61%

INJECTABLE;INJECTION - 76%

RELATED EXCIPIENT COMPANIES

1 Pfanstiehl

1 BioSpectra

EXCIPIENTS BY APPLICATIONS

2 Parenteral

1 Topical

GLOBAL SALES INFORMATION

66 Finished Drug Prices

MARKET PLACE

11 APIs

8 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM

4 USP

4 Others

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 127

MARKET PLACE

FINISHED DOSAGE FORMULATIONS

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

GLOBAL SALES INFORMATION

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CEP 2022-502 - Rev 00