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1. Compound 545
2. Exypaque
3. Iohexol 350
4. Nycodenz
5. Omnipaque
1. 66108-95-0
2. Omnipaque
3. Nycodenz
4. Exypaque
5. Iohexolum
6. Omnipaque 240
7. Omnipaque 70
8. Omnipaque 140
9. Omnipaque 180
10. Omnipaque 210
11. Omnipaque 300
12. Omnipaque 350
13. Win 39424
14. Oraltag
15. Win-39424
16. Chebi:31709
17. N,n'-bis(2,3-dihydroxypropyl)-5-(n-(2,3-dihydroxypropyl)acetamido)-2,4,6-triiodoisophthalamide
18. 5-[acetyl(2,3-dihydroxypropyl)amino]-1-n,3-n-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide
19. 5-[acetyl(2,3-dihydroxypropyl)amino]-n,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamide
20. N1,n3-bis(2,3-dihydroxypropyl)-5-(n-(2,3-dihydroxypropyl)acetamido)-2,4,6-triiodoisophthalamide
21. 4419t9mx03
22. Nsc-759636
23. Ncgc00166000-01
24. Dsstox_cid_3157
25. 5-(n-2,3-dihydroxypropylacetamido)-2,4,6-triiodo-n,n'-bis(2,3-dihydroxypropyl)isophthalamide
26. Dsstox_rid_76895
27. Dsstox_gsid_23157
28. 1,3-benzenedicarboxamide, 5-(acetyl(2,3-dihydroxypropyl)amino)-n,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-
29. Histodenz
30. Iohexolum [inn-latin]
31. 1,3-benzenedicarboxamide, 5-[acetyl(2,3-dihydroxypropyl)amino]-n1,n3-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-
32. 5-[acetyl(2,3-dihydroxypropyl)amino]-n,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide
33. 5-[n-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodo-n,n'-bis(2,3-dihydroxypropyl)isophthalamide
34. Smr000857075
35. Einecs 266-164-2
36. Brn 2406632
37. Unii-4419t9mx03
38. Omnipaque (tn)
39. 1,3-benzenedicarboxamide, 5-[acetyl(2,3-dihydroxypropyl)amino]-n,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-
40. N,n'-bis(2,3-dihydroxypropyl)-5-[n-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodoisophthalamide
41. Prestwick_802
42. Cas-66108-95-0
43. Iohexol [usan:usp:inn:ban:jan]
44. Iohexol [vandf]
45. Iohexol [usan]
46. Iohexol [inn]
47. Iohexol [jan]
48. Iohexol [mi]
49. Iohexol [mart.]
50. Prestwick0_000512
51. Prestwick1_000512
52. Prestwick2_000512
53. Prestwick3_000512
54. Iohexol [usp-rs]
55. Iohexol [who-dd]
56. Iohexol [who-ip]
57. Nycodenz;omnipaque;exypaque
58. Ec 266-164-2
59. Iohexol, Analytical Standard
60. Schembl26501
61. Bspbio_000463
62. Mls001332585
63. Mls001332586
64. Mls002153854
65. Iohexol (jp17/usp/inn)
66. Iohexol [ep Impurity]
67. Iohexol [orange Book]
68. Spbio_002384
69. Iohexol [ep Monograph]
70. Bpbio1_000511
71. Iohexol [usp Monograph]
72. Chembl1200455
73. Dtxsid6023157
74. Bcbcmap01_000051
75. Iohexolum [who-ip Latin]
76. Hms1569h05
77. Hms2096h05
78. Hms2235d07
79. Hms3369o04
80. Hms3713h05
81. Albb-028959
82. Amy21804
83. Bcp31800
84. Hy-b0594
85. Tox21_112286
86. Bdbm50247977
87. Iohexol (mixture Of Isomers)
88. Mfcd00077732
89. S4531
90. Akos015895399
91. Tox21_112286_1
92. Ac-1934
93. Ccg-220512
94. Db01362
95. Nsc 759636
96. Smp1_000152
97. Ncgc00166000-02
98. Ncgc00166000-04
99. As-12699
100. Ft-0627276
101. I0903
102. D01817
103. D91214
104. Histodenz(tm), Nonionic Density Gradient Medium
105. 108i950
106. A835339
107. Q410683
108. Sr-01000838892
109. Sr-01000838892-2
110. Iohexol, European Pharmacopoeia (ep) Reference Standard
111. Iohexol, United States Pharmacopeia (usp) Reference Standard
112. 5-(n-dhp-acetamido)-2,4,6-triiodo-n,n'-b Is-dhp-isophthalami
113. Iohexol, Pharmaceutical Secondary Standard; Certified Reference Material
114. Iohexol For Peak Identification, European Pharmacopoeia (ep) Reference Standard
115. 1,3-benzenedicarboxamide, 5-(acetyl(2,3-dihydroxypropyl)amino)-n,n'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo
116. 1-n,3-n-bis(2,3-dihydroxypropyl)-5-[n-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodobenzene-1,3-dicarboxamide
117. 5-[acetyl(2,3-dihydroxypropyl)amino]-n1,n3-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide
118. N1,n3-bis(2,3-dihydroxypropyl)-5-[n-(2,3-dihydroxypropyl)acetamido]-2,4,6-triiodobenzene-1,3-dicarboxamide
119. N1,n3-bis[2,3-bis(oxidanyl)propyl]-5-[2,3-bis(oxidanyl)propyl-ethanoyl-amino]-2,4,6-tris(iodanyl)benzene-1,3-dicarboxamide
| Molecular Weight | 821.1 g/mol |
|---|---|
| Molecular Formula | C19H26I3N3O9 |
| XLogP3 | -3 |
| Hydrogen Bond Donor Count | 8 |
| Hydrogen Bond Acceptor Count | 9 |
| Rotatable Bond Count | 12 |
| Exact Mass | 820.8803 g/mol |
| Monoisotopic Mass | 820.8803 g/mol |
| Topological Polar Surface Area | 200 Ų |
| Heavy Atom Count | 34 |
| Formal Charge | 0 |
| Complexity | 653 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 3 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 4 | |
|---|---|
| Drug Name | Omnipaque 180 |
| PubMed Health | Iohexol (Injection) |
| Drug Classes | Radiological Non-Ionic Contrast Media |
| Active Ingredient | Iohexol |
| Dosage Form | Solution |
| Route | Injection, oral, rectal |
| Strength | 38.8% |
| Market Status | Prescription |
| Company | Ge Healthcare |
| 2 of 4 | |
|---|---|
| Drug Name | Omnipaque 240 |
| Active Ingredient | Iohexol |
| Dosage Form | Solution |
| Route | Injection, oral, rectal |
| Strength | 51.8% |
| Market Status | Prescription |
| Company | Ge Healthcare |
| 3 of 4 | |
|---|---|
| Drug Name | Omnipaque 180 |
| PubMed Health | Iohexol (Injection) |
| Drug Classes | Radiological Non-Ionic Contrast Media |
| Active Ingredient | Iohexol |
| Dosage Form | Solution |
| Route | Injection, oral, rectal |
| Strength | 38.8% |
| Market Status | Prescription |
| Company | Ge Healthcare |
| 4 of 4 | |
|---|---|
| Drug Name | Omnipaque 240 |
| Active Ingredient | Iohexol |
| Dosage Form | Solution |
| Route | Injection, oral, rectal |
| Strength | 51.8% |
| Market Status | Prescription |
| Company | Ge Healthcare |
Iohexol ia used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures.
Iohexol is an effective non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures. Its low systemic toxicity is the combined result of low chemotoxicity and low osmolality.
Contrast Media
Substances used to allow enhanced visualization of tissues. (See all compounds classified as Contrast Media.)
V08AB02
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
V08AB02 - Iohexol
Absorption
Small amounts are absorbed through the bladder via intravesical instillation. Following intrauterine instillation, the majority of the medium within the uterine cavity is discharged into the vagina immediately upon termination of procedure. However, any medium retained in the uterine or peritoneal cavity is absorbed systemically within 60 minutes. May not be absorbed for up to 24 hours if tubes are obstructed and dilated.
Route of Elimination
Iohexol is absorbed from cerebrospinal fluid (CSF) into the bloodstream and is eliminated by renal excretion. No significant metabolism, deiodination, or biotransformation occurs.
Volume of Distribution
350-849 mL/kg
Clearance
109 mL/min [Adult patients receiving 16-18 ml of iohexol (180 mgI/mL) by lumbar intrathecal injection]
Intrathecal half-life is 3.4 hours (mean). Intravascular is approximately 2 hours (with normal renal function).
Organic iodine compounds block x-rays as they pass through the body, thereby allowing body structures containing iodine to be delineated in contrast to those structures that do not contain iodine. The degree of opacity produced by these compounds is directly proportional to the total amount (concentration and volume) of the iodinated contrast agent in the path of the x-rays. After intrathecal administration into the subarachnoid space, diffusion of iohexol in the CSF allows the visualization of the subarachnoid spaces of the head and spinal canal. After intravascular administration, iohexol makes opaque those vessels in its path of flow, allowing visualization of the internal structures until significant hemodilution occurs.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42382
Submission : 2025-08-04
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-13
Pay. Date : 2021-09-14
DMF Number : 36038
Submission : 2021-09-15
Status : Active
Type : II
Certificate Number : R0-CEP 2021-313 - Rev 00
Issue Date : 2022-03-02
Type : Chemical
Substance Number : 1114
Status : Valid
Registrant Name : Encomac Co., Ltd.
Registration Date : 2022-07-15
Registration Number : 20210308-210-J-719(2)
Manufacturer Name : Zhejiang Starry Pharmaceutical Co., Ltd.
Manufacturer Address : No.1 Starry Road, Xianju Modern Industrial Centralization Zone, Xianju County, Zhejiang, China
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-03
Pay. Date : 2023-03-23
DMF Number : 38195
Submission : 2023-03-20
Status : Active
Type : II
Certificate Number : CEP 2022-240 - Rev 01
Issue Date : 2025-08-05
Type : Chemical
Substance Number : 1114
Status : Valid
NDC Package Code : 62331-066
Start Marketing Date : 2022-07-04
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmaline Co., Ltd.
Registration Date : 2022-05-17
Registration Number : 20220517-210-J-1297
Manufacturer Name : Divi's Laboratories Ltd.
Manufacturer Address : Unit-2, Chippada Village, Annavaram Post – 531 162, Bheemunipatnam Mandal, Visakhapatnam District, Andhra Pradesh, INDIA
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23148
Submission : 2009-10-02
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-044 - Rev 02
Issue Date : 2013-01-17
Type : Chemical
Substance Number : 1114
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26641
Submission : 2013-01-24
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-018 - Rev 02
Issue Date : 2014-09-02
Type : Chemical
Substance Number : 1114
Status : Valid
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Registration Number : 304MF10054
Registrant's Address : No. 1 Starry Road of Xianju Modern Industrial Centralization Zone, Xianju, Zhejiang, ...
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Latest Date of Registration : 2022-03-16
Registration Number : 227MF10106
Registrant's Address : Zhejiang Province Chemical and Medical Materials Base, Linhai Park
Initial Date of Registration : 2015-04-09
Latest Date of Registration : 2015-04-09
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Initial Date of Registration : 2024-12-04
Latest Date of Registration : 2024-12-04
Registration Number : 219MF10263
Registrant's Address : Zhejiang Province Chemical and Medical Materials Base, Linhai Park
Initial Date of Registration : 2007-08-16
Latest Date of Registration : 2014-07-01
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Registration Number : 20250213-210-J-1743
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Registrant Name : Pharmaline Co., Ltd.
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Manufacturer Name : Divi's Laboratories Ltd.
Manufacturer Address : Unit-2, Chippada Village, Annavaram Post – 531 162, Bheemunipatnam Mandal, Visakhap...
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Registration Number : 20200107-210-J-363(1)
Manufacturer Name : GE Healthcare AS
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Manufacturer Name : GE Healthcare AS
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Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2021-02-15
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Drugs in Development
Details:
Iohexol is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Lung Diseases.
Lead Product(s): Iohexol,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Jung Im Jung
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 01, 2023
Lead Product(s) : Iohexol,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Jung Im Jung
Deal Size : Inapplicable
Deal Type : Inapplicable
Chest CT Using Low-concentration Iodine Contrast Media
Details : Iohexol is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Lung Diseases.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 01, 2023
Details:
LY3556050 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): LY3556050,Metformin,Iohexol
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 14, 2022
Lead Product(s) : LY3556050,Metformin,Iohexol
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of Effect of LY3556050 on Metformin in Healthy Participants
Details : LY3556050 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 14, 2022
Details:
LY3526318 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): LY3526318,Iohexol,Simvastatin,Metformin
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 14, 2022
Lead Product(s) : LY3526318,Iohexol,Simvastatin,Metformin
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of LY3526318 in Healthy Male Japanese Participants
Details : LY3526318 is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 14, 2022
Details:
Iohexol is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of undefined medical condition.
Lead Product(s): Iohexol,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Ligand Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 13, 2020
Lead Product(s) : Iohexol,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Ligand Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Comparison of Captisol-Enabledâ„¢ Iohexol and Omnipaqueâ„¢ in Patients With Impaired Renal...
Details : Iohexol is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 13, 2020
Details:
Infigratinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Breast Neoplasms.
Lead Product(s): Infigratinib,Tamoxifen Citrate,Iohexol,Iopamidol
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Jennifer Lee Caswell-Jin
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 07, 2020
Lead Product(s) : Infigratinib,Tamoxifen Citrate,Iohexol,Iopamidol
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Jennifer Lee Caswell-Jin
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Infigratinib is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Breast Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 07, 2020
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CAS Number : CAS-618-88-2
End Use API : Iohexol
About The Company : Shreeneel Chemicals is dedicated to quality healthcare development and fostering a knowledgeable environment. The company was founded by Mr. Sanjay Tavethiya an...
CAS Number : CAS-13290-96-5
End Use API : Iohexol
About The Company : Shreeneel Chemicals is dedicated to quality healthcare development and fostering a knowledgeable environment. The company was founded by Mr. Sanjay Tavethiya an...
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PharmaCompass offers a list of Iohexol 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 Iohexol manufacturer or Iohexol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Iohexol manufacturer or Iohexol supplier.
PharmaCompass also assists you with knowing the Iohexol API Price utilized in the formulation of products. Iohexol API Price is not always fixed or binding as the Iohexol Price is obtained through a variety of data sources. The Iohexol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DSSTox_CID_3157 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSSTox_CID_3157, including repackagers and relabelers. The FDA regulates DSSTox_CID_3157 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSSTox_CID_3157 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 DSSTox_CID_3157 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DSSTox_CID_3157 supplier is an individual or a company that provides DSSTox_CID_3157 active pharmaceutical ingredient (API) or DSSTox_CID_3157 finished formulations upon request. The DSSTox_CID_3157 suppliers may include DSSTox_CID_3157 API manufacturers, exporters, distributors and traders.
click here to find a list of DSSTox_CID_3157 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DSSTox_CID_3157 DMF (Drug Master File) is a document detailing the whole manufacturing process of DSSTox_CID_3157 active pharmaceutical ingredient (API) in detail. Different forms of DSSTox_CID_3157 DMFs exist exist since differing nations have different regulations, such as DSSTox_CID_3157 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DSSTox_CID_3157 DMF submitted to regulatory agencies in the US is known as a USDMF. DSSTox_CID_3157 USDMF includes data on DSSTox_CID_3157's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSSTox_CID_3157 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The DSSTox_CID_3157 Drug Master File in Japan (DSSTox_CID_3157 JDMF) empowers DSSTox_CID_3157 API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the DSSTox_CID_3157 JDMF during the approval evaluation for pharmaceutical products. At the time of DSSTox_CID_3157 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a DSSTox_CID_3157 Drug Master File in Korea (DSSTox_CID_3157 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of DSSTox_CID_3157. The MFDS reviews the DSSTox_CID_3157 KDMF as part of the drug registration process and uses the information provided in the DSSTox_CID_3157 KDMF to evaluate the safety and efficacy of the drug.
After submitting a DSSTox_CID_3157 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 DSSTox_CID_3157 API can apply through the Korea Drug Master File (KDMF).
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A DSSTox_CID_3157 CEP of the European Pharmacopoeia monograph is often referred to as a DSSTox_CID_3157 Certificate of Suitability (COS). The purpose of a DSSTox_CID_3157 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DSSTox_CID_3157 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DSSTox_CID_3157 to their clients by showing that a DSSTox_CID_3157 CEP has been issued for it. The manufacturer submits a DSSTox_CID_3157 CEP (COS) as part of the market authorization procedure, and it takes on the role of a DSSTox_CID_3157 CEP holder for the record. Additionally, the data presented in the DSSTox_CID_3157 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DSSTox_CID_3157 DMF.
A DSSTox_CID_3157 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DSSTox_CID_3157 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing DSSTox_CID_3157 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for DSSTox_CID_3157 API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture DSSTox_CID_3157 as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain DSSTox_CID_3157 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DSSTox_CID_3157 NDC to their finished compounded human drug products, they may choose to do so.
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DSSTox_CID_3157 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 DSSTox_CID_3157 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 DSSTox_CID_3157 GMP manufacturer or DSSTox_CID_3157 GMP API supplier for your needs.
A DSSTox_CID_3157 CoA (Certificate of Analysis) is a formal document that attests to DSSTox_CID_3157's compliance with DSSTox_CID_3157 specifications and serves as a tool for batch-level quality control.
DSSTox_CID_3157 CoA mostly includes findings from lab analyses of a specific batch. For each DSSTox_CID_3157 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.
DSSTox_CID_3157 may be tested according to a variety of international standards, such as European Pharmacopoeia (DSSTox_CID_3157 EP), DSSTox_CID_3157 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DSSTox_CID_3157 USP).
