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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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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
About the Company : Brother Enterprises Holding Co., Ltd. was founded in 1991 and is headquartered in Haining City, Zhejiang Province, China. With over 30 years of experience, Brother Enterprises has ...
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About the Company : As an EU-GMP certified global company and an established hallmark for pharmaceutical standards, Global Calcium has stood the test of time since its inception in 1979 as Calcium Ind...
About the Company : The Juste Group is the result of a merger of two companies: Justesa Imagen, centered on Chemicals, and Juste Farma, a pharmaceutical company. It has completed 100 years of growth, ...
About the Company : HENGDIAN GROUP was established in 1975, till now it has become a transnational,conglomerate group and been one of the largest private-owned enterprises in China. The Pharmaceutical...
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RLD : Yes
TE Code :
Brand Name : OMNIPAQUE 240
Dosage Form : SOLUTION;INJECTION, ORAL, RECTAL
Dosage Strength : 51.8%
Approval Date : 1985-12-26
Application Number : 18956
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : OMNIPAQUE 300
Dosage Form : SOLUTION;INJECTION, ORAL, RECTAL
Dosage Strength : 64.7%
Approval Date : 1985-12-26
Application Number : 18956
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : OMNIPAQUE 350
Dosage Form : SOLUTION;INJECTION, ORAL
Dosage Strength : 75.5%
Approval Date : 1985-12-26
Application Number : 18956
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : OMNIPAQUE 140
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 30.2%
Approval Date : 1988-11-30
Application Number : 18956
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : OMNIPAQUE 210
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 45.3%
Approval Date : 1989-06-30
Application Number : 18956
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : OMNIPAQUE 70
Dosage Form : SOLUTION;URETHRAL
Dosage Strength : 15.1%
Approval Date : 1994-06-01
Application Number : 18956
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : OMNIPAQUE 9
Dosage Form : SOLUTION;ORAL
Dosage Strength : 1.9%
Approval Date : 2018-04-17
Application Number : 18956
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : OMNIPAQUE 12
Dosage Form : SOLUTION;ORAL
Dosage Strength : 2.6%
Approval Date : 2018-04-17
Application Number : 18956
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : OMNIPAQUE 240
Dosage Form : SOLUTION;INJECTION, ORAL, RECTAL
Dosage Strength : 51.8%
Approval Date : 1995-10-24
Application Number : 20608
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : OMNIPAQUE 300
Dosage Form : SOLUTION;INJECTION, ORAL, RECTAL
Dosage Strength : 64.7%
Approval Date : 1995-10-24
Application Number : 20608
RX/OTC/DISCN : RX
RLD : No
TE Code :
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Regulatory Info :
Registration Country : Sweden
Brand Name : Omnipaque
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 350 MG I / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Omnipaque
Dosage Form : Iohexol 300Mg I/Ml 100Ml 1 Units Parenteral Use
Dosage Strength : 1 bottle 300 mg I/ml 100 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Omnipaque
Dosage Form : Iohexol 300Mg I/Ml 200Ml 1 Units Parenteral Use
Dosage Strength : 1 bottle 300 mg I/ml 200 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Omnipaque
Dosage Form : Iohexol 350Mg I/Ml 100Ml 1 Units Parenteral Use
Dosage Strength : 1 bottle 350 mg I/ml 100 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Omnipaque
Dosage Form : Iohexol 350Mg I/Ml 50Ml 1 Units Parenteral Use
Dosage Strength : 1 bottle 350 mg I/ml 50 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Omnipaque
Dosage Form : Injection fluid, resolution
Dosage Strength : 140 mg IN/ml
Packaging : Bottle of plastic
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Omnipaque
Dosage Form : Injection fluid, resolution
Dosage Strength : 240 mg IN/ml
Packaging : Bottle of plastic
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Omnipaque
Dosage Form : Injection fluid, resolution
Dosage Strength : 300 mg IN/ml
Packaging : Bottle of plastic
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Omnipaque
Dosage Form : Injection fluid, resolution
Dosage Strength : 350 mg IN/ml
Packaging : Bottle of plastic
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Accupaque
Dosage Form : Inj Sol
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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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 Accupaque manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Accupaque, including repackagers and relabelers. The FDA regulates Accupaque manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Accupaque 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 Accupaque manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Accupaque supplier is an individual or a company that provides Accupaque active pharmaceutical ingredient (API) or Accupaque finished formulations upon request. The Accupaque suppliers may include Accupaque API manufacturers, exporters, distributors and traders.
click here to find a list of Accupaque suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Accupaque DMF (Drug Master File) is a document detailing the whole manufacturing process of Accupaque active pharmaceutical ingredient (API) in detail. Different forms of Accupaque DMFs exist exist since differing nations have different regulations, such as Accupaque USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Accupaque DMF submitted to regulatory agencies in the US is known as a USDMF. Accupaque USDMF includes data on Accupaque's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Accupaque USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Accupaque suppliers with USDMF on PharmaCompass.
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 Accupaque Drug Master File in Japan (Accupaque JDMF) empowers Accupaque 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 Accupaque JDMF during the approval evaluation for pharmaceutical products. At the time of Accupaque JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Accupaque suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Accupaque Drug Master File in Korea (Accupaque KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Accupaque. The MFDS reviews the Accupaque KDMF as part of the drug registration process and uses the information provided in the Accupaque KDMF to evaluate the safety and efficacy of the drug.
After submitting a Accupaque 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 Accupaque API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Accupaque suppliers with KDMF on PharmaCompass.
A Accupaque CEP of the European Pharmacopoeia monograph is often referred to as a Accupaque Certificate of Suitability (COS). The purpose of a Accupaque CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Accupaque EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Accupaque to their clients by showing that a Accupaque CEP has been issued for it. The manufacturer submits a Accupaque CEP (COS) as part of the market authorization procedure, and it takes on the role of a Accupaque CEP holder for the record. Additionally, the data presented in the Accupaque CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Accupaque DMF.
A Accupaque CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Accupaque 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 Accupaque suppliers with CEP (COS) on PharmaCompass.
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 Accupaque as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Accupaque 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 Accupaque 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 Accupaque and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Accupaque NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Accupaque suppliers with NDC on PharmaCompass.
Accupaque 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 Accupaque 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 Accupaque GMP manufacturer or Accupaque GMP API supplier for your needs.
A Accupaque CoA (Certificate of Analysis) is a formal document that attests to Accupaque's compliance with Accupaque specifications and serves as a tool for batch-level quality control.
Accupaque CoA mostly includes findings from lab analyses of a specific batch. For each Accupaque 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.
Accupaque may be tested according to a variety of international standards, such as European Pharmacopoeia (Accupaque EP), Accupaque JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Accupaque USP).
