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1. Uk 109,496
2. Uk 109496
3. Uk-109,496
4. Uk-109496
5. Uk109,496
6. Uk109496
7. Vfend
1. 137234-62-9
2. Vfend
3. (2r,3s)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1h-1,2,4-triazol-1-yl)butan-2-ol
4. Uk-109496
5. (+/-)-voriconazole
6. Voriconazole Vfend
7. Uk-109,496
8. Uk 109496
9. Voriconzole
10. (2r,3s)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1,2,4-triazol-1-yl)butan-2-ol
11. Vcz
12. Voriconazole, (+/-)-
13. Chembl638
14. Nsc-759888
15. Jfu09i87tr
16. Usg4b1cd29
17. Cpd000466350
18. (r-(r*,s*))-alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha-(1h-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol
19. 4-pyrimidineethanol, Alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha-(1h-1,2,4-triazol-1-ylmethyl)-, (alphar,betas)-
20. Chebi:10023
21. 173967-54-9
22. Vrc
23. Voriconazol
24. Dsstox_cid_26485
25. Dsstox_rid_81656
26. Dsstox_gsid_46485
27. (2r,3s)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-((1h)-1,2,4-triazol-1-yl)-butan-2-ol
28. (alphar,betas)-alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha(1h-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol
29. 4-pyrimidineethanol, Alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha-(1h-1,2,4-triazol-1-ylmethyl)-, (r-(r*,s*))-
30. Voriconazole Related Compound A
31. 188416-29-7
32. Voriconazolum
33. Vorikonazole
34. Voriconazole [usan:inn:ban]
35. Drg-0301
36. Smr000466350
37. Cas-137234-62-9
38. Vfend (tn)
39. Vfend I.v.
40. Unii-jfu09i87tr
41. Pfizer
42. Ncgc00164622-01
43. Voriconazole Solution
44. Voriconazole- Bio-x
45. Voriconazole - Vfend
46. (alphar,betas)-alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha-(1h-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol
47. Voriconazole In Combination With Mgcd290
48. Voriconazole [mi]
49. Voriconazole [inn]
50. Voriconazole [jan]
51. Unii-usg4b1cd29
52. Voriconazole [usan]
53. Voriconazole [vandf]
54. Schembl36233
55. Voriconazole [mart.]
56. Mls000759464
57. Mls001424082
58. Mls006010028
59. Voriconazole [usp-rs]
60. Voriconazole [who-dd]
61. Voriconazole [ema Epar]
62. Dtxsid5046485
63. Voriconazole (jp17/usp/inn)
64. Zinc14864
65. Amy8903
66. Voriconazole, >=98% (hplc)
67. Bcpp000019
68. Dtxsid201019420
69. Hms2051n09
70. Hms3260m22
71. Hms3713f12
72. Pharmakon1600-01502346
73. Voriconazole [orange Book]
74. Voriconazole [ep Monograph]
75. Tox21_112241
76. Tox21_500150
77. Voriconazole [usp Monograph]
78. Voriconazole 2.0 Mg/ml In Methanol
79. Ac-823
80. Bdbm50333117
81. Nsc759888
82. S1442
83. Akos005145705
84. Tox21_112241_1
85. Ccg-100941
86. Cs-1227
87. Db00582
88. Hy-w337569
89. Ks-1157
90. Nc00191
91. Nsc 759888
92. Ncgc00164622-02
93. Ncgc00164622-04
94. Ncgc00164622-06
95. Ncgc00260835-01
96. Bv164532
97. Hy-76200
98. ( Inverted Exclamation Marka)-voriconazole
99. Voriconazole Related Compound A Rs [usp]
100. Cs-0448910
101. Sw197571-2
102. V0116
103. C07622
104. D00578
105. Ab00639948-04
106. Ab00639948-06
107. Ab00639948_07
108. Ab00639948_08
109. Voriconazole Related Compound A [usp-rs]
110. Voriconazole, Vetranal(tm), Analytical Standard
111. 234v629
112. A807215
113. Q412236
114. J-006986
115. Voriconazole Related Compound A [usp Impurity]
116. Z2616414875
117. Voriconazole, European Pharmacopoeia (ep) Reference Standard
118. Voriconazole, United States Pharmacopeia (usp) Reference Standard
119. (2r,3s)-2,3-bis(2,4-difluorophenyl)-1-(1h-1,2,4-triazol-1-yl)butan-2-ol
120. 2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1h-1,2,4-triazol-1-yl) Butan-2-ol
121. 4-[[4-[2-(5-ethyl-2-pyridyl)ethoxy]phenyl]methylene]-1-oxo-1,3-thiazolidin-5-one
122. Voriconazole, Pharmaceutical Secondary Standard: Certified Reference Material
123. (.alpha.r,.beta.s)-a-(2,4-difluorophenyl)-5-fluoro-.beta.-methyl-.alpha.-(1h-1,2,4-triazol-1-ylmethyl)-4-pyrimidineethanol
124. (2r,3s)-2-(2,4-difluoro-phenyl)-3-(5-fluoro-pyrimidin-4-yl)-1-[1,2,4]triazol-1-yl-butan-2-ol
125. (2r,3s)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1h-1,2,4-triazol-1-yl) Butan-2-ol
126. (2r,3s)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1h-1,2,4-triazol-1-yl)-2-butanol
127. (2r,3s)-2-(2,4-difluorophenyl)-3-(5-fluoro-4-pyrimidinyl)-1-(1h-1,2,4-triazol-1-yl)butan-2-ol
128. 2r,3s-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1h-1,2,4-triazol-1-yl)butan-2-ol-4-pyrimidineethanol, ?-(2,4-difluorophenyl)-5-fluoro-?-methyl-?-(1h-1,2,4-triazol-1-ylmethyl)-,?(?r,?s)-
129. 4-pyrimidineethanol, .alpha.-(2,4-difluorophenyl)-5-fluoro-.beta.-methyl-.alpha.-(1h-1,2,4-triazol-1-ylmethyl)-, (.alpha.r,.beta.s)-rel-
130. 4-pyrimidineethanol, A-(2,4-difluorophenyl)-5-fluoro-.beta.-methyl-.alpha.-(1h-1,2,4-triazol-1-ylmethyl)-, (.alpha.r,.beta.s)-
131. 4-pyrimidineethanol, Alpha-(2,4-difluorophenyl)-5-fluoro-beta-methyl-alpha-(1h-1,2,4-triazol-1-ylmethyl)-, (alphar,betas)-rel-
| Molecular Weight | 349.31 g/mol |
|---|---|
| Molecular Formula | C16H14F3N5O |
| XLogP3 | 1.5 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 5 |
| Exact Mass | 349.11504457 g/mol |
| Monoisotopic Mass | 349.11504457 g/mol |
| Topological Polar Surface Area | 76.7 Ų |
| Heavy Atom Count | 25 |
| Formal Charge | 0 |
| Complexity | 448 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 4 | |
|---|---|
| Drug Name | Vfend |
| PubMed Health | Voriconazole (By mouth) |
| Drug Classes | Antifungal |
| Drug Label | VFEND (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is:Voriconazole... |
| Active Ingredient | Voriconazole |
| Dosage Form | Tablet; Injectable; For suspension |
| Route | injection; oral; Iv (infusion); Oral; iv (infusion) |
| Strength | 200mg/5ml; 200mg; 200mg/vial; 50mg |
| Market Status | Prescription |
| Company | Pfizer |
| 2 of 4 | |
|---|---|
| Drug Name | Voriconazole |
| PubMed Health | Voriconazole |
| Drug Classes | Antifungal |
| Drug Label | VFEND (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is:Voriconazole... |
| Active Ingredient | Voriconazole |
| Dosage Form | Tablet; Injectable; For suspension |
| Route | Iv (infusion); Oral |
| Strength | 200mg/5ml; 200mg; 200mg/vial; 50mg |
| Market Status | Prescription |
| Company | Mylan Pharms; Sandoz; Teva Pharms |
| 3 of 4 | |
|---|---|
| Drug Name | Vfend |
| PubMed Health | Voriconazole (By mouth) |
| Drug Classes | Antifungal |
| Drug Label | VFEND (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is:Voriconazole... |
| Active Ingredient | Voriconazole |
| Dosage Form | Tablet; Injectable; For suspension |
| Route | injection; oral; Iv (infusion); Oral; iv (infusion) |
| Strength | 200mg/5ml; 200mg; 200mg/vial; 50mg |
| Market Status | Prescription |
| Company | Pfizer |
| 4 of 4 | |
|---|---|
| Drug Name | Voriconazole |
| PubMed Health | Voriconazole |
| Drug Classes | Antifungal |
| Drug Label | VFEND (voriconazole), a triazole antifungal agent, is available as a lyophilized powder for solution for intravenous infusion, film-coated tablets for oral administration, and as a powder for oral suspension. The structural formula is:Voriconazole... |
| Active Ingredient | Voriconazole |
| Dosage Form | Tablet; Injectable; For suspension |
| Route | Iv (infusion); Oral |
| Strength | 200mg/5ml; 200mg; 200mg/vial; 50mg |
| Market Status | Prescription |
| Company | Mylan Pharms; Sandoz; Teva Pharms |
For the treatment of esophageal candidiasis, cadidemia, invasive pulmonary aspergillosis, and serious fungal infections caused by Scedosporium apiospermum and Fusarium spp.
FDA Label
Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
- treatment of invasive aspergillosis;
- treatment of candidaemia in non-neutropenic patients;
- treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);
- treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.
Voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections.
Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT)
recipients.
Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
- treatment of invasive aspergillosis;
- treatment of in candidaemianon-neutropenic patients;
- treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);
- Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.
Vfend should be administered primarily to patients with progressive, possibly life-threatening infections.
Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows:
- treatment of invasive aspergillosis;
- treatment of candidaemia in non-neutropenic patients;
- treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei);
- Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.
Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections.
Treatment of candidaemia in non-neutropenic patients, Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei), Treatment of invasive aspergillosis, Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.
Voriconazole is a fungistatic triazole antifungal used to treat infections by inhibiting fungal growth. It is known to cause hepatotoxic and photosensitivity reactions in some patients.
14-alpha Demethylase Inhibitors
Compounds that specifically inhibit STEROL 14-DEMETHYLASE. A variety of azole-derived ANTIFUNGAL AGENTS act through this mechanism. (See all compounds classified as 14-alpha Demethylase Inhibitors.)
Antifungal Agents
Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)
Cytochrome P-450 CYP3A Inhibitors
Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP3A. (See all compounds classified as Cytochrome P-450 CYP3A Inhibitors.)
J02AC03
J02AC03
J02AC03
J02AC03
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
J - Antiinfectives for systemic use
J02 - Antimycotics for systemic use
J02A - Antimycotics for systemic use
J02AC - Triazole and tetrazole derivatives
J02AC03 - Voriconazole
Absorption
The oral bioavailability is estimated to be 96% in healthy adults. Population pharmacokinetic studies report a reduced bioavailability pediatric patients with a mean of 61.8% (range 44.664.5%) thought to be due to differences in first-pass metabolism or due to differences in diet. Of note, transplant patients also have reduced bioavailability but this is known to increase with time after transplantation and may be due in part to gastrointestinal upset from surgery and some transplant medications. Tmax is 1-2 hours with oral administration. When administered with a high-fat meal Cmax decreases by 34% and AUC by 24%. pH does not have an effect on absorption of voriconazole. Differences in Cmax and AUC have been observed between healthy adult males and females with Cmax increasing by 83% and AUC by 113% although this has not been observed to significantly impact medication safety profiles.
Route of Elimination
Voriconazole is eliminated via hepatic metabolism with less than 2% of the dose excreted unchanged in the urine.
Volume of Distribution
The estimated volume of distribution of voriconazole is 4.6 L/kg. Population pharmacokinetic studies estimate the median volume of distribution to be 77.6 L with the central compartment estimated at 1.07 L/kg Voriconazole is known to achieve therapeutic concentrations in many tissues including the brain, lungs, liver, spleen, kidneys, and heart.
Clearance
The clearance of voriconazole is estimated to be a mean of 5.25-7 L/h in healthy adults for the linear portion of the drug's kinetics.
Voriconazole undergoes extensive hepatic metabolism through cytochrome enzymes CYP2C9, CYP2C19, and CYP3A4. CYP2C19 mediates N-oxidation with an apparent Km of 14 M and an apparent Vmax of 0.22 nmol/min/nmol CYP2C19. Voriconazole N-oxide is the major circulating metabolite, accounting for 72% of radiolabeled metabolites found. CYP3A4 contributes to N-oxidation with a Km of 16 M and Vmax of 0.05 nmol/min/nmol CYP3A4 as well as 4-hydroxylation with a Km of 11 M and a Vmax of 0.10 nmol/min/nmol CYP3A4. CYP3A5 and CYP3A7 provide minor contributions to N-oxidation and 4-hydroxylation. The N-oxide and 4-hydroxylated metabolites undergo glucuronidation and are excreted through the urine with other minor glucuronidated metabolites.
Voriconazole has known human metabolites that include Hydroxymethyl Voriconazole and Voriconazole N-Oxide.
S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560
Voriconazole follows non-linear kinetics and has a terminal half-life of elimination which is dose-dependent.
Voriconazole is used to treat fungal infections caused by a variety of organisms but including _Aspergillus spp._ and _Candida spp_. Voriconazole is a triazole antifungal exhibiting fungistatic activity against fungal pathogens. Like other triazoles, voriconazole binds to 14-alpha sterol demethylase, also known as CYP51, and inhibits the demethylation of lanosterol as part of the ergosterol synthesis pathway in yeast and other fungi. The lack of sufficient ergosterol disrupts fungal cell membrane function and limits fungal cell growth. With fungal growth limited, the host's immune system is able to clear the invading organism.
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Average Price (USD/KGS) |
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Regulatory Info :
Registration Country : Sweden
Brand Name : Voriconazole Orion
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 200 MG
Packaging :
Approval Date :
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Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Brand Name : Voriconazole Orion
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info : Registered in EU
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 50MG
Packaging :
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Regulatory Info : Registered in EU
Registration Country : Germany
We are the TIEFENBACHER GROUP, Health Pioneers since 1963.
Regulatory Info :
Registration Country : Germany
Brand Name :
Dosage Form :
Dosage Strength : 200MG
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Regulatory Info :
Registration Country : Germany
Regulatory Info :
Registration Country : Norway
Brand Name : Voriconazole Accord
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 50 mg
Packaging : Blister
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Voriconazole Accord
Dosage Form : Filmtabl
Dosage Strength : 50mg
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Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Voriconazole Actavis
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 200 MG
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Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : VORICONAZOLE ARISTO
Dosage Form : Film-Coated Tablets
Dosage Strength : 50 mg
Packaging : 28 UNITS 50 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Brand Name : Voriconazol-Mepha
Dosage Form : Lactabs
Dosage Strength : 200mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Voriconazole Pfizer
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 50 MG
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DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 21266
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 21266
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PharmaCompass also assists you with knowing the Voriconazole API Price utilized in the formulation of products. Voriconazole API Price is not always fixed or binding as the Voriconazole Price is obtained through a variety of data sources. The Voriconazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Voriconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Voriconazole, including repackagers and relabelers. The FDA regulates Voriconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Voriconazole 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 Voriconazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Voriconazole supplier is an individual or a company that provides Voriconazole active pharmaceutical ingredient (API) or Voriconazole finished formulations upon request. The Voriconazole suppliers may include Voriconazole API manufacturers, exporters, distributors and traders.
click here to find a list of Voriconazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Voriconazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Voriconazole active pharmaceutical ingredient (API) in detail. Different forms of Voriconazole DMFs exist exist since differing nations have different regulations, such as Voriconazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Voriconazole DMF submitted to regulatory agencies in the US is known as a USDMF. Voriconazole USDMF includes data on Voriconazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Voriconazole 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 Voriconazole Drug Master File in Japan (Voriconazole JDMF) empowers Voriconazole 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 Voriconazole JDMF during the approval evaluation for pharmaceutical products. At the time of Voriconazole 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 Voriconazole Drug Master File in Korea (Voriconazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Voriconazole. The MFDS reviews the Voriconazole KDMF as part of the drug registration process and uses the information provided in the Voriconazole KDMF to evaluate the safety and efficacy of the drug.
After submitting a Voriconazole 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 Voriconazole API can apply through the Korea Drug Master File (KDMF).
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A Voriconazole CEP of the European Pharmacopoeia monograph is often referred to as a Voriconazole Certificate of Suitability (COS). The purpose of a Voriconazole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Voriconazole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Voriconazole to their clients by showing that a Voriconazole CEP has been issued for it. The manufacturer submits a Voriconazole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Voriconazole CEP holder for the record. Additionally, the data presented in the Voriconazole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Voriconazole DMF.
A Voriconazole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Voriconazole 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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A Voriconazole written confirmation (Voriconazole WC) is an official document issued by a regulatory agency to a Voriconazole manufacturer, verifying that the manufacturing facility of a Voriconazole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Voriconazole APIs or Voriconazole finished pharmaceutical products to another nation, regulatory agencies frequently require a Voriconazole WC (written confirmation) as part of the regulatory process.
click here to find a list of Voriconazole suppliers with Written Confirmation (WC) 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 Voriconazole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Voriconazole 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 Voriconazole 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 Voriconazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Voriconazole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Voriconazole suppliers with NDC on PharmaCompass.
Voriconazole 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 Voriconazole 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 Voriconazole GMP manufacturer or Voriconazole GMP API supplier for your needs.
A Voriconazole CoA (Certificate of Analysis) is a formal document that attests to Voriconazole's compliance with Voriconazole specifications and serves as a tool for batch-level quality control.
Voriconazole CoA mostly includes findings from lab analyses of a specific batch. For each Voriconazole 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.
Voriconazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Voriconazole EP), Voriconazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Voriconazole USP).
