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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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USDMF
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-08
Pay. Date : 2012-11-26
DMF Number : 21443
Submission : 2008-03-18
Status : Active
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23697
Submission : 2010-04-07
Status : Active
Type : II
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-11
Pay. Date : 2017-04-28
DMF Number : 31545
Submission : 2017-05-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25100
Submission : 2011-07-04
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-26
Pay. Date : 2014-01-06
DMF Number : 27842
Submission : 2014-01-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31709
Submission : 2017-06-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-12-13
DMF Number : 24717
Submission : 2011-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-06
Pay. Date : 2013-09-25
DMF Number : 27256
Submission : 2013-09-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-21
Pay. Date : 2013-09-11
DMF Number : 21523
Submission : 2008-04-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-04
Pay. Date : 2015-07-14
DMF Number : 25343
Submission : 2011-09-23
Status : Active
Type : II
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DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 21266
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 21266
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A RT-016239 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of RT-016239, including repackagers and relabelers. The FDA regulates RT-016239 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. RT-016239 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 RT-016239 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A RT-016239 supplier is an individual or a company that provides RT-016239 active pharmaceutical ingredient (API) or RT-016239 finished formulations upon request. The RT-016239 suppliers may include RT-016239 API manufacturers, exporters, distributors and traders.
click here to find a list of RT-016239 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A RT-016239 DMF (Drug Master File) is a document detailing the whole manufacturing process of RT-016239 active pharmaceutical ingredient (API) in detail. Different forms of RT-016239 DMFs exist exist since differing nations have different regulations, such as RT-016239 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A RT-016239 DMF submitted to regulatory agencies in the US is known as a USDMF. RT-016239 USDMF includes data on RT-016239's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The RT-016239 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of RT-016239 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 RT-016239 Drug Master File in Japan (RT-016239 JDMF) empowers RT-016239 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 RT-016239 JDMF during the approval evaluation for pharmaceutical products. At the time of RT-016239 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 RT-016239 Drug Master File in Korea (RT-016239 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of RT-016239. The MFDS reviews the RT-016239 KDMF as part of the drug registration process and uses the information provided in the RT-016239 KDMF to evaluate the safety and efficacy of the drug.
After submitting a RT-016239 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 RT-016239 API can apply through the Korea Drug Master File (KDMF).
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A RT-016239 CEP of the European Pharmacopoeia monograph is often referred to as a RT-016239 Certificate of Suitability (COS). The purpose of a RT-016239 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of RT-016239 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of RT-016239 to their clients by showing that a RT-016239 CEP has been issued for it. The manufacturer submits a RT-016239 CEP (COS) as part of the market authorization procedure, and it takes on the role of a RT-016239 CEP holder for the record. Additionally, the data presented in the RT-016239 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the RT-016239 DMF.
A RT-016239 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. RT-016239 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 RT-016239 suppliers with CEP (COS) on PharmaCompass.
A RT-016239 written confirmation (RT-016239 WC) is an official document issued by a regulatory agency to a RT-016239 manufacturer, verifying that the manufacturing facility of a RT-016239 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting RT-016239 APIs or RT-016239 finished pharmaceutical products to another nation, regulatory agencies frequently require a RT-016239 WC (written confirmation) as part of the regulatory process.
click here to find a list of RT-016239 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 RT-016239 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for RT-016239 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 RT-016239 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 RT-016239 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a RT-016239 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of RT-016239 suppliers with NDC on PharmaCompass.
RT-016239 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 RT-016239 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 RT-016239 GMP manufacturer or RT-016239 GMP API supplier for your needs.
A RT-016239 CoA (Certificate of Analysis) is a formal document that attests to RT-016239's compliance with RT-016239 specifications and serves as a tool for batch-level quality control.
RT-016239 CoA mostly includes findings from lab analyses of a specific batch. For each RT-016239 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.
RT-016239 may be tested according to a variety of international standards, such as European Pharmacopoeia (RT-016239 EP), RT-016239 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (RT-016239 USP).
