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1. 6-chloro-5-(2,3-dichlorophenoxy)-2-methylthiobenzimidazole
2. Egaten
3. Fasicare
4. Fasinex
5. Flukare
6. Tremacide
1. 68786-66-3
2. Fasinex
3. Egaten
4. 6-chloro-5-(2,3-dichlorophenoxy)-2-(methylthio)-1h-benzo[d]imidazole
5. Triclabendazol
6. Triclabendazolum
7. 5-chloro-6-(2,3-dichlorophenoxy)-2-(methylthio)-1h-benzimidazole
8. Nvp-ega230
9. Ega230b
10. 6-chloro-5-(2,3-dichlorophenoxy)-2-methylsulfanyl-1h-benzimidazole
11. Nsc-759250
12. Cpd000466357
13. Mls001424101
14. Chembl1086440
15. 1h-benzimidazole, 6-chloro-5-(2,3-dichlorophenoxy)-2-(methylthio)-
16. Cga89317
17. 4784c8e03o
18. Ncgc00164610-01
19. Smr000466357
20. 5-chloro-6-(2,3-dichlorophenoxy)-2-(methylthio)benzimidazole
21. 6-chloro-5-(2,3-dichlorophenoxy)-2-(methylthio)-1h-benzimidazole
22. 6-[2,3-bis(chloranyl)phenoxy]-5-chloranyl-2-methylsulfanyl-1h-benzimidazole
23. 5-chloro-6-(2,3-dichlorophenoxy)-2-(methylsulfanyl)-1h-1,3-benzodiazole
24. Triclabendazol [inn-spanish]
25. Triclabendazolum [inn-latin]
26. Ccris 8988
27. Cga 89317
28. 5-chloro-6-(2,3-dichlorophenoxy)-2-methylsulfanyl-1h-benzimidazole
29. Unii-4784c8e03o
30. 6-chloro-5-(2,3-dichlorophenoxy)-2-methylthio-benzimidazole
31. Fasinex (tn)
32. Egaten (tn)
33. 1h-benzimidazole, 5-chloro-6-(2,3-dichlorophenoxy)-2-(methylthio)-
34. Dsstox_cid_23952
35. Dsstox_rid_80094
36. Triclabendazole [mi]
37. Dsstox_gsid_43952
38. Oprea1_236106
39. Triclabendazole (usan/inn)
40. Triclabendazole [inn]
41. Cid_50248
42. Mls000759473
43. Mls000876812
44. Schembl165712
45. Triclabendazole [usan]
46. Triclabendazole [mart.]
47. Dtxsid7043952
48. Triclabendazole [who-dd]
49. Bdbm58491
50. Chebi:94759
51. Triclabendazole [usan:inn:ban]
52. Hms2051e16
53. Hms2232d14
54. Hms3370h02
55. Hms3393e16
56. Hms3652m16
57. Hms3715p16
58. Hms3744i09
59. Kuc103451n
60. Pharmakon1600-01505786
61. Hy-b0621
62. Zinc1444556
63. Tox21_112231
64. Cga-89317
65. Mfcd00864519
66. Nsc759250
67. S4114
68. Stk332284
69. Triclabendazole [orange Book]
70. Akos005439340
71. Akos015950804
72. Ac-7627
73. At10531
74. Ccg-100881
75. Ccg-268150
76. Db12245
77. Ks-5329
78. Nc00131
79. Nsc 759250
80. Sb17173
81. Ncgc00164610-02
82. Sbi-0207022.p001
83. Triclabendazole 100 Microg/ml In Methanol
84. Cas-68786-66-3
85. Ft-0602564
86. Sw197511-2
87. T2826
88. Triclabendazole 100 Microg/ml In Acetonitrile
89. D07364
90. Ab00639964-10
91. Ab00639964_12
92. Ab00639964_13
93. 786t663
94. A836250
95. Q419739
96. Sr-01000759363
97. Sr-01000759363-4
98. Triclabendazole, Vetranal(tm), Analytical Standard
99. Brd-k81916719-001-05-5
100. 6-chloro-5-(2,3-dichlorophenoxy)-2-(methylthio)benzimidazole
101. Triclabendazole, Europepharmacopoeia (ep) Reference Standard
102. 5-chloro-6-(2',3'-dichlorophenoxy)-2-(methylthio)benzimidazole
103. 5-chloro-6-(2,3-dichlorophenoxy)-2-(methylthio)-1h-benzo[d]imidazole
104. 6-chloro-5-(2,3-dichlorophenoxy)-2-(methylsulfanyl)-1h-1,3-benzodiazole
105. 6-chloro-5-(2,3-dichlorophenoxy)-2-(methylsulfanyl)-1h-benzimidazole
106. 5-[2,3-bis(chloranyl)phenoxy]-6-chloranyl-2-methylsulfanyl-1h-benzimidazole
107. 6-chloro-5-(2,3-dichlorophenoxy)-2-methylsulfanyl-1h-benzimidazole;triclabendazole
108. Triclabendazole For System Suitability, Europepharmacopoeia (ep) Reference Standard
109. Ja9
| Molecular Weight | 359.7 g/mol |
|---|---|
| Molecular Formula | C14H9Cl3N2OS |
| XLogP3 | 5.7 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 3 |
| Exact Mass | 357.950117 g/mol |
| Monoisotopic Mass | 357.950117 g/mol |
| Topological Polar Surface Area | 63.2 Ų |
| Heavy Atom Count | 21 |
| Formal Charge | 0 |
| Complexity | 365 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
This drug is indicated for the treatment of fascioliasis in patients aged 6 years old and above.
FDA Label
Triclabendazole and its metabolites are active against both the immature and mature worms of _Fasciola hepatica_ and _Fasciola gigantica_ helminths. **Effect on QT interval** This drug may prolong the cardiac QT interval. Monitor ECG in patients with a history of QT prolongation or who are taking medications known to prolong the QT interval.
Antiplatyhelmintic Agents
Agents used to treat cestode, trematode, or other flatworm infestations in man or animals. (See all compounds classified as Antiplatyhelmintic Agents.)
P - Antiparasitic products, insecticides and repellents
P02 - Anthelmintics
P02B - Antitrematodals
P02BX - Other antitrematodal agents
P02BX04 - Triclabendazole
Absorption
After a single oral dose of 10 mg/kg triclabendazole with a 560-kcal meal to patients diagnosed with fascioliasis, mean peak plasma concentrations (Cmax) for triclabendazole, the sulfoxide, and sulfone metabolites were 1.16, 38.6, and 2.29 mol/L, respectively. The area under the curve (AUC) for triclabendazole, the sulfoxide and sulfone metabolites were 5.72, 386, and 30.5 molh/L, respectively. After the oral administration of a single dose of triclabendazole at 10 mg/kg with a 560 calorie meal to patients with fascioliasis, the median Tmax for the parent compound as well as the active sulfoxide metabolite was 3 to 4 hours. **Effect of Food** Cmax and AUC of triclabendazole and sulfoxide metabolite increased about 2-3 times when triclabendazole was administered as a single dose at 10 mg/kg with a meal containing approximately 560 calories. Additionally, the sulfoxide metabolite Tmax increased from 2 hours in fasting subjects to 4 hours in fed subjects.
Route of Elimination
No data regarding excretion is available in humans. In animals, triclabendazole is primarily excreted by the biliary tract in the feces (90%), together with the sulfoxide and sulfone metabolite. Less than 10% of an oral dose is found excreted in the urine.
Volume of Distribution
The apparent volume of distribution (Vd) of the sulfoxide metabolite in fed patients is about 1 L/kg.
Based on in vitro studies, triclabendazole is mainly metabolized by CYP1A2 enzyme (approximately 64%) into its active _sulfoxide_ metabolite and to a lesser extent by CYP2C9, CYP2C19, CYP2D6, CYP3A, and FMO (flavin containing monooxygenase). This sulfoxide metabolite is further metabolized mainly by CYP2C9 to the active sulfone metabolite, and to a smaller extent by CYP1A1, CYP1A2, CYP1B1, CYP2C19, CYP2D6, and CYP3A4, _in vitro_.
The plasma elimination half-life (t1/2) of triclabendazole, the sulfoxide and sulfone metabolites in human is about 8, 14, and 11 hours, respectively.
Triclabendazole is an anthelmintic agent against _Fasciola_ species. The mechanism of action against Fasciola species is not fully understood at this time. In vitro studies and animal studies suggest that triclabendazole and its active metabolites (_sulfoxide_ and _sulfone_) are absorbed by the outer body covering of the immature and mature worms, causing a reduction in the resting membrane potential, the inhibition of tubulin function as well as protein and enzyme synthesis necessary for survival. These metabolic disturbances lead to an inhibition of motility, disruption of the worm outer surface, in addition to the inhibition of spermatogenesis and egg/embryonic cells. **A note on resistance** In vitro studies, in vivo studies, as well as case reports suggest a possibility for the development of resistance to triclabendazole. The mechanism of resistance may be multifactorial and include changes in drug uptake/efflux mechanisms, target molecules, and changes in drug metabolism. The clinical significance of triclabendazole resistance in humans is not yet elucidated.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37483
Submission : 2022-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31790
Submission : 2018-04-13
Status : Active
Type : II
Certificate Number : CEP 2023-358 - Rev 00
Issue Date : 2024-09-23
Type : Chemical
Substance Number : 2609
Status : Valid
NDC Package Code : 86055-0006
Start Marketing Date : 2017-01-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2022-025 - Rev 00
Issue Date : 2024-06-14
Type : Chemical
Substance Number : 2609
Status : Valid
Certificate Number : CEP 2021-380 - Rev 00
Issue Date : 2023-10-13
Type : Chemical
Substance Number : 2609
Status : Valid
Date of Issue : 2021-12-16
Valid Till : 2024-12-15
Written Confirmation Number : WC-0503n
Address of the Firm :
NDC Package Code : 82139-0003
Start Marketing Date : 2022-10-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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PharmaCompass offers a list of Triclabendazole 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 Triclabendazole manufacturer or Triclabendazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Triclabendazole manufacturer or Triclabendazole supplier.
PharmaCompass also assists you with knowing the Triclabendazole API Price utilized in the formulation of products. Triclabendazole API Price is not always fixed or binding as the Triclabendazole Price is obtained through a variety of data sources. The Triclabendazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Triclabendazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Triclabendazole, including repackagers and relabelers. The FDA regulates Triclabendazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Triclabendazole 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 Triclabendazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Triclabendazole supplier is an individual or a company that provides Triclabendazole active pharmaceutical ingredient (API) or Triclabendazole finished formulations upon request. The Triclabendazole suppliers may include Triclabendazole API manufacturers, exporters, distributors and traders.
click here to find a list of Triclabendazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Triclabendazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Triclabendazole active pharmaceutical ingredient (API) in detail. Different forms of Triclabendazole DMFs exist exist since differing nations have different regulations, such as Triclabendazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Triclabendazole DMF submitted to regulatory agencies in the US is known as a USDMF. Triclabendazole USDMF includes data on Triclabendazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Triclabendazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Triclabendazole suppliers with USDMF on PharmaCompass.
A Triclabendazole CEP of the European Pharmacopoeia monograph is often referred to as a Triclabendazole Certificate of Suitability (COS). The purpose of a Triclabendazole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Triclabendazole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Triclabendazole to their clients by showing that a Triclabendazole CEP has been issued for it. The manufacturer submits a Triclabendazole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Triclabendazole CEP holder for the record. Additionally, the data presented in the Triclabendazole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Triclabendazole DMF.
A Triclabendazole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Triclabendazole 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 Triclabendazole suppliers with CEP (COS) on PharmaCompass.
A Triclabendazole written confirmation (Triclabendazole WC) is an official document issued by a regulatory agency to a Triclabendazole manufacturer, verifying that the manufacturing facility of a Triclabendazole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Triclabendazole APIs or Triclabendazole finished pharmaceutical products to another nation, regulatory agencies frequently require a Triclabendazole WC (written confirmation) as part of the regulatory process.
click here to find a list of Triclabendazole 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 Triclabendazole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Triclabendazole 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 Triclabendazole 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 Triclabendazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Triclabendazole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Triclabendazole suppliers with NDC on PharmaCompass.
Triclabendazole 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 Triclabendazole 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 Triclabendazole GMP manufacturer or Triclabendazole GMP API supplier for your needs.
A Triclabendazole CoA (Certificate of Analysis) is a formal document that attests to Triclabendazole's compliance with Triclabendazole specifications and serves as a tool for batch-level quality control.
Triclabendazole CoA mostly includes findings from lab analyses of a specific batch. For each Triclabendazole 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.
Triclabendazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Triclabendazole EP), Triclabendazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Triclabendazole USP).
