Synopsis
Synopsis
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CEP/COS
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JDMF
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KDMF
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VMF
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Europe
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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EDQM
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USP
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JP
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Others
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US Patents
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Health Canada Patents
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Stock Recap #PipelineProspector
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1. Fk228
2. Fr 901228
3. Fr-901228
4. Fr901228
5. L-valine, N-(3-hydroxy-7-mercapto-1-oxo-4-heptenyl)-d-valyl-d-cysteinyl-(z)-2,3-didehydro-2-aminobutanoyl-, Xi-lactone, Cyclic (1-2)-disulfide, (s-(e))-
6. Romidepsin
1. Romidepsin
2. Depsipeptide
3. Fk228
4. Chromadax
5. 128517-07-7
6. Antibiotic Fr 901228
7. Fr901228
8. Fk 228
9. Fk-228
10. Fr 901228
11. Fr-901228
12. Nsc-630176
13. Chembl343448
14. (1s,4s,7z,10s,16e,21r)-7-ethylidene-4,21-di(propan-2-yl)-2-oxa-12,13-dithia-5,8,20,23-tetrazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
15. Chebi:61080
16. Nsc 630176
17. Nsc630176
18. Nsc754143
19. (1s,4s,7z,10s,16e,21r)-7-ethylidene-4,21-di(propan-2-yl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
20. C24h36n4o6s2
21. (1s,4s,7z,10s,16e,21r)-7-ethylidene-4,21-bis(propan-2-yl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
22. Istodax (tn)
23. Romidepsin [usan]
24. Cx3t89xqbk
25. (1s,4s,7z,10s,16e,21r)-7-ethylidene-4,21-bis(1-methylethyl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo(8.7.6)tricos-16-ene-3,6,9,19,22-pentone
26. Hdinhib_000006
27. Romidepsina
28. Romidepsine
29. Romidepsinum
30. Oxa-12,8,20,23-tetrazabicyclo[8.7.6]tricosane, Cyclic Peptide Deriv.
31. Romidepsin (fk228)
32. Romidepsin; Fk-228
33. Romidepsin [mi]
34. Fk-901228
35. Romidepsin [inn]
36. Romidepsin [jan]
37. Romidepsin [vandf]
38. Probes1_000153
39. Probes2_000337
40. Romidepsin [mart.]
41. Romidepsin [who-dd]
42. Depsipeptide [who-dd]
43. Romidepsin (jan/usan/inn)
44. Schembl677497
45. Gtpl7006
46. Romidepsin [orange Book]
47. Romidepsin, >=98% (hplc)
48. Bdbm19151
49. Romidepsin (fk228 ,depsipeptide)
50. Cyclo((2z)-2-amino-2-butenoyl-l-valyl-(3s,4e)-3-hydroxy-7-mercapto-4-heptenoyl-d-valyl-d-cysteinyl), Cyclic (3->5)-disulfide
51. Zinc3935130
52. Mfcd18433404
53. S3020
54. Api0005301
55. Cs-0985
56. Db06176
57. Nsc-754143
58. Hy-15149
59. D06637
60. Ab01273968-01
61. Sr-01000941579
62. Q7363205
63. Sr-01000941579-1
64. L-valine,3-didehydro-2- Aminobutanoyl-,.xi.-lactone, Cyclic (1.fwdarw.2)-disulfide
65. L-valine,3-didehydro-2-aminobutanoyl-,.xi.-lactone, Cyclic (1.fwdarw.2)-disulfide
66. (1s,4s,7z,10s,16e,21r)-7- Ethylidene-4,21-di(propan-2-yl)-2-oxa-12,13-dithia-5,8,20,23- Tetrazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
67. (1s,4s,7z,10s,16e,21r)-7-ethylidene-4,21-bis(1methylethyl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16ene-3,6,9,19,22-pentone
68. (e)-(1s,10s,21r)-7-[(z)-ethylidene]-4,21-diisopropyl-2- Oxa-12,13-dithia-5,8,20,23- Tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
69. (e)-(1s,10s,21r)-7-[(z)-ethylidene]-4,21-diisopropyl-2- Oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone
70. Cyclo((2z)-2-amino-2-butenoyl-l-valyl-(3s,4e)-3-hydroxy-7-mercapto-4-heptenoyl-d-valyl-d-cysteinyl), Cyclic (3->5)-disulphide
71. Cyclo[(2z)-2-amino-2-butenoyl-l-val Yl-(3s,4e)-3-hydroxy-7-mercapto-4-heptenoyl-d-valy L-d-cysteinyl], Cyclic (3-5) Disulfide
72. Cyclo[(2z)-2-amino-2-butenoyl-l-valyl-(3s,4e)-3-hydroxy-7-mercapto-4-heptenoyl-d-valyl-d-cysteinyl], Cyclic (3-5) Disulfide
Molecular Weight | 540.7 g/mol |
---|---|
Molecular Formula | C24H36N4O6S2 |
XLogP3 | 2.2 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 2 |
Exact Mass | 540.20762723 g/mol |
Monoisotopic Mass | 540.20762723 g/mol |
Topological Polar Surface Area | 193 Ų |
Heavy Atom Count | 36 |
Formal Charge | 0 |
Complexity | 905 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 4 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 2 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
For the treatment of cutaneous T-cell lymphoma (CTCL) or/and peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior systemic therapy. These indications are based on response rate. Clinical benefit such as improvement in overall survival has not been demonstrated.
FDA Label
treatment of peripheral T-cell lymphoma (PTCL),
Antibiotics, Antineoplastic
Chemical substances, produced by microorganisms, inhibiting or preventing the proliferation of neoplasms. (See all compounds classified as Antibiotics, Antineoplastic.)
Histone Deacetylase Inhibitors
Compounds that inhibit HISTONE DEACETYLASES. This class of drugs may influence gene expression by increasing the level of acetylated HISTONES in specific CHROMATIN domains. (See all compounds classified as Histone Deacetylase Inhibitors.)
L01XX39
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agents
L01X - Other antineoplastic agents
L01XH - Histone deacetylase (hdac) inhibitors
L01XH02 - Romidepsin
Absorption
Romidepsin exhibited linear pharmacokinetics at standard doses.
Volume of Distribution
44.5L
Clearance
8.4L/h
Romidepsin undergoes extensive hepatic metabolism in vitro primarily by CYP3A4 with minor contribution from CYP3A5, CYP1A1, CYP2B6 and CYP2C19.
Approximately 3 hours
Romidepsin is a prodrug, where it becomes active once taken up into the cell. The active metabolite has a free thiol group, which interacts with zinc ions in the active site of class 1 and 2 HDAC enzymes, resulting in inhibition of its enzymatic activity. Certain tumors have over expressed HDACs and downregulated/mutated histone acetyltransferases. This imbalance of HDAC relative to histone acetyltransferase can lead to a decrease in regulatory genes, ensuing tumorigenesis. Inhibition of HDAC may restore normal gene expression in cancer cells and result in cell cycle arrest and apoptosis.
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Global Sales Information
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ABOUT THIS PAGE
A Romidepsin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Romidepsin, including repackagers and relabelers. The FDA regulates Romidepsin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Romidepsin 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 Romidepsin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Romidepsin supplier is an individual or a company that provides Romidepsin active pharmaceutical ingredient (API) or Romidepsin finished formulations upon request. The Romidepsin suppliers may include Romidepsin API manufacturers, exporters, distributors and traders.
click here to find a list of Romidepsin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Romidepsin DMF (Drug Master File) is a document detailing the whole manufacturing process of Romidepsin active pharmaceutical ingredient (API) in detail. Different forms of Romidepsin DMFs exist exist since differing nations have different regulations, such as Romidepsin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Romidepsin DMF submitted to regulatory agencies in the US is known as a USDMF. Romidepsin USDMF includes data on Romidepsin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Romidepsin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Romidepsin suppliers with USDMF on PharmaCompass.
A Romidepsin written confirmation (Romidepsin WC) is an official document issued by a regulatory agency to a Romidepsin manufacturer, verifying that the manufacturing facility of a Romidepsin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Romidepsin APIs or Romidepsin finished pharmaceutical products to another nation, regulatory agencies frequently require a Romidepsin WC (written confirmation) as part of the regulatory process.
click here to find a list of Romidepsin 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 Romidepsin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Romidepsin 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 Romidepsin 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 Romidepsin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Romidepsin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Romidepsin suppliers with NDC on PharmaCompass.
Romidepsin 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 Romidepsin 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 Romidepsin GMP manufacturer or Romidepsin GMP API supplier for your needs.
A Romidepsin CoA (Certificate of Analysis) is a formal document that attests to Romidepsin's compliance with Romidepsin specifications and serves as a tool for batch-level quality control.
Romidepsin CoA mostly includes findings from lab analyses of a specific batch. For each Romidepsin 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.
Romidepsin may be tested according to a variety of international standards, such as European Pharmacopoeia (Romidepsin EP), Romidepsin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Romidepsin USP).
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