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1. 2-(3,5-bis(trifluoromethyl)phenyl)-n,2-dimethyl-n-(4-(2-methylphenyl)-6-(4-methylpiperazin-1-yl)pyridin-3-yl)propanamide
2. 2-(3,5-bis(trifluoromethyl)phenyl)-n-methyl-n-(4-(2-methylphenyl)-6-(4-methylpiperazin-1-yl)pyridin-3-yl)-2-methylpropanamide
3. Benzeneacetamide, N, Alpha, Alpha-trimethyl-n-(4-(2-methylphenyl)-6-(4-methyl-1-piperazinyl)-3-pyridinyl)-3,5-bis(trifluoromethyl)-
4. Benzeneacetamide, N, Alpha,alpha-trimethyl-n-(4-(2-methylphenyl)-6-(4-methyl-1-piperazinyl)-3-pyridinyl)-3,5-bis(trifluoromethyl)-, Hydrochloride (1:2)
5. Netupitant Dihydrochloride
6. Netupitant Hydrochloride
7. Ro 67-3189 000
8. Ro 673189000
9. Ro-67-3189
10. Ro-67-3189 000
11. Ro-673189000
1. 290297-26-6
2. 2-[3,5-bis(trifluoromethyl)phenyl]-n,2-dimethyl-n-[4-(2-methylphenyl)-6-(4-methylpiperazin-1-yl)pyridin-3-yl]propanamide
3. 2-(3,5-bis(trifluoromethyl)phenyl)-n,2-dimethyl-n-(6-(4-methylpiperazin-1-yl)-4-(o-tolyl)pyridin-3-yl)propanamide
4. Ro-67-3189
5. Ro-673189000
6. Ro 67-3189/000
7. Chembl206253
8. Chebi:85155
9. 7732p08tir
10. Cid 6451149
11. Ro 67-31898/000
12. Benzeneacetamide, N,alpha,alpha-trimethyl-n-[4-(2-methylphenyl)-6-(4-methyl-1-piperazinyl)-3-pyridinyl]-3,5-bis(trifluoromethyl)-
13. 2-(3,5-bis(trifluoromethyl)phenyl)-n,2-dimethyl-n-(4-(2-methylphenyl)-6-(4-methylpiperazin-1-yl)pyridin-3-yl)propanamide
14. 2-(3,5-bis(trifluoromethyl)phenyl)-n,2-dimethyl-n-(6-(4-methylpiperazin-1-yl)-4-o-tolylpyridin-3-yl)propanamide
15. 2-[3,5-bis(trifluoromethyl)phenyl]-~{n},2-dimethyl-~{n}-[4-(2-methylphenyl)-6-(4-methylpiperazin-1-yl)pyridin-3-yl]propanamide
16. Netupitant [usan]
17. Netupitant [usan:inn]
18. Unii-7732p08tir
19. Benzeneacetamide, N,alpha,alpha-trimethyl-n-(4-(2-methylphenyl)-6-(4-methyl-1-piperazinyl)-3-pyridinyl)-3,5-bis(trifluoromethyl)-
20. Cid6451149
21. Netupitant [mi]
22. Netupitant [inn]
23. Netupitant (usan/inn)
24. Netupitant [vandf]
25. Netupitant [who-dd]
26. Schembl445804
27. Gtpl5742
28. Netupitant(cid-6451149)
29. Netupitant [orange Book]
30. Dtxsid50183271
31. Glxc-15009
32. Hms3887e19
33. Bcp08751
34. Ex-a2747
35. Bdbm50178574
36. Mfcd25976831
37. S4654
38. Zinc11681563
39. Akos027251056
40. Ccg-270121
41. Cs-3337
42. Db09048
43. Sb18973
44. Cid-6451149
45. Ncgc00390569-01
46. 2-(3,5-bis(trifluoromethyl)phenyl)-n-methyl-n-(4-(2-methylphenyl)-6-(4-methylpiperazin-1-yl)pyridin-3-yl)-2-methylpropanamide
47. Ac-29232
48. As-10239
49. Hy-16346
50. Ro 67-31898
51. Akynzeo Capsule Component Netupitant
52. Netupitant Component Akynzeo Capsule
53. Ft-0699740
54. A14428
55. D05152
56. Ro-67-3189/000
57. Q19598139
58. 2-(3,5-bis(trifluoromethyl)phenyl)-n,2-dimethyl-n-(6-(4-methylpiperazin-1-yl)-4-o-tolylpyridin-3-yl)propanamide, Aldrichcpr
59. 2-(3,5-bis(trifluoromethyl)phenyl)-n,2-dimethyl-n-(6-(4-methylpiperazin-1yl)-4-(o-tolyl)pyridin-3yl)propanamide
60. 2-(3,5-bis-trifluoromethyl-phenyl)-n-methyl-n-[6-(4-methyl-piperazin-1-yl)-4-o-tolyl-pyridin-3-yl]-isobutyramide
61. 2-[3,5-bis(trifluoromethyl)phenyl]-n,2-dimethyl-n-[4-(2-methylphenyl)-6-(4-methyl-1-piperazinyl)-3-pyridinyl]propanamide
62. Benzeneacetamide, N,.alpha.,.alpha.-trimethyl-n-(4-(2-methylphenyl)-6-(4-methyl-1-piperazinyl)-3-pyridinyl)-3,5-bis(trifluoromethyl)-
63. Gaw
64. N,alpha,alpha-trimethyl-n-[4-(2-methylphenyl)-6-(4-methyl-1-piperazinyl)-3-pyridinyl]-3,5-bis(trifluoromethyl)-benzeneacetamide
Molecular Weight | 578.6 g/mol |
---|---|
Molecular Formula | C30H32F6N4O |
XLogP3 | 6.8 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 10 |
Rotatable Bond Count | 5 |
Exact Mass | 578.24803063 g/mol |
Monoisotopic Mass | 578.24803063 g/mol |
Topological Polar Surface Area | 39.7 Ų |
Heavy Atom Count | 41 |
Formal Charge | 0 |
Complexity | 865 |
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 |
Netupitant is an antiemitic drug approved by the FDA in October 2014 for use in combination with palonosetron for the prevention of acute and delayed vomiting and nausea associated with cancer chemotherapy including highly emetogenic chemotherapy.
FDA Label
Absorption
Upon oral administration of a single dose of netupitant, netupitant started to be measurable in plasma between 15 minutes and 3 hours after dosing. Plasma concentrations reached Cmax in approximately 5 hours. There was a greater than dose-proportional increase in the systemic exposure with the dose increase from 10 mg to 300 mg and a dose-proportional increase in systemic exposure with a dose increase from 300 mg to 450 mg.
Route of Elimination
Primarily fecal.
Volume of Distribution
In cancer patients, Vz/F: 1982 906 L (mean SD).
Clearance
Estimated systemic clearance of 20.3 9.2 L/h (mean SD).
Once absorbed, netupitant is extensively metabolized to form three major metabolites: desmethyl derivative, M1; N-oxide derivative, M2; and OH-methyl derivative, M3. Metabolism is mediated primarily by CYP3A4 and to a lesser extent by CYP2C9 and CYP2D6. Metabolites M1, M2 and M3 were shown to bind to the substance P/neurokinin 1 (NK1) receptor.
96 hours with CV% of 61.
Delayed emesis (vomiting) has been largely associated with the activation of tachykinin family neurokinin 1 (NK1) receptors (broadly distributed in the central and peripheral nervous systems) by substance P. As shown in in vitro and in vivo studies, netupitant inhibits substance P mediated responses.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31207
Submission : 2017-01-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31593
Submission : 2017-03-31
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0033
Start Marketing Date : 2017-03-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26715
Submission : 2013-07-19
Status : Active
Type : II
NDC Package Code : 42973-212
Start Marketing Date : 2020-12-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : HKINNOEN Co., Ltd.
Registration Date : 2017-05-17
Registration Number : Su203-4-ND
Manufacturer Name : (Manufacturing other than undifferentiated process) HAS Healthcare Advanced Synthesis SA@[Undifferentiated manufacturing plant 1] JETPHARMA SA@[Undifferentiated manufacturing plant 2] Micro-Macinazione SA
Manufacturer Address : Via Industria 24, 6710 Biasca, Switzerland@Via Sottobisio 42 A/C POBox 234 6828 Balerna, Switzerland@Zona artigianale 11 6995 Madonna del Piano, Switzerland
Date of Issue : 2022-01-04
Valid Till : 2022-07-14
Written Confirmation Number : WC-0021A4
Address of the Firm :
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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PharmaCompass offers a list of Netupitant 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 Netupitant manufacturer or Netupitant supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Netupitant manufacturer or Netupitant supplier.
PharmaCompass also assists you with knowing the Netupitant API Price utilized in the formulation of products. Netupitant API Price is not always fixed or binding as the Netupitant Price is obtained through a variety of data sources. The Netupitant Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Netupitant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Netupitant, including repackagers and relabelers. The FDA regulates Netupitant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Netupitant 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 Netupitant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Netupitant supplier is an individual or a company that provides Netupitant active pharmaceutical ingredient (API) or Netupitant finished formulations upon request. The Netupitant suppliers may include Netupitant API manufacturers, exporters, distributors and traders.
click here to find a list of Netupitant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Netupitant DMF (Drug Master File) is a document detailing the whole manufacturing process of Netupitant active pharmaceutical ingredient (API) in detail. Different forms of Netupitant DMFs exist exist since differing nations have different regulations, such as Netupitant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Netupitant DMF submitted to regulatory agencies in the US is known as a USDMF. Netupitant USDMF includes data on Netupitant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Netupitant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Netupitant suppliers with USDMF 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 Netupitant Drug Master File in Korea (Netupitant KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Netupitant. The MFDS reviews the Netupitant KDMF as part of the drug registration process and uses the information provided in the Netupitant KDMF to evaluate the safety and efficacy of the drug.
After submitting a Netupitant 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 Netupitant API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Netupitant suppliers with KDMF on PharmaCompass.
A Netupitant written confirmation (Netupitant WC) is an official document issued by a regulatory agency to a Netupitant manufacturer, verifying that the manufacturing facility of a Netupitant active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Netupitant APIs or Netupitant finished pharmaceutical products to another nation, regulatory agencies frequently require a Netupitant WC (written confirmation) as part of the regulatory process.
click here to find a list of Netupitant 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 Netupitant as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Netupitant 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 Netupitant 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 Netupitant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Netupitant NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Netupitant suppliers with NDC on PharmaCompass.
Netupitant 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 Netupitant 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 Netupitant GMP manufacturer or Netupitant GMP API supplier for your needs.
A Netupitant CoA (Certificate of Analysis) is a formal document that attests to Netupitant's compliance with Netupitant specifications and serves as a tool for batch-level quality control.
Netupitant CoA mostly includes findings from lab analyses of a specific batch. For each Netupitant 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.
Netupitant may be tested according to a variety of international standards, such as European Pharmacopoeia (Netupitant EP), Netupitant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Netupitant USP).