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1. 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one
2. E-2007
3. E2007
4. Er-155055-90
5. Fycompa
6. Perampanel Hydrate
7. Perampanel Hydrate (4:3)
1. 380917-97-5
2. Fycompa
3. E2007
4. Er-155055-90
5. E-2007
6. 3-(2-cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one
7. E 2007
8. Perampanel (usan)
9. Chebi:71013
10. Benzonitrile, 2-(1',6'-dihydro-6'-oxo-1'-phenyl[2,3'-bipyridin]-5'-yl)-
11. 2-(2-oxo-1-phenyl-5-pyridin-2-ylpyridin-3-yl)benzonitrile
12. H821664npk
13. Perampanel [usan]
14. Fycompa (tn)
15. 5'-(2-cyanophenyl)-1'-phenyl-2,3'-bipyridinyl-6'(1'h)-one
16. 2-(6'-oxo-1'-phenyl-1',6'-dihydro-2,3'-bipyridin-5'-yl)benzonitrile
17. 2-(6'-oxo-1'-phenyl[1',6'-dihydro[2,3'-bipyridine]]-5'-yl)benzonitrile
18. Benzonitrile, 2-(1',6'-dihydro-6'-oxo-1'-phenyl(2,3'-bipyridin)-5'-yl)-
19. Perampanel [usan:inn]
20. Perampanelum
21. Unii-h821664npk
22. Perampanel(e2007
23. Perampanel [mi]
24. Perampanel [inn]
25. Perampanel [vandf]
26. Perampanel [who-dd]
27. Schembl194370
28. Gtpl7050
29. Chembl1214124
30. Perampanel [orange Book]
31. Dtxsid80191501
32. Bcp06505
33. Ex-a2128
34. Bdbm50184410
35. Zinc30691797
36. Akos016340421
37. Ch-0056
38. Cs-1160
39. Db08883
40. Sb16816
41. Ncgc00378863-02
42. Ac-27375
43. Am806751
44. Hy-14745
45. D08964
46. Q868658
47. 2-(6-oxo-1-phenyl-1,6-dihydro-[2,3-bipyridin]-5-yl)benzonitrile
48. 3-(2-cyanophenyl)-1-phenyl-5-(2-pyridyl)-1,2-dihydropyridin-2-one
49. 1174302-51-2
50. 6zp
Molecular Weight | 349.4 g/mol |
---|---|
Molecular Formula | C23H15N3O |
XLogP3 | 3.4 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 3 |
Rotatable Bond Count | 3 |
Exact Mass | 349.121512110 g/mol |
Monoisotopic Mass | 349.121512110 g/mol |
Topological Polar Surface Area | 57 Ų |
Heavy Atom Count | 27 |
Formal Charge | 0 |
Complexity | 664 |
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 |
1 of 2 | |
---|---|
Drug Name | Fycompa |
PubMed Health | Perampanel (By mouth) |
Drug Classes | Anticonvulsant, Central Nervous System Agent |
Drug Label | FYCOMPA tablets contain perampanel, a non-competitive AMPA receptor antagonist. Perampanel is described chemically as 2-(2-oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3-yl) benzonitrile hydrate (4:3).The molecular formula is C23H15N3O 3/4H2O,... |
Active Ingredient | Perampanel |
Dosage Form | Tablet |
Route | Oral |
Strength | 8mg; 4mg; 12mg; 6mg; 2mg; 10mg |
Market Status | Prescription |
Company | Eisai |
2 of 2 | |
---|---|
Drug Name | Fycompa |
PubMed Health | Perampanel (By mouth) |
Drug Classes | Anticonvulsant, Central Nervous System Agent |
Drug Label | FYCOMPA tablets contain perampanel, a non-competitive AMPA receptor antagonist. Perampanel is described chemically as 2-(2-oxo-1-phenyl-5-pyridin-2-yl-1,2-dihydropyridin-3-yl) benzonitrile hydrate (4:3).The molecular formula is C23H15N3O 3/4H2O,... |
Active Ingredient | Perampanel |
Dosage Form | Tablet |
Route | Oral |
Strength | 8mg; 4mg; 12mg; 6mg; 2mg; 10mg |
Market Status | Prescription |
Company | Eisai |
Used in patients over 12 years old for the treatment of partial-onset seizures that may or may not occur with generalized seizures.
FDA Label
Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.
Fycompa is indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.
Perampanel is involved in inhibiting neuronal excitation in the central nervous system leading to such effects as decreased pyschomotor performance.
N03AX22
N03AX22
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
N - Nervous system
N03 - Antiepileptics
N03A - Antiepileptics
N03AX - Other antiepileptics
N03AX22 - Perampanel
Absorption
After oral adminitration, perampanel is absorbed rapidly and completely.
Route of Elimination
Perampanel is eliminated mostely in the feces (48%) and to a lesser exten in the urine (22%).
Volume of Distribution
The volume of distribution of perampanel was not quantified.
Clearance
In healthy patients, perampanel has a clearance of about 12 mL/min.
Perampanel is highly metabolized by CYP3A4 and/or CYP3A5 primary oxidation and by sequential glucuronidation.
Perampanel has a long elmination half-life of about 105 hours.
The exact mechanism of action of perampanel in seizures is not yet determined, but it is known that perampanel decreases neuronal excitation by non-competitive ihibition of the AMPA receptor.
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NDC Package Code : 58159-099
Start Marketing Date : 2023-12-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
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GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-23
Pay. Date : 2016-04-18
DMF Number : 30475
Submission : 2016-04-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38218
Submission : 2023-05-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31312
Submission : 2017-01-31
Status : Active
Type : II
Date of Issue : 2023-04-06
Valid Till : 2026-05-19
Written Confirmation Number : WC-0281
Address of the Firm :
NDC Package Code : 50379-0024
Start Marketing Date : 2021-01-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-03-17
Registration Number : 434-31-ND
Manufacturer Name : MSN Organics Private Limited
Manufacturer Address : Sy.No.224/A, Bibinagar (Village), Bihinagar (Mandal), Yadadri Bhuvanagiri District, Telangana, 508126, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-11-02
Pay. Date : 2022-10-25
DMF Number : 35608
Submission : 2021-02-01
Status : Active
Type : II
NDC Package Code : 50379-0020
Start Marketing Date : 2016-10-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2020-11-25
Registration Number : Number 173-29-ND
Manufacturer Name : MSN Organics Private Limited
Manufacturer Address : Sy. No. 224/A, Bibinagar(Village), Bibinagar(Mandal), Yadadri Bhuvanagiri District, Telangana, Pincode: 508 126, India
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-23
Pay. Date : 2016-04-18
DMF Number : 30475
Submission : 2016-04-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38218
Submission : 2023-05-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-01
Pay. Date : 2016-06-20
DMF Number : 30649
Submission : 2016-06-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-11-02
Pay. Date : 2022-10-25
DMF Number : 35608
Submission : 2021-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31312
Submission : 2017-01-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-08-27
Pay. Date : 2016-06-30
DMF Number : 30391
Submission : 2016-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-07-08
Pay. Date : 2016-05-09
DMF Number : 30527
Submission : 2016-06-02
Status : Active
Type : II
USDMF
GDUFA
DMF Review : Complete
Rev. Date : 2024-12-31
Pay. Date : 2024-12-16
DMF Number : 40753
Submission : 2024-12-04
Status : Active
Type : II
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PharmaCompass offers a list of Perampanel 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 Perampanel manufacturer or Perampanel supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Perampanel manufacturer or Perampanel supplier.
PharmaCompass also assists you with knowing the Perampanel API Price utilized in the formulation of products. Perampanel API Price is not always fixed or binding as the Perampanel Price is obtained through a variety of data sources. The Perampanel Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Perampanel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perampanel, including repackagers and relabelers. The FDA regulates Perampanel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perampanel 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 Perampanel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Perampanel supplier is an individual or a company that provides Perampanel active pharmaceutical ingredient (API) or Perampanel finished formulations upon request. The Perampanel suppliers may include Perampanel API manufacturers, exporters, distributors and traders.
click here to find a list of Perampanel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Perampanel DMF (Drug Master File) is a document detailing the whole manufacturing process of Perampanel active pharmaceutical ingredient (API) in detail. Different forms of Perampanel DMFs exist exist since differing nations have different regulations, such as Perampanel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Perampanel DMF submitted to regulatory agencies in the US is known as a USDMF. Perampanel USDMF includes data on Perampanel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Perampanel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Perampanel 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 Perampanel Drug Master File in Korea (Perampanel KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Perampanel. The MFDS reviews the Perampanel KDMF as part of the drug registration process and uses the information provided in the Perampanel KDMF to evaluate the safety and efficacy of the drug.
After submitting a Perampanel 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 Perampanel API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Perampanel suppliers with KDMF on PharmaCompass.
A Perampanel written confirmation (Perampanel WC) is an official document issued by a regulatory agency to a Perampanel manufacturer, verifying that the manufacturing facility of a Perampanel active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Perampanel APIs or Perampanel finished pharmaceutical products to another nation, regulatory agencies frequently require a Perampanel WC (written confirmation) as part of the regulatory process.
click here to find a list of Perampanel 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 Perampanel as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Perampanel 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 Perampanel 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 Perampanel and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Perampanel NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Perampanel suppliers with NDC on PharmaCompass.
Perampanel 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 Perampanel 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 Perampanel GMP manufacturer or Perampanel GMP API supplier for your needs.
A Perampanel CoA (Certificate of Analysis) is a formal document that attests to Perampanel's compliance with Perampanel specifications and serves as a tool for batch-level quality control.
Perampanel CoA mostly includes findings from lab analyses of a specific batch. For each Perampanel 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.
Perampanel may be tested according to a variety of international standards, such as European Pharmacopoeia (Perampanel EP), Perampanel JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Perampanel USP).