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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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Number of Transactions |
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Details:
Lepsiramp is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Lepsiramp,Perampanel
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Advanced Research Network | Global Napi Pharmaceuticals for Global Advanced Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 14, 2025

Lead Product(s) : Lepsiramp,Perampanel
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Advanced Research Network | Global Napi Pharmaceuticals for Global Advanced Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioequivalence Assessment Between Two Perampanel Oral Suspension Formulations
Details : Lepsiramp is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
May 14, 2025

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Details:
Perampanel is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Epilepsy.
Lead Product(s): Perampanel,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 10, 2024

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Lead Product(s) : Perampanel,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioequivalence Study of Perampanel Tablets 12 mg
Details : Perampanel is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Epilepsy.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 10, 2024

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Details:
Perampanel is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Epilepsy.
Lead Product(s): Perampanel,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 10, 2024

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Lead Product(s) : Perampanel,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioequivalence Study of Perampanel Tablets 10 mg
Details : Perampanel is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Epilepsy.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 10, 2024

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Details:
Fycompa is a selective, non-competitive AMPA glutamate receptor antagonist indicated for treating partial-onset seizures and primary generalized tonic-clonic seizures in patients aged 12 & older.
Lead Product(s): Perampanel,Inapplicable
Therapeutic Area: Neurology Brand Name: Fycompa
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 13, 2024

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Lead Product(s) : Perampanel,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Fycompa® Approved in China for Primary Generalized Tonic-clonic Seizures
Details : Fycompa is a selective, non-competitive AMPA glutamate receptor antagonist indicated for treating partial-onset seizures and primary generalized tonic-clonic seizures in patients aged 12 & older.
Product Name : Fycompa
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 13, 2024

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Details:
Fycompa (perampanel) is a selective, non-competitive AMPA glutamate receptor antagonist indicated for treating partial-onset and primary generalized tonic-clonic seizures in patients aged 12 & older.
Lead Product(s): Perampanel,Inapplicable
Therapeutic Area: Neurology Brand Name: Fycompa
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 18, 2024

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Lead Product(s) : Perampanel,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Eisai's Antiepileptic Drug Fycompa Injection Formulation Launches in Japan
Details : Fycompa (perampanel) is a selective, non-competitive AMPA glutamate receptor antagonist indicated for treating partial-onset and primary generalized tonic-clonic seizures in patients aged 12 & older.
Product Name : Fycompa
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 18, 2024

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Details:
Fycompa (perampanel) is a selective, non-competitive AMPA glutamate receptor antagonist indicated for treating partial-onset and primary generalized tonic-clonic seizures in patients aged 12 & older.
Lead Product(s): Perampanel,Inapplicable
Therapeutic Area: Neurology Brand Name: Fycompa
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 18, 2024

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Lead Product(s) : Perampanel,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Antiepileptic Drug Fycompa® Injection Formulation Approved in Japan
Details : Fycompa (perampanel) is a selective, non-competitive AMPA glutamate receptor antagonist indicated for treating partial-onset and primary generalized tonic-clonic seizures in patients aged 12 & older.
Product Name : Fycompa
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 18, 2024

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Details:
Perampanel oral suspension is first-in-class anti-epileptic agent, With epileptic seizures being mediated by neurotransmitter glutamate, agent is highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures.
Lead Product(s): Perampanel,Inapplicable
Therapeutic Area: Neurology Brand Name: Fycompa-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 27, 2023

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Lead Product(s) : Perampanel,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Akums gets DCGI Approval for Perampanel Oral Suspension
Details : Perampanel oral suspension is first-in-class anti-epileptic agent, With epileptic seizures being mediated by neurotransmitter glutamate, agent is highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated w...
Product Name : Fycompa-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 27, 2023

Details:
Perampanel is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Depressive Disorder.
Lead Product(s): Perampanel,Ketamine Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: American Foundation for Suicide Prevention | National Center for PTSD | VA Connecticut Healthcare System
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 27, 2023

Lead Product(s) : Perampanel,Ketamine Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : American Foundation for Suicide Prevention | National Center for PTSD | VA Connecticut Healthcare System
Deal Size : Inapplicable
Deal Type : Inapplicable
The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects
Details : Perampanel is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Depressive Disorder.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 27, 2023

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Details:
The completion of the acquisition, strengthens the company's Commercial Portfolio with the First and Only AMPA Receptor Antagonist Marketed Product for Epilepsy. Fycompa (perampanel), an oral medication, is a selective non-competitive AMPA receptor antagonist.
Lead Product(s): Perampanel,Inapplicable
Therapeutic Area: Neurology Brand Name: Fycompa
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Catalyst Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: $160.0 million
Deal Type: Acquisition January 25, 2023

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Lead Product(s) : Perampanel,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Catalyst Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Catalyst Pharmaceuticals Completes the Acquisition of U.S. Rights to FYCOMPA® (Perampanel) CIII
Details : The completion of the acquisition, strengthens the company's Commercial Portfolio with the First and Only AMPA Receptor Antagonist Marketed Product for Epilepsy. Fycompa (perampanel), an oral medication, is a selective non-competitive AMPA receptor antag...
Product Name : Fycompa
Product Type : Miscellaneous
Upfront Cash : $160.0 million
January 25, 2023

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Details:
Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist used to treat partial-onset seizures with or without secondarily generalized seizures, and as adjunctive treatment of primary generalized tonic-clonic seizures in patients with epilepsy.
Lead Product(s): Perampanel,Inapplicable
Therapeutic Area: Neurology Brand Name: Fycompa
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Catalyst Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: $160.0 million
Deal Type: Divestment December 20, 2022

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Lead Product(s) : Perampanel,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Catalyst Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Divestment
Eisai to Divest Rights for Anti-Epileptic Drug Fycompa® (perampanel) CIII In United States to Cat...
Details : Fycompa (perampanel) is a non-competitive AMPA glutamate receptor antagonist used to treat partial-onset seizures with or without secondarily generalized seizures, and as adjunctive treatment of primary generalized tonic-clonic seizures in patients with ...
Product Name : Fycompa
Product Type : Miscellaneous
Upfront Cash : $160.0 million
December 20, 2022

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Patents & EXCLUSIVITIES
Patent Expiration Date : 2025-05-23
US Patent Number : 6949571
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 202834
Patent Use Code : U-106
Delist Requested :
Patent Use Description : TREATMENT OF EPILEPSY
Patent Expiration Date : 2025-05-23

Patent Expiration Date : 2025-05-23
US Patent Number : 6949571
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 202834
Patent Use Code : U-2088
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-05-23

Patent Expiration Date : 2025-05-23
US Patent Number : 6949571
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 202834
Patent Use Code : U-2428
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-05-23

Patent Expiration Date : 2025-05-23
US Patent Number : 6949571
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 202834
Patent Use Code : U-2089
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-05-23

Patent Expiration Date : 2025-05-23
US Patent Number : 6949571
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 202834
Patent Use Code : U-2428
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-05-23

Patent Expiration Date : 2025-05-23
US Patent Number : 6949571
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 202834
Patent Use Code : U-2089
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-05-23

Patent Expiration Date : 2026-07-01
US Patent Number : 8772497
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 202834
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-07-01

Patent Expiration Date : 2025-05-23
US Patent Number : 6949571
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 202834
Patent Use Code : U-2088
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-05-23

Patent Expiration Date : 2025-05-23
US Patent Number : 6949571
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 202834
Patent Use Code : U-2089
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-05-23

Patent Expiration Date : 2025-05-23
US Patent Number : 6949571
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 202834
Patent Use Code : U-2088
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-05-23

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Exclusivity Code : PC
Exclusivity Expiration Date : 2025-11-25
Application Number : 209801
Product Number : 1
Exclusivity Details :

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Exclusivity Code : PC
Exclusivity Expiration Date : 2025-11-25
Application Number : 209801
Product Number : 2
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Exclusivity Code : PC
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Product Number : 3
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Exclusivity Code : PC
Exclusivity Expiration Date : 2025-11-25
Application Number : 209801
Product Number : 4
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Product Number : 5
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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.
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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 [USAN:INN] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perampanel [USAN:INN], including repackagers and relabelers. The FDA regulates Perampanel [USAN:INN] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perampanel [USAN:INN] API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Perampanel [USAN:INN] supplier is an individual or a company that provides Perampanel [USAN:INN] active pharmaceutical ingredient (API) or Perampanel [USAN:INN] finished formulations upon request. The Perampanel [USAN:INN] suppliers may include Perampanel [USAN:INN] API manufacturers, exporters, distributors and traders.
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A Perampanel [USAN:INN] DMF (Drug Master File) is a document detailing the whole manufacturing process of Perampanel [USAN:INN] active pharmaceutical ingredient (API) in detail. Different forms of Perampanel [USAN:INN] DMFs exist exist since differing nations have different regulations, such as Perampanel [USAN:INN] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Perampanel [USAN:INN] DMF submitted to regulatory agencies in the US is known as a USDMF. Perampanel [USAN:INN] USDMF includes data on Perampanel [USAN:INN]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Perampanel [USAN:INN] USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Perampanel [USAN:INN] Drug Master File in Korea (Perampanel [USAN:INN] KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Perampanel [USAN:INN]. The MFDS reviews the Perampanel [USAN:INN] KDMF as part of the drug registration process and uses the information provided in the Perampanel [USAN:INN] KDMF to evaluate the safety and efficacy of the drug.
After submitting a Perampanel [USAN:INN] 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 [USAN:INN] API can apply through the Korea Drug Master File (KDMF).
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A Perampanel [USAN:INN] written confirmation (Perampanel [USAN:INN] WC) is an official document issued by a regulatory agency to a Perampanel [USAN:INN] manufacturer, verifying that the manufacturing facility of a Perampanel [USAN:INN] active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Perampanel [USAN:INN] APIs or Perampanel [USAN:INN] finished pharmaceutical products to another nation, regulatory agencies frequently require a Perampanel [USAN:INN] WC (written confirmation) as part of the regulatory process.
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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 [USAN:INN] as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Perampanel [USAN:INN] 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 [USAN:INN] 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 [USAN:INN] and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Perampanel [USAN:INN] NDC to their finished compounded human drug products, they may choose to do so.
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Perampanel [USAN:INN] 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 [USAN:INN] 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 [USAN:INN] GMP manufacturer or Perampanel [USAN:INN] GMP API supplier for your needs.
A Perampanel [USAN:INN] CoA (Certificate of Analysis) is a formal document that attests to Perampanel [USAN:INN]'s compliance with Perampanel [USAN:INN] specifications and serves as a tool for batch-level quality control.
Perampanel [USAN:INN] CoA mostly includes findings from lab analyses of a specific batch. For each Perampanel [USAN:INN] 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 [USAN:INN] may be tested according to a variety of international standards, such as European Pharmacopoeia (Perampanel [USAN:INN] EP), Perampanel [USAN:INN] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Perampanel [USAN:INN] USP).