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Producer
Produced in
India|
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MSDS
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CoAAll certificates
MSDS
CoA
Distributor
Produced in
World|
Employees: 200+
|
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GMP
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CEP|
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MSDS|
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CoA
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Producer
Produced in
Czech Republic|
Audit Report:
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CoA
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CoA
Producer
Produced in
China|
Employees: 700+
|
Audit Report:
Certifications:
MSDS
|
BSE/TSE|
CoAAll certificates
MSDS
BSE/TSE
CoA
Producer
Produced in
Unknown|
Audit Report:
Certifications:
USDMF
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CoAAll certificates
USDMF
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
USDMF
|
CoAAll certificates
USDMF
CoA
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Perampanel | CAS No: 380917-97-5 | GMP-certified suppliers
A medication that supports management of partial-onset and primary generalized tonic-clonic seizures in epilepsy patients, enabling reliable seizure control across key global markets.
Therapeutic categories
AMPA Receptor AntagonistsAnticonvulsantsCentral Nervous System DepressantsCytochrome P-450 CYP1A2 SubstratesCytochrome P-450 CYP2B6 InducersCytochrome P-450 CYP2B6 Inducers (weak)
Generic name
Perampanel
Molecule type
small molecule
CAS number
380917-97-5
DrugBank ID
DB08883
Approval status
Approved drug
ATC code
N03AX22
Primary indications
- Perampanel is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in epileptic patients four years of age and older
- It is also indicated as an adjunct in the treatment of primary generalized tonic-clonic seizures in epileptic patients aged 12 years and older
Product Snapshot
- Perampanel is an oral small‑molecule formulation supplied mainly as tablets and suspensions
- It is used for management of partial‑onset seizures and as an adjunct for primary generalized tonic‑clonic seizures
- It is approved in the US, Canada, and the EU
Clinical Overview
Perampanel (CAS 380917-97-5) is a noncompetitive AMPA glutamate receptor antagonist used in the management of epilepsy. It is indicated for partial-onset seizures with or without secondary generalization in patients four years of age and older, and as adjunctive therapy for primary generalized tonic-clonic seizures in patients twelve years and older. It is marketed globally under the name Fycompa. Clinical use carries a boxed warning for serious behavioral and psychiatric reactions, including aggression, hostility, and homicidal ideation.
Pharmacologically, perampanel is a centrally acting anticonvulsant that reduces excitatory neurotransmission. Although the full mechanism remains unresolved, the compound binds allosterically to AMPA-type ionotropic glutamate receptors and produces noncompetitive inhibition. This decreases glutamate-mediated neuronal excitation and contributes to seizure control. Reduced psychomotor performance has been observed as a functional correlate of AMPA antagonism.
Perampanel exhibits linear pharmacokinetics at therapeutic doses and is orally bioavailable. It is extensively metabolized, predominantly via CYP3A pathways, and is classified as both a substrate and a modulator of multiple cytochrome P450 isoenzymes. These interactions create potential for altered exposure when co-administered with enzyme inducers or inhibitors. Elimination occurs mainly through hepatic metabolism followed by renal and fecal excretion. The compound’s relatively long half-life supports once-daily dosing, though specific values may vary by population and co-medication status.
Safety considerations include dose-dependent dizziness, somnolence, irritability, gait disturbances, and psychiatric reactions. Monitoring for behavioral changes is essential, particularly during titration. Caution is warranted in patients receiving other central nervous system depressants or drugs that significantly affect CYP3A activity.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemistry, impurity profiles, and polymorphic form. Consistent compliance with ICH guidelines, validated analytical methods, and traceable regulatory documentation supports reliable integration into finished-dose development and global supply chains.
Pharmacologically, perampanel is a centrally acting anticonvulsant that reduces excitatory neurotransmission. Although the full mechanism remains unresolved, the compound binds allosterically to AMPA-type ionotropic glutamate receptors and produces noncompetitive inhibition. This decreases glutamate-mediated neuronal excitation and contributes to seizure control. Reduced psychomotor performance has been observed as a functional correlate of AMPA antagonism.
Perampanel exhibits linear pharmacokinetics at therapeutic doses and is orally bioavailable. It is extensively metabolized, predominantly via CYP3A pathways, and is classified as both a substrate and a modulator of multiple cytochrome P450 isoenzymes. These interactions create potential for altered exposure when co-administered with enzyme inducers or inhibitors. Elimination occurs mainly through hepatic metabolism followed by renal and fecal excretion. The compound’s relatively long half-life supports once-daily dosing, though specific values may vary by population and co-medication status.
Safety considerations include dose-dependent dizziness, somnolence, irritability, gait disturbances, and psychiatric reactions. Monitoring for behavioral changes is essential, particularly during titration. Caution is warranted in patients receiving other central nervous system depressants or drugs that significantly affect CYP3A activity.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemistry, impurity profiles, and polymorphic form. Consistent compliance with ICH guidelines, validated analytical methods, and traceable regulatory documentation supports reliable integration into finished-dose development and global supply chains.
Identification & chemistry
| Generic name | Perampanel |
|---|---|
| Molecule type | Small molecule |
| CAS | 380917-97-5 |
| UNII | H821664NPK |
| DrugBank ID | DB08883 |
Pharmacology
| Summary | Perampanel is a centrally acting antiseizure agent that reduces neuronal excitation through non‑competitive inhibition of AMPA‑type glutamate receptors, primarily targeting GluA1-containing receptors. By dampening excitatory neurotransmission, it modulates cortical network activity relevant to seizure propagation. Its pharmacodynamic profile includes dose‑related suppression of psychomotor responses consistent with reduced excitatory signaling. |
|---|---|
| Mechanism of action | 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. |
| Pharmacodynamics | Perampanel is involved in inhibiting neuronal excitation in the central nervous system leading to such effects as decreased pyschomotor performance. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glutamate receptor 1 | Humans | antagonist |
ADME / PK
| Absorption | After oral adminitration, perampanel is absorbed rapidly and completely. |
|---|---|
| Half-life | Perampanel has a long elmination half-life of about 105 hours. |
| Protein binding | Perampanel is 95-96% plasma protein bound with most binding to the plasma proteins α1-acid glycoprotein and albumin. |
| Metabolism | Perampanel is highly metabolized by CYP3A4 and/or CYP3A5 primary oxidation and by sequential glucuronidation. |
| 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. |
Formulation & handling
- Low aqueous solubility and moderate lipophilicity support use in solid oral dosage forms with dissolution‑enhancing excipients for consistent bioavailability.
- Available as tablets and oral suspensions; suspension formulations require attention to uniformity and physical stability due to the hydrophobic API.
- Food slows absorption rate without affecting extent, so formulations do not require food‑dependent release mechanisms.
Regulatory status
| Lifecycle | The API’s U.S. market exclusivity has largely matured, with one key patent expired in 2021 and the remaining protection ending in 2026. With products already established in the US, Canada, and the EU, the ingredient is transitioning toward a post‑exclusivity competitive environment. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Perampanel is supplied by a single originator manufacturer, which provides the branded product across the US, Canada, and EU markets. The brand maintains broad global availability, with no alternative branded versions indicated in these regions. US patent protection partly expired in 2021, while another patent extends to 2026, suggesting that generic competition may be limited until the remaining protection lapses. |
|---|
Safety
| Toxicity | The FDA label includes an important warning of serious or life-threatening behavioral and psychiatric adverse reactions including aggression, hostility, irritability, anger, and homicidal thoughts in patients taking perampanel. |
|---|
High Level Warnings:
- Associated with severe neuropsychiatric toxicities, including aggression, hostility, irritability, and rare reports of homicidal ideation
- These effects have been observed at therapeutic exposure levels
- Behavioral adverse events may present abruptly and have been noted across dose ranges, indicating the need for controls that limit unintended exposure during manufacturing or handling
Perampanel is a type of Antiepileptics
Antiepileptics, also known as antiseizure or anticonvulsant drugs, belong to the pharmaceutical category of active pharmaceutical ingredients (APIs) used for the treatment of epilepsy and other seizure disorders. These medications work by modulating the activity of neurotransmitters and ion channels in the brain to prevent or reduce the occurrence of seizures.
Antiepileptic APIs are classified into various chemical classes, including hydantoins, barbiturates, benzodiazepines, succinimides, and others. Each class of antiepileptics exerts its therapeutic effects through distinct mechanisms, targeting different components of the brain's neural network involved in seizure generation and propagation.
These APIs are typically formulated into oral tablets, capsules, or liquids for easy administration. Some antiepileptic drugs are also available in injectable forms for emergency situations. The dosage and treatment duration vary based on the patient's age, seizure type, and medical history.
The development of antiepileptic APIs requires rigorous research, including preclinical and clinical trials, to establish safety, efficacy, and optimal dosing regimens. Pharmaceutical companies follow strict quality control standards to ensure the purity, stability, and consistent quality of these APIs.
While antiepileptics are primarily used for epilepsy management, they are also prescribed for other neurological conditions such as bipolar disorder, neuropathic pain, and migraine prophylaxis. However, it is important to note that these medications may have potential side effects, including drowsiness, dizziness, cognitive impairment, and mood changes, which should be carefully monitored by healthcare professionals.
In conclusion, antiepileptics represent a crucial category of pharmaceutical APIs utilized in the treatment of epilepsy and other seizure disorders. These drugs play a vital role in managing and improving the quality of life for individuals affected by these conditions, helping to reduce the frequency and severity of seizures.
Perampanel API manufacturers & distributors
Compare qualified Perampanel API suppliers worldwide. We currently have 6 companies offering Perampanel API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Intas Pharma | Producer | United Kingdom | Unknown | CoA, USDMF | 30 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lifecare Laboratories | Producer | India | India | CoA, MSDS | 50 products |
| MSN Organics | Producer | India | India | CoA, USDMF | 21 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 136 products |
| Zhejiang Hengkang Pharmac... | Producer | China | China | BSE/TSE, CoA, MSDS | 31 products |
When sending a request, specify which Perampanel API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Perampanel API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Perampanel API
Sourcing
What matters most when sourcing GMP-grade Perampanel?
When sourcing GMP-grade Perampanel, the key considerations are regulatory compliance for US, Canadian, and EU markets and verification that the material meets current GMP standards. Because supply comes from a single originator manufacturer, confirming authenticated source and secure supply channels is essential. Patent protection extending to 2026 may limit generic availability, so procurement planning should account for constrained supplier options.
Which documents are typically required when sourcing Perampanel API?
Request the core API documentation set: CoA (5 companies), USDMF (3 companies), MSDS (3 companies), BSE/TSE (2 companies), CEP (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Perampanel API?
Known or reported manufacturers for Perampanel: LGM Pharma, Lifecare Laboratories, Zhejiang Hengkang Pharmaceutical Co. Ltd. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Perampanel API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Perampanel manufacturers?
Audit reports may be requested for Perampanel: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Perampanel API on Pharmaoffer?
Reported supplier count for Perampanel: 5 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Perampanel API?
Production countries reported for Perampanel: India (2 producers), China (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Perampanel usually hold?
Common certifications for Perampanel suppliers: CoA (5 companies), USDMF (3 companies), MSDS (3 companies), BSE/TSE (2 companies), CEP (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Perampanel (CAS 380917-97-5) used for?
Perampanel is used for the treatment of epilepsy. It is indicated for partial‑onset seizures with or without secondary generalization in patients four years and older, and as adjunctive therapy for primary generalized tonic‑clonic seizures in patients twelve years and older. Its therapeutic effect comes from noncompetitive allosteric inhibition of AMPA receptors to reduce excitatory glutamate signaling.
Which therapeutic class does Perampanel fall into?
Perampanel belongs to the following therapeutic categories: AMPA Receptor Antagonists, Anticonvulsants, Central Nervous System Depressants, Cytochrome P-450 CYP1A2 Substrates, Cytochrome P-450 CYP2B6 Inducers. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Perampanel mainly prescribed for?
The primary indications for Perampanel: Perampanel is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in epileptic patients four years of age and older, It is also indicated as an adjunct in the treatment of primary generalized tonic-clonic seizures in epileptic patients aged 12 years and older. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Perampanel work?
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.
What should someone know about the safety or toxicity profile of Perampanel?
Perampanel is associated with notable neuropsychiatric toxicity, including aggression, hostility, irritability, and rare reports of homicidal ideation, which can occur abruptly at therapeutic doses. Other dose‑related effects include dizziness, somnolence, gait disturbance, and reduced psychomotor performance. Caution is needed with concurrent CNS depressants or CYP3A modulators due to altered exposure, and close monitoring for behavioral changes is essential during titration and ongoing use.
What are important formulation and handling considerations for Perampanel as an API?
Perampanel’s low aqueous solubility and moderate lipophilicity favor solid oral dosage forms that include dissolution‑enhancing excipients to support reliable bioavailability. For oral suspensions, its hydrophobicity requires measures to maintain uniformity and physical stability throughout shelf life. Food slows the absorption rate but not the extent, so no food‑dependent release features are needed in the formulation.
Is Perampanel a small molecule?
Perampanel is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Perampanel?
Oral Perampanel shows no unusual chemical stability issues, but its low aqueous solubility requires formulations that maintain consistent dissolution. Tablet forms are generally stable, while oral suspensions need attention to physical stability and uniform resuspension because the API is hydrophobic. Food effects do not pose stability concerns, as food slows absorption rate but does not alter overall exposure.
Regulatory
Where is Perampanel approved or in use globally?
Perampanel is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Perampanel right now?
Perampanel is approved for use in the United States, Canada, and the European Union. Its authorization in these regions establishes a defined regulatory framework for manufacturing and distribution. Patent status is jurisdiction‑specific and determines market exclusivity periods, which may differ across these regions.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Perampanel procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Perampanel. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Perampanel included in the PRO Data Insights coverage?
PRO Data Insights coverage for Perampanel: 211 verified transactions across 75 suppliers and 35 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Perampanel?
Market report availability for Perampanel: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
