Suppliers and packagers for FYCOMPA

FYCOMPA

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Catalyst Pharms	FYCOMPA	perampanel	SUSPENSION;ORAL	208277	NDA	Eisai Inc.	62856-290-38	340 mL in 1 BOTTLE (62856-290-38)	2016-04-30
Catalyst Pharms	FYCOMPA	perampanel	SUSPENSION;ORAL	208277	NDA	Catalyst Pharmaceuticals, Inc.	69616-290-38	340 mL in 1 BOTTLE (69616-290-38)	2024-01-02
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834	NDA	Eisai Inc.	62856-272-14	14 TABLET in 1 PACKET (62856-272-14)	2012-10-22
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834	NDA	Eisai Inc.	62856-272-30	30 TABLET in 1 BOTTLE (62856-272-30)	2012-10-22
Catalyst Pharms	FYCOMPA	perampanel	TABLET;ORAL	202834	NDA	Eisai Inc.	62856-272-90	90 TABLET in 1 BOTTLE (62856-272-90)	2012-10-22

Suppliers and packagers for FYCOMPA

Last updated: May 25, 2026

Fycompa (perampanel) Suppliers: What Companies Manufacture, Supply, and Distribute the Drug and Its Key Components?

Executive summary: Fycompa (perampanel) is marketed in the U.S. as an oral solid product by Eisai Inc. The branded supply chain for perampanel tablet strengths is supported by Eisai manufacturing/contract manufacturing, with downstream distribution via major U.S. wholesale distributors. Public records typically identify Eisai as the labeler/distributor in FDA listings and Eisai’s suppliers for manufacturing as either internal or contract entities, while ingredient-level “API suppliers” are not reliably disclosed in a single consolidated public source.

Who is the manufacturer or labeler for Fycompa (perampanel) in the U.S.?

Quick answer: Eisai Inc. is the U.S. labeler associated with Fycompa on FDA drug listings and related regulatory databases. That labeler is the accountable party for the branded product, including supply continuity, quality systems, and regulatory compliance.

What does “supplier” mean in Fycompa procurement?

In pharmaceutical procurement, “suppliers” typically splits into:

• Finished-dose manufacturer(s) (tablets) used for commercial supply
• Labeler/distributor responsible for U.S. market placement
• API (perampanel) supplier(s) and excipient suppliers
• Packaging component suppliers (bottles, blister components, carton printing)
• Logistics and wholesale distributors handling U.S. distribution

For Fycompa, the most consistently identifiable public entity is the U.S. labeler (Eisai), while API and excipient suppliers are often disclosed only in filings that are not always available in a single unified view.

What finished-dose manufacturing sites supply Fycompa tablets?

Quick answer: Fycompa tablets are produced through Eisai’s manufacturing network and/or contract manufacturing under Eisai quality oversight. The specific tablet manufacturing site(s) can be identified through FDA product listings that include manufacturing details and through label and submission documentation, but a single authoritative public list of all sites used across all strengths and markets is not always present in one place.

Which Fycompa strengths and dosage forms matter for supplier mapping?

Suppliers can differ by:

• Strength (for example, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg tablets, subject to market availability by period)
• Packaging configuration (bottles vs blister)
• Country (U.S. vs EU vs other regions)

Procurement and regulatory risk typically depend on the manufacturing site(s) tied to each strength/packager combination.

Which wholesalers distribute Fycompa in the U.S.?

Quick answer: Fycompa distribution in the U.S. flows through the major pharmaceutical wholesalers that carry Eisai-branded products. These typically include companies such as:

• McKesson
• AmerisourceBergen
• Cardinal Health
• Owens & Minor

Brand availability and allocation can shift by wholesaler and period, but the purchasing channel for most U.S. hospital and retail pharmacy procurement routes through these distribution networks.

Who supplies the perampanel API used for Fycompa?

Quick answer: Public disclosures that name specific perampanel API manufacturers are not consistently available across all jurisdictions and time windows. In practice, procurement diligence relies on:

• DMF-linked API manufacturer names when accessible in the regulatory dossier context
• cGMP inspection coverage for DMF-associated sites
• supply chain statements within regulatory submissions and quality agreements

The only entity that is consistently identifiable from public U.S. drug listings is the branded labeler, Eisai Inc. for finished-dose supply.

What excipient and packaging suppliers support Fycompa tablets and bottles?

Quick answer: Excipient and packaging suppliers are commonly qualified suppliers within the manufacturer’s supply chain and are not always listed publicly at the component level. Where component disclosure exists, it is usually tied to:

• specific dosage form build sheets
• component specifications in submissions
• packaging configuration used in a particular market

Component-level sourcing is mainly handled in quality agreements between the finished-dose manufacturer (or contract manufacturer) and packaging/excipient vendors.

How does Eisai’s supplier model work for Fycompa (internal vs contract manufacturing)?

Quick answer: Eisai generally operates a hybrid model across oncology, neurology, and specialty lines, using internal manufacturing and contract manufacturing where qualification, capacity, or cost structures support the supply plan. For Fycompa, the supply chain is managed under Eisai’s regulatory responsibility as the U.S. labeler.

What drives changes in Fycompa supplier selection?

Supplier switching usually occurs due to:

• capacity expansion or bottleneck resolution
• site remediation or inspection outcomes
• cost optimization and multi-year supply contracts
• changes in packaging format or blister/bottle sourcing
• regulatory submissions requiring manufacturing comparability work

What patent estate does Fycompa tie to supplier sourcing (generic risk)?

Supplier selection for procurement can be influenced by generic and authorized generic entry risk. For perampanel, patent and exclusivity status determine whether alternate manufacturers can legally supply the market.

Why supplier mapping matters for patent challenges

When Paragraph IV generic filings occur, litigation and settlement terms can constrain:

• who can manufacture
• when generics can launch
• whether authorized generics are allowed
• which strengths or NDCs are affected

This can create short-term supply pressure that pushes purchasing toward specific qualified lots or sites.

What FDA status is Fycompa in, and how does that affect sourcing?

Quick answer: Fycompa is a marketed brand with active FDA listings as an oral antiepileptic (antiepileptic drug). Its regulatory status dictates that suppliers for finished-dose supply must comply with current manufacturing and labeling requirements for the listed NDCs.

Orange Book relevance

Fycompa’s legal and exclusivity framework is tracked in the Orange Book for drug products and approved application listings, which helps determine when FDA can approve generics or when exclusivity blocks entry.

How to identify the correct Fycompa suppliers for procurement: an evidence-based checklist

Quick answer: Procurement teams typically triangulate supplier identity using three evidence layers:

1. FDA labeling and product listings: identifies the U.S. labeler and manufacturing disclosure where present
2. NDC-level build and packaging configuration: ties the lot/strength to a specific manufacturing and packaging setup
3. Quality system traceability: the lot release and CoA trail back to the actual manufacturing site and batch genealogy

This is the practical way to identify which company’s site produced which commercial lots.

Key Takeaways

• Eisai Inc. is the U.S. branded labeler and accountable supplier for Fycompa (perampanel) finished-dose supply in FDA contexts.
• U.S. distribution is handled through major wholesalers such as McKesson, AmerisourceBergen, and Cardinal Health.
• Component-level suppliers for perampanel API and excipients are not consistently published in a single public place; supplier identification typically requires regulatory dossier context (DMF-linked sites) and quality/lot traceability rather than a public vendor list.
• Supplier mapping for procurement should be done at NDC strength and packaging configuration level, using the lot-to-site evidence trail.

FAQs

Which company owns Fycompa in the U.S.?

Eisai Inc. is the U.S. labeler associated with Fycompa.

Are there multiple manufacturing sites for Fycompa tablets?

Yes, commercial supply can use multiple sites across strengths and packaging configurations depending on qualified capacity and regulatory approvals.

Who distributes Fycompa to pharmacies and hospitals?

Fycompa typically distributes through major U.S. pharmaceutical wholesalers including McKesson, AmerisourceBergen, and Cardinal Health.

Can a generic supplier manufacture perampanel tablets while patents are active?

Only to the extent permitted by FDA approvals and the applicable patent/exclusivity constraints tied to each NDC and strength, including any relevant litigation and settlement terms.

How do buyers confirm the real manufacturing source of Fycompa lots?

By traceability from the lot CoA and documentation to the manufacturing site referenced in product release and quality records, often aligned to NDC build details.

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. Drugs@FDA.
3. FDA labeling and product listing records for Fycompa (perampanel).