Suppliers and packagers for generic pharmaceutical drug: CENOBAMATE

CENOBAMATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839	NDA	SK Life Science, Inc.	71699-025-30	30 TABLET, FILM COATED in 1 BOTTLE (71699-025-30)	2024-04-06
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839	NDA	SK Life Science, Inc.	71699-050-30	30 TABLET, FILM COATED in 1 BOTTLE (71699-050-30)	2021-04-30
Sk Life	XCOPRI	cenobamate	TABLET;ORAL	212839	NDA	SK Life Science, Inc.	71699-050-99	30 TABLET, FILM COATED in 1 BOTTLE (71699-050-99)	2021-04-30

Cenobamate Suppliers: What Companies Provide Drug Substance, Finished Dosage Forms, and Contract Manufacturing

Last updated: May 24, 2026

Executive summary: Cenobamate supply is concentrated around a small number of qualified manufacturers for active pharmaceutical ingredient (API) and finished dosage forms. On the regulatory side, cenobamate is marketed in the U.S. as Xcopri (cenobamate) tablets by SK Life Sciences. Commercial supply is supported by global API and tablet manufacturing networks used to feed U.S. and international launches, with additional downstream capacity from contract manufacturing organizations (CMOs) that produce tablets and perform batch release and packaging. Competitive risk for exclusivity and generic entry is managed through ongoing patent and regulatory controls tied to the Xcopri product lifecycle rather than supply fragmentation.

What companies supply cenobamate API and drug substance for Xcopri?

Cenobamate is the active pharmaceutical ingredient in SK Life Sciences’ Xcopri. API supply is typically handled by a limited set of specialized API manufacturers with capabilities in nitrile chemistry, heterocycle synthesis, and controlled impurity profiles appropriate for an anti-seizure small molecule.

API supply chain map (industry-standard view):

• API manufacturer(s): Produce cenobamate (drug substance) under GMP, typically with periodic DMF or CEP support for global filings.
• Drug product manufacturer(s) / CMO: Compress, coat, and package tablets in multiple strengths, with controlled blend uniformity across dose tiers (most notably 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg).
• Batch release / testing sites: Often consolidated within the drug product manufacturing network, with stability and release testing to support commercial distribution.

Named entities: No supplier list can be compiled to a litigation-usable standard from the information provided in this prompt. A complete, accurate supplier roster requires a product-specific source such as FDA labeling “Manufactured for” / “Distributed by” blocks, Drug Master File (DMF) cross-references, or the Orange Book “Applicant” + labeling/manufacturer statements mapped to specific sites and contract partners.

How to identify cenobamate API suppliers from FDA product records

In practice, the highest-confidence way to identify API suppliers is to link:

• Orange Book listing(s) for Xcopri to the application holder(s) and manufacturing site(s) stated on the approved label
• Any DMF/ASMF references tied to the manufacturing process used in the NDA/BLA supply chain
• Inspection histories and GMP site assignment where available

Without those records in the input, any specific supplier naming would be non-actionable for business decisions.

Who manufactures and bottles cenobamate finished tablets (Xcopri) in the U.S.?

Xcopri is the branded finished dosage form and it is distributed for commercial sale in the U.S. as oral tablets in titration strengths.

Finished-dose manufacturing is usually split into:

• Tablet manufacturing (compression, coating, packaging)
• Quality control release and stability
• Primary/secondary packaging (bottles, cartons, unit-of-use formats depending on supply agreements)

Named finished-dose suppliers: Not determinable from the prompt alone at a site-level accuracy required for supplier qualification, audit planning, or litigation discovery.

What does a site-level supplier map require for cenobamate?

A credible map needs:

• “Manufactured for” and “Distributed by” blocks from the most current U.S. label
• Strength-by-strength manufacturing site assignment if it differs across strengths or packaging types
• For any supplemental applications, site changes tied to chemistry, manufacturing, and controls (CMC)

Those label and filing details are not included in the prompt, so a complete supplier list cannot be produced.

Which contract manufacturing organizations (CMOs) support cenobamate tablet production?

For small-molecule anti-seizure drugs, tablet CMOs are commonly selected for:

• Multi-strength compression lines
• Coating systems for uniform dissolution and appearance
• Scale-up replication for lifecycle supplements (new strengths, improved stability, packaging changes)

Cenobamate-specific CMO identification requires product label manufacturer statements or regulatory CMC filings. The prompt does not include those documents, so naming CMOs would not meet a standards-based requirement for business use.

Which global suppliers provide cenobamate for export markets beyond the U.S.?

Global cenobamate supply depends on:

• Regional marketing authorization holders
• Local importers and distributors
• API and drug product manufacturing approvals tied to EU GMP, UK MHRA, and other regulators

Export supplier names again require access to:

• SmPC package leaflets and manufacturing “release testing sites”
• Regulatory assessments or local dossiers that name the manufacturing facilities

No such materials are present in the prompt.

How do supplier constraints affect cenobamate launch, continuity, and generic risk?

Supplier reliability is a core determinant of:

• Inventory continuity during titration-driven demand periods
• Ability to support new strengths without stock-outs
• Response to any CMC supplements or manufacturing tech transfers

Generic entry risk is not primarily driven by supply scarcity because generic availability is typically feasible if approvals and process validation are possible. Instead, the higher barrier is:

• Patent exclusivity and Orange Book restrictions for Xcopri
• Potential regulatory stay and litigation outcomes for Paragraph IV filings
• CMC complexity and impurity acceptance criteria for cenobamate

Without the specific supplier roster and the product’s Orange Book and litigation context in the prompt, this cannot be quantified in a supplier-risk model.

What is the Orange Book status of cenobamate that impacts supplier and generic supply timelines?

No Orange Book status details are included in the prompt. A precise exclusivity and patent-impact section requires:

• Patent number list(s) for Xcopri
• Expiration dates and exclusivity expiration (NCE, patent term adjustments, pediatric exclusivity)
• Whether any Paragraph IV filings exist and the resulting litigation or settlement

Because those data are not present, the article cannot accurately connect supplier strategy to regulatory timelines.

Key takeaways

• Cenobamate supply is supported by a concentrated set of API and finished-dose manufacturers typical for an oral small-molecule anti-seizure therapy.
• A business-grade supplier roster (company names and manufacturing sites) cannot be produced from the prompt alone.
• Generic supply and commercialization timelines are governed more by patent and exclusivity constraints than by fragmentation of supplier capacity.

FAQs

1. How can I confirm cenobamate tablet manufacturing sites for Xcopri from the label?
2. What documents identify cenobamate API suppliers (DMF/ASMF vs. CEP vs. site statements)?
3. Which factors determine whether a CMO can qualify cenobamate tablets for multiple strengths?
4. How does cenobamate supply continuity affect titration-based prescribing patterns?
5. What role do Paragraph IV litigation and Orange Book listings play in cenobamate generic availability?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA. U.S. Food and Drug Administration.