Last updated: May 31, 2026
XCOPRI (cenobamate) Suppliers: API Manufacturers, Contract Development and Manufacturing, and Key Material Sources
XCOPRI (cenobamate) is manufactured through a vertically integrated and outsourced supply chain that typically spans active pharmaceutical ingredient (API) production, key intermediates, and finished-dosage contract manufacturing for tablets. The supplier set is governed by (1) Orange Book-listed drug substance and finished-product patent filings, (2) FDA CDER Chemistry Manufacturing Controls (CMC) submissions, and (3) supplier listings embedded in DMFs and manufacturing site disclosures linked to FDA inspections.
Source-linked supplier identification requires FDA/Orange Book and DMF-backed manufacturing-site data. Without those specific, citable listings for XCOPRI drug substance and product, a complete and accurate supplier list cannot be produced.
What suppliers make XCOPRI (cenobamate) drug substance API?
Featured snippet: XCOPRI’s API suppliers are the API-manufacturing sites referenced in FDA DMFs and the CMC sections of the approved NDA for cenobamate. A definitive supplier list depends on the exact drug substance manufacturing sites disclosed in those submissions.
API and key intermediate supply chain for cenobamate
Cenobamate manufacturing normally requires upstream supply of halogenated aromatic and nitrile-containing intermediates, followed by cyclization and purification steps that drive impurity profiles (genotoxic and nitrosamine-relevant) and crystallization control for solid-state form.
Supplier identification must map to:
- Drug substance manufacturing site addresses tied to the NDA/DMF
- Intermediate DMF entries that feed cenobamate synthesis
- Quality agreement relationships for incoming raw materials and catalysts
- Quality system scope consistent with FDA inspection history
Which companies contract manufacture XCOPRI tablets (finished dosage form)?
Featured snippet: Finished-dose tablet suppliers are the tablet manufacturing and packaging sites disclosed in XCOPRI’s FDA-approved CMC and inspection records. A definitive list requires those named sites.
Tablet and packaging touchpoints
For XCOPRI 25 mg, 50 mg, 100 mg, and 150 mg tablet strengths, finished dosage typically involves:
- Tablet compression or tableting under validated granulation and blending processes
- Film coating, if used in the product’s dosage form build
- Packaging line qualification for bottling and/or unit-dose formats
- Control of cross-contamination risk and cleaning validation for high-potency neuroactive compounds
How many XCOPRI manufacturing sites are listed on FDA inspections and CMC disclosures?
Featured snippet: The count equals the number of drug substance and drug product manufacturing addresses disclosed in the approved dossier and shown in FDA inspections.
A complete count requires site-level disclosures. Without direct access to the FDA manufacturing site list tied to XCOPRI’s approved submissions, any number would be speculative and not suitable for supplier due diligence.
What Orange Book listings and patent assignees imply about XCOPRI supply chain?
Featured snippet: Orange Book listings identify approved products and referenced patents; they do not directly disclose supplier identities. Supplier mapping requires CMC/DMF manufacturing-site data.
How Orange Book data supports supplier sourcing
Orange Book entries help identify:
- The exact product(s) and NDA reference
- Associated patent categories (drug substance, formulation, method of use)
- Product changes that may correspond to manufacturing transfers
Those patent-linked product changes can correlate with CMC supplements that often include manufacturing site updates, which then link to supplier substitutions.
What DMFs cover cenobamate and its intermediates for XCOPRI supply?
Featured snippet: DMFs that cover cenobamate and intermediates identify the substance suppliers; the DMF owner and manufacturing site are the supplier.
DMF-based mapping requirements
A supplier list is built from:
- DMF holders (cross-referenced through FDA review history)
- DMF type (drug substance vs. drug product vs. intermediate)
- Manufacturing site addresses on file
- Changes tracked by CMC supplement histories
Without the DMF table or its site-level contents for cenobamate and intermediates, the supplier list cannot be made complete and accurate.
Which raw-material suppliers are critical for cenobamate API quality?
Featured snippet: Key raw materials are starting materials, catalysts, and solvents whose impurity carryover must be controlled to meet specification and regulatory limits.
Due diligence categories that drive supplier qualification
- Halogenated aromatic starting materials and nitrile precursors
- Reagents used in ring formation steps
- Hydrogenation or oxidation reagents (impurity and residue controls)
- Crystallization solvents and anti-solvent selection driving polymorph risk
A supplier map for these categories requires material-spec and supplier-qualification dossiers, which must be source-backed to avoid mixing unrelated industrial grades or non-approved routes.
How does XCOPRI supplier availability affect generic or biosimilar risk?
Featured snippet: Supply chain constraints can slow generic entry if API intermediates, controlled impurities, or solid-state forms are hard to replicate.
Patent and process interplay
Even if patents are the main barrier, supply chain constraints matter through:
- Ability to source the same or acceptable alternative intermediates
- Ability to match impurity profile (especially those flagged for genotoxic risk)
- Ability to reproduce solid-state form and dissolution performance
This affects Paragraph IV readiness, ANDA technical feasibility, and inspection readiness for manufacturing sites.
Where do XCOPRI manufacturing transfers typically show up in FDA records?
Featured snippet: Manufacturing transfers appear as CMC supplements that update manufacturing sites, process controls, and validation batches.
Transfer signals
- New manufacturing address added to drug substance or drug product
- Process change affecting impurity control strategy
- Validation completion milestones in supplements
Supplier identification is anchored to the specific approved site lists in those supplements.
XCOPRI supplier landscape: what matters for licensing and procurement?
Featured snippet: For licensing and procurement, the supplier landscape is decided by named FDA manufacturing sites for (1) drug substance and (2) finished tablets, plus validated packaging lines and quality agreements.
Procurement due diligence checklist for XCOPRI suppliers
- GMP certification and FDA inspection outcomes for each site
- DMF linkages and cross-referenced approval history
- Impurity control strategy alignment (spec compliance and batch release)
- Supply continuity for key intermediates and solvents
- Cold-chain or temperature control needs (if any) for packaging materials
Key Takeaways
- XCOPRI supplier identification requires FDA-backed manufacturing-site data from NDA/CMC submissions and DMF entries for cenobamate and its intermediates.
- Orange Book listings alone do not disclose supplier identities; supplier mapping depends on DMF owner/site and approved CMC manufacturing addresses.
- A complete, defensible supplier list cannot be produced without the site-level FDA/DMF information tied specifically to XCOPRI.
- For procurement, the critical supplier set is split between drug substance (API) manufacturing sites and finished-tablet manufacturing and packaging sites, each with validated quality agreements and impurity controls.
FAQs
- Which FDA database lists the exact XCOPRI API manufacturing sites?
- How do cenobamate DMFs identify the drug substance and intermediate suppliers?
- What manufacturing-site changes in XCOPRI CMC supplements indicate a supplier transfer?
- How should companies qualify an XCOPRI tablet contract manufacturer for potency and impurity control?
- What supplier constraints most commonly delay generic cenobamate ANDA launches?
References
- FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
- FDA. (n.d.). Drugs@FDA. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA. (n.d.). CDER Drug Approvals and CMC review materials. U.S. Food and Drug Administration. https://www.fda.gov/drugs
