Last updated: April 23, 2026
What commercial suppliers supply nuvigil?
“Nuvigil” is the brand name for armodafinil (CAS 118139-41-4). Commercial supply chains for armodafinil generally split into: (1) API manufacturers, (2) intermediates and custom synthesis providers, and (3) formulation/finished-dose CMOs. Public-facing “supplier lists” for armodafinil are limited because many companies supply through internal procurement frameworks rather than open distributor catalogs.
Actionable bottom line: For procurement and partner diligence, the supplier universe is defined by:
- FDA Drug Master File (DMF) holders for armodafinil and related intermediates (API and manufacturing aids).
- ANDA and branded drug manufacturing sites for finished-dose supply.
- Contract synthesis and intermediate suppliers that support armodafinil process chemistry (not always named in public-facing sources).
Which firms are known to supply Nuvigil or armodafinil in the US market?
Based on the branded drug manufacturing linkage used in US regulatory filings and the typical branded supply model for armodafinil, Nuvigil’s market presence is anchored to:
- Cephalon LLC / Teva Pharmaceuticals branded ownership and commercialization
- One or more API and finished-dose manufacturing sites listed in FDA drug and facility records tied to Nuvigil
Public records frequently show drug product manufacturing handled by established CMOs or internal sites, with API produced by specialized armodafinil makers using proprietary process routes.
How do you map “suppliers” into procurement-ready categories?
Use this procurement segmentation for due diligence and contracting:
| Category |
What to contract for |
What to verify |
Typical regulatory hook |
| API supplier |
Armodafinil API |
Site qualification, DMF status, impurity profile capability, batch consistency |
FDA DMF (API) |
| Intermediate supplier |
Key armodafinil intermediates |
Chemical specification and change control discipline |
Often DMFs or filings tied to API |
| Finished-dose supplier |
Nuvigil tablets (10-year demand runs) |
Hold time, packaging specs, stability program, tablet uniformity |
FDA facility listings and NDA/ANDA linkages |
What are the best public sources to identify armodafinil suppliers?
Use these sources to identify actual manufacturing and filing responsibility rather than “brokers”:
- FDA Drug Master File (DMF) database
- Confirms API/intermediate filing holders for armodafinil-related components.
- FDA Orange Book (armodafinil products and regulatory linkages)
- Shows branded products and approved references.
- FDA Facility Registration and Drug Establishment listings
- Narrows to registered manufacturing sites for drug product and (in some cases) API production.
What does the supply chain typically require for armodafinil?
Armodafinil supply generally depends on controlled synthesis steps that require:
- Process control for chiral and impurity-sensitive intermediates
- Qualified solvents/reagents and validated purification
- Analytical capability for specified impurities and polymorph control (where relevant to the solid-state form of the API)
For procurement, the key is to verify:
- Impurity acceptance thresholds used in the drug substance specification
- Consistency across commercial batches
- Change control and requalification triggers for process updates
Procurement target checklist (API and finished dose)
Use this as a direct contracting and vendor qualification set:
- GMP compliance at the production site (inspection history review)
- Regulatory documentation: DMF reference for API and any related intermediates
- Specification alignment: impurity profile and assay limits consistent with approved products
- Supply assurance: lead times, minimum order quantities, and capacity for scaling
- Packaging integrity for API (if supplying under compendial or drug-substance spec frameworks)
What risks affect armodafinil supplier selection?
Supplier selection for nuvigil/armodafinil carries recurring operational risks:
- Regulatory dependency on DMFs: if a vendor’s DMF reference is not held/accessible, qualification delays follow.
- Impurity sensitivity: small process changes can shift impurity burdens, triggering batch rejections.
- Geopolitical and logistics exposure: finished-dose packaging and API shipments can face route volatility.
Competitive supplier diligence approach
When building a sourcing strategy for armodafinil:
- Prioritize DMF-linked API manufacturers over general chemical distributors.
- Use facility registration to confirm where tablets are actually made and packaged.
- Demand validation evidence around impurities and solid-state handling.
Key Takeaways
- “Suppliers for Nuvigil” maps to armodafinil API manufacturers, intermediate makers, and finished-dose tablet CMOs, not retail distributors.
- The most reliable identification method is FDA DMF + facility registration + Orange Book linkage, which ties supply responsibility to regulatory records.
- Contracting should require DMF accessibility, impurity specification alignment, GMP site qualification, and supply continuity terms.
FAQs
-
Is “Nuvigil supplier” the same as armodafinil API supplier?
No. Nuvigil refers to finished-dose tablets; API supply is often produced by separate GMP manufacturers with DMFs.
-
Where can I find authoritative evidence of armodafinil API suppliers?
FDA DMF listings and facility registration records tied to approved products.
-
Do finished-dose CMO suppliers appear in public lists?
Often indirectly via facility registrations and regulatory documentation linkages for the branded product.
-
What matters most in choosing an armodafinil API supplier?
DMF status, impurity control capability, and commercial batch consistency under GMP.
-
Can a broker supply armodafinil reliably?
Brokers can source material, but procurement diligence should verify the actual GMP manufacturer and regulatory filing path.
References (APA)
[1] FDA. (n.d.). Drug Master Files (DMF). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/dmf/
[2] 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/ob/
[3] FDA. (n.d.). Drug Establishment Registration and Listing. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-establishment-registration-and-listing-drugs
