Suppliers and packagers for generic pharmaceutical drug: armodafinil

armodafinil

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma Ltd	ARMODAFINIL	armodafinil	TABLET;ORAL	206069	ANDA	Aurobindo Pharma Limited	65862-805-05	500 TABLET in 1 BOTTLE (65862-805-05)	2018-03-06
Aurobindo Pharma Ltd	ARMODAFINIL	armodafinil	TABLET;ORAL	206069	ANDA	Aurobindo Pharma Limited	65862-805-30	30 TABLET in 1 BOTTLE (65862-805-30)	2018-03-06
Aurobindo Pharma Ltd	ARMODAFINIL	armodafinil	TABLET;ORAL	206069	ANDA	Aurobindo Pharma Limited	65862-805-60	60 TABLET in 1 BOTTLE (65862-805-60)	2018-03-06

Armodafinil API and Finished-Dose Suppliers: Who Manufactures It, Where It Comes From, and What to Check in Supply Contracts

Last updated: May 24, 2026

Armodafinil supply chains split between (1) branded finished-dose manufacturers and (2) API producers. In practice, supplier lists for armodafinil vary by geography and regulatory track record, and the most decision-relevant work is to verify FDA regulatory status (Orange Book and any relevant filings), current manufacturing sites, and whether the supplier can support NDA/ANDA-validated quality systems and controlled substance handling requirements where applicable.

Who supplies armodafinil (API and finished tablets) in 2026?

Answer: Armodafinil is manufactured by multiple generic and branded supply networks. The branded supply in the US historically tracks to Cephalon/Teva ownership of Nuvigil (armodafinil). Generic armodafinil tablets are sourced through ANDA supply chains that include multiple US and non-US contract manufacturers and API producers, with sites listed in regulatory filings and FDA databases.

Because “supplier” can mean API only, finished dose only, or either through CMOs, the actionable diligence is to anchor supplier identification to (a) FDA drug-application manufacturing site listings and (b) Orange Book product listings by labeler/ANDA holder, then map those labelers to API and CMO sources used in commercial lots.

What “supplier” should mean in procurement for armodafinil

Procurement typically needs three supplier layers:

1. ANDA labeler / finished-dose manufacturer (the firm distributing the commercial product in a market)
2. API manufacturer (the firm producing armodafinil active ingredient)
3. CMO packager/tablet manufacturer (if the labeler outsources manufacturing and packaging)

In regulatory and litigation contexts, the most important are items (1) and (2), because they tie to manufacturing sites and chemistry control strategies, not only physical logistics.

Which companies market armodafinil tablets in the US (Orange Book labelers)?

Answer: US commercial armodafinil exists in branded and ANDA forms. The Orange Book labeler and NDA/ANDA applicant determine who the FDA considers responsible for the approved product, label strength, dosage form, and listing.

For supplier due diligence, map:

• NDA product labeler (branded)
• ANDA holders by strength and dosage form
• Manufacturing site details linked to those approved products

What to check immediately in FDA/Orange Book exports

• Labeler name (responsible applicant)
• Dosage form (tablets) and strength (commonly 50 mg, 100 mg, 150 mg, 200 mg depending on label)
• Patent and exclusivity tie-ins (impacts launch readiness and lot supply planning)
• Application type (NDA vs ANDA)

What API suppliers produce armodafinil?

Answer: API production for armodafinil is handled by specialized API manufacturing firms serving global ANDA supply chains. Supplier identity is best verified against FDA-linked manufacturing disclosures (site-level information appears in application dossiers and inspection databases, and is reflected indirectly through ANDA approvals and manufacturing site documentation).

How to validate an armodafinil API supplier fast

For each potential API supplier, contracts and audit plans should confirm:

• GMP status and FDA inspection history for the API manufacturing site
• Quality system scope for armodafinil (not generic “pharma solids” only)
• Impurity profile control aligned to pharmacopeial and regulatory specifications used in approved submissions
• Crystallization and chiral purity controls (armodafinil is the (R)-enantiomer of modafinil; consistent enantiomeric control is a core quality attribute)
• Ability to support regulatory batches (tech transfer documents, validation packages, batch records)

Are there common API sources concentrated in certain geographies?

Commercial supply is typically concentrated in countries with mature high-potency and chiral API capabilities. The procurement impact is that long lead times often occur in winter or when sites run dedicated batches for multiple ANDA labelers.

Which suppliers provide armodafinil finished tablets (CMOs vs in-house)?

Answer: Many generic armodafinil tablets are produced under outsourcing models where ANDA labelers use contract manufacturing for tableting and packaging. Branded supply can be handled by the NDA holder’s network, but current market mixes still rely on external manufacturers for scale and redundancy.

What matters for finished-dose supplier selection

• Tablet composition and formulation controls: excipient controls, dissolution specifications, and coating/tablet hardness process windows
• Analytical method support: dissolution, assay, and impurity methods that align with ANDA expectations
• Packaging and labeling readiness: US NDC packaging compliance and serialized packaging readiness where required
• Supply continuity: ability to run multi-strength programs without cross-contamination issues

What is the link between armodafinil suppliers and FDA approval pathways?

Answer: Supplier eligibility is driven by which applicant holds the NDA/ANDA and which manufacturing sites are used to produce drug substance and drug product for approved commercial batches. The FDA pathway (NDA or ANDA) does not name API suppliers publicly in a consistent way, but site and responsibility details can be traced via FDA records and product-level filings.

NDA vs ANDA supplier implications

• NDA (branded): manufacturing network is tied to the NDA holder and approved manufacturing sites
• ANDA (generics): each ANDA applicant maintains its own quality system and supports its own commercial manufacturing strategy

In practice, ANDA labelers may source from the same API producers and CMOs, but the legally responsible party is the ANDA applicant.

Do any supplier constraints exist for armodafinil (quality, regulatory, logistics)?

Answer: The main constraints are quality control of chiral purity and impurity profiles, plus reliable GMP capacity for commercial lot runs at multiple strengths.

Quality attributes to anchor in supplier qualification

• Enantiomeric purity (armodafinil is a single-enantiomer drug)
• Specified impurities and degradation products under approved specs
• Stability-indicating method controls used during shelflife development and stability programs
• Residual solvents and residual catalysts, if relevant to process route
• Particle size / polymorph control if it affects dissolution and bioavailability

Commercial constraints that affect supplier availability

• Dedicated manufacturing slots for controlled and high-demand strengths
• Batch size constraints tied to API crystallization and isolation yield
• Lead times for packaging materials and US labeling components

How does armodafinil supplier selection change by strength (50/100/150/200 mg)?

Answer: Strength-specific manufacturing can differ in fill depth, tablet compression profiles, and packaging layouts. Supplier qualification should be strength-specific even if the API batch is common across strengths, because tablet process parameters and dissolution outcomes can vary.

Procurement should confirm:

• Same API supplier and lot release strategy across strengths (if applicable)
• Tablet press and granulation equipment availability for each strength
• Strength-specific stability programs and commercial release testing plans

What are the key diligence checks when contracting armodafinil suppliers?

Answer: Use a contract and audit checklist tied to regulatory traceability and lot release.

Diligence checklist for API supplier contracts

• Site GMP compliance history and coverage for armodafinil
• Change control process covering polymorph, crystallization, and process parameter shifts
• Batch record access for regulatory and customer audits
• CoA format and method details (assay, impurities, solvents, water, enantiomeric purity)
• Packaging and transport conditions for API integrity
• Supply agreement terms for allocation during shortage

Diligence checklist for finished-dose supplier contracts

• Tablet formulation and dissolution spec alignment with customer requirements
• Batch release testing (assay, impurities, dissolution) and method validation
• Traceability for excipients and colorants where applicable
• Complaint handling and deviation CAPA timelines
• Labeling/serialization capability for US market distribution

Key Takeaways

• Armodafinil supply is typically distributed across multiple ANDA labelers and CMO networks, with API supply handled by specialized API producers.
• The most decision-grade supplier identification is anchored to FDA Orange Book product records by applicant and manufacturing site documentation, then mapped to API manufacturers and CMOs through site-level disclosures and audit evidence.
• Supplier selection should be driven by validated enantiomeric purity, impurity control, and stability-indicating method capability for armodafinil, not only by “tablet availability.”
• Contracting must include change control, audit rights, and shortage allocation to protect regulatory and commercial continuity.

FAQs

1. How do I identify the API manufacturer for a specific armodafinil ANDA labeler?
   Map the ANDA applicant to the approved manufacturing sites disclosed in FDA-linked records, then confirm the API site via batch CoAs, audit findings, and regulatory tech transfer documentation.

2. What quality controls matter most for armodafinil API?
   Chiral/enantiomeric purity, impurity and degradation profile control, residual solvents/catalysts, and stability-indicating analytical methods.

3. Can the same armodafinil API supplier support multiple tablet strengths?
   Often yes, but strength-specific finished-dose validation and dissolution performance still require qualification for each strength and manufacturing process set.

4. What supplier risks drive armodafinil shortages?
   Limited crystallization/isolation capacity for API, packaging material lead times, and GMP slot constraints across multiple products at shared manufacturing sites.

5. How do I structure a supply contract to reduce regulatory batch rejection risk?
   Require lot traceability, defined CoA testing acceptance criteria, change control notice windows, and audit rights tied to regulatory readiness and deviation handling timelines.

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (public database).
2. FDA Drug Approval and Labeling records for armodafinil (application and labeler records).