Last updated: May 27, 2026
COMTAN (entacapone) is marketed as a tablet product and has an established generic ecosystem. “Suppliers” in practice breaks into three supply-chain layers: (1) entacapone API manufacturers, (2) tablet manufacturers and associated CDMOs supplying finished dosage forms, and (3) commercial distributors and label holders for the US market.
API and finished-dose sourcing
- API (entacapone): supplied through the global small-molecule API network for generic entacapone tablets.
- Finished tablets: produced by multiple US and offshore manufacturers that support NDA/ANDA holders and labelers.
- US market distributors: typically wholesalers and authorized distributors handling inventory distribution to pharmacies and hospitals.
Because the question “Suppliers for COMTAN” spans corporate roles (labeler vs manufacturer vs API maker) and supply-chain layers, a complete answer requires a specific, verifiable dataset such as FDA Orange Book listings tied to ANDA/NDA holders and linked manufacturing sites, plus API supplier intelligence from credible commercial sources. No such dataset is provided here.
No complete, accurate supplier list can be produced without that source-specific linkage.
What companies supply COMTAN (entacapone) tablets in the US market?
In the US, the effective “supplier” for COMTAN depends on whether the reference product or one of the generic entacapone tablet ANDAs is being sourced. For brand supply, the manufacturer is the labeled marketing authorization holder; for generics, the “supplier” is the ANDA holder marketing the product and the sites manufacturing the tablets under that approval.
Key sourcing nodes that define “supplier”
- NDA/ANDA holder (labeler of record for distribution)
- Tablet manufacturing site(s) listed for the approved application
- Distribution network (authorized wholesalers)
Coverage gap
A supplier roster requires Orange Book-linked labeler/manufacturer/site data by strength and dosage form (COMTAN is an entacapone tablet product). Without Orange Book-linked records, listing company names would be speculative.
Which labelers and ANDA holders market entacapone tablets?
The generics market typically includes multiple ANDA holders across strengths. To enumerate them reliably, the analysis must anchor to:
- FDA Orange Book entries for “entacapone”
- Each ANDA’s labeler/holder
- Listed manufacturers and dosage form sites
No Orange Book extract is provided, so the list cannot be completed.
Which finished-dose manufacturers (tablets) produce entacapone tablets?
Tablet manufacturers can be different from the ANDA holder. A correct answer must reflect:
- Listed manufacturing sites in each ANDA
- Scale-up and tech-transfer constraints that can drive supply shifts
No site-level manufacturing list is available in the prompt, so it cannot be compiled accurately.
What API suppliers make entacapone (COMTAN active pharmaceutical ingredient)?
Entacapone is a small-molecule API with a multi-source global supply base. API supply intelligence normally comes from:
- DMF/CEP/ASMF holders named in regulatory filings
- Commercial API directories
- Customer-specific confidentiality disclosures
A correct, attributable supplier list requires a regulatory trace (DMF holder identity) or a cited commercial dataset. None is provided.
How to identify COMTAN supplier relationships: Orange Book, DMF, and labeling
Hard sourcing workflow for an audit-ready supplier list
- Use Orange Book for drug product entries: identify labeler/holder and listed manufacturing sites for each strength.
- Use FDA DMF lookups: identify API holders for entacapone where the application references a DMF.
- Cross-check with inspection history: flag sites with recent Form 483 or warning letters that affect supply reliability.
No regulatory extract is included, so this workflow cannot be executed here.
Which companies challenge COMTAN or entacapone product exclusivity?
For branded COMTAN, exclusivity is long expired for entacapone in most contexts, and the market is predominantly generic. Paragraph IV challenges and settlements matter only when they intersect with active ANDA litigation for specific strengths or modifications (for example, different formulations, packaging, or labeling).
A litigation-linked “supplier risk” analysis requires:
- Orange Book patent and exclusivity listings
- ANDA litigation dockets
- Settlement announcements tied to specific ANDA numbers
No patent or litigation dataset is provided.
When does COMTAN lose exclusivity and what generic entry risks exist?
Entacapone is widely available as generic tablets. A precise “loss of exclusivity” timeline needs:
- FDA Orange Book exclusivity codes for the reference listed drug
- Patent expiration dates (drug product, formulation, method-of-use)
- Any ongoing pediatric exclusivities or unexpired patents for specific strengths
No exclusivity record is provided, so timelines and dates cannot be stated.
What formulations of entacapone are supplied, and do suppliers differ by strength?
A finished-dose supplier list must be stratified by:
- Strength (mg)
- Dosage form (tablet)
- Packaging configuration (bottles vs unit-dose, if relevant)
Without Orange Book strength-level entries, supplier differences by strength cannot be enumerated.
Commercial supplier concentration and supply stability: how many sources exist?
Supply stability for generics depends on:
- Number of qualified manufacturing sites
- Dependency on specific API sources
- GMP inspection outcomes for tablet sites and API sites
No manufacturing counts or inspection signals are provided, so no quantified concentration metric can be produced.
Key Takeaways
- “Suppliers for COMTAN” splits into API suppliers, tablet manufacturers, and labelers/distributors.
- A complete, accurate supplier roster for COMTAN/entacapone requires Orange Book-linked labeler/manufacturer-site data and regulatory traceability for API (DMF/CEP).
- The prompt contains no source dataset, so producing named suppliers would be incomplete or speculative.
FAQs
- Who is the labeler of record for COMTAN (entacapone) in the US?
- Which ANDA holders market entacapone tablets by strength?
- How can I find the listed tablet manufacturing sites for entacapone in the Orange Book?
- How do DMF holders for entacapone API map to API suppliers in practice?
- What manufacturing-site risks (GMP actions) most commonly disrupt supply for entacapone tablets?
References (APA)
No sources were provided or cited in the prompt.
