Last updated: June 17, 2026
DYANAVEL XR 5 suppliers: Who manufactures, supplies, and distributes this amphetamine product?
Executive summary: Dyanavel XR 5 is an FDA-approved extended-release amphetamine formulation (amphetamine mixed salts). The product is marketed in the US by Tris Pharma, Inc.. Public, product-linked supply-chain details typically route through (1) the branded manufacturer or its contract manufacturing organizations (CMOs), (2) API suppliers for amphetamine mixed salts (or their key intermediates), and (3) packaging and label/distribution partners. However, a complete supplier roster (named API sites, CMO plants, and distribution intermediaries) is not available from the provided information set, so no supplier list can be published without risking incorrect attributions.
Who supplies the API for DYANAVEL XR 5 (amphetamine mixed salts)?
Direct answer: The named API supplier(s) for Dyanavel XR 5 are not determinable from the information provided.
Which amphetamine mixed salts supply chains power extended-release products?
Extended-release amphetamine products generally rely on:
- AMPHETAMINE mixed salts API (or key salt components) sourced through qualified suppliers
- Release-controlling excipients and polymer systems for XR performance
- Blending and controlled-release processing performed at a finished-dose facility
Without the Dyanavel XR 5 product-specific manufacturing declarations or site-level filings, supplier identification cannot be verified.
Who manufactures the finished dose for DYANAVEL XR 5?
Direct answer: The finished-dose manufacturer (finished goods CMO or internal Tris Pharma site) is not identifiable from the provided information.
Does the FDA label name a manufacturer or packager?
Drug labels sometimes show:
- “Manufactured for” the NDA holder (marketing authorization holder)
- “Distributed by” or “Packaged by” specific entities
Those label-level entities can indicate the operational supply chain, but the specific Dyanavel XR 5 label text is not provided here.
What contract manufacturing organizations (CMOs) supply DYANAVEL XR 5?
Direct answer: No CMO named to Dyanavel XR 5 can be stated from the information provided.
What filings typically identify CMOs for branded amphetamine XR products?
CMO names often surface through:
- FDA drug establishment inspection lists and 483-linked plant identifiers
- Label “manufactured for” entities
- Patent filings listing manufacturing method claims and examples
- Third-party supply statements in investor materials
None of those source artifacts are included in the prompt.
Who distributes DYANAVEL XR 5 in the US?
Direct answer: Tris Pharma, Inc. is the marketing company for Dyanavel XR products in the US, but the named distribution channel partners (wholesalers, logistics integrators) are not available from the provided information.
Is “distributed by” different from “manufactured by”?
Yes. For many controlled-substance products, distribution is separated into:
- Packaging and finished-dose manufacturing
- Wholesale distribution and pharmacy channel logistics
- Controlled-substance handling and compliance programs
A supplier roster requires label and distribution data that is not included.
How can competitors source DYANAVEL XR 5 components (API, excipients, XR polymers)?
Direct answer: Component sourcing for Dyanavel XR 5 cannot be mapped to named suppliers from the provided information.
Generic and authorized-OTC entrants often face what supply constraints?
- Limited qualified supply for amphetamine salts and regulatory controls around controlled-substance manufacturing
- Higher burden for demonstrating consistent XR release performance
- Container closure and dose unit manufacturing constraints
A credible supplier mapping requires source documents not present in the prompt.
What supplier data is typically listed in Orange Book, labeling, and FDA resources?
Direct answer: The Orange Book and FDA labeling can identify the NDA holder and sometimes the listed manufacturer/packager, but supplier entities for API and CMOs require additional site-level or label text.
Where would you find supplier names for DYANAVEL XR 5 if label text were available?
- FDA label “Manufactured for” and “Distributed by” lines
- NDC directory manufacturer fields
- Drug establishment registration and listing databases (site-level, not always product-level)
No such fields are supplied in the prompt.
Key takeaways
- Dyanavel XR 5 is marketed in the US by Tris Pharma, Inc.
- A named list of API suppliers, finished-dose manufacturers/CMOs, and distribution partners for Dyanavel XR 5 cannot be produced from the provided information.
- Producing a reliable supplier roster requires product-specific label/manufacturer lines and site-linked manufacturing records, neither of which are included.
FAQs
- Who is the NDA holder for DYANAVEL XR 5?
Tris Pharma, Inc.
- Does DYANAVEL XR 5 have multiple manufacturers or just one?
That cannot be determined from the provided information.
- Are API suppliers for amphetamine XR listed publicly?
Not consistently; often only the NDA holder and label manufacturing/packaging entity are visible without deeper site records.
- How do I identify the finished-dose CMO for DYANAVEL XR 5?
By the label “manufactured for”/packaged by entity and then matching to FDA establishment/site identifiers, neither of which are provided here.
- Can wholesalers be identified as suppliers for DYANAVEL XR 5?
Wholesalers are typically distribution channel entities, but their names must come from label/distribution documentation not included in the prompt.
References
- (No citable sources were provided in the prompt.)
