Last updated: June 6, 2026
DYANAVEL XR 10 suppliers: Who manufactures, supplies, and packs Dyanavel XR (amphetamine) 10 mg products for the US market?
DYANAVEL XR 10 is marketed in the US as an extended-release oral amphetamine product. Publicly accessible, reliable supplier and manufacturing attribution depends on the exact labeled product configuration (strength, dosage form, and NDA/labeler) and on the FDA’s listing data that tie the product to specific manufacturing and packaging sites.
What companies supply and manufacture DYANAVEL XR 10 (amphetamine) for FDA labeling and US distribution?
DYANAVEL XR 10 is supplied under the brand’s FDA application and labeler information. For US product-market supply chain mapping, the most probative sources are:
- FDA “Orange Book” (application/NDA linkage and active ingredient identification)
- FDA “CDER Drug Label Information” (labeler/manufacturer info)
- FDA NDC Directory and labeler/manufacturing site listings (where available)
- FDA’s current Good Manufacturing Practice (cGMP) site listings by product (where tied)
- Third-party commercial packer/manufacturer records only after cross-checking against FDA listing artifacts
Hard supplier mapping for “DYANAVEL XR 10” requires the exact NDC/labeler and the FDA listing record for that NDC. Without the specific NDC/labeler entry, “supplier” attribution cannot be made accurately at the site level.
Which entities typically appear in DYANAVEL XR XR supply chains?
In US branded extended-release stimulant products, the label typically spans multiple distinct roles:
- NDA holder / brand owner (marketing authorization and labeling responsibility)
- API supplier (active pharmaceutical ingredient manufacturer)
- Finished-dose manufacturer (formulation and fill for extended-release beads/tablets-capsules depending on product)
- Packager (bottling/labeling, secondary packaging)
- Distribution partners (often wholesalers, logistics firms, or affiliates)
To identify the specific companies for DYANAVEL XR 10, the labeler and manufacturing/packaging sites must be matched to the correct FDA listing entry for the 10 mg strength.
How do you identify DYANAVEL XR 10 manufacturing and packaging sites by NDC and labeler?
Best-practice approach used in patent and regulatory diligence:
- Pull the DYANAVEL XR 10 mg NDC for the exact package size.
- Match the NDC to the FDA labeler record (labeler name tied to the product listing).
- Use the FDA product listing fields that identify:
- Manufacturer and packager
- Repackager (if applicable)
- Relabeler (if applicable)
Why NDC-level matching matters
DYANAVEL XR is sold in multiple strengths and package configurations. Even when the same brand is used, the NDC can point to different packaging/labeling operations, and sometimes to different manufacturing sites within the same corporate group.
What does the Orange Book say about DYANAVEL XR 10 suppliers and manufacturing responsibility?
The Orange Book supports:
- NDA-level linkage for the active ingredient and dosage form
- Patent and exclusivity status (for supplier risk and product lifecycle)
It does not always provide a full “site-by-site” supply chain. For supplier resolution, Orange Book is typically paired with:
- FDA labeler/manufacturer listing
- NDC directory
- Label (US prescribing information) “Manufactured for/ by” section
Which contract manufacturers and packers handle extended-release amphetamine products like DYANAVEL XR?
For many extended-release oral products, manufacturing often splits into:
- API production at one site
- Formulation and dosage manufacturing at another site
- Bottling and packaging at a third site
This pattern exists across stimulant brands, but the exact contractor names for DYANAVEL XR 10 must be confirmed from the product-specific FDA listing and label.
What suppliers can change without patent impact, and what changes can trigger regulatory or litigation risk?
Supplier changes affecting DYANAVEL XR 10 may come from:
- Contract manufacturing reassignments
- Line additions and equipment transfers
- Packaging vendor swaps
Patent and litigation risk typically rises only if:
- The generics/sponsors allege different formulation or manufacturing process that maps to protected process claims
- A supply-chain change is used to support a “design-around” argument in patent disputes
Still, supplier attribution is an operational diligence input; patent estate evaluation is separate from manufacturing attribution.
What generic and biosimilar entry risks exist for DYANAVEL XR 10 supplier substitution?
DYANAVEL XR is a small-molecule extended-release amphetamine product. Supplier substitution risk for generics is mainly about:
- Bioequivalence and formulation equivalence
- Scale-up and process controls
- Release-profile matching
Those are regulated through ANDA bioequivalence submissions and CMC. Supplier changes for the reference listed drug do not automatically invalidate generic entry, but they can affect comparative CMC narratives during litigation.
DYANAVEL XR 10: What is the current FDA market status that governs who supplies it?
Market status for branded stimulants is generally consistent with:
- Ongoing US distribution under the NDA
- Manufacturing and packaging governed by cGMP and site authorizations
However, “who supplies it” is a labeling and listing question. The accurate answer depends on the specific FDA product listing record for the 10 mg strength.
Key takeaways
- Supplier identification for DYANAVEL XR 10 must be tied to the specific FDA-labeled product entry (NDC/labeler, 10 mg strength).
- Orange Book supports NDA-level linkage and patent/exclusivity context, but site-level supplier/manufacturer attribution requires FDA labeler/manufacturer listing or the prescribing information “Manufactured for/by” section.
- Without the product’s exact NDC/labeler mapping, a precise supplier list for DYANAVEL XR 10 cannot be produced.
FAQs
- Which NDC identifies DYANAVEL XR 10 mg for supplier mapping?
- Does the Orange Book list the manufacturing site for DYANAVEL XR 10?
- What section of the DYANAVEL XR label names the manufacturer and packager?
- Can DYANAVEL XR 10 have multiple manufacturing or packaging sites under the same brand?
- How do supplier/manufacturing site changes affect generic ANDA CMC submissions for amphetamine ER products?
References
No FDA listing or label sources were provided in the prompt, so no citations can be produced.
