Last updated: May 28, 2026
DYANAVEL XR 20 is an extended-release amphetamine formulation (amphetamine mixed salts) marketed by Neos Therapeutics. Supply chain visibility in public filings is fragmented, with Orange Book, FDA labeling, and contract-manufacturing disclosures typically naming drug-substance and drug-product manufacturers at the application/label level rather than listing all upstream suppliers. For “DYANAVEL XR 20” specifically, public references consistently support identifying the labeled manufacturer/packager rather than a comprehensive upstream raw-material supplier roster.
Who supplies DYANAVEL XR 20 (drug product manufacturer and labeler)?
Short answer: The DYANAVEL XR 20 supply chain in FDA-labeled materials is anchored to Neos Therapeutics as the applicant/labeler for the finished drug product, with the drug-product manufacturing and packaging performed by named third parties at the application and labeling level (the FDA label typically lists the “manufactured for” entity).
What does the FDA label typically name for DYANAVEL XR 20?
For branded, prescription oral solids, FDA product labeling commonly includes:
- Applicant/label holder: the company that lists the NDA in FDA’s registration databases.
- “Manufactured for” or “Distributed by” entities: the label-level drug product manufacturer/packager.
- Strength-specific identification: “DYANAVEL XR 20” corresponds to the 20 mg extended-release strength.
Practical outcome for sourcing: procurement teams should treat the label’s “manufactured for” entity as the contract manufacturing organization (CMO) responsible for packaging and release for the labeled dosage form, unless alternate label versions exist by site.
What companies manufacture DYANAVEL XR (amphetamine) extended-release?
Short answer: DYANAVEL XR’s finished dose manufacturing is handled through contract manufacturing and packaging arrangements that are reflected in the NDA labeling and FDA submissions rather than in a single publicly consolidated supplier list.
How to map “DYANAVEL XR 20” to manufacturing sites
For extended-release amphetamine products, manufacturing and packaging are usually staged across:
- API (amphetamine mixed salts) synthesis or procurement (upstream).
- Tablet core manufacturing (mixing, granulation, compression).
- Extended-release layer engineering (if applicable to the platform).
- Coating, drying, and uniformity controls.
- Packaging into bottle/blister and serialization where required.
Public documents typically name only steps 2 through 5 (finished product) at the label/submission level, not every API supplier.
Which raw-material suppliers support amphetamine mixed salts ER?
Short answer: Upstream suppliers of amphetamine mixed salts are generally not comprehensively listed in public sources. NDA CMC sections can include drug-substance manufacturers, but public extracts often do not publish the full supplier roster.
What is usually visible publicly for API sourcing?
For controlled-substance APIs, commonly visible public markers include:
- Drug substance manufacturer named at NDA approval time.
- Changes disclosed via supplements.
- Site transfers disclosed via FDA filings.
Procurement implication: when negotiating supply agreements for DYANAVEL XR 20, buyers typically request:
- Supplier-of-record for API and key excipients.
- Batch release testing responsibilities.
- Alternate source qualification status.
- Cold chain and stability commitments (for excipients and packaged product, as applicable).
What is the NDA/Orange Book status of DYANAVEL XR 20?
Short answer: DYANAVEL XR is an FDA-approved product, with the listed patents and exclusivity status governed by Orange Book and related FDA exclusivity determinations. Patent-exclusivity and generic-entry timing can affect supplier leverage, but supplier identity is governed by the manufacturing/packaging disclosure rather than exclusivity.
Why Orange Book matters for sourcing
Orange Book does not list suppliers in a complete upstream manner. It does, however, affect:
- Generic and authorized generic risk for the brand.
- Negotiation leverage when allocating manufacturing capacity during supply disruptions.
- Whether a fallback formulation or process transfer can be justified.
How to identify the procurement “suppliers” that matter for DYANAVEL XR 20?
Short answer: In practice, buyers operationalize “suppliers” as:
- Finished drug product CMO/packager(s) named on labeling.
- API supplier(s) disclosed in NDA CMC supplements (usually via direct request, not public listing).
- Primary logistics and distribution partners (often disclosed through label or distributor arrangements).
Supply-chain due diligence targets (what to validate)
For DYANAVEL XR 20 procurement, the critical supplier validations are:
- CGMP site qualification and inspection history.
- Batch release and analytical methods ownership.
- Serialization, labeling compliance, and UDI readiness.
- Forecast adherence and safety-stock strategy.
- Controlled-substance handling and DEA logistics compatibility.
Supplier landscape: brand supply vs. alternative-dose forms
Short answer: DYANAVEL XR includes multiple strengths. Even when the brand remains the same, the manufacturing line and packaging configuration can change by strength.
Why “DYANAVEL XR 20” can differ from other strengths
Strength-specific differences that can change the supplier operationally:
- Blister vs bottle packaging ratios or labeling format by strength.
- Compression tooling differences if tablet geometry varies.
- Extended-release coating program differences.
Procurement implication: supplier documents should be strength-specific, not just “DYANAVEL XR” generic.
Key Takeaways
- DYANAVEL XR 20 sourcing is anchored to Neos Therapeutics as the labeler/applicant, with the finished drug product manufacturer/packager reflected in FDA label language (“manufactured for”).
- Public sources usually do not provide a complete list of upstream API and excipient suppliers.
- For procurement and risk planning, the actionable “supplier” set is the label-level drug product manufacturer/packager plus the API/drug-substance supplier-of-record from NDA CMC disclosures and supplements.
- Strength-specific packaging and manufacturing parameters can vary, so “DYANAVEL XR 20” should be handled as a distinct SKU in supplier qualification.
FAQs
1) Who is the manufacturer for DYANAVEL XR 20 on the FDA label?
The FDA label’s “manufactured for” and “distributed by” language identifies the label-level finished drug product manufacturer/packager for DYANAVEL XR 20.
2) Are DYANAVEL XR 20 API suppliers publicly listed?
API suppliers are often not fully enumerated in public sources; visibility generally comes from NDA CMC documentation and supplements rather than Orange Book.
3) Do different strengths of DYANAVEL XR use the same manufacturing site?
Not always. Strength-specific tablet geometry and packaging configurations can drive site or line differences, even within the same brand.
4) How can supply disruptions affect DYANAVEL XR 20 availability?
Supply disruptions can stem from limited capacity at the finished product CMO/packager, API shortages for amphetamine mixed salts, or packaging/labeling constraints for controlled-substance distribution.
5) What documents should a buyer request to qualify a DYANAVEL XR 20 supplier?
Buyer qualification typically hinges on site qualification, CGMP status, batch release responsibility, analytical method ownership, serialization/labeling compliance, and controlled-substance logistics capability.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA database.
- FDA. Drug Labeling for DYANAVEL XR (amphetamine). FDA label repository.
- FDA. Approved NDA Application information and regulatory history (DYANAVEL XR). FDA databases.
