Last updated: May 27, 2026
ADZENYS XR-ODT is an amphetamine-sulfate extended-release product marketed in the US under the ADZENYS name. Supplier identification depends on the label’s “Manufactured for”/“Distributed by” lines and the current FDA “Applicant” and “Manufacturer” entries tied to the listed drug. Without the specific label/manufacturer page text and the current FDA listing for the exact dosage form and strength, a complete, accurate supplier map (API source, finished-dose manufacturer, packaging site, and contract packager) cannot be produced.
What companies supply and manufacture ADZENYS XR-ODT in the US?
Direct answer: The reliable way to identify ADZENYS XR-ODT suppliers is through the FDA “Drug Label Information” (manufactured for/distributed by on the carton insert) and the FDA Drugs@FDA record for the listed drug and its NDA. That text specifies the finished-dose manufacturer and sometimes packaging/manufacturing sites; FDA listing sections identify the “Applicant” (marketing authorization holder) and the listed manufacturer(s).
Which label lines identify ADZENYS XR-ODT suppliers?
Look for:
- “Manufactured for” (typically the marketing authorization holder or distributor)
- “Manufactured by” or “Distributed by”
- Packaging/labeling references such as “Packaged by” or “Prepared for”
- The dosage form and strengths tied to each site
These label lines are the primary source for finished-dose supplier identification in US marketing.
What does the FDA listing typically show?
FDA listing entries usually separate:
- Applicant (NDA holder)
- Manufacturer (sites responsible for manufacture/processing and sometimes packaging)
- Filing type and revisions over time
How to map ADZENYS XR-ODT suppliers to API vs finished-dose manufacturing?
Direct answer: US supplier chains for extended-release oral disintegrating products generally separate (1) API sourcing and (2) finished-dose manufacturing and packaging, but ADZENYS XR-ODT supplier names must be taken from the approved labeling and FDA listing to be accurate.
API supplier identification: what “suppliers” can mean
- API manufacturer (amphetamine sulfate API)
- Intermediate or excipient suppliers (co-crystals, film-formers, superdisintegrants, buffering agents)
- Finished-dose manufacturer (formulation, tablet compression or molding for ODT, coating/controlled release mechanics)
For ADZENYS XR-ODT, only finished-dose and label-disclosed manufacturing sites are consistently discoverable from FDA and labeling records. API suppliers require either label disclosures that name the API source (uncommon) or upstream procurement documentation not present in public FDA listings.
Finished-dose and packaging suppliers
FDA label and listing records are the authoritative sources for:
- Tablet/ODT manufacturing facility
- Secondary packaging and labeling facility (if disclosed)
Who is the applicant/marketing authorization holder for ADZENYS XR-ODT?
Direct answer: The applicant is the NDA holder shown in the current Drugs@FDA listing for ADZENYS XR-ODT. The marketing authorization holder is often also the “Manufactured for” entity on the label, but supplier identification must follow the label lines and the FDA listing record tied to the exact NDA.
Why applicant vs manufacturer matters for licensing
- Licensing and risk allocation typically tracks the NDA holder (regulatory responsibility) and the manufacturing authorization holder (GMP supply responsibility).
- When a generic or AB-rated product challenges supply or manufacturing, paragraph IV and litigation strategies focus on the listed drug’s NDA and the disclosed manufacturing chain.
When do ADZENYS XR-ODT suppliers change?
Direct answer: Changes usually occur via:
- Manufacturing site supplements (FDA CMC submissions)
- Labeling “Manufactured for” entity updates due to commercial transfers
- Acquisition or contract manufacturing shifts
But identifying supplier change dates requires a revision history from the FDA label “Drug Label Information” and corresponding supplements, which are not available in the information provided here.
What generic or authorized suppliers compete with ADZENYS XR-ODT delivery and dose form?
Direct answer: Competitive supplier sets depend on which product strength(s) and AB-rated equivalents exist for amphetamine sulfate extended-release ODT and how the market routes through pharmacy distribution. A reliable competitor supplier mapping again depends on:
- The exact ADZENYS XR-ODT strengths
- Their AB rating status
- The Orange Book listing entries and applicant/manufacturer lines for each AB-rated product
No Orange Book extract or Drugs@FDA record details were provided, so an accurate “supplier-by-product” competitive table cannot be produced.
What is the Orange Book status of ADZENYS XR-ODT and how does it affect supply?
Direct answer: Orange Book status affects regulatory exclusivity and generic entry timing, which can reshape supplier demand. But supplier and litigation landscape mapping requires:
- NDA number for ADZENYS XR-ODT
- Orange Book listing and listed patents
- Exclusivity start/end dates
- Any granted or pending generic/authorized generic entries
Those data points are not included in the prompt.
Supplier due diligence checklist for ADZENYS XR-ODT (what to verify in documents)
Direct answer: For supplier selection, the minimum diligence should confirm:
- FDA label-disclosed finished-dose manufacturing sites
- GMP status for each site involved in ODT manufacturing and packaging
- Controlled substance handling compliance for amphetamine sulfate
- Stability program coverage for the exact dosage form and strength
- Serialization/packaging configurations used in the market
These steps are standard for controlled-substance CNS stimulants, but the specific named ADZENYS XR-ODT suppliers still must be sourced from the label and FDA record.
Key Takeaways
- Public supplier identification for ADZENYS XR-ODT must be grounded in the FDA Drugs@FDA record and the current prescribing information label’s “manufactured for/distributed by” and manufacturing site lines.
- Without the NDA record and label text for the exact ADZENYS XR-ODT strength(s), a complete and accurate supplier list (API source, finished-dose manufacturer, and packaging site) cannot be generated.
FAQs
- How do I find the finished-dose manufacturer for ADZENYS XR-ODT on the label?
- What does the FDA “Applicant” entry tell you versus the “Manufacturer” entry for ADZENYS XR-ODT?
- Which manufacturing changes (CMC supplements) most often drive supplier site switches for extended-release ODTs?
- How should supply chain diligence differ for amphetamine sulfate extended-release products under controlled substance regulations?
- How do Orange Book exclusivity and patent lists change the procurement risk for ADZENYS XR-ODT suppliers?
References
- FDA. Drugs@FDA. “ADZENYS XR-ODT” (lookup required for NDA-specific applicant/manufacturer and label manufacturing lines).
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (lookup required for NDA-specific status and related supplier impact).
