Last updated: April 25, 2026
Who manufactures Azstarys (amphetamine/amphetamine extended-release + immediate-release)?
Azstarys is a branded attention-deficit/hyperactivity disorder (ADHD) product with an amine-based stimulant combination: serdexmethylphenidate/dexmethylphenidate (extended-release plus immediate-release components). Manufacturing for branded stimulants typically runs through a small set of contract manufacturing organizations (CMOs) for finished dose manufacturing, with additional external suppliers for key drug substances, intermediates, and excipients.
No sourceable, specific CMO/CDMO name and site-level supplier list is present in the information provided in this request.
What supplier categories exist for Azstarys, even when CMO names are not disclosed?
For a branded oral solid ADHD medicine like Azstarys, the supplier stack normally divides into:
- Finished dosage manufacturing (tablet/capsule formulation into saleable product)
- Drug substance manufacturing (active ingredient manufacture for the extended-release and immediate-release moieties)
- Direct materials (API/intermediate synthesis inputs, excipients, packaging components)
A company-level supplier list cannot be produced from the request as written.
What is required to name “suppliers” for azstarys in a patent-analysis standard?
A defensible supplier list requires at minimum:
- Labeled manufacturer of record and site from the most recent package insert and/or labeling
- Listed CMO/CDMO in regulatory filings (e.g., FDA facility listings, application manufacturing sections, or approval documents)
- If “suppliers” means raw materials, specific named suppliers from procurement or published chemistry/manufacturing details (typically not publicly enumerated for every excipient/API component)
Those data points are not included in the prompt.
How investors and R&D teams operationalize supplier due diligence for Azstarys
When supplier names are not provided upfront, teams usually build a supplier map using three high-signal anchors:
- Labeling manufacturer of record (finished product release entity)
- FDA facility inspection and drug establishment listings for the drug product and relevant dosage form
- API/DS linkages from patents and manufacturing disclosure (where present)
No actionable supplier entity names can be extracted without source text to cite.
Key Takeaways
- “Suppliers for Azstarys” requires company- and site-level names from regulatory labeling or filings.
- The current request does not contain any source material to produce a complete, citeable supplier list.
- A standards-based supplier map for Azstarys must be grounded in labeling manufacturer-of-record and facility listings, then validated against application manufacturing disclosures.
FAQs
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What does “suppliers for Azstarys” typically mean in practice?
It means finished product manufacturer of record and, where disclosed, CMOs for drug substance and final dosage manufacturing.
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Are Azstarys suppliers publicly listed on the package labeling?
Often yes for the manufacturer of record, but specific CMOs and component suppliers are not always disclosed in label text.
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How do analysts confirm Azstarys manufacturing facilities?
By cross-referencing FDA drug establishment facility listings and labeling manufacturer information.
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Do patents always name Azstarys manufacturing suppliers?
No. Patents generally disclose chemistry and process details, not full procurement supplier rosters.
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What is the fastest way to build a supplier roster for a branded stimulant like Azstarys?
Start with label manufacturer of record, then validate with FDA facility and inspection records, then link to drug substance manufacturing where available.
References
[1] FDA. Drug Establishments (Drug Products). https://www.fda.gov/drugs/drug-establishments-drug-products
[2] FDA. Drugs@FDA: Azstarys (serdexmethylphenidate/dexmethylphenidate) prescribing information and approvals. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book
