Last updated: May 26, 2026
APTENSIO XR is an FDA-approved central nervous system stimulant (extended-release amphetamine salts) marketed in tablet form. Specific contract manufacturing, packaging, API sourcing, and label-claim “supplier” identities are not reliably identifiable from the information provided here, so a complete, accurate supplier map cannot be produced.
Who manufactures and supplies APTENSIO XR tablets under contract?
APTENSIO XR is sold as an extended-release solid oral dose. In the US market, “supplier” typically resolves into three tiers: (1) API manufacturer of amphetamine sulfate or equivalent amphetamine salt inputs, (2) finished-dose contract manufacturer (drug product site that formulates and tablets), and (3) packaging/labeling and distribution entities listed by FDA and in commercial supply chains.
A supplier map requires FDA listing records (Orange Book “Manufactured for” and NDA holder/manufacturing site lines), Drug Establishment Registration and Listing (DERL) site identifiers tied to the dosage form, and verifiable patent/CMC or labeling references. None of those sources are included in the input, so supplier identities cannot be stated without risking inaccuracies.
What does “supplier” mean for APTENSIO XR in US filings?
- API supplier: amphetamine salt(s) manufacturing site(s) for the NDA.
- Drug product supplier: finished-dose manufacturing site(s) for the extended-release tablet.
- Packaging/labeling supplier: site(s) that perform secondary packaging and labeling under the NDA.
What API and raw materials suppliers support APTENSIO XR?
APTENSIO XR’s active substance is an amphetamine salt mixture in an extended-release tablet. API and excipient suppliers would typically include:
- amphetamine salt API producers (regulated under cGMP and DEA rules for controlled substances),
- controlled-substance logistics providers,
- excipient manufacturers used in extended-release matrices and coatings,
- contract analytical testing labs for release testing.
No API sourcing list, excipient supplier list, or DEA/controlled-substance supply chain documentation is included in the prompt, so identities cannot be listed.
What finished-dose contract manufacturers make APTENSIO XR?
Finished-dose supply for extended-release tablets is commonly split between:
- formulation and tableting (drug product manufacturing),
- granulation (if applicable),
- coating and extended-release layering,
- final packaging and distribution.
Identities require FDA NDA manufacturing site detail or label imprint/manufacturing site references. Those details are not provided, so contract manufacturer names cannot be stated.
What packaging and labeling suppliers distribute APTENSIO XR?
Packaging and labeling suppliers are usually identifiable from:
- the “Packaged by / Distributed by” label section,
- FDA DERL entries that show “Packaging” roles by site,
- commercial product labels or NDC directory entries.
The prompt does not include APTENSIO XR labeling text, NDC, or listing records, so no packaging and labeling suppliers can be enumerated.
Which sources are used to identify reliable APTENSIO XR suppliers?
A defensible supplier list is derived from:
- FDA Orange Book entry for APTENSIO XR (drug product manufacturing/labeler lines).
- FDA SPL/RLD label content (manufacturer/distributor statements).
- FDA DERL data by dosage form and role (manufacturer/packer).
- NDC directory listing (labeler/manufacturer crosswalk).
- DEA registration and controlled substance handling documentation (when publicly traceable).
No such records are available in the current input, so a complete supplier roster cannot be compiled.
Can you list APTENSIO XR supplier companies and sites?
Not from the information provided.
Key Takeaways
- A “suppliers” answer for APTENSIO XR requires specific, citable FDA listing data (Orange Book/NDA manufacturer lines, DERL site roles, and/or label manufacturer/distributor statements).
- The prompt does not include those identifiers or records, so supplier names, API sources, and manufacturing site details cannot be stated accurately.
FAQs
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How can I identify the NDA labeler and manufacturing site for APTENSIO XR?
Use the FDA Orange Book and the SPL label “Manufactured for/Distributed by” lines for the product’s NDA and NDC.
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Are APTENSIO XR API suppliers publicly listed?
API suppliers are sometimes inferable from NDA CMC/establishment listings tied to manufacturing sites, but direct public API supplier brand names are not consistently disclosed.
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Which FDA databases show packaging vs manufacturing roles for controlled-substance products like APTENSIO XR?
FDA DERL records show establishment registration roles and site activities; Orange Book adds NDA product manufacturing context.
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Do APTENSIO XR tablets come from one or multiple manufacturing sites?
Extended-release stimulant products can use more than one commercial manufacturing or packaging site across time; the supplier list changes with supplements and site transfers reflected in FDA records.
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What documentation supports a supplier due diligence package for APTENSIO XR?
NDA labeling/manufacturing statements, FDA establishment registrations for the relevant dosage form, and cGMP inspection histories for the manufacturing sites.
References
No sources were provided in the prompt.
