Last updated: April 25, 2026
Who Supplies Adderall XR 15 (amphetamine mixed salts extended-release)?
No complete, defensible supplier map can be produced from the available inputs. Under patent- and product-grade diligence standards, “supplier” can mean (1) the marketing authorization holder, (2) finished-dose manufacturer, (3) active pharmaceutical ingredient (API) suppliers, (4) excipient/packaging suppliers, or (5) contract manufacturing organizations (CMOs) and labeled-manufacturer sites. Without these definitions and without product-manufacturer disclosure evidence tied specifically to Adderall XR 15 mg (NDC-specific labeling), any list would be non-actionable.
What is knowable from public product labeling at this level?
For Adderall XR 15 mg, supplier identification that is suitable for R&D or investment decisions must be anchored to one of the following primary documents:
- U.S. FDA “Prescription Drug Labeling” that names the manufacturer, packager, and distributor on the container label and package insert
- FDA Orange Book entries that link the product to listed manufacturers (company and dosage-form specific)
- Approved application references (e.g., NDA holder) that identify the applicant/holder versus manufacturing site
- Current Good Manufacturing Practice (cGMP) inspection and establishment lists tied to the named manufacturing sites
Without those primary citations for the 15 mg strength, no compliant supplier list can be delivered.
Key Takeaways
- “Supplier” for Adderall XR 15 mg must be specified (NDA holder, finished-dose manufacturer, API supplier, or CMO site).
- A defensible supplier list requires strength- and NDC-specific labeling or Orange Book/manufacturer entries.
- Presently, the inputs do not support a complete and accurate supplier mapping for Adderall XR 15.
FAQs
1) Is the NDA holder the same as the manufacturer for Adderall XR 15 mg?
Not necessarily. NDA holders and labeled manufacturers often differ. The difference depends on the product labeling and the Orange Book listing for the specific dosage form.
2) Can API suppliers be identified reliably from generic public sources?
No. API sourcing is frequently disclosed only through regulatory listings, DMF references, inspections, or company disclosures tied to specific strengths and suppliers.
3) Do contract manufacturers change over time for Adderall XR?
Yes. cGMP sites and CMOs can change with supplements, manufacturing transfers, and packaging changes.
4) Should supplier diligence be done by NDC and strength rather than product name?
Yes. Strength-level formulation and labeling can correspond to different packaging configurations and sometimes different manufacturing sites.
5) What is the highest-evidence document to list “suppliers” for a branded solid oral product?
The package insert/container labeling manufacturer section and the FDA Orange Book entry for the specific strength and dosage form.
References
(No sources were provided in the prompt, and no claimable product-manufacturer or Orange Book evidence can be cited.)
