Last updated: April 26, 2026
Who Supplies FOCALIN XR (dexmethylphenidate extended-release) APIs and Finished-Dose Components?
FOCALIN XR is dexmethylphenidate extended-release (ER), an oral central nervous system stimulant used for ADHD. In drug-patent and procurement due diligence, “suppliers” typically means (1) the active pharmaceutical ingredient (API) manufacturer(s) and (2) the contract manufacturer(s) that produce the finished dosage form (FDF). Public filings for branded FOCALIN XR itself do not provide a reliable, complete supplier list in one place. The supplier stack is instead traced through FDA submissions, controlled substance registrations tied to the finished product, and supply-chain disclosure in public regulatory documents for the underlying API and finished product.
Below is the supplier map that can be supported with publicly citable source types.
What are the supplier categories for FOCALIN XR?
| Supplier layer |
What it supplies |
How it is evidenced in public records |
| API supplier(s) |
Dexmethylphenidate (ER dosage form needs drug substance) |
FDA drug master file (DMF) references and API-related regulatory documentation tied to the NDA/BLA manufacturing chain |
| Finished-dose manufacturer(s) |
Tablets/capsule components and packaged FDF |
FDA labeling/manufacturing site information and NDA manufacturing descriptions (holder vs. site) |
| Packaging and secondary supply |
Bottling, blistering, labeling |
FDA labeling and manufacturing site references for “manufactured for” / “packaged by” statements |
| Active controlled substance handling |
Scheduled material handling at registered sites |
DEA registration records aligned to manufacturing/distribution activities |
What does the public record show about FOCALIN XR manufacturing and packaging sites?
FOCALIN XR (dexmethylphenidate HCl ER) is marketed by Novartis Pharmaceuticals Corporation in the US. Public labeling and FDA product details identify the applicant/holder and list manufacturing and packaging sites. These statements are the practical starting point for vendor qualification because they identify the physical sites responsible for commercial product release.
| Item |
Publicly stated in labeling / FDA product details (directional) |
Vendor due-diligence meaning |
| Market authorization holder |
Novartis Pharmaceuticals Corporation |
NDA holder controls supplier nomination but may outsource production |
| Finished product manufacturing and packaging |
Listed on US labeling via “manufactured for” / “packaged by” style text |
These are the contract manufacturing sites to qualify for quality agreement, batch release, and supply continuity |
Actionable procurement interpretation: For supplier selection, treat the labeling manufacturing sites as your baseline “FDF manufacturers/packagers,” then back-map to the API DMF references used in FDA review to identify the drug-substance suppliers.
Which suppliers should you target first?
1) FOCALIN XR commercial FDF manufacturers and packagers listed on the US prescribing information and FDA product records. These are the sites that produce and/or package the product distributed in the US.
2) Dexmethylphenidate ER API DMF holders referenced by the NDA submission chain. These are the drug-substance sources feeding the manufacturing sites above.
3) Secondary service providers where stated (over-labeling, bottling, imprinting, and distribution logistics) only where the labeling or FDA manufacturing statements explicitly attribute responsibility to a named site.
How to operationalize a “supplier list” for FOCALIN XR
Because the most defensible supplier list is the combination of (a) named manufacturing/packaging sites and (b) DMF-linked API sources, procurement due diligence should be executed in two linked steps:
Step 1: Lock the FDF sites tied to commercial product release
- Extract the manufacturing/packaging sites as named in the approved US labeling.
- Confirm those sites on FDA product listings for the specific dosage form strength (FOCALIN XR exists across strengths).
- Use those sites to obtain:
- current GMP inspection status,
- capacity and change-control history,
- batch release responsibilities,
- supply continuity plan and allocation policies.
Step 2: Back-map API sources through FDA submission linkage
- Identify the dexmethylphenidate API drug-substance information linked to the NDA via FDA resources that index DMFs and application references.
- Determine which DMF(s) cover dexmethylphenidate used for ER formulations.
- Qualify DMF holders and API production sites via:
- DMF status,
- impurity profile alignment for ER grade,
- polymorph/particle-size controls (where applicable),
- regulatory history and associated manufacturing networks.
What suppliers matter from an investment and risk perspective?
For FOCALIN XR, the supplier risk is less about generic “stimulant supply” and more about:
- Controlled substance supply chain continuity (DEA-registered handling and inventory turnover),
- ER formulation conversion risk (API grade and excipient compatibility),
- Site-specific GMP performance for the labeled manufacturing and packaging sites,
- Single-site dependencies for either API or FDF.
The supplier landscape must therefore be evaluated at both layers (API and FDF) and at the site level.
Key Takeaways
- Supplier identification for FOCALIN XR should be grounded in (1) labeled FDA manufacturing/packaging sites for the finished dosage form and (2) DMF-linked dexmethylphenidate API sources tied to the NDA submission chain.
- Treat the FOCALIN XR prescribing information and FDA product records as the authoritative source for the commercial FDF packager/manufacturer sites to qualify.
- Back-map to API DMF references to identify drug-substance suppliers feeding those FDF sites, then qualify them for DEA and GMP-relevant continuity.
FAQs
Who is the marketing authorization holder for FOCALIN XR?
FOCALIN XR is marketed in the US under Novartis Pharmaceuticals Corporation as the holder/applicant on product documentation. (See FDA label/product details sources.)
How do I identify the finished-dose manufacturing suppliers for FOCALIN XR?
Use the US prescribing information and FDA product details that list the company and specific manufacturing and packaging sites attributed to commercial supply.
How do I identify the dexmethylphenidate API supplier(s) for FOCALIN XR?
Back-map through FDA drug submission linkage, using DMF references tied to the NDA chain for dexmethylphenidate used in the ER formulation.
Are packaging suppliers different from manufacturing suppliers for FOCALIN XR?
Yes. Public labeling often separates “manufactured for” versus “packaged by” at different sites; qualification should cover both functions where attributed.
What supplier risk is most relevant for FOCALIN XR?
Supply continuity risk driven by site-specific GMP performance and controlled substance handling/availability at DEA-registered stages, plus ER formulation dependency on the correct drug substance grade.
References
[1] U.S. Food and Drug Administration (FDA). FOCALIN XR prescribing information and product labeling (dexmethylphenidate hydrochloride extended-release). FDA Drugs@FDA product page. APA citation.
[2] U.S. Food and Drug Administration (FDA). Drugs@FDA: FOCALIN XR (dexmethylphenidate hydrochloride extended-release) product information, applicant/holder and labeling/manufacturing details. APA citation.
[3] U.S. Drug Enforcement Administration (DEA). DEA registration and controlled substance handling framework for manufacturers/distributors (for site qualification context). APA citation.
