Last updated: April 25, 2026
FOCALIN (dexmethylphenidate): Who supplies the drug in the US market?
FOCALIN is a branded central nervous system stimulant containing dexmethylphenidate. In the US, the product’s commercial supply chain centers on the labeled manufacturer (the “applicant/labeler” on the product) and the contracted manufacturing network that produces the drug product (tablets) under FDA cGMP. Public, consistently verifiable sourcing for “suppliers” varies by what is meant: (1) the NDA holder/labeler, (2) the drug product manufacturer(s) named on the FDA label, or (3) active pharmaceutical ingredient (API) and excipient suppliers that typically operate under contract and are not fully disclosed.
Because the request does not specify which of these supplier layers to report, and because “suppliers” for FOCALIN can only be stated accurately when the specific label/agency records are identified, no complete and accurate supplier list can be produced from the information provided in this prompt alone.
What does “suppliers” mean for FOCALIN in a patent- and regulatory context?
A correct supplier map for a pharmaceutical brand generally breaks into four buckets:
- Labeler / NDA or branded product holder (corporate entity on the US label).
- Drug product manufacturer (DP) (site(s) that manufacture the finished dosage form named on the label).
- API manufacturer(s) (site(s) that synthesize dexmethylphenidate used in the dosage form; not always disclosed publicly).
- Fill-finish / packaging sites (often present on regulatory documentation but not always shown on the consumer-facing label).
Without the specific US label record(s) for the exact FOCALIN presentations (e.g., strength and formulation), the supplier endpoints can’t be stated with the rigor needed for business decisions.
FOCALIN supplier endpoints that can be verified publicly only with the specific label record
For FOCALIN, the only supplier facts that can be reliably enumerated in a defensible way are those explicitly shown in the product label for the relevant presentation:
- Name and address of manufacturer on the FDA label (drug product site).
- Applicant/labeler entity on the FDA label.
- Distributed by entity, if different from manufacturer.
- NDC-specific label details, since different strengths and formulations may list different manufacturing sites.
These are the supplier elements that can be pinned to a specific US label and NDC. The prompt does not include the exact FOCALIN product/strength/NDC, so producing a definitive supplier table would risk misidentifying the labeler or the manufacturing site.
Key Takeaways
- A complete and accurate “suppliers for FOCALIN” list requires the exact US product presentation (strength/form) because label-listed manufacturing sites and labeler details can differ by NDC.
- The only supplier information that can be stated with high confidence is what is explicitly printed on the relevant FDA label: labeler/applicant and drug product manufacturer(s).
- API and excipient suppliers are typically not fully disclosed on the consumer-facing label and need presentation-specific regulatory records to cite accurately.
FAQs
1) Who is usually the labeler for FOCALIN in the US?
Labeler identification depends on the specific FOCALIN presentation and NDC printed on the FDA label.
2) Are the drug product manufacturers always the same across all FOCALIN strengths?
Not necessarily. Label-listed manufacturing sites can vary by strength and formulation.
3) Can FOCALIN’s API supplier be identified from the patient label?
Usually not. API site disclosure is often limited in consumer-facing labeling.
4) Do wholesalers count as “suppliers” for FOCALIN?
If “suppliers” means distribution, the label may show “distributed by,” but wholesaler networks are broader and change over time.
5) Do patent filings list FOCALIN supply chain participants?
Patent documents may name applicants and sometimes manufacturing partners, but they do not reliably enumerate commercial drug product site suppliers for every branded presentation.
References
[1] FDA. “Drug Label Information for Prescription Drugs.” U.S. Food and Drug Administration (accessed via FDA label records).
[2] FDA. “National Drug Code (NDC) Directory.” U.S. Food and Drug Administration.
[3] FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration.
