Last updated: May 26, 2026
Quillivant XR suppliers: which companies manufacture, package, and distribute the extended-release methylphenidate product?
Who supplies Quillivant XR in the US market?
Quillivant XR is an extended-release formulation of methylphenidate HCl. The supply chain typically involves: (1) drug substance and finished-dose manufacturers, (2) packaging and labeling contractors, and (3) wholesale distribution for US commercial channels.
What matters for supplier mapping
- Finished-dose manufacturing (who makes Quillivant XR drug product)
- Packaging and labeling (who does bottle/box packaging and label application)
- Commercial distribution (who sells into the US wholesale channel)
Which company is the marketing authorization holder for Quillivant XR?
Quillivant XR is marketed in the US by Supernus Pharmaceuticals, Inc. as the NDA holder/labeler.
Regulatory anchor
- NDA/labeler identification comes from FDA’s Orange Book and the FDA package labeling/labeler fields for Quillivant XR product entries. (Orange Book listings are the best index for labeler and product-level identity.)
What manufacturing and packaging contractors support Quillivant XR?
How to identify the actual finished-dose and packaging suppliers
For branded, liquid pediatric CNS products like Quillivant XR, the supplier identity is usually found in one of three places:
- FDA Orange Book “Manufacturer” and labeler fields for the listed product
- FDA drug product listing (structured product information tied to NDC)
- CGMP manufacturing/packaging indications embedded in labeling and submissions (varies by dataset)
Why this is critical
Supplier disputes and supply-risk assessments hinge on whether a company is:
- the finished-dose manufacturer (bulk fill and final release),
- the packaging supplier (secondary packaging, bottle fill/labeling), or
- the distribution supplier only (wholesale distribution with no manufacturing role).
What is the Orange Book listing and NDC mapping for Quillivant XR?
Where does Quillivant XR sit in the Orange Book?
Orange Book entries for Quillivant XR support:
- Labeler/Applicant
- Dosage form
- Active ingredient
- Strength(s)
- Patent-protected status (which can indirectly affect supply via exclusivity and generic development)
Because you asked specifically for suppliers, the key supplier-relevant data from Orange Book is the product listing metadata tied to:
- the labeler/applicant and
- the listed manufacturing firm(s) for the NDC entries.
Which companies supply Quillivant XR as wholesalers in the US?
What wholesale distribution looks like
Wholesale distribution for a branded CNS medicine like Quillivant XR usually flows through national wholesalers and specialty distributors. Supplier mapping at the wholesale level commonly shows:
- national wholesalers (for inventory pooling and distribution),
- specialty channels (for pediatric and controlled distribution workflows),
- pharmacy benefit channel intermediaries (indirect).
For supplier identification that is decision-grade (rather than a generic list of wholesalers), you need the product’s NDC-specific distribution/labeler-linked firm fields that appear in FDA labeling and associated market authorization records.
How many supplier sites typically exist for Quillivant XR?
Site multiplicity and resilience
For liquid extended-release products, firms often use:
- primary manufacturing sites for bulk drug product and final fill,
- backup sites for bottling/packaging and secondary packaging,
- additional contractors for labeling/serialization.
Supplier-count and site-level details are obtained from:
- FDA drug establishment data (establishment registrations),
- product listing metadata tied to the NDC and labeler,
- inspection history at specific establishments (when needed for compliance risk).
Which supplier changes are most likely for Quillivant XR?
Repackaging, relabeling, and contractor transitions
Common change drivers that affect supplier identity include:
- packaging line changes (label application methods, serialization system upgrades),
- scale-up or line relocation within the same manufacturing company,
- contractor swaps for secondary packaging.
These show up in updated NDC listings and refreshed establishment identifiers.
Key takeaways
- Marketing authorization holder/labeler: Quillivant XR is marketed in the US by Supernus Pharmaceuticals, Inc.
- Operational “supplier” mapping needs NDC-linked product listing data to separate finished-dose manufacturing, packaging/labeling, and wholesale distribution roles.
- The most decision-grade supplier identification is from FDA Orange Book product metadata and FDA listing fields tied to the product NDCs, not generic assumptions about wholesalers.
FAQs
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How can I confirm the Quillivant XR finished-dose manufacturer from FDA data?
Use the Quillivant XR Orange Book/NDC product listing metadata fields for manufacturer/labeler and cross-check against FDA drug establishment identifiers tied to the same NDC.
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Who supplies Quillivant XR packaging and labeling services?
Look for packaging/labeler contractors in NDC-level listing fields and reconcile with FDA drug establishment registrations for the relevant product.
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Does Quillivant XR have multiple manufacturing sites?
Liquid pediatric products often use more than one site for fill-finish and packaging; confirm via FDA establishment data linked to the product NDCs.
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Can supplier identity change without Orange Book changes?
Yes. Packaging and labeling contractor swaps can occur without changing Orange Book patent terms, so supplier mapping must be NDC and establishment driven.
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How do wholesalers affect Quillivant XR supply risk?
Wholesalers do not usually create manufacturing capacity, but they can expose allocation risk during shortages; evaluate supply risk by linking NDC distribution channels to labeler and manufacturing release capacity.
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Quillivant XR entries and related product listing metadata).
- FDA. Drugs@FDA. Quillivant XR product labeling and regulatory listing fields (labeler/NDA context).
