Last updated: May 28, 2026
Qudexy XR suppliers: who manufactures and supplies Trokendi XR (topiramate ER) equivalents across the supply chain
Qudexy XR (topiramate extended-release) is supplied by Supernus Pharmaceuticals, Inc. under its commercial operation in the US. Manufacturing and supply chain participation for Qudexy XR is not identified in the provided information, so supplier-level attribution (API makers, finished-dose contract manufacturers, and packaging/release sites) cannot be stated accurately from the current inputs.
Who supplies Qudexy XR to US pharmacies and wholesalers?
Answer: Supernus Pharmaceuticals, Inc. supplies Qudexy XR for the US market.
What does “supplier” mean in Qudexy XR distribution?
In pharmaceutical distribution, “supplier” typically maps to one or more of the following:
- Market authorization holder / commercial sponsor (responsible for distribution and typically the NDA sponsor)
- Finished-dose manufacturer (site that produces and releases the drug product)
- API supplier (site that makes topiramate API)
- Contract packaging and labeling participants
No API or contract-manufacturing sites are provided in the current information, so they cannot be listed.
Which companies manufacture the Qudexy XR finished drug product?
Answer: Not determinable from the provided information.
What manufacturing-site data would normally be used
Finished-dose manufacturer and packaging sites are typically evidenced by:
- FDA labeling “Manufactured for/Manufactured by” statements
- FDA drug establishment listings and facility inspection records
- NDA/ANDA manufacturing changes and site-qualification disclosures
No such site-level evidence is included in the current inputs.
Who provides topiramate API for Qudexy XR?
Answer: Not determinable from the provided information.
API supply chain mapping (typical)
When disclosed, topiramate API suppliers are identifiable via:
- DMF holders and cross-reference statements tied to the approved NDA
- Establishment registration and listing for API production sites
- Quality agreements referenced in regulatory filings
No DMF or API supplier information is included here.
What contract manufacturing and packaging suppliers support Qudexy XR?
Answer: Not determinable from the provided information.
Where contract-packaging data typically appears
- Labeling “Packaged by” or “Distributed by” sections
- FDA labeling text in the prescribing information
- Product listing metadata on distributor-of-record systems
No such data is provided.
How does Qudexy XR sourcing compare with branded and generic topiramate ER?
Answer: Not determinable from the provided information.
Typical comparison dimensions
- Whether the same manufacturer supplies both branded and generic ER topiramate products
- Differences in release-testing and packaging sites
- Whether AB-rated generics use identical API sources or different polymorph/formulation routes
No comparative supplier facts are included in the current inputs.
What supplier risks affect Qudexy XR availability?
Answer: Not quantifiable from the provided information.
Common availability risk drivers
- single-site manufacturing dependencies
- API supply constraints
- packaging component availability (bottles, closures, labels)
- regulatory or quality actions affecting specific facilities
No facility-specific or quality-event information is present.
Orange Book listings: do they identify Qudexy XR suppliers?
Answer: Not determinable from the provided information.
What the Orange Book usually provides
The Orange Book lists:
- NDA and drug product
- application type and patent/exclusivity data
It does not reliably list API or contract manufacturing suppliers.
No Orange Book entry text is included in the current inputs.
Key Takeaways
- Commercial supply/distribution of Qudexy XR is attributed to Supernus Pharmaceuticals, Inc. based on the provided information.
- API, finished-dose manufacturing, and packaging/release suppliers are not identified in the provided information, so they cannot be listed without introducing inaccuracies.
FAQs
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Is Supernus the manufacturer of Qudexy XR or only the distributor?
From the provided information, only Supernus is identified as the supplier; manufacturing-site attribution is not provided.
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Can Qudexy XR supplier names be inferred from the Orange Book?
The Orange Book generally does not list granular API or contract manufacturing suppliers.
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Which facilities supply topiramate ER for Qudexy XR?
Facility-level supplier information is not provided in the current inputs.
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Do generics of topiramate ER use the same API suppliers as Qudexy XR?
Not determinable from the provided information.
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Where can Qudexy XR manufacturing site details typically be found?
In the prescribing information labeling sections and FDA establishment/listing records, neither of which are included in the current inputs.
References (APA)
No sources were provided in the current inputs.
