Last updated: April 26, 2026
What is QUVIVIQ and who is the drug’s supply chain?
QUVIVIQ is daridorexant, an oral orexin receptor antagonist indicated for insomnia.
For QUVIVIQ, the publicly identifiable “supplier” entities in the US market cluster into two groups:
- Marketing authorization holder / brand owner (regulatory and commercial lead)
- Commercial manufacturing (drug substance and drug product) and packaging/labeling participants (GMP supply chain)
Brand owner / regulatory lead (US):
- Idorsia Pharmaceuticals US Inc. (QUVIVIQ labeler listed in US prescribing information and FDA labeling records).
Which manufacturers produce QUVIVIQ drug product in the US?
US market labeling and product records identify the drug product manufacturing and packaging operations tied to QUVIVIQ’s commercial supply.
QUVIVIQ (daridorexant) supplier/manufacturing participants shown in FDA labeling records include:
- Idorsia Pharmaceuticals Inc. (global company entity associated with commercial supply in QUVIVIQ’s FDA submission ecosystem)
- Manufacturing and packaging sites listed in the US prescribing information (drug product and packaging)
Which suppliers matter for sourcing and contracting?
For procurement and R&D partnership workflows, QUVIVIQ’s relevant supplier roles typically map to the following contract categories:
1) Regulatory lead (label owner and MAH-style accountability)
- Idorsia Pharmaceuticals US Inc.
2) Drug product manufacturing (fill-finish and finished dosage production)
- Commercial GMP sites identified in FDA labeling (drug product manufacturing and packaging/labeling).
3) Drug substance manufacturing (API supply)
- API suppliers are typically disclosed in the FDA review trail and CMC section of submissions, but the publicly searchable label documents often point directly to the finished dosage manufacturing and packaging/labeling sites rather than naming the full API chain.
Where are QUVIVIQ “supplier” details documented?
The most operationally useful source is the FDA-reviewed US prescribing information, which lists manufacturing and packaging/labeling information for the marketed dosage form.
Primary documentation basis used here:
- FDA label (prescribing information) for QUVIVIQ, which enumerates manufacturing/packaging participants and corporate labeler.
QUVIVIQ supplier snapshot (market-facing)
| Supply-chain role |
Entity named in public FDA labeling records |
Evidence basis |
| Brand owner / labeler (US) |
Idorsia Pharmaceuticals US Inc. |
US prescribing information labeler listing |
| Drug product manufacturing and packaging/labeling |
Manufacturing and packaging entities and sites listed on the label |
US prescribing information “Manufactured for/packaged by” style sections and FDA label records |
What does this mean for procurement timelines and risk?
- Contracting with the brand owner: Idorsia Pharmaceuticals US Inc. is the market-facing party that controls label accountability and commercial supply coordination.
- GMP qualification: Finished-dose manufacturing and packaging/labeling sites named in the FDA label are the reference points used for supplier qualification, batch traceability, and audit plans.
- API chain transparency: Public label documents often emphasize drug product and packaging. If you are building a parallel API supply strategy, the most reliable path is the full CMC disclosure in FDA review materials tied to daridorexant’s NDA/BLA submission history (not always fully enumerated on the label).
Key Takeaways
- QUVIVIQ (daridorexant) is marketed under Idorsia Pharmaceuticals US Inc. in the US.
- The FDA US prescribing information is the primary public source for the specific GMP drug product manufacturing and packaging/labeling entities and sites used in commercial supply.
- For contracting and audit readiness, prioritize the labeler plus the finished-dose manufacturing/packaging participants named in the FDA label; API-chain detail is less consistently exposed in label-only disclosures.
FAQs
1) Who is the labeler for QUVIVIQ in the US?
Idorsia Pharmaceuticals US Inc.
2) Do supplier names appear in the QUVIVIQ prescribing information?
Yes. The US label includes manufacturing and packaging/labeling information tied to the marketed dosage form.
3) Is the API supplier fully disclosed on the QUVIVIQ label?
Not consistently. Public label documents more reliably enumerate drug product and packaging participants than the complete API chain.
4) What should procurement teams anchor on for QUVIVIQ sourcing?
The FDA label’s named manufacturing/packaging participants and the labeler.
5) Where is the best source for QUVIVIQ supplier/site verification?
The FDA-reviewed US prescribing information and associated FDA labeling records for QUVIVIQ.
References
[1] U.S. Food and Drug Administration. QUVIVIQ (daridorexant) Prescribing Information (US label). FDA label records.
