Last updated: May 30, 2026
SOVUNA (suvorexant) supply is anchored by the drug’s branded manufacturer and its downstream contract manufacturing and packaging network for the finished-dose product. Without the drug’s specific dosage strength(s) and the jurisdiction of sale, a complete, verified supplier map (API maker, contract manufacturer, packager, and labeled-distribution partners) cannot be produced to an actionable standard.
Who manufactures SOVUNA (suvorexant) and supplies the finished-dose drug?
Answer: SOVUNA’s finished dosage manufacturing and supply are controlled through the brand’s FDA-listed applicant/manufacturer chain, with additional contract manufacturing and packaging typically used for commercial scale.
What is the branded manufacturer vs. contract manufacturing arrangement?
For branded products like SOVUNA, the “labeler” and the “manufacturer” entries in FDA product listings typically separate:
- Drug product labeler (the entity responsible for marketing and regulatory filings)
- Drug product manufacturing site(s) (tablet/capsule manufacturing)
- Packaging/distribution sites (secondary packaging and logistics)
- API manufacturing site(s) (often multiple qualified suppliers)
What supplier identifiers matter for due diligence?
When mapping SOVUNA suppliers, the operationally relevant identifiers are:
- FDA Establishment IDs for drug product manufacturing and packaging
- Orange Book / FDA submission ownership (who holds relevant listings)
- ANDA/BLA cross-reference not applicable (SOVUNA is an NDA small-molecule branded product)
- Lot release and GMP batch provenance in supply agreements (CMO and packager qualification)
Which companies supply suvorexant API for SOVUNA?
Answer: SOVUNA’s API suppliers are not determinable from the question alone to a verified, source-backed level.
What upstream supplier categories exist for suvorexant?
Potential upstream supplier roles for suvorexant include:
- API synthetic manufacturers (crude-to-finished API)
- Key intermediate suppliers (qualified vendors for stages of synthesis)
- API re-packagers/wholesalers (less common if API is directly used by the CMO)
How are API suppliers validated in practice?
Supply qualification typically includes:
- GMP compliance at the API site
- impurity profile match to the NDA specifications
- change control governance (API manufacturing process tech transfers)
What contract manufacturing organization (CMO) sites make SOVUNA tablets or capsules?
Answer: The CMO and packaging sites cannot be verified without the specific SOVUNA strength and the FDA-labeled establishment listings for the relevant dosage form.
How to identify the CMO from regulatory listings
Actionable supplier mapping relies on reconciling:
- FDA drug establishment registrations (manufacturing/packaging)
- NDC label and manufacturer fields (linked to product listings)
- Changes in listed sites across time (site additions or transfers)
What is the Orange Book status of SOVUNA and how does it affect supplier access?
Answer: Orange Book status affects generic entry and formulation or method-of-use differentiation, not the direct identity of API suppliers. Supplier risk can still shift if generic approvals drive secondary capacity or API sourcing diversification.
How exclusivity and patent posture influence supply strategy
When exclusivity is active, branded supply often remains consolidated; later, supplier diversification can accelerate in anticipation of competitive pressure. The question does not provide the required Orange Book and patent context for SOVUNA.
What formulation and dosage strengths determine the supplier network for SOVUNA?
Answer: Supplier networks can differ by:
- strength (10 mg vs 15 mg vs 20 mg, etc.)
- dosage form (if different presentations exist)
- packaging configuration (bottles vs blisters vs unit-dose cartons)
The question does not specify which SOVUNA presentation to map, so a complete supplier list would be incomplete.
What generic entry risks change SOVUNA supply chain demand and pricing?
Answer: Generic risks depend on ANDA approvals, paragraph IV challenges, and settlement dates, which require SOVUNA-specific litigation and FDA approval data to calculate.
What typically happens to branded suppliers when generics launch?
Common operational impacts include:
- tighter volume forecasts and reallocation across CMOs
- increased allocation controls on API
- price pressure on finished-dose manufacturing capacity
Key Takeaways
- A verified supplier map for SOVUNA requires FDA-labeled manufacturing and packaging establishment data tied to the exact SOVUNA strength and presentation.
- API suppliers and CMO/packager identities are typically discoverable from FDA listings (NDC label/manufacturer fields and establishment registrations), but those specifics are not provided in the request.
- Orange Book and patent posture affect competitive dynamics more than supplier identity, yet they determine how quickly supply networks re-optimize post-entry.
FAQs
- How do I find the FDA-labeled manufacturer for a specific SOVUNA NDC number?
- Are suvorexant API suppliers the same for every SOVUNA strength?
- Which FDA listings distinguish drug product manufacturing vs packaging for SOVUNA?
- Do paragraph IV filings for suvorexant affect upstream API supply agreements for brands?
- What evidence is used to qualify a new CMO for a branded insomnia product like SOVUNA?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed 2026-05-30).
- FDA. Drugs@FDA: FDA Approved Drug Products. U.S. Food and Drug Administration. (Accessed 2026-05-30).
- FDA. National Drug Code Directory. U.S. Food and Drug Administration. (Accessed 2026-05-30).
