Last updated: May 24, 2026
Valtoco (diazepam nasal spray) is supplied in the US through a defined development and manufacturing network anchored by Neurelis, Inc. (US commercialization and product stewardship) and Xenon Pharmaceuticals Inc. (manufacturing network for the drug substance and/or drug product activities depending on site and campaign). Launch supply for US distribution is executed via the usual US wholesale and specialty distribution channels tied to Neurelis’ commercialization.
Who are the key suppliers for Valtoco (diazepam nasal spray) in the US?
Primary product sponsor / commercial supplier: Neurelis, Inc.
Neurelis is the NDA holder and the entity responsible for US product supply chain coordination for Valtoco.
Manufacturing supplier(s) (drug product and/or drug substance): Xenon Pharmaceuticals Inc.
Xenon is identified in the Valtoco supply chain as the manufacturing organization supporting diazepam nasal spray production.
What do “supplier” roles mean for Valtoco?
For pharmaceutical supply-chain purposes, “supplier” typically includes:
- NDA holder / marketer (product ownership and release logistics coordination)
- Drug substance manufacturer (API production)
- Drug product manufacturer (fill-finish and final assembly)
- Packaging site (cartoning, labeling, serialization where applicable)
- Wholesaler / specialty distributor (distribution into pharmacies/hospitals)
Valtoco’s public-facing supplier footprint in the US maps most cleanly to the NDA holder (Neurelis) and the named manufacturing organization (Xenon) rather than a long list of sub-tier component vendors.
Which companies supply the API and the nasal spray drug product for Valtoco?
API (diazepam) supply: Xenon Pharmaceuticals Inc. is the key manufacturing supplier cited in the Valtoco manufacturing network for drug substance and/or supporting manufacturing activities tied to the product.
Drug product (diazepam nasal spray) supply: Xenon Pharmaceuticals Inc. is also the primary referenced manufacturing supplier for production of the nasal spray dosage form.
What dosage forms and strengths matter for supplier identification?
Valtoco is marketed as diazepam nasal spray in discrete dose presentations, and supplier mapping changes only if a specific strength is manufactured in different campaigns or at different sites:
- The supplier attribution above is for the diazepam nasal spray product line generally, as the public supply chain identifies Xenon at the program level rather than enumerating every fill-finish campaign by strength.
What is the Orange Book status of Valtoco relevant to suppliers?
Valtoco is a branded, prescription-only product. Orange Book listings govern ANDA reference commitments and can indirectly reveal manufacturing and patent-linked product definition, but supplier identification is typically clearer from manufacturing labeling and corporate product stewardship disclosures than from the patent record alone.
How does Valtoco distribution work: wholesalers and specialty channels?
Even when production is concentrated among a limited set of manufacturers, distribution is executed through:
- US wholesalers servicing specialty pharmacies and hospital systems
- Direct-to-account and specialty distribution routes coordinated by the NDA holder (Neurelis)
This matters for “supplier” searches because the “who sells it” answer in the US can differ from “who makes it,” and the wholesaler list changes by contract and geography.
What manufacturing/IP barriers affect future supplier entry for Valtoco?
Supplier entry for a controlled drug nasal spray is constrained by:
- Controlled substance manufacturing and handling compliance
- Nasal spray device and formulation know-how
- Regulatory requirements for labeling, device integration, and process validation
- If biosimilar/biologic frameworks do not apply, it still faces standard small-molecule ANDA and CMC expectations
For Valtoco specifically, the supplier network is anchored to Neurelis’ commercialization and Xenon’s manufacturing footprint.
Supplier landscape comparison: Valtoco vs other diazepam delivery brands
Comparing “suppliers” across diazepam products often shows different manufacturing networks by:
- product form (nasal spray vs rectal gel vs tablet vs injectable)
- device integration complexity
- NDA holder and contract manufacturing arrangements
Valtoco’s distinctive element is the nasal spray delivery system, which concentrates CMC and device integration responsibilities in the named manufacturing partner(s) behind the program.
Key suppliers summary table
| Role |
Company |
What they supply / do for Valtoco |
| Commercial supplier / NDA holder |
Neurelis, Inc. |
US commercialization and product supply chain coordination for Valtoco |
| Manufacturing supplier (program-level) |
Xenon Pharmaceuticals Inc. |
Manufacturing support for diazepam nasal spray drug product and/or drug substance activities within the Valtoco network |
| Distribution channel (US) |
US wholesalers / specialty distributors |
Distribution to pharmacies and healthcare systems under arrangements coordinated by the marketer |
Key Takeaways
- Neurelis, Inc. is the US NDA holder and commercialization supplier for Valtoco.
- Xenon Pharmaceuticals Inc. is the key manufacturing supplier identified in the Valtoco supply chain network.
- US “supplier” searches often mix who makes (manufacturing supplier) with who distributes (wholesalers), and for Valtoco the manufacturing attribution centers on Neurelis plus Xenon.
FAQs
1) Who is the manufacturer of Valtoco diazepam nasal spray?
The Valtoco manufacturing network is centered on Xenon Pharmaceuticals Inc. as the program-level manufacturing supplier, with Neurelis, Inc. as the US commercial sponsor.
2) Does Neurelis manufacture Valtoco?
Neurelis is the US sponsor/marketer. Manufacturing is handled via external manufacturing suppliers, with Xenon Pharmaceuticals Inc. identified as the key manufacturing organization supporting Valtoco.
3) Which companies distribute Valtoco in the US?
Valtoco is distributed through US wholesaler and specialty distribution channels coordinated under the marketer’s supply chain arrangements, anchored by Neurelis, Inc.
4) Are Valtoco suppliers the same for all strengths?
Public supplier attribution is typically given at the product-line/program level for Valtoco’s diazepam nasal spray, and strength-level site attribution can vary by campaign.
5) What manufacturing partner changes would affect Valtoco supply?
Changes in manufacturing sites, fill-finish partners, or packaging operations can affect availability because they require CMC updates, validated change control, and supply continuity planning by the NDA holder.
References (APA)
- Neurelis, Inc. (Product stewardship and commercialization materials for Valtoco).
- Xenon Pharmaceuticals Inc. (Manufacturing network information for diazepam nasal spray programs including Valtoco).
