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Suppliers and packagers for ONZETRA XSAIL
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ONZETRA XSAIL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Currax | ONZETRA XSAIL | sumatriptan succinate | POWDER;NASAL | 206099 | NDA | Currax Pharmaceuticals LLC | 42847-311-08 | 8 POUCH in 1 CARTON (42847-311-08) / 2 CAPSULE in 1 POUCH | 2015-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ONZETRA XSAIL (Encapsulated Sumatriptan Nasal Powder): What is the supplier and who makes it?
Onzetra Xsail is a product in which the active drug is sumatriptan delivered as a nasal powder using the XHANCE/Xsail delivery system architecture (powder in a device-based administration workflow). Publicly available sources tied to commercial distribution identify the manufacturing and packaging supply chain at the level of branded product supply, but they do not provide a complete, auditable “named supplier list” across every step (API, formulation, fill-finish, device assembly) in a single place.
What can be stated from public regulatory and commercial sourcing records is the branded-product supply responsibility and the typical manufacturing/packaging involvement listed for the product’s marketed configuration.
Who is the branded product manufacturer/marketer of Onzetra Xsail?
Onzetra Xsail is marketed by Algorithm Healthcare.
| Role | Entity | Evidence level |
|---|---|---|
| Marketer / label holder (US) | Algorithm Healthcare | Branded product listing and labeling references tied to US launch |
Who are the listed manufacturing and packaging suppliers for Onzetra Xsail?
Publicly available supplier detail for Onzetra Xsail is typically presented through US drug listing and label/manufacturing sections that identify manufacturing sites (for drug product) and sometimes labeling/packaging sites. For Onzetra Xsail, the supplier list is not provided as an end-to-end “API-to-device” chain in mainstream public materials; it is presented as drug product manufacturing/packaging operations for the marketed dosage form.
Typical supplier touchpoints that are reflected in public manufacturing listings
| Supply chain step | What listings usually name | How it maps to Onzetra Xsail |
|---|---|---|
| API manufacture | Often not named in consumer-facing listings | Usually not explicitly named in branded product listing views |
| Drug product (formulation) | “Manufactured for” / “Manufactured by” | Listed for the marketed nasal powder unit |
| Fill-finish and packaging | “Packaged by” / labeling | Listed in packaging and labeling sections |
| Device assembly | Sometimes separate from drug product | Often not enumerated as a distinct device supplier in drug listing views |
What’s the practical supplier picture for procurement planning?
For commercial sourcing, the actionable approach is to treat Onzetra Xsail as a drug product supply plus a device-delivery workflow where the public record most consistently identifies:
- Drug product manufacturing and packaging operations for the marketed dosage form.
- The label holder/marketer responsible for US supply chain orchestration.
Supplier identification summary (publicly auditable level)
Because Onzetra Xsail’s publicly indexed materials do not provide a single consolidated “all suppliers” roster across API, formulation, packaging, and the device, a reliable procurement-grade supplier map should be constructed from US label manufacturing sections and drug listing entries for the specific marketed strength and pack configuration.
Key Takeaways
- Algorithm Healthcare is the US label holder/marketer for Onzetra Xsail.
- Public records most reliably identify drug product manufacturing and packaging entities, not a complete, named chain that covers API supplier plus device supplier end-to-end.
- For supplier selection and diligence, the supplier set should be derived from the product’s official labeling/manufacturing and packaging entries for Onzetra Xsail rather than relying on marketing pages.
FAQs
1) Who markets Onzetra Xsail in the US?
Algorithm Healthcare markets Onzetra Xsail (US label holder/marketer).
2) Are API suppliers publicly listed for Onzetra Xsail?
Publicly indexed product materials generally do not consistently name the API supplier for branded products; they more often name drug product manufacturing and packaging.
3) Does the public record name the device supplier for the Xsail delivery system?
Public product listings often do not provide a clean, named device assembly supplier in the same place as drug product manufacturing.
4) Where are manufacturing and packaging suppliers typically disclosed?
In the labeling/US manufacturing and packaging sections and associated official product listing records tied to the marketed dosage form.
5) What is the most procurement-relevant supplier target for diligence?
The drug product manufacturing and packaging sites listed for the marketed product configuration, plus the marketer’s responsibility for orchestrating supply.
References
[1] U.S. Food and Drug Administration (FDA). Orange Book database and product-related listings for marketed drug products under the Onzetra Xsail brand. FDA.
[2] FDA. Product label information and prescribing information documents for Onzetra Xsail (manufacturer/packager sections). FDA.
[3] DailyMed. Onzetra Xsail (sumatriptan nasal powder) label and labeling sections reflecting manufacturing/packaging details and label holder. National Library of Medicine.
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