Last updated: April 25, 2026
Who supplies IMITREX STATDOSE (sumatriptan) and what is the supply chain footprint?
What is IMITREX STATDOSE and who manufactures it?
IMITREX STATDOSE is a branded injectable formulation of sumatriptan (commonly administered subcutaneously) used for acute treatment of migraine attacks.
Manufacturer (brand owner and listed drug sponsor):
- GlaxoSmithKline LLC (GSK).
Source: FDA “Drugs@FDA” listing for IMITREX STATDOSE.
Market application record (key supplier gate):
- The FDA’s listing for IMITREX STATDOSE identifies the sponsor/manufacturer responsible for the marketed product under the NDA/label.
Source: Drugs@FDA (product label and listing).
Who are the manufacturing and supply-site parties?
For injectable products, the practical “suppliers” that matter to operations are the manufacturing sites and labeler/sponsor on the FDA record.
Manufacturing and supply-site information
- The site-level manufacturers for IMITREX STATDOSE are listed on Drugs@FDA (labeling and/or product details pages, including manufacturing by and/or packing by and/or labeler details).
Source: Drugs@FDA.
Packaging and delivery-system supply
- STATDOSE units are prefilled or presentation-specific delivery systems; in practice, the delivery system and device components come from specialized vendors. Those upstream suppliers are not reliably enumerated in public FDA listing data for combination drug-device packaging. The public record typically supports only:
- the drug product manufacturer(s)
- and the labeler/sponsor
Source: Drugs@FDA product listing and label.
What supplier categories does the public record support for IMITREX STATDOSE?
Supported by Drugs@FDA public listing:
- Labeler/sponsor (brand owner)
- Drug product manufacturer and/or packer sites (where identified in the listing/label)
Source: Drugs@FDA.
Not consistently supported in public FDA listing at a vendor level:
- Raw material starting material suppliers
- Device component vendors used in STATDOSE presentation
Source: Drugs@FDA does not typically enumerate upstream vendor identities.
What are the actionable supplier “touchpoints” for procurement and compliance?
- Primary supplier to contract: GSK as the labeled sponsor for IMITREX STATDOSE.
- Secondary supplier to validate: the specific manufacturing/packing sites shown in the product listing/label details.
- Quality/compliance due diligence: verify that the site(s) remain current by checking the latest Drugs@FDA listing and the current package insert manufacturing information.
Key Takeaways
- IMITREX STATDOSE is sponsored by GlaxoSmithKline LLC in the FDA Drugs@FDA record.
- The FDA listing is the authoritative public source for identifying the manufacturer and supply-site parties tied to the marketed drug product.
- Upstream raw-material and device-component suppliers are not consistently disclosed at vendor level in public FDA listing data for STATDOSE presentations.
FAQs
1) Who is the labeled manufacturer/sponsor for IMITREX STATDOSE?
GlaxoSmithKline LLC is the sponsor/labeler listed in FDA Drugs@FDA for IMITREX STATDOSE.
2) Can I get the exact manufacturing site addresses from public sources?
Yes, when the Drugs@FDA listing/label pages identify manufacturing and packing by sites for the specific product presentation.
3) Does the FDA listing name raw material suppliers?
No, not reliably. Public Drugs@FDA listing data typically does not provide upstream vendor names for starting materials.
4) Does the FDA listing name the STATDOSE device component vendors?
Not consistently at the vendor level. Public labeling generally identifies the drug product sponsor and manufacturing sites, not all component suppliers.
5) Where is the most defensible place to verify current suppliers?
FDA Drugs@FDA product listing and the current label/package insert manufacturing information.
References
[1] U.S. Food and Drug Administration. Drugs@FDA: IMITREX STATDOSE (sumatriptan) product listing. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
