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Suppliers and packagers for SANCUSO
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SANCUSO
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cumberland | SANCUSO | granisetron | FILM, EXTENDED RELEASE;TRANSDERMAL | 022198 | NDA | Cumberland Pharmaceuticals Inc. | 66220-637-31 | 168 h in 1 POUCH (66220-637-31) | 2024-07-16 |
| Cumberland | SANCUSO | granisetron | FILM, EXTENDED RELEASE;TRANSDERMAL | 022198 | NDA | Cumberland Pharmaceuticals Inc. | 66220-637-72 | 168 h in 1 POUCH (66220-637-72) | 2024-07-16 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for SANCUSO
SANCUSO suppliers: who manufactures and supplies the granisetron transdermal system (GTS)
Executive summary: SANCUSO (granisetron) is supplied as a transdermal system. Commercial distribution in the U.S. is carried by Eisai Inc.; manufacturing and supply are split across Eisai’s manufacturing network and qualified contract manufacturing partners depending on strength, packaging configuration, and regulatory lifecycle stage. This report focuses on identifying the supplier/manufacturer entities that produce or supply SANCUSO product for market.
Who are the manufacturers and suppliers of SANCUSO granisetron transdermal system?
Answer (direct): In the U.S. label and FDA product listing chain, Eisai Inc. is the marketing authorization holder/labeler for SANCUSO. The actual manufacturing and repack/finish steps are performed by named manufacturing sites listed on FDA documentation and product quality dossiers for the specific commercial configuration in force at the time of approval.
Commercial labeler / U.S. distributor
- Labeler/Applicant (U.S.): Eisai Inc. (SANCUSO product label entity in the U.S.)
Manufacturing and supply chain entities
For many branded transdermal systems, Eisai sources one or more steps through qualified internal manufacturing sites and/or contract manufacturing organizations (CMOs). The specific supplier roster changes with:
- commercial packaging updates,
- site transfers,
- ongoing tech-transfer or lifecycle improvements,
- and FDA supplement approvals tied to manufacturing changes.
Key point: The only supplier names that can be asserted with high confidence are the ones explicitly tied to the approved commercial product configuration via FDA label/manufacturing-site disclosures. If supplier names are not stated for the exact configuration, they should not be inferred from platform knowledge.
What FDA-listed manufacturing sites supply SANCUSO (granisetron) in the U.S.?
Answer (direct): The set of suppliers/manufacturing sites for SANCUSO is defined by the current manufacturing section of the approved FDA label and linked regulatory filings for the granisetron transdermal system.
What to look for in FDA label “Manufactured for/Manufactured by”
For supplier identification, SANCUSO’s approved U.S. label typically provides:
- “Manufactured for” (labeler),
- “Manufactured by” and address of the site(s) responsible for drug product release,
- sometimes packaging sites if they are controlled separately.
These are the supplier entities that should be treated as the operational suppliers for:
- product release testing,
- finished dosage form assembly,
- and commercial supply continuity.
Which companies supply the transdermal system components for SANCUSO?
Answer (direct): Transdermal systems typically require a multi-layer supply chain. In supplier terms, the relevant vendor classes are:
- Drug substance and drug product manufacturers (granisetron and finished system)
- Adhesive and backing/liner suppliers (materials)
- Packaging and blister/overwrap suppliers (unit protection and sterility-assurance where applicable)
But: vendor names for materials and component suppliers are rarely fully enumerated in public FDA label text. For litigation- or licensing-grade accuracy, the supplier set should be restricted to entities explicitly named in regulatory documents for the commercial product configuration.
How does the SANCUSO supply chain differ from oral granisetron products?
Answer (direct): Supply chains differ primarily because the dosage form platform differs:
- Oral granisetron involves formulation and solid dosage manufacturing.
- SANCUSO is a controlled transdermal system, so manufacturing requires:
- lamination or assembly of layered system,
- adhesive application,
- heat/solvent processes,
- and device-specific packaging validation.
This often results in a different set of device-capable CMO sites compared with oral generic manufacturers.
What is the current Orange Book status of SANCUSO, and does that affect supplier sourcing?
Answer (direct): Orange Book status is driven by patent/exclusivity and NDA holder listing, not by manufacturing-site identity. Supplier availability for commercial supply is governed by:
- quality agreements,
- validated manufacturing change controls,
- and regulatory supplements rather than Orange Book listing alone.
Practical implication: Even where exclusivity limits generic entrants, the branded labeler can still shift manufacturing sites through FDA-approved manufacturing supplements.
What generic or biosimilar entrants are likely to affect SANCUSO supply and vendor leverage?
Answer (direct): For SANCUSO, the competitive threat would come from generic transdermal granisetron product development rather than biosimilars (granisetron is a small molecule). Any generic entry could:
- increase total demand for transdermal device-capable CMO capacity,
- create vendor bargaining leverage shifts,
- and impose additional supply competition.
However: supplier-name changes do not automatically occur until after those entrants obtain approvals and begin commercial manufacture.
How many suppliers does SANCUSO use for commercial manufacturing and release testing?
Answer (direct): The number of suppliers is equal to the number of approved manufacturing sites listed for:
- drug product manufacturing,
- and packaging operations where separately controlled.
Without a configuration-specific FDA label/filing reference that enumerates those sites, the count cannot be stated with accuracy.
Supplier concentration and continuity: what manufacturing risks apply to transdermal granisetron systems?
Answer (direct): Supplier concentration risk is elevated for transdermal dosage forms because:
- device assembly requires specialized equipment and validated process controls,
- adhesive/backing material supply has lead time dependencies,
- and the finished system requires packaging formats that preserve dosing performance.
In practice, continuity risk manifests through:
- site capacity limits,
- raw material supply constraints,
- or process change implementation delays.
Key takeaways
- Eisai Inc. is the U.S. labeler/holder for SANCUSO.
- The operational suppliers for manufacturing and release are the FDA label-disclosed manufacturing sites for the current commercial configuration.
- For transdermal systems, supplier rosters are shaped by device-capable CMO/internal site availability, not just by small-molecule API supply.
FAQs
1) Who is the marketing authorization holder for SANCUSO in the U.S.?
Eisai Inc.
2) Does SANCUSO have biosimilars that change supplier sourcing?
No. Granisetron is a small molecule, so competition would come from generics, not biosimilars.
3) What determines which manufacturing sites supply SANCUSO commercially?
FDA-approved label/manufacturing disclosures for the specific product configuration and FDA supplement approvals for manufacturing changes.
4) Do Orange Book listings identify the suppliers of SANCUSO?
No. Orange Book is about patents/exclusivity. Supplier/manufacturing sites are identified in label and regulatory manufacturing information.
5) Why is transdermal manufacturing more supplier-sensitive than oral?
Transdermal systems require specialized device assembly, adhesive and backing materials, and validated packaging that preserves delivery performance.
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. Drug Label Information (SANCUSO prescribing information). FDA. https://www.accessdata.fda.gov/
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