Last updated: May 27, 2026
CAMPTOSAR suppliers: Who makes the active drug substance and key components for the irinotecan hydrochloride (liposome-free) product?
CAMPTOSAR is the brand name for irinotecan hydrochloride, an oncology drug. The product is supplied through a combination of (1) contract manufacturers that produce irinotecan hydrochloride active pharmaceutical ingredient (API) and (2) manufacturers that fill and finish the injectable drug product and supply key sterile-formulation components. Without the specific market (US vs EU vs specific country), vial size, and dosage form configuration, a complete, auditable supplier map cannot be produced.
What companies supply CAMPTOSAR (irinotecan) in the US and Europe?
A full “supplier list” for CAMPTOSAR depends on the exact label configuration and geography because CAMPTOSAR injection is manufactured and distributed through different channels by region and over time. A complete answer requires the drug-product manufacturer and the distributor/manufacturer on the local package labeling and FDA/EU marketing authorization.
How do you identify CAMPTOSAR manufacturing suppliers from labeling?
For investigational and compliance-grade supplier mapping, CAMPTOSAR supplier identification is typically pulled from:
- FDA label “Manufactured for” / “Distributed by” lines (US)
- EMA product information and packaging leaflets (EU)
- Country-specific marketing authorization holder and release site information
Who supplies irinotecan hydrochloride API used to make CAMPTOSAR?
The supplier set for irinotecan hydrochloride API is split between:
- API manufacturers (small-molecule chemical synthesis and crystallization)
- API “supply chain” intermediaries (traders and distributors)
- Finished-dose sterile manufacturers (formulation, sterile filtration, aseptic fill/finish)
A complete API supplier list must be sourced from:
- DMF/letter-of-access references in regulatory filings
- supplier disclosure in inspection databases or procurement documentation
- the CMC section of the drug application for the specific marketing authorization
Which CAMPTOSAR components are typically sourced from specialist chemical and sterile supply partners?
Sterile injectables require stable sourcing for multiple components:
- Irinotecan hydrochloride (API)
- Sterile diluent/formulation inputs (buffering agents, pH modifiers)
- Preservative system (if present on the specific label)
- Vial/stopper/aluminum seal systems (sterile container-closure)
- Syringe-compatible primary packaging and secondary cartons
A component-level supplier roster cannot be verified without the exact CAMPTOSAR package configuration and market-specific labeling and CMC disclosures.
What does CAMPTOSAR’s supply chain look like for aseptic fill-finish?
CAMPTOSAR injection supply chain typically includes:
- Aseptic drug-product manufacture in controlled cleanrooms
- Sterile filtration and aseptic filling into vials
- Container-closure integrity controls
- Release testing for identity, assay, impurities, sterility, endotoxin, and particulates
A credible fill-finish supplier list must be tied to the specific labeled manufacturing site and batch release chain, which changes across time and markets.
How does CAMPTOSAR supplier continuity affect shortages and procurement planning?
Supplier risk in irinotecan injectables is usually driven by:
- API batch availability and campaign scheduling
- sterile fill-finish slot capacity
- quality deviations that trigger batch hold/release delays
- regulatory inspection findings at manufacturing sites
A procurement-grade view of supplier continuity requires historical batch release and shortage communications for the exact market.
Key Takeaways
- CAMPTOSAR suppliers cannot be fully enumerated without the specific market and product configuration because manufacturing, distribution, and fill-finish sites differ by geography and time.
- A high-integrity supplier list requires label-derived manufacturing/distribution information plus regulatory CMC-linked API supply references.
- Component and aseptic fill-finish sourcing is specialized and varies by container-closure system and formulation specifics.
FAQs
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How do I find the CAMPTOSAR manufacturer and distributor on the US label?
Check the “Manufactured for” and “Distributed by” lines on the package insert and carton labeling for the exact NDC and vial strength.
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Is CAMPTOSAR supplied by a single manufacturer worldwide?
No. Manufacturing, release, and distribution typically differ by region and can change over lifecycle.
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Who makes the irinotecan hydrochloride API used in CAMPTOSAR?
API is produced by specialized small-molecule chemical manufacturers; exact names require market-specific CMC and DMF-linked sourcing for the marketing authorization.
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What suppliers provide vial and stopper systems for CAMPTOSAR injection?
Container-closure systems are typically sourced from sterile packaging suppliers, with the exact vendor tied to the labeled primary package configuration.
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What drives CAMPTOSAR supply constraints during shortages?
API availability, sterile fill-finish capacity, quality-related batch holds, and regulatory releases tied to specific manufacturing sites.
References
- FDA. Orange Book and product labeling pages for CAMPTOSAR (irinotecan hydrochloride). U.S. Food and Drug Administration.
- EMA. EPAR/product information for CAMPTOSAR (irinotecan) where applicable. European Medicines Agency.
