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Suppliers and packagers for ALOXI
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ALOXI
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Helsinn Hlthcare | ALOXI | palonosetron hydrochloride | INJECTABLE;INTRAVENOUS | 021372 | NDA AUTHORIZED GENERIC | Cipla USA Inc. | 69097-927-35 | 1 VIAL in 1 CARTON (69097-927-35) / 5 mL in 1 VIAL | 2018-03-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ALoxi (palonosetron) suppliers: who makes the drug product, APIs, and key contract manufacturing inputs
ALoxi is palonosetron, a branded antiemetic used to prevent chemotherapy-induced nausea and vomiting (CINV) and postoperative nausea and vomiting (PONV). Public supply chain visibility concentrates on the branded drug’s marketing authorization holders and the contract manufacturing footprint behind injectable vials; exact API source lines are typically not disclosed in FDA public labeling. This overview maps the most consistently identified supplier categories for ALOXi: (1) manufacturer of the finished sterile injectable drug product, (2) manufacturer of palonosetron drug substance where listed, and (3) packaging component suppliers used in vial and carton manufacturing.
Who supplies ALOXi (palonosetron) in the US market and which companies are listed on labeling?
Featured snippet answer: ALOXi is marketed in the US by Helsinn Therapeutics (via its US affiliate), and the finished drug product manufacturers for the injectable are identified on the product’s FDA labeling and marketing documentation.
What entities are responsible for ALOXi’s US supply chain?
- Marketing authorization / label holder: Helsinn (US commercial entity for ALOXi)
- Finished drug product manufacturer: Listed in US prescribing information section “How Supplied/Storage and Handling” and FDA labeling records for the specific NDC strength and presentation (typically sterile injectable vials).
- Drug substance (API) supplier: Listed, when disclosed, in FDA Drug Master File references and/or inspectional records and some CMC packages; not consistently visible in public label text.
How to identify the correct supplier for each presentation (NDC-specific)
ALoxi is sold as injection (vial) with NDCs that can differ by strength and packaging. Supplier identification must be tied to the specific NDC, because:
- different CMO sites can manufacture different strengths
- labeling may update manufacturing sites over time
- vial/kit packaging can shift vendors without changing the drug substance
A sourcing screen should use the NDC-to-manufacturer mapping from FDA label/labeler fields for each ALOXi vial package in your distribution lane.
What companies manufacture ALOXi injectable vials (CDMO/finished drug product) and how are they sourced?
Featured snippet answer: The ALOXi finished injectable supply is produced by one or more sterile injectable manufacturers/CMOs with GMP-sterile capability; those sites are typically named in FDA labeling “Manufactured for/Distributed by” and/or “Manufactured by” lines for each NDC.
Where in US labeling do you find the finished product manufacturing site?
In US prescribing information and package insert text, the finished product site is usually shown as:
- “Manufactured for [label holder]” and/or
- “Manufactured by [manufacturer name]” tied to the vial presentation.
Typical supplier categories inside sterile vial manufacturing
Even when the exact CMO is not visible, sterile injectable supply chains usually include:
- aseptic filling line operator (drug product manufacturer)
- vial and elastomer supplier (Type I glass vials; stoppers)
- secondary packaging supplier (cartons, labels, unit-level overwrap)
- cold-chain and logistics vendor for distribution temperature control
For ALOXi, the vial presentation dominates; sterile aseptic controls and container-closure integrity testing are core supplier qualification work streams.
Who supplies palonosetron API (drug substance) for ALOXi and what does “drug substance” sourcing look like?
Featured snippet answer: Palonosetron API sourcing is usually handled through specialized API manufacturers and intermediate suppliers; public labeling may not list the API site, but it is commonly traceable via DMF/CMC references.
What “API suppliers” generally means in ALOXi procurement
In practice, buyers often see:
- palonosetron drug substance (bulk powder)
- key intermediates used to synthesize palonosetron
- solvent and reagent suppliers qualified under the API supplier’s quality system
- crystallization and purification vendors if the API is subcontracted in stages
How API sourcing shows up in regulatory artifacts
Palonosetron API suppliers can be identified through:
- FDA DMF references linked to the approved application
- inspectional observations and firm addresses captured in enforcement and warning letter records (when applicable)
- CMC exhibits in publicly available regulatory submissions (limited in plain text)
Procurement due diligence typically requires:
- DMF confirmation for the exact synthesis route
- impurity profile match (process-related impurities and residuals)
- polymorph/crystal form specification control
- microbial/endotoxin controls for subsequent sterile manufacturing transfer
What excipient, vial, stopper, and container-closure suppliers support ALOXi?
Featured snippet answer: ALOXi requires sterile container-closure systems and pharmaceutical-grade excipients suitable for injectable formulations; suppliers for vials, stoppers, and labels are commonly different from the drug substance and finished product manufacturers.
Container-closure components that are typically supplier-managed
- Glass vial supplier (Type I borosilicate glass is common for injectables)
- Elastomeric stopper supplier (rubber stopper with appropriate extractables limits)
- Seals and caps (aluminum crimp seals)
- Label material and printing house (adhesive compatibility and barcode/lot trace)
- Carton and leaflet suppliers (secondary packaging and labeling artwork)
How to map these suppliers for a specific ALOXi NDC
A reliable supplier map requires:
- the labeler/manufacturer name from NDC records
- packaging spec sheets from the finished product manufacturer’s quality system
- lot-level packaging material traceability during audits
Without NDC-level details tied to specific manufacturing lots, packaging supplier names are not consistently recoverable from public sources.
What FDA filings and Orange Book listings indicate about ALOXi’s manufacturing and supply footprint?
Featured snippet answer: ALOXi is a prescription injectable; where patent/approval data are published, the FDA label and application data show the manufacturing chain at the firm level, while the full CMC supplier list sits behind DMFs and proprietary exhibits.
Does ALOXi have ANDA/Orange Book visibility that affects supplier landscape?
- If there are listed patents and branded exclusivity, the supplier landscape affects generic tendering and biosimilar-like substitution risk (for injectables, substitution is limited by formulation/presentation).
- If there are no active ANDA products for the same NDC, procurement stays concentrated on the branded manufacturer/CMO network.
How to use Orange Book data for supplier diligence
For each ALOXi NDC:
- confirm the application number
- confirm the listed patents tied to the drug product (drug substance and formulation)
- map the application’s manufacturing firms shown in FDA records
This yields the procurement-relevant firm list for regulatory and audit work.
How many supplier sites typically exist for ALOXi and what is the procurement risk?
Featured snippet answer: Most sterile injectable brands rely on multiple GMP sites or at least multiple qualified packaging and filling lines; the risk profile is tied to whether manufacturing is concentrated in a single site.
What drives supplier concentration risk for sterile injectables
- sterile filling capacity constraints
- vial and stopper availability during tight supply periods
- inspection history and quality events at specific sterile manufacturing sites
- batch release testing capacity (sterility, endotoxin, particulate)
What to examine in contracts and QMS for ALOXi supply continuity
- site redundancy or parallel capacity agreements
- long-term supply agreements for vial/stoppers
- change control commitments (C of C)
- audit rights for API and aseptic manufacturing
Key takeaway tables: ALOXi supplier categories and what to extract for due diligence
| Supplier category | What to extract | Where it is usually shown |
|---|---|---|
| Brand/label holder | Legal entity tied to NDC labeler | FDA labeler field, prescribing information |
| Finished sterile drug product manufacturer (CMO) | “Manufactured by/for” site name for each NDC | FDA label and NDC records (NDC specific) |
| API (palonosetron) manufacturer | DMF-linked API firm and synthesis route | DMF references and CMC artifacts (limited public label disclosure) |
| Container-closure suppliers | vial, stopper, seal suppliers used in packaging | Packaging specs from manufacturer QMS; not typically public |
| Secondary packaging suppliers | carton, labels, leaflet print houses | Packaging specs and artwork approvals |
Key Takeaways
- ALOXi supply is split across three supplier layers: label holder, finished sterile injectable manufacturers, and API/container-closure suppliers.
- Finished product manufacturers are the most consistently identifiable via NDC-specific FDA labeling.
- Palonosetron API and packaging component suppliers are frequently not fully visible in public label text and are best mapped through DMF/CMC-linked regulatory artifacts and manufacturer packaging specifications.
- Procurement and licensing diligence should be NDC- and lot-linked because sterile brands often shift CMOs and packaging inputs over time.
FAQs
1) Which firm is the labeler/manufacturer of ALOXi on FDA NDC records?
The labeler/manufacturer names are shown per NDC in FDA listing and labeler fields; use NDC-level records to avoid mixing strengths and presentations.
2) Does ALOXi have a generic version that changes supplier options?
Generic entry depends on whether approved ANDAs exist for the same NDC/presentation; supplier options can expand when multiple approved products exist.
3) Are vial and stopper suppliers listed in ALOXi prescribing information?
Often not; packaging component supplier identities usually require packaging specs and manufacturer QMS documentation.
4) How can you identify the palonosetron API supplier for ALOXi?
Use DMF references tied to the approved application and cross-check with CMC firm listings in regulatory artifacts.
5) What supply-chain risk is most common for sterile injectable antiemetics like ALOXi?
Site concentration for aseptic filling/release testing and component shortages (vials, stoppers, sterile filtration consumables).
References
- FDA. Drugs@FDA: ALOXi (palonosetron hydrochloride) product information and labeling records. US Food and Drug Administration.
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration.
- FDA. NDC Directory and labeling submission records (labeler/manufacturer fields). US Food and Drug Administration.
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