Suppliers and packagers for JEVTANA KIT

JEVTANA KIT

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi Aventis Us	JEVTANA KIT	cabazitaxel	SOLUTION;INTRAVENOUS	201023	NDA	Sanofi-Aventis U.S. LLC	0024-5824-11	1 KIT in 1 CARTON (0024-5824-11) * 5.7 mL in 1 VIAL, GLASS (0024-5823-15) * 5.7 mL in 1 VIAL, GLASS (0024-5822-01)	2010-06-17

JEVTANA KIT Suppliers: Who Manufactures the Cabazitaxel Kit and What Are the Supply Risks

Last updated: June 8, 2026

Jevtana Kit is a packaged supply chain built around cabazitaxel and the required infusion components. The supplier set is defined by (1) the cabazitaxel drug substance and drug product manufacturers and (2) the packaging and distribution for the Jevtana kit components used in the U.S. and other regulated markets. Public, definitive manufacturer identity by exact kit component is constrained to what is listed on regulatory filings and distributor/labeler records.

Jevtana kit: Who supplies cabazitaxel drug product and infusion kit components?

Core supply chain entities

• Labeler / marketing authorization holder: The U.S. market for Jevtana is supplied by the branded sponsor responsible for filings and label manufacturing arrangements.
• Cabazitaxel drug substance and drug product manufacturers: Typically a contract manufacturing network covering aseptic or terminal processes for the drug product and related intermediates.
• Kit component manufacturers: Infusion-use items supplied as part of the kit format (for example, diluent/infusion packaging, as required by the label) are usually manufactured by packaging partners under controlled specifications.

What “Jevtana kit suppliers” means operationally

1. Primary drug product supply (cabazitaxel vials/concentrate as marketed).
2. Packaging line and kit assembly for the final “kit” presentation.
3. Distribution partners used for hospital/wholesaler delivery and temperature-controlled logistics (if applicable for the label’s storage conditions).

How to map Jevtana kit supply to real supplier contracts

• Identify the exact NDC entries for Jevtana kits and then tie those to:
  • the listed manufacturer(s) on the NDC record,
  • the site listed on the FDA application/CMC module (for the marketed presentation),
  • the labeler and distributor network reflected in wholesaler packaging data.

Jevtana (cabazitaxel) kit: What suppliers appear on U.S. product listings and labeler records?

The supplier roster for Jevtana kits is determined by the combination of:

• NDC-specific manufacturer listing (manufacturer of record for that package strength/form),
• labeler (sponsor/MAH),
• distributor/wholesaler channel (varies by region and contract).

Market-level supplier structure

• Single branded sponsor with multiple manufacturing sites is common for oncology injectables.
• Kit assembly is frequently done by a packaging/fulfillment partner rather than the drug substance site.

Supply chain choke points to check for Jevtana kits

• Sterile fill-finish and container closure integrity testing capacity.
• Shelf-life stability and re-test cycles for the kit components.
• Cold-chain or controlled-room storage handling at third-party logistics sites.
• Kit assembly capacity for the specific presentation and strength.

How many Jevtana kit suppliers exist and how are they split across strengths?

A practical count of “suppliers” depends on whether the question is scoped to:

• drug substance manufacturers (upstream),
• drug product manufacturers (filled vials/bottles),
• kit assembly/secondary packaging suppliers (downstream),
• distribution partners (channel).

In most branded injectable oncology kits:

• The number of drug product sites is typically limited.
• The number of packaging/kit assembly sites may be even smaller, because the kit presentation is tightly controlled.

Jevtana kit suppliers vs. drug product suppliers: Are they the same entities?

For Jevtana kits, suppliers are often not the same across tiers:

• Cabazitaxel drug product may be manufactured at a pharma manufacturing site with aseptic expertise.
• Kit assembly and labeling may occur under a separate packaging network with clinical-grade change control.
• Distributors are frequently wholesalers and specialty distributors with logistics agreements, not manufacturers.

Which companies supply Jevtana kits outside the U.S.?

Geographic supply varies by:

• local marketing authorization holders,
• tendering and hospital procurement,
• packaging language requirements,
• regional wholesaler networks.

The “supplier” concept shifts from:

• NDC-based U.S. product records to
• local MAH + local packager/distributor in each market.

What supplier risks apply to Jevtana (cabazitaxel) kit sourcing?

Key risks that can surface in kit supply contracts:

• Single-site dependence for sterile fill-finish.
• Regulatory-locked packaging specifications (kit components must match label).
• Manufacturing cycle disruptions affecting kit assembly and release.
• Temperature and handling constraints that raise logistics failure rates.

How to evaluate Jevtana kit supply continuity using CMC and distribution signals

Use a supplier due diligence checklist driven by public signals:

• NDC listing history for manufacturer changes.
• Recalls or FDA inspection outcomes linked to manufacturing sites.
• Shortages and supply communications that name affected presentations.
• Changes in label or packaging configurations that imply kit-assembly changes.

---

Key Takeaways

• “Jevtana kit suppliers” are best described as a layered network: cabazitaxel drug product manufacturer(s), kit assembly/packaging partners, and specialty distribution channels.
• The most actionable supplier identification method is NDC-specific manufacturer mapping plus regulatory labeler/CMC site linkage for the exact Jevtana kit presentation.
• The highest operational risk areas are sterile fill-finish capacity, kit assembly capacity, and logistics handling for oncology injectables.

FAQs

1. How do I identify the exact manufacturer behind an NDC for Jevtana kit?
2. Are Jevtana kit packaging and kit assembly handled by the same site as cabazitaxel fill-finish?
3. What do Jevtana shortages typically indicate about supplier capacity or release bottlenecks?
4. How can I track changes in Jevtana kit supplier/manufacturer over time from public records?
5. What should procurement teams verify in supplier qualification for oncology kits like Jevtana?

References

1. FDA. Drug Shortages. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA. U.S. Food and Drug Administration.
3. FDA. Labeling for Jevtana (cabazitaxel) kit presentation. U.S. Food and Drug Administration.
4. FDA. NDC Directory / National Drug Code Directory. U.S. Food and Drug Administration.