Last updated: April 26, 2026
Who Supplies Cabenuva Kit (cabotegravir + rilpivirine) Components?
What exactly is the Cabenuva Kit?
Cabenuva (cabotegravir and rilpivirine) is a long-acting injectable HIV regimen delivered as a kit. It is administered as two injections at the same visit:
- Cabotegravir injection (long-acting integrase inhibitor)
- Rilpivirine injection (long-acting NNRTI)
Commercial supply involves multiple roles across drug substance, drug product, and kit packaging.
Who supplies Cabenuva Kit manufacturing and packaging?
Cabenuva’s drug product manufacturing and commercial packaging are handled by contract manufacturing organizations and/or Janssen manufacturing sites, with kit finalization performed for co-administration.
The publicly listed responsible suppliers include:
| Role |
Supplier / Organization |
What they supply |
Evidence source |
| Marketing authorization holder |
Janssen Biotech, Inc. (US) |
Responsible party for the product in the US market |
FDA label and product listing [1] |
| Drug product / injection supply |
Janssen (manufacturing network) |
Cabotegravir and rilpivirine injectable components |
FDA label manufacturing information [1] |
| Kit / co-packaging |
Janssen network and/or contract packaging |
Final “kit” configuration for administration |
FDA label packaging/manufacturing section [1] |
Which component is from which supplier (cabotegravir vs rilpivirine)?
Public label manufacturing sections identify manufacturers by name (and sometimes by site) for each injection and for the packaged product. For Cabenuva, these are listed under the label’s manufacturing/packaging disclosures.
From the US prescribing information, the responsible manufacturers and packaging entities are those credited in the Manufactured for / Distributed by and Manufacturing sites sections of the label. The label identifies the entities tied to:
- Cabotegravir injection component manufacturing
- Rilpivirine injection component manufacturing
- Final packaged kit presentation
Source: Cabenuva US prescribing information, “Manufactured for” and “Manufactured by/Packaged by” sections [1].
What are the key suppliers for Cabenuva in the US supply chain?
The US product is supplied under Janssen’s product ownership, with manufacturing and packaging attributed in the label.
Key named supplier organizations in the US label disclosure include:
- Janssen Biotech, Inc. (US responsible party) [1]
- Manufacturers and packagers named in the label for:
- cabotegravir injection
- rilpivirine injection
- Cabenuva kit packaging/presentation [1]
Are there different suppliers by market (EU vs US)?
Yes. Cabenuva is marketed globally with label-specific disclosures that can list different manufacturing and packaging sites by region. The US label’s named suppliers do not necessarily match those listed on the EU SmPC.
Source: US prescribing information manufacturing disclosures [1].
Actionable shortlist for vendor qualification
For procurement, the supplier set you need to map into an RFP is constrained to three buckets aligned to the label:
-
Responsible product holder (US)
- Janssen Biotech, Inc. [1]
-
Named manufacturers for each injection component
- Cabotegravir injection component manufacturer(s) listed on the label [1]
- Rilpivirine injection component manufacturer(s) listed on the label [1]
-
Named packager / kit finalizer
- The entity credited for kit packaging in the label [1]
These are the supplier entities that are contractually relevant and auditable through label-based manufacturing transparency.
Key Takeaways
- Cabenuva is supplied as a two-injection regimen within a co-administered kit: cabotegravir plus rilpivirine.
- In the US, Janssen Biotech, Inc. is the responsible party, and the label names the manufacturing/packaging entities for the injection components and the kit presentation [1].
- Supplier identification for Cabenuva is label-driven: procurement should map named component manufacturers and the kit packager from the Cabenuva prescribing information.
FAQs
1) Is Cabenuva supplied by a single supplier?
No. The label discloses separate manufacturing and packaging responsibilities for the injection components and the final kit presentation [1].
2) Who is the responsible party for Cabenuva in the US?
Janssen Biotech, Inc. [1]
3) Are the cabotegravir and rilpivirine components sourced from the same manufacturer?
They can be, but the definitive answer is the label’s manufacturing disclosures for each component, which list the named manufacturers [1].
4) What determines which supplier is relevant to “the Cabenuva Kit”?
The label’s disclosed kit packaging/presentation entity and the manufacturers of each injection component [1].
5) Do suppliers change across countries?
Yes. Market-specific labels can list different manufacturing and packaging sites, so supplier mapping should be label- and jurisdiction-specific [1].
References
[1] Janssen Biotech, Inc. Cabenuva (cabotegravir and rilpivirine) prescribing information (US label). U.S. Food and Drug Administration.
