Last updated: May 28, 2026
JATENZO Suppliers: Which Companies Manufacture and Supply Jatenzo (Testosterone Undecanoate) for Market Distribution?
JATENZO (testosterone undecanoate) is supplied in the U.S. market by Bristol Myers Squibb (BMS), with commercial manufacturing and packaging performed through contract manufacturing network(s) using drug-product and packaging suppliers listed on FDA approvals and current labeling. BMS is the NDA holder and market authorization supplier, while specific plant-level manufacturers can be traced via FDA product labeling, NDA manufacturing section, and the Orange Book entry for the specific dosage form and strength.
However, a complete supplier map at the level of named contract manufacturing organizations (CMOs), package suppliers, and API suppliers cannot be produced from the information provided in the request.
Who supplies JATENZO to pharmacies and wholesalers?
BMS supplies JATENZO as the marketing authorization holder in the U.S., and it controls commercial availability through its distribution and supply chain arrangements. Distribution into the retail and specialty pharmacy channels is executed via wholesalers and specialty distributors, with product shipment tied to the specific NDC and manufacturing/packager configuration.
What entity is listed as the holder on JATENZO labeling?
Bristol Myers Squibb is the listed marketing authorization holder on U.S. product labeling for JATENZO.
How do you identify the actual manufacturer/packager for a specific NDC?
Identify the manufacturer/packager listed in the FDA-approved prescribing information “Manufactured for” / “Distributed by” section for each JATENZO NDC. That is the most direct method for mapping site-level supply.
Which API suppliers make testosterone undecanoate for JATENZO?
JATENZO uses testosterone undecanoate (androgen) as the active pharmaceutical ingredient. API sourcing suppliers are not identified in the request, and there is no general, reliable public crosswalk that enumerates all testosterone undecanoate API vendors for branded testosterone products by product name.
What documents typically list testosterone undecanoate API suppliers?
Publicly searchable supplier names, when available, are usually found in:
- NDA labeling manufacturing details (sometimes does not name API sites)
- FDA manufacturing disclosures within approval correspondence
- Orange Book “manufacturer” listing at the product level (often not API-level vendors)
- Contract references in litigation/CMC exhibits (not provided here)
What contract manufacturers (CMOs) produce JATENZO capsules?
The request does not include the specific NDC(s), label revision, or FDA filing references needed to lock the site-level CMO names. Without those, naming specific CMOs would risk inaccuracy.
What is the typical path to confirm JATENZO capsule manufacturing sites?
- Pull the current and historical JATENZO label for each NDC strength
- Match the label’s “Manufactured by” and “Packaged by” lines to the facility
- Cross-check with the Orange Book listing for the same dosage form and strength
How many manufacturers are listed for JATENZO in the FDA Orange Book?
The number of JATENZO manufacturers depends on:
- Whether multiple NDCs exist for different strengths
- Whether the Orange Book lists separate entries by manufacturer/labeler
- Changes in sites across label revisions
The request does not provide the Orange Book entry text or NDC list needed to quantify and name each manufacturer.
What supplier and manufacturing risks exist for JATENZO supply continuity?
The main operational risk drivers for supply continuity in controlled testosterone oral products are:
- Dependence on limited capsule manufacturing and packaging capacity
- Stability constraints for API or final blend handling
- Changes in manufacturing site qualification or packaging configuration
A quantified risk assessment requires site-level supplier mapping, which cannot be generated from the request.
What is the strongest evidence trail to identify JATENZO suppliers?
The evidence trail that yields the most defensible supplier list is:
- Current JATENZO prescribing information (labeling “manufactured for/distributed by” lines)
- FDA Orange Book entry for the specific strength and dosage form
- NDA manufacturing/CMC summaries where they are publicly accessible
- NDC-to-label mapping by strength and package configuration
The request provides none of these inputs, so a complete named supplier list cannot be produced.
Key Takeaways
- Bristol Myers Squibb supplies JATENZO as the marketing authorization holder in the U.S.
- Named plant-level manufacturers and packagers require NDC-specific labeling and/or Orange Book entry text.
- API supplier names for testosterone undecanoate cannot be enumerated accurately from the information provided.
FAQs
- Is JATENZO manufactured by Bristol Myers Squibb or by contract manufacturers?
- How can I find the manufacturer and packager for my JATENZO NDC?
- Does the Orange Book list the same JATENZO supplier across all strengths?
- What happens to JATENZO supply if a packaging site changes?
- Are testosterone undecanoate API suppliers listed publicly for branded products like JATENZO?
References
No sources were cited because the request did not include FDA label/Orange Book text, NDCs, or specific publicly verifiable supplier identifiers.
