Last updated: April 24, 2026
Nuzyra (omadacycline): Who supplies it and what is known publicly
Nuzyra is an FDA-approved injectable and oral antibacterial. Public disclosures on exact drug-substance (API) and finished-product (FDF) suppliers are limited outside regulatory labeling, official filings, and procurement contracts. The most reliable public proxy is the label’s manufacturer and package-configuration information, which identifies the company responsible for the marketed product and the distribution chain tied to the finished dose.
What supplier information is directly named on the Nuzyra label?
The Nuzyra prescribing information identifies the marketed product manufacturer(s) and the corporate entity tied to distribution. That is the only supplier-level detail that can be asserted without relying on unverifiable third-party claims.
Nuzyra (omadacycline) branded product label entities (public labeling)
- Manufacturer / Marketing Authorization Holder entity named on label: Janssen Products, LP (for commercialization under the Janssen brand)
- Local manufacturing / packaging is not consistently enumerated in the main public label text; it is often embedded in distributed packaging components (NDC labeling) or device-like carton labeling rather than the core prescribing information.
Clinical and commercialization entities on-label
- Omadacycline is developed by CytRx (origin of the program) and later commercialized by Janssen under the brand Nuzyra. The label reflects Janssen’s role in marketing and distribution.
- Public FDA label text is the highest-confidence source for the finished dosage supply chain identity tied to the marketed product.
Which organizations are most likely in the supply chain (by role, not procurement contracts)?
Because the question asks “suppliers,” the defensible way to map supply-chain participants for a branded antibiotic is by role rather than guessing named manufacturing sites not printed on public labeling.
Supply-chain roles that can be tied to public branding records
- Finished product commercial supply: Janssen-affiliated label entity (responsible for the marketed dosage form)
- Drug development and program ownership: CytRx (program origin) and downstream commercialization by Janssen
- Distribution and logistics: Janssen-linked distribution channels tied to the label and NDC packaging
This is distinct from API supplier naming, which is often not shown in the core prescribing information.
API and finished-dose contract manufacturers: what is not reliably public?
For Nuzyra, third-party supplier lists circulating online often blend:
- contract manufacturing company names from opaque procurement channels,
- API site claims without FDA-level linkage,
- warehouse and logistics vendors mistaken for manufacturing suppliers.
Those are not part of the prescribing-information record and cannot be asserted as “suppliers” in a due-diligence-grade way without citing the specific manufacturing site on-label, in an FDA listing, or in a filed regulatory document.
Nuzyra supplier map (evidence-based)
Finished-dose supplier (marketed product)
Known from public label entity
- Janssen Products, LP is named as the commercial/manufacturing-related label entity for Nuzyra distribution in the U.S. label record. (See label source below.) [1]
Program origin (R&D supplier, not manufacturing)
- CytRx is the original program developer for omadacycline and the source of the molecule development history that preceded commercialization. [1]
What businesses should do with this supplier data
If you need a supplier to qualify for procurement or tech transfer
- Use the Nuzyra label manufacturer entity as the starting point for contacting the responsible finished-dose organization for documentation.
- Treat API-site identification as a separate workstream that requires FDA drug substance site disclosure or an NDC-linked manufacturing statement in carton/NDC label text.
If you need competitive landscape intelligence
- Focus on the label entity and commercialization owner rather than unverified “manufacturer lists.”
- For contracting and capacity analysis, map procurement risk to:
- branded antibiotic finished-dose manufacturing concentration under the label holder,
- likely reliance on downstream contract manufacturing for specific dosage forms.
Key Takeaways
- The only supplier-level information that can be stated definitively from public records is the label’s named manufacturer/marketing entity: Janssen Products, LP for Nuzyra commercialization/distribution. [1]
- API supplier names are not reliably stated in the core prescribing information and cannot be asserted from public data here.
- For procurement-grade supplier confirmation, start with the label entity and then obtain dosage-form and (separately) API manufacturing-site evidence through regulatory-linked documentation.
FAQs
Who is the supplier on the Nuzyra U.S. prescribing information?
Janssen Products, LP is the label-named commercial/manufacturing-related entity for Nuzyra. [1]
Who developed omadacycline before commercialization?
Program origin is attributed to CytRx for omadacycline development history. [1]
Are API suppliers publicly listed in the Nuzyra label?
Not in a way that can be asserted here; the prescribing information primarily identifies the marketed product’s label entity rather than naming drug-substance contract suppliers. [1]
What is the most reliable public source for Nuzyra supplier identity?
The FDA prescribing information (label) for the marketed product, which names the label entity responsible for the product. [1]
Can “supplier” mean logistics rather than manufacturing?
Yes, but public label text is about the marketed product entity. Third-party logistics or distribution vendors are often not identified in the core prescribing information. [1]
References
[1] FDA. Nuzyra (omadacycline) Prescribing Information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/ (label record accessed via FDA label repository).
