Last updated: May 27, 2026
OPZELURA (ruxolitinib) suppliers: manufacturing, API sources, and contract manufacturers
OPZELURA (ruxolitinib cream) has a concentrated supply chain centered on the ruxolitinib active pharmaceutical ingredient (API) and branded finished-dose manufacturing. The key suppliers are the API producer(s) supplying ruxolitinib and the contract manufacturers filling and packaging OPZELURA batches for distribution.
Who supplies the ruxolitinib API used to make OPZELURA?
Ruxolitinib used for topical ruxolitinib products is sourced from companies that manufacture ruxolitinib drug substance under GMP. For OPZELURA, the identifiable supply nodes are typically:
- Ruxolitinib drug substance manufacturers (API site producing ruxolitinib)
- Finished-dose manufacturers producing the topical cream and packaged product
- Packaging and labeling vendors supporting cartons, tubes, and distribution-ready configurations
Where this is documented for OPZELURA: supplier identities are most reliably surfaced through FDA drug establishment listings and Orange Book / FDA product manufacturing site information tied to the listed NDA and manufacturing establishments.
What establishments manufacture OPZELURA finished cream and packaging?
For OPZELURA, the manufacturing system is normally split into:
- Drug product (DS to DP conversion): cream compounding, filling into tubes, and packaging components
- Labeling and secondary packaging: carton labeling and distribution pack assembly
- Batch release and QC labs: in-house or contract analytical release
What companies are listed as OPZELURA drug product manufacturers on FDA records?
OPZELURA’s FDA manufacturing site entries identify the establishment(s) responsible for:
- Drug substance handling (if applicable)
- Drug product manufacturing (filling/packaging)
- Release testing roles (depending on site listing format)
For a direct supplier list, the starting points are:
- FDA NDC / labeler and drug establishment registrations
- FDA Drugs@FDA manufacturing information linked to OPZELURA
- Orange Book listing tied to ruxolitinib topical cream NDA
Which contract manufacturers produce OPZELURA cream and tubes?
Topical steroid-sparing therapies like OPZELURA typically use a contract or hybrid network:
- One or two primary drug-product sites for cream compounding and tube filling
- A secondary site for packaging/labeling if not performed at the primary plant
The “supplier” question, in practice, maps to:
- The site(s) filling tubes and assembling cartons
- The API site(s) supplying ruxolitinib drug substance
How do OPZELURA supply chain changes impact availability and distribution?
A disruption at either node affects timelines:
- API supply constraints can limit batch start dates and create longer lead-time procurement.
- Fill-finish constraints (tube filling or labeling capacity) can bottleneck release even when API supply is intact.
For OPZELURA, allocation and lot release depend on the ability to maintain:
- GMP compliance across sites
- Consistency in formulation and container closure system
- Stability and batch release testing completion
What Orange Book or FDA listings reveal about OPZELURA manufacturing suppliers?
OPZELURA’s supplier exposure is documented through:
- FDA labeler/manufacturer information tied to NDCs
- Drug establishment registrations (site-specific)
- NDA manufacturing change history (varies by submission type and public record)
A supplier list that can be used operationally should reflect site names and roles, not just the brand company.
Key Takeaways
- OPZELURA’s supplier set consists of ruxolitinib API manufacturers and drug-product/packaging establishments listed on FDA records.
- The most decision-grade supplier identification comes from FDA drug establishment and NDC-linked manufacturing information for OPZELURA’s NDA and labeled products.
- Availability risk is driven by constraints at either the API node or the fill-finish/packaging node.
FAQs
- How can I identify the FDA-listed manufacturing establishments for OPZELURA by NDC?
- Are OPZELURA’s tube filling and secondary packaging performed by the same supplier?
- Which FDA databases provide the most reliable OPZELURA manufacturing-site supplier names?
- Do OPZELURA manufacturing changes show up in public drug establishment listings?
- What supply-chain bottlenecks most often affect OPZELURA drug-product release timelines?
References
- U.S. Food and Drug Administration. Drugs@FDA: OPZELURA (ruxolitinib) product information and labeling. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. Drugs@FDA and NDC/labeler manufacturing establishment information. https://www.fda.gov/drugs/drug-approvals-and-databases/ndc-directory
