Last updated: May 31, 2026
Zeposia (Ozanimod) Suppliers: Which Companies Provide the Active Ingredient, Drug Substance, and Finished Dosage Forms?
Zeposia’s supply chain is split between (1) the manufacturer(s) of the active ingredient (ozanimod), (2) the drug substance and drug product manufacturing sites listed for Zeposia, and (3) the commercial sourcing entities tied to distribution in the US. Specific supplier names and site-level manufacturing assignments are not provided in the available information in this chat, so a complete, accurate supplier list cannot be produced.
Which companies supply the active ingredient ozanimod for Zeposia?
A complete supplier answer requires the drug master file (DMF) holder and/or the company names tied to ozanimod drug substance manufacture used for marketed Zeposia. No DMF holder data, no site-specific drug substance manufacturer names, and no verified sourcing disclosures are present in the provided material, so identifying active-ingredient suppliers would be incomplete.
What role do ozanimod DMFs play in Zeposia supply sourcing?
DMFs typically identify the substance manufacturer and process scope used by the marketing authorization holder. Without DMF or submission-linked information, the supplier chain cannot be mapped.
Who manufactures Zeposia finished dosage forms (capsules) for US distribution?
A finished-product supplier list normally comes from FDA approvals, labeling manufacturing sections, and inspection-relevant site identifiers. No Orange Book manufacturing site entries, FDA label “Manufactured by” lines, or application supplement data are included in the available input, so an authoritative manufacturer roster cannot be generated.
Which dosage strengths and pack configurations matter for supplier mapping?
Supplier assignment can differ by strength, packaging, or scale-up batches. No strength-level manufacturing disclosures are included, so the supplier list cannot be made complete.
What does the Orange Book say about Zeposia manufacturers and patents tied to supply?
The Orange Book can connect products to application holders and listed drug substance/product characteristics, sometimes including manufacturer identifiers. No Orange Book listing data is provided here, so supplier names tied to the approved application cannot be extracted.
Is Zeposia an FDA-listed reference drug with standard supplier records?
Yes in principle, but the underlying Orange Book entry data needed to name suppliers is not available in the current context.
What contract manufacturing organizations (CMOs) support Zeposia commercial scale?
CMOs for drug product (fill-finish, packaging) and drug substance (synthetic intermediates, final purification) can be visible through label manufacturing statements and inspection histories. No verified CMO or fill-finish assignments are present.
How do CMOs differ across drug substance vs. drug product for Zeposia?
Drug substance CMOs produce ozanimod; drug product CMOs handle encapsulation, blending, coating, and packaging. Without site-level manufacturing evidence, naming CMOs would not be accurate.
Which Zeposia suppliers support European vs US markets?
Geography can change based on marketing authorization holders and manufacturing networks. No EU SmPC/EPAR manufacturing sections or US label manufacturing sections are included, so cross-region suppliers cannot be listed.
What supply risks exist for Zeposia based on supplier concentration?
Supply risk analysis requires at least: number of qualified manufacturers, batch release dependencies, regulatory inspection outcomes, and substitution history. No supply network or inspection/release data is provided here, so risk quantification cannot be produced.
Key Takeaways
- Zeposia supplier identification requires FDA labeling/or Orange Book manufacturing statements, and/or DMF and regulatory submission linkages.
- No supplier names for ozanimod drug substance or Zeposia drug product are contained in the available information in this chat, so an accurate supplier list cannot be compiled.
FAQs
- How can I identify Zeposia drug substance suppliers without guessing?
- Where do I find the “Manufactured by” and “Distributed by” entities for Zeposia on the label?
- Does Zeposia rely on a single ozanimod DMF or multiple substance sources?
- Do different Zeposia strengths come from different manufacturing sites?
- How do Orange Book records connect to supply chain stakeholders for marketed products?
References (APA)
- None.
