Last updated: June 1, 2026
XADAGO (safinamide) Suppliers: Who Makes the API, Key Intermediates, and Finished Dosage Forms?
XADAGO (safinamide) is marketed in the US by Eisai. The drug’s supply chain runs through a defined set of API and finished-dose manufacturing sites reflected in regulatory submissions and listing records. However, specific supplier identities (named API vendors, intermediate suppliers, and contract manufacturers by site) are not provided in the available source set.
What suppliers make XADAGO (safinamide) API and finished tablets in the US?
A complete, supplier-by-supplier mapping for XADAGO requires the exact Orange Book listing-linked manufacturers and the underlying FDA drug-substance/drug-product manufacturing site data (typically from FDA labeling, facility listings, and submission records). In the available information, only the brand holder is identifiable.
Drug product and brand holder
- Brand: XADAGO
- Marketing authorization holder in the US: Eisai
API and manufacturing site suppliers
- Not stated in the available material.
Which companies supply safinamide to Eisai for XADAGO?
XADAGO’s supplier set is determined by:
- API sourcing and GMP manufacture for safinamide (drug substance),
- Finished-dose manufacturing for XADAGO tablets (drug product),
- Any secondary packaging, labeling, and distribution partners.
In the available source set, no company names beyond Eisai are provided for safinamide API or finished-dose supply.
What to look for in records
- Finished dose manufacturer(s) and packager(s) tied to the NDA filing.
- Drug substance manufacturer(s) for safinamide.
- US FDA facility registration links for the product.
How many XADAGO contract manufacturers support the supply chain?
A count requires enumerating:
- Separate sites for drug substance,
- Separate sites for drug product,
- Packaging and release sites.
The available source set does not enumerate these entities, so a supplier count cannot be produced without introducing unsupported names.
What do XADAGO Orange Book listings reveal about manufacturers and facilities?
Orange Book listings usually show:
- NDA number,
- Proprietary name,
- Dosage form,
- Strength,
- Applicant/holder,
- Patent and exclusivity, not always full supplier granularity.
In the available source set, manufacturer-level Orange Book details for XADAGO are not included, so the supplier list cannot be extracted.
Are there authorized generic or parallel supply sources for XADAGO (safinamide)?
Authorized generic and parallel supply are typically reflected by:
- Additional NDA holders,
- Generic approvals,
- Private label arrangements,
- Contract manufacturing disclosures in regulatory documents.
The available source set does not provide the presence or identities of any authorized generic or parallel suppliers.
What supplier risks exist if safinamide API is sourced from a limited number of vendors?
Risk framing depends on whether safinamide API production is concentrated. That requires supplier-specific data:
- single-source vs multi-source API,
- geography and site redundancy,
- historical shortages,
- regulatory inspection outcomes per site.
No supplier/site list is available in the available source set, so site-specific risk profiling cannot be generated.
Which upstream chemical suppliers support safinamide intermediate supply?
Upstream supplier identification requires:
- manufacturer of key intermediates disclosed in chemistry section,
- supplier qualification lists in regulatory submissions,
- DMF/CEP-backed supply chains.
No intermediate supplier identities are present in the available source set.
How does XADAGO supply chain differ by country (EU vs US suppliers)?
Country-level supplier sets often diverge due to:
- local GMP requirements,
- regional packaging,
- import/export controls.
No jurisdictional supplier mapping is available in the provided information.
Key Takeaways
- Eisai is the identifiable brand/marketing entity for XADAGO (safinamide) in the US.
- Supplier-level detail (named API suppliers, drug product contract manufacturers, packagers, and intermediate providers) is not present in the available source set.
- Without manufacturer/facility listing data, a defensible supplier map cannot be produced.
FAQs
-
Who is the US marketing authorization holder for XADAGO (safinamide)?
Eisai.
-
Does Orange Book list XADAGO’s API suppliers?
Orange Book typically lists applicant/holder and patent/exclusivity data; it is not a complete API supplier directory.
-
Which documents usually identify XADAGO API manufacturing sites?
NDA-linked drug substance manufacturing disclosures in FDA submissions and related facility listing records.
-
Can XADAGO be supplied by multiple manufacturers across countries?
Yes in principle, but country-specific supplier identity requires facility-level regulatory data.
-
What information is required to compile a full XADAGO supplier roster?
Manufacturer and facility data tied to the NDA for both drug substance and drug product, plus packaging/release sites.
References
- Eisai. XADAGO (safinamide) US product information and labeling records.
- FDA. Orange Book (Drug Products Approved for Marketing) entries for XADAGO.
