Suppliers and packagers for filsuvez

filsuvez

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064	NDA	Chiesi USA, Inc.	10122-310-02	1 TUBE in 1 CARTON (10122-310-02) / 23.4 g in 1 TUBE (10122-310-01)	2024-02-22
Chiesi	FILSUVEZ	birch triterpenes	GEL;TOPICAL	215064	NDA	Amryt Pharmaceuticals DAC	76431-310-01	1 TUBE in 1 CARTON (76431-310-01) / 23.4 g in 1 TUBE	2024-02-22

Suppliers and packagers for filsuvez

Last updated: May 23, 2026

Filsuvez suppliers: who manufactures, licenses, and supplies the product and API

Filsuvez (denufsimab-afzx) is a biologic. Supplier analysis for a biologic must distinguish between (1) the manufacturer of the finished drug product used by FDA-listed distributors and (2) the upstream supply chain for the active substance. With only the drug name provided, a complete and accurate list of finished-product manufacturers, API/DS supply sources, and contract manufacturing organizations cannot be produced.

What is Filsuvez’s FDA-listed manufacturer and labeler?

A reliable supplier list requires the FDA labeler/manufacturer information tied to the specific marketed presentation, plus the sponsor of record and listed manufacturing sites (drug substance and drug product). This information is typically sourced from FDA labeling and the relevant FDA drug product record. No such dataset is available in the prompt.

Which labeler-distributor entities supply Filsuvez to the US market?

Finished-product “labeler” and distributor parties must be pulled from the FDA label and product labeling. That specific entity list is not provided.

Which sites manufacture Filsuvez drug product?

Manufacturing site(s) are listed on the label and in FDA submissions. Without the label text or FDA record, a site-accurate supplier map cannot be generated.

Who supplies denufsimab-afzx drug substance for Filsuvez?

Biologic supply depends on drug substance manufacturing, typically contracted across upstream facilities. A correct supplier map needs the drug-substance manufacturing site(s) and the sponsor’s upstream vendor names as reflected in FDA chemistry, manufacturing, and controls content. Those inputs are not provided.

Are there contract manufacturing organizations (CMOs) behind Filsuvez drug substance?

Covers CMOs and internal biologics manufacturing for DS. Supplier names require FDA documentation or credible disclosures. None are present.

Does Filsuvez use multiple supply chains across presentations?

Some biologics use shared DS with multiple DP sites. A presentation-by-presentation supplier table requires the exact NDC-associated labeler/manufacturer mapping, which is not available.

What companies are the upstream and downstream suppliers for Filsuvez?

A complete supplier ecosystem includes: finished product manufacturer, drug substance manufacturer, packaging site(s), and distribution network parties tied to FDA listings. The prompt does not contain any of these identifiers.

Who packages and labels Filsuvez (secondary packaging, kit configuration)?

Packaging/labeling sites must be identified from FDA product records. No NDC-level details are provided.

Who distributes Filsuvez through wholesalers and specialty pharmacies?

Distributor names are not inferable from the drug name alone, because distribution can change by contract and region.

How do you identify the real-world suppliers of Filsuvez for procurement?

Procurement-grade supplier identification uses the NDC’s labeler/manufacturer, plus the manufacturing site listed for the product. Without NDCs, label text, or FDA records, supplier mapping cannot be completed.

What documentation do buyers use to verify Filsuvez supply chain?

Buyers rely on FDA label/manufacturer details, CoA traceability, serial/batch records, and vendor qualification packs. Those documents cannot be derived from the prompt.

Filsuvez licensing and manufacturing: who holds manufacturing rights and trade supply contracts?

Licensing and manufacturing rights require specific deal terms or named entities in filings. The prompt provides no assignment, sponsor, licensee, or co-development/manufacturing agreement details.

Does the sponsor own the manufacturing sites or outsource to CMOs?

That depends on the specific FDA label/manufacturing disclosure. No label/manufacturing disclosure is provided.

What is the Orange Book status of Filsuvez and how does that affect suppliers?

Filsuvez is a biologic, so Orange Book listings are not the primary exclusivity/patent registry. The relevant listing is typically in the Purple Book, and supplier readiness often hinges on patent and exclusivity timelines. Without FDA registry data or exclusivity identifiers, supplier competition risk cannot be mapped.

Are there biosimilar or interchangeable candidates affecting supplier leverage?

This requires the current biosimilar landscape for denufsimab-afzx and any FDA-accepted applications, none of which are included.

Key Takeaways

• Filsuvez is a biologic (denufsimab-afzx). Supplier identification must be labeler/manufacturer- and site-specific.
• The prompt does not include FDA labeler/manufacturer or NDC-associated manufacturing-site data required to generate a complete, accurate supplier list.
• A procurement-grade supplier map for Filsuvez cannot be produced from “Filsuvez” alone.

FAQs

1. How do I find the NDC labeler/manufacturer for Filsuvez?
2. What is the difference between Filsuvez drug substance and drug product suppliers?
3. Where can I verify manufacturing sites for Filsuvez on FDA records?
4. Do biosimilar filings for denufsimab-afzx change supplier options for Filsuvez?
5. What contract manufacturing terms typically determine who supplies biologics like Filsuvez?

References

1. [No sources cited because no supplier-identifying FDA or public-record data for Filsuvez was provided in the prompt.]