Suppliers and packagers for firazyr

firazyr

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Takeda Pharms Usa	FIRAZYR	icatibant acetate	INJECTABLE;SUBCUTANEOUS	022150	NDA	Takeda Pharmaceuticals America, Inc.	54092-702-01	1 SYRINGE, GLASS in 1 CARTON (54092-702-01) / 3 mL in 1 SYRINGE, GLASS	2011-08-25
Takeda Pharms Usa	FIRAZYR	icatibant acetate	INJECTABLE;SUBCUTANEOUS	022150	NDA	Takeda Pharmaceuticals America, Inc.	54092-702-02	1 SYRINGE, GLASS in 1 CARTON (54092-702-02) / 3 mL in 1 SYRINGE, GLASS	2011-08-25
Takeda Pharms Usa	FIRAZYR	icatibant acetate	INJECTABLE;SUBCUTANEOUS	022150	NDA	Takeda Pharmaceuticals America, Inc.	54092-702-03	3 SYRINGE, GLASS in 1 CARTON (54092-702-03) / 3 mL in 1 SYRINGE, GLASS	2011-08-25

FIRAZYR (icatibant) Suppliers: Who Manufactures, Supplies, and Sources the Marketed Drug and Key In-Country Inputs

Last updated: May 26, 2026

Firzyr is marketed in multiple markets as icatibant acetate for acute attacks of hereditary angioedema (HAE). The supplier picture depends on the country’s label holder and on whether the channel is branded supply, contract manufacturing, or biosimilar-style substitutes (not applicable here, since icatibant is a small molecule). The most material supplier inputs for downstream market access are: drug substance (icatibant acetate) and drug product (syringe/solution), with packaging and sterile filling as the typical constraint points.

Because “suppliers for FIRAZYR” can mean (1) the label holder who supplies the branded product into each country, (2) contract manufacturers (CMOs) producing drug substance and drug product, or (3) raw-material sourcing, the actionable supplier map is presented below in two layers: (a) market-facing branded supply and (b) manufacturing supply chain constraints relevant to sourcing and generic/parallel import risk.

---

Who supplies Firazyr (icatibant) in major markets?

Featured snippet:

• Firazyr supply is typically tied to the marketing authorization holder (MAH) and the local distributor in each country, with production occurring at licensed sterile drug product sites and upstream drug substance plants. Branded supply for icatibant is usually managed through global pharma operations with outsourced portions to sterile fill-finish sites, depending on region.

Label holder and distribution structure

Firazyr is an MAH-controlled branded product. Market entry, tender supply, and hospital procurement rely on:

• MAH (global brand owner)
• Local affiliate or importer/distributor
• Wholesaler/retailer channel (tender and hospital purchasing)

Practical supplier categories (how procurement teams frame “suppliers”)

1. Brand supplier (MAH or local distributor)
   Used for hospital procurement, tendering, and supply agreements.
2. Drug substance supplier (icatibant acetate API)
   Used for sourcing, cost benchmarking, and contract manufacturing qualification.
3. Sterile fill-finish and packaging supplier
   Used for syringe assembly, sterile filtration/filling, labeling, and serialization.

---

What companies manufacture Firazyr drug product (icatibant sterile injection)?

Featured snippet:

• Firazyr drug product is a sterile injectable solution in a prefilled syringe. The primary manufacturing nodes are sterile filling/finishing sites plus packaging and labeling facilities. The set of plants used varies by regulatory region and year.

Manufacturing steps that define the supplier bottleneck

• Sterile API-to-solution formulation (manifold mixing under GMP controls)
• Sterile filtration and aseptic filling
• Prefilled syringe assembly and inspection
• Secondary packaging and labeling
• Cold-chain handling if required by the local label (varies by country packaging configuration)

Where supplier lists break down

Public supplier lists for branded products are often incomplete because:

• CMOs are frequently disclosed only in regulatory dossiers or MAH filings
• plant usage can shift by batch year without changing the brand’s MAH

For an operational supplier procurement view, the supplier-of-record is usually the MAH’s distribution entity, while manufacturing suppliers are verified via:

• regulatory dossier appendices (CTD module 3 manufacturing)
• batch certificate and commercial QA audit packages
• supply agreements and change control notices

---

Which companies supply icatibant acetate (API) for Firazyr?

Featured snippet:

• API supply is the upstream node for any attempt to qualify alternative manufacturing. For icatibant acetate, API supply is generally handled by the MAH’s global API network and/or qualified CMOs.

API sourcing focus areas

• Synthetic route and impurity profile control (GMP release specifications)
• Salt form control (acetate salt consistency)
• Analytical method transfer readiness (HPLC/related substances)
• Change control tolerance (process changes can trigger comparability work)

Supplier due diligence points (what procurement/litigation teams verify)

• Source of starting materials and control strategy
• Impurity monitoring and regulatory-aligned specification sets
• Stability program and retest periods
• DMF or ASMF status where applicable (when cited in country submissions)

---

What are the key regulatory filings that identify Firazyr manufacturing suppliers?

Featured snippet:

• Manufacturing suppliers are identified via CTD Module 3 in national/regional regulatory submissions and via ASMF/DMF references in the application.

Orange Book relevance?

• The Orange Book is US-specific and is most useful for patent and exclusivity rather than a supplier list.
• For manufacturing supplier verification, the more direct sources are:
  • FDA drug product and manufacturing facility listings
  • European Medicines Agency (EMA) assessment documents and national EPAR equivalents
  • national label dossiers for manufacturing site declarations

---

What patent estate and exclusivity affect supplier access to Firazyr?

Featured snippet:

• Supplier entry risk for “Firazyr competitors” is driven by US and EU patent coverage, not by exclusivity alone. For a small molecule like icatibant, the main constraints for generics are composition/formulation, method-of-use, and manufacturing process patents, plus any remaining exclusivity periods tied to reference product history.

Why supplier strategy cannot ignore IP

If a party attempts to supply an authorized generic, parallel trade, or branded refill channel, IP can block:

• launch of a generic substitute
• manufacturing changes that rely on patented process steps
• marketing of alternative salt forms or device configurations (less common here, as the marketed product is already standardized)

---

When do Firazyr competitors (generics/authorized substitutes) enter, and what does that do to supply?

Featured snippet:

• Generic entry for small molecules tends to shift supply pricing and tender availability. For Firazyr, generic dynamics depend on whether approved substitutes exist in each market and whether they face patent or exclusivity blocks.

Impact on “suppliers”

Once approved generics exist:

• procurement expands from single-brand supply to multi-source bids
• sterile fill-finish capability becomes the main capacity constraint
• tender lists may include multiple manufacturers with bioequivalence demonstrated via reference product linkage

---

How do distributors and tender suppliers differ from manufacturing suppliers?

Featured snippet:

• For hospital and government procurement, “supplier” usually means the tender-contract entity (MAH/local distributor/authorized wholesaler), not the manufacturing plant.

Example operating model in branded specialty drugs

• MAH sets supply forecasts and allocates inventory to local distributors
• local distributor handles import, warehousing, QA release distribution into hospitals
• sterile manufacturing and packaging are centralized at selected GMP sites

---

Which sourcing risks matter if you are qualifying a new Firazyr supply chain?

Featured snippet:

• The biggest risks are sterile fill-finish capacity, batch release variability, and regulatory documentation completeness (CoA consistency, stability data package, and manufacturing site qualification).

Risk checklist used in qualification and procurement

• GMP status and inspection history of fill-finish site
• ability to provide complete batch documentation (CoA, assay, impurities, sterility, endotoxin)
• device compatibility and extractables/leachables if device is changed
• labeling and serialization readiness by country

---

Key Takeaways

• “Suppliers for FIRAZYR” breaks into market-facing supply (MAH/local distributor into hospitals) and manufacturing supply (sterile injection fill-finish and icatibant acetate API).
• For procurement and qualification, the critical nodes are sterile fill-finish and packaging plus upstream icatibant acetate API.
• IP and regulatory status can limit competition and keep supply concentrated with MAH-controlled channels in many markets.
• Operational supplier verification is driven by regulatory dossier manufacturing site declarations, batch certificates, and QA audit packages, not by high-level public marketing information.

---

FAQs

1) Are Firazyr suppliers the same as the manufacturers of sterile injection syringes?
No. Hospital supply usually comes from the MAH’s distribution network or authorized wholesalers. Syringe manufacturing is performed at GMP sterile fill-finish sites.

2) What is the most important upstream supplier for Firazyr sourcing?
The icatibant acetate API supplier is the key upstream node because drug product formulation and release specifications depend on API impurity control and salt form consistency.

3) Can distributors change without changing manufacturing suppliers?
Yes. MAH/local distributor changes affect tender contracting but do not necessarily change the manufacturing plant producing the batches.

4) What is the main manufacturing constraint for icatibant injection supply?
Sterile fill-finish capacity and aseptic processing controls, including sterility assurance testing and batch release documentation.

5) Do patent constraints affect supply beyond market entry?
Yes. Even when supply exists, patent coverage can restrict alternative manufacturing routes, device/process changes, and marketing of substitutes, shaping who can legally supply competitive product.

---

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. FDA.
2. FDA. Drug Product Manufacturing Information and Facility Listings. U.S. FDA.
3. EMA. European Public Assessment Reports (EPAR) and related assessment documents for icatibant-containing products. European Medicines Agency.
4. US FDA. Drug Applications and Manufacturing/Labeling Resources (CTD Module 3 structure and references). U.S. FDA.