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

Suppliers for the Pharmaceutical Drug: Firazyr (Icatibant)

Last updated: July 30, 2025

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Introduction

Firazyr (icabitabant) is a prescription medication used primarily for the treatment of acute attacks of hereditary angioedema (HAE), a rare genetic disorder characterized by sudden, severe swelling in various parts of the body. Developed and marketed by Shire Pharmaceuticals, now a part of Takeda Pharmaceutical, Firazyr acts as a selective bradykinin B2 receptor antagonist, effectively reducing swelling episodes in HAE patients. This article explores the key suppliers involved in the manufacturing and distribution of Firazyr, assessing their roles, capacities, and implications for stakeholders in the pharmaceutical supply chain.

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Manufacturing and Supply Chain Overview

The supply chain for Firazyr involves a complex network encompassing active pharmaceutical ingredient (API) producers, formulation manufacturers, packaging entities, and distributors. Given the critical nature of HAE treatment and the rarity of the condition, ensuring a uniform and reliable supplier base remains paramount for maintaining drug availability globally.

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Active Pharmaceutical Ingredient (API) Suppliers

1. Takeda Pharmaceutical's In-House API Production

Takeda Pharmaceutical, the originator of Firazyr, maintains core API manufacturing facilities responsible for producing icatibant. Their vertical integration ensures stringent quality control and consistent supply. The company operates multiple manufacturing sites, including facilities in:

• Ireland: Takeda's primary European manufacturing hub, specializing in biologics and small-molecule APIs.
• Japan: Home to Takeda's global R&D and manufacturing operations.

Maintaining in-house API production provides Takeda with strategic control over supply, quality, and regulatory compliance.

2. Contract Manufacturing Organizations (CMOs)

Despite in-house capabilities, Takeda also relies on CMOs to supplement API production, especially to meet global demand. Leading CMOs involved include:

• Fujifilm Diosynth Biotechnologies: Engaged in biologics and small-molecule manufacturing, emphasizing high-yield, scalable processes compatible with stringent regulatory standards.
• Lonza Group: Known for contract synthesis and process development services, capable of manufacturing APIs at large scales.

Partnering with reputable CMOs mitigates supply risks, accommodates scaling needs, and ensures continuity amid manufacturing constraints.

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Formulation and Finished Dosage Manufacturers

Following API synthesis, Firazyr is formulated into a lyophilized powder for injection, requiring specialized manufacturing expertise.

1. Takeda's Manufacturing Facilities

Takeda's dedicated facilities in:

• Scotland (Glasgow): Responsible for formulation, lyophilization, and packaging. These sites adhere to Good Manufacturing Practice (GMP) guidelines, ensuring product safety and efficacy.

2. Contract Formulation Manufacturers

To manage production volume fluctuations and regional distribution priorities, Takeda collaborates with external formulators, including:

• Humira's supply chain partners: While primarily associated with certain biologics, similar contractual arrangements exist for small-molecule formulations.

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Distribution and Logistics Partners

The distribution network for Firazyr is extensive, involving wholesale distributors, specialty pharmacies, and healthcare providers.

• Takeda's Global Distribution Network: An integrated system ensuring cold chain management, inventory control, and delivery to hospitals and clinics worldwide.
• Regional Distributors: Companies such as Cardinal Health, McKesson, and local specialty distribution firms facilitate access to this orphan drug.

Ensuring efficient logistics, especially in regions with limited healthcare infrastructure, is essential for timely treatment.

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Market and Regional Variability in Supplier Dynamics

Due to regional regulatory approvals and manufacturing capacities, supplier configurations vary:

• United States & Europe: Fully supplied via Takeda's in-house facilities and strategic CMOs, with direct distribution channels.
• Emerging Markets: Reliance on local distributors and regulatory-approved importers, which may source from Takeda or authorized third-party manufacturers.

Regulatory compliance and import/export restrictions influence supply chain complexity further, especially for a specialty drug like Firazyr with limited global manufacturing sites.

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Risks and Opportunities in the Firazyr Supply Chain

Supply Risks

• Single-source API dependency: A potential bottleneck if the API manufacturer encounters production issues.
• Regulatory delays: Cross-border supply chains may face hurdles due to varying registration and compliance timelines.
• Cold chain disruptions: The lyophilized formulation requires robust temperature control, risking spoilage or delays.

Opportunities for Diversification

• Multiple API suppliers: Engaging additional CMOs to reduce dependency.
• Regional manufacturing expansions: Establishing local formulation facilities to enhance access.
• Strategic inventory management: Maintaining buffer stocks for critical markets.

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Implications for Stakeholders

• Pharmaceutical companies: Need robust supply agreements and diversified sourcing to ensure uninterrupted availability.
• Healthcare providers: Depend on the reliability of supply chains, emphasizing the importance of regulatory coordination.
• Patients: Depend on consistent access, underscoring importance of transparent supply chain management.
• Investors and analysts: Should monitor supply chain stability as part of risk assessment, especially considering the drug's specialized market.

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Key Takeaways

• Firazyr’s primary API supply is managed by Takeda, complemented by reputable CMOs to meet global demand.
• The drug's formulation and packaging are primarily handled within Takeda’s facilities, with external partnerships to manage scalability.
• Distribution relies on a combination of Takeda’s global logistics network and regional partners, emphasizing cold chain integrity.
• Supply chain resilience hinges on diversification of API sources, regional manufacturing capacity, and effective logistics.
• Stakeholders must prioritize transparency, quality control, and regulatory compliance to ensure continued patient access.

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FAQs

1. Who are the main suppliers of the active ingredient in Firazyr?
Takeda produces icatibant in-house at its European and Japanese facilities. It also collaborates with CMOs such as Fujifilm Diosynth and Lonza to augment production capacity and mitigate supply risks.

2. Can the supply chain for Firazyr be affected by manufacturing disruptions?
Yes. Dependence on a limited number of API providers and specialized formulation facilities presents risks. Manufacturing interruptions at any point could delay supply, emphasizing the importance of a diversified sourcing strategy.

3. Are there regional differences in Firazyr’s manufacturing and supply?
Yes. While Takeda primarily manages global production and distribution, some regional markets rely on localized distributors and regulatory channels, potentially affecting supply speed and availability.

4. What role do CMOs play in Firazyr’s supply chain?
CMOs support API synthesis, formulation, and packaging, enabling Takeda to scale production efficiently and manage regional demands while maintaining GMP compliance.

5. How is supply chain security maintained for this critical, orphan drug?
Through strategic partnerships, diversified suppliers, robust logistics, and inventory management, Takeda aims to ensure continuous access to Firazyr worldwide despite supply challenges.

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References

1. Takeda Pharmaceuticals. Firazyr prescribing information. 2022.
2. European Medicines Agency. Firazyr (icatibant) summary. 2021.
3. U.S. Food and Drug Administration. Firazyr (icatibant) FDA approval documents. 2018.
4. Contract Pharma. Top CMOs for small-molecule and biologic APIs. 2022.
5. Supply Chain Dive. Managing cold chain logistics for specialty pharmaceuticals. 2022.