Suppliers and packagers for generic pharmaceutical drug: ICATIBANT ACETATE

ICATIBANT ACETATE

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
Alembic	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	213773	ANDA	Alembic Pharmaceuticals Limited	46708-654-03	1 SYRINGE, GLASS in 1 CARTON (46708-654-03) / 3 mL in 1 SYRINGE, GLASS	2024-06-14
Alembic	ICATIBANT ACETATE	icatibant acetate	INJECTABLE;SUBCUTANEOUS	213773	ANDA	Alembic Pharmaceuticals Limited	46708-654-09	3 SYRINGE, GLASS in 1 CARTON (46708-654-09) / 3 mL in 1 SYRINGE, GLASS	2024-06-14

ICATIBANT ACETATE: GLOBAL SUPPLY CHAIN ANALYSIS

Last updated: February 19, 2026

This report details the global supplier landscape for ICATIBANT ACETATE, a bradykinin B2 receptor antagonist. The analysis focuses on active pharmaceutical ingredient (API) manufacturers, contract development and manufacturing organizations (CDMOs), and key raw material providers critical to its production. Understanding this ecosystem is essential for ensuring supply chain resilience and mitigating risk for stakeholders in the pharmaceutical industry.

Who are the Primary API Manufacturers for ICATIBANT ACETATE?

The production of ICATIBANT ACETATE API is concentrated among a limited number of specialized manufacturers. These companies possess the complex synthesis capabilities and quality control systems required for pharmaceutical-grade active ingredients.

• Bachem AG: A Swiss-based company, Bachem is a significant supplier of APIs, including peptides like ICATIBANT ACETATE. They operate multiple manufacturing sites globally, adhering to stringent Good Manufacturing Practices (GMP) standards. Their involvement suggests a reliance on advanced peptide synthesis technologies. Bachem's capacity and regulatory compliance are key factors for pharmaceutical clients.

• Polypeptide Group: With facilities in Europe and North America, Polypeptide is another leading manufacturer of peptide APIs. They offer custom synthesis services and have a broad portfolio of therapeutic peptides. Their expertise in solid-phase and solution-phase peptide synthesis positions them as a crucial supplier for complex molecules like ICATIBANT ACETATE.

• Other Potential Suppliers: While less publicly disclosed, other specialized peptide manufacturers or CDMOs with peptide synthesis capabilities may also be involved in the ICATIBANT ACETATE supply chain. These could include companies in Asia, such as China and India, which have a growing presence in API manufacturing. Due diligence on these suppliers is recommended to assess their GMP compliance, production scale, and regulatory track record.

What CDMOs are Involved in the Manufacturing and Formulation of ICATIBANT ACETATE Products?

Beyond API synthesis, Contract Development and Manufacturing Organizations (CDMOs) play a vital role in drug product formulation, sterile filling, and packaging of ICATIBANT ACETATE. These partnerships are critical for bringing the finished drug product to market.

• Lonza Group AG: A global leader in contract development and manufacturing, Lonza has extensive experience in sterile drug product manufacturing, including injectables. Their capabilities cover formulation development, aseptic filling, lyophilization, and packaging. Lonza's involvement signifies a reliance on established, high-capacity manufacturing networks.

• Catalent, Inc.: Catalent offers a comprehensive suite of services for drug development and manufacturing, including softgel, oral solids, sterile drug manufacturing, and biologics. Their facilities are equipped to handle complex injectable formulations and large-scale commercial production, making them a potential partner for ICATIBANT ACETATE.

• Thermo Fisher Scientific: Through its Patheon brand, Thermo Fisher Scientific provides end-to-end pharmaceutical services, including API manufacturing, drug product development, and commercial manufacturing. Their global network of facilities and expertise in sterile injectables make them a significant player in the CDMO space for products like ICATIBANT ACETATE.

• Aesica Pharmaceuticals GmbH (now part of Recipharm): Aesica, now integrated into Recipharm, has a strong background in sterile manufacturing of injectables. Their expertise in controlled drug release and complex formulations could be relevant for ICATIBANT ACETATE products.

The selection of a CDMO depends on factors such as manufacturing scale, technological expertise, regulatory experience, and geographic reach. Pharmaceutical companies often engage multiple CDMOs to ensure redundancy and meet global demand.

Which Raw Materials are Critical for ICATIBANT ACETATE Synthesis?

The synthesis of ICATIBANT ACETATE, a decapeptide, requires a specific set of protected amino acids and reagents. The availability and quality of these raw materials are foundational to the entire production process.

• Protected Amino Acids: ICATIBANT ACETATE is composed of the amino acid sequence D-Arg-Arg-Pro-Gly-D-Phe-Ser-D-Phe-Lys-Lys-Gly-NH2. Key protected amino acids include:

  • N-epsilon-Fmoc-L-Lysine (Fmoc-Lys(Boc)-OH or similar variants): This is crucial for the lysine residues. The tert-butyloxycarbonyl (Boc) group is a common protecting group for the epsilon-amino function of lysine.
  • Fmoc-L-Proline: For the proline residue.
  • Fmoc-Glycine: For the glycine residues.
  • Fmoc-L-Serine: With appropriate side-chain protection (e.g., t-butyl ether).
  • Fmoc-D-Phenylalanine: For the D-phenylalanine residues.
  • Fmoc-D-Arginine: With appropriate side-chain protection (e.g., Pbf or Pmc).

  Suppliers of these specialized protected amino acids are essential. Companies like Iris Biotech GmbH and Novabiochem (Merck KGaA) are prominent in this sector, offering a wide range of Fmoc-protected amino acids. The chirality of the D-amino acids is critical and requires specialized synthesis or sourcing.

• Resins for Solid-Phase Peptide Synthesis (SPPS): For typical peptide synthesis, functionalized resins are used. A Rink Amide resin is commonly employed for C-terminal amidation, as is present in ICATIBANT ACETATE. Companies such as Advanced ChemTech and PerkinElmer (which acquired OpusBio, a resin supplier) provide these specialized resins.

• Coupling Reagents: Reagents that facilitate the formation of peptide bonds are critical. Common examples include:

  • HBTU (O-(Benzotriazol-1-yl)-N,N,N',N'-tetramethyluronium hexafluorophosphate)
  • HATU (1-[Bis(dimethylamino)methylene]-1H-1,2,3-triazolo[4,5-b]pyridinium 3-oxid hexafluorophosphate)
  • DIC (N,N'-Diisopropylcarbodiimide) in combination with HOBt (Hydroxybenzotriazole) or Oxyma Pure.

  These reagents are available from major chemical suppliers such as Sigma-Aldrich (Merck KGaA), TCI America, and Fisher Scientific.

• Solvents and Cleavage Reagents: High-purity solvents like N,N-Dimethylformamide (DMF), N-Methylpyrrolidone (NMP), and Dichloromethane (DCM) are used extensively. Reagents for cleaving the peptide from the resin and removing protecting groups, such as Trifluoroacetic Acid (TFA), are also vital. Suppliers include bulk chemical manufacturers and distributors.

The supply of these raw materials is subject to global chemical market dynamics, regulatory oversight, and the manufacturing capacity of specialized chemical producers. Disruptions in this upstream supply chain can have significant downstream impacts on ICATIBANT ACETATE production.

What is the Regulatory Landscape for ICATIBANT ACETATE Production?

The production and sale of ICATIBANT ACETATE are governed by stringent regulatory requirements established by health authorities worldwide. Compliance is non-negotiable for all parties involved.

• Good Manufacturing Practices (GMP): All API manufacturers and CDMOs involved in producing ICATIBANT ACETATE must adhere to GMP guidelines. These are enforced by agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. GMP ensures that products are consistently produced and controlled according to quality standards. Regular inspections and audits are conducted.

• Drug Master Files (DMFs): API manufacturers typically submit DMFs to regulatory agencies. A DMF contains confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. This allows regulatory bodies to review the API information without disclosing proprietary details to the drug product applicant. Companies like Bachem and Polypeptide maintain DMFs for their APIs.

• Marketing Authorization Applications (MAAs) / New Drug Applications (NDAs): Pharmaceutical companies seeking to market ICATIBANT ACETATE-based drugs must submit comprehensive applications. These applications include data from clinical trials, chemistry, manufacturing, and controls (CMC) sections detailing the entire supply chain, from API to finished product. Regulatory approval is required before a drug can be marketed.

• Impurity Profiling and Control: Regulatory agencies require thorough characterization of impurities in both the API and the finished drug product. Manufacturers must establish analytical methods to detect, quantify, and control these impurities within acceptable limits.

• Supply Chain Audits and Qualification: Pharmaceutical companies are responsible for qualifying their API suppliers and CDMOs. This involves rigorous audits to ensure compliance with GMP and other relevant regulations. Regulatory agencies may also audit these third-party manufacturers as part of their oversight.

The complex regulatory framework necessitates robust quality management systems and a deep understanding of international pharmaceutical standards for all participants in the ICATIBANT ACETATE supply chain.

What are the Key Challenges and Risks in the ICATIBANT ACETATE Supply Chain?

The specialized nature of peptide manufacturing and the global reach of the supply chain present several inherent challenges and risks.

• Supply Chain Concentration: The limited number of specialized API manufacturers for complex peptides like ICATIBANT ACETATE creates a risk of supply disruption. A single point of failure at a major supplier could have widespread consequences.
• Raw Material Volatility: The availability and pricing of highly specific protected amino acids and reagents can be subject to market fluctuations, geopolitical events, and production issues at upstream chemical suppliers.
• Quality Control and Compliance: Maintaining consistent, high-quality production across multiple manufacturing sites and contract manufacturers requires rigorous quality assurance. Deviations from GMP can lead to product recalls and regulatory action.
• Intellectual Property and Patent Expiry: While patents provide market exclusivity, their expiry opens the door for generic competition. This can impact pricing and the overall market dynamics for ICATIBANT ACETATE. Understanding patent landscapes is crucial for long-term supply strategy.
• Geopolitical and Environmental Factors: Global supply chains are susceptible to disruptions from political instability, trade disputes, natural disasters, and pandemics, all of which can impact manufacturing, logistics, and raw material sourcing.
• Lead Times: Peptide synthesis is often a lengthy process. Extended lead times for API production and subsequent drug product manufacturing can impact inventory management and market responsiveness.

Proactive risk mitigation strategies, including dual sourcing, robust supplier qualification programs, and strategic inventory management, are essential for ensuring the reliable supply of ICATIBANT ACETATE.

Key Takeaways

• The ICATIBANT ACETATE API manufacturing is concentrated among specialized peptide synthesis firms, notably Bachem AG and Polypeptide Group.
• Key CDMOs involved in formulation and sterile manufacturing include Lonza Group AG, Catalent, Inc., and Thermo Fisher Scientific.
• Critical raw materials include specialized Fmoc-protected amino acids (e.g., L-Lysine, D-Phenylalanine, D-Arginine), Rink Amide resins, and peptide coupling reagents.
• Production is governed by stringent GMP regulations enforced by agencies like the FDA and EMA, requiring detailed DMFs and thorough CMC documentation.
• Significant supply chain risks include concentration of API suppliers, raw material volatility, quality control challenges, and geopolitical disruptions.

Frequently Asked Questions

What is the primary therapeutic use of ICATIBANT ACETATE?

ICATIBANT ACETATE is used for the symptomatic treatment of acute attacks in patients with hereditary angioedema (HAE) [1]. It acts as a selective bradykinin B2 receptor antagonist.

Are there any approved generic versions of ICATIBANT ACETATE?

As of the latest available information, the primary branded product is Firazyr®. The market for generic ICATIBANT ACETATE is evolving. Manufacturers interested in developing generics must navigate existing patents and meet stringent bioequivalence requirements. Patent expiry dates and litigation outcomes are critical factors.

What are the main analytical methods used for quality control of ICATIBANT ACETATE API?

Standard analytical techniques include High-Performance Liquid Chromatography (HPLC) for purity and assay, Mass Spectrometry (MS) for molecular weight confirmation and impurity identification, Nuclear Magnetic Resonance (NMR) spectroscopy for structural elucidation, Karl Fischer titration for water content, and amino acid analysis to confirm composition.

How does the solid-phase peptide synthesis (SPPS) process impact the supply chain for ICATIBANT ACETATE?

SPPS relies on a sequence of coupling and deprotection steps on a solid resin support. This process demands a consistent supply of high-purity protected amino acids, specialized resins, and coupling reagents. The scalability of SPPS and the efficiency of resin-bound synthesis are key considerations for API manufacturers.

What are the typical storage conditions for ICATIBANT ACETATE API and finished product?

ICATIBANT ACETATE API is typically stored under controlled conditions to maintain its stability. This often involves refrigeration (e.g., 2-8°C) and protection from light and moisture. The finished drug product, usually an injectable solution, also requires specific storage conditions as defined by the manufacturer and approved by regulatory agencies, often involving refrigeration.

Citations

[1] National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Hereditary Angioedema. Retrieved from https://www.niddk.nih.gov/health-information/blood-diseases/hereditary-angioedema