SEBETRALSTAT: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kalvista	EKTERLY	sebetralstat	TABLET;ORAL	219301	NDA	KalVista Pharmaceuticals Ltd	82928-300-04	4 BLISTER PACK in 1 CARTON (82928-300-04) / 1 TABLET in 1 BLISTER PACK (82928-300-01)	2025-07-07
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: September 7, 2025

Introduction

Sebetralstat is an emerging therapeutic agent designed for the prophylactic treatment of hereditary angioedema (HAE), a rare genetic disorder characterized by recurrent episodes of severe swelling. As a targeted therapy, sebetralstat's supply chain dynamics significantly influence its commercial viability, accessibility, and regulatory landscape. This analysis provides a comprehensive overview of the key suppliers involved in the manufacturing and distribution of seetralstat, highlighting their roles, strategic positioning, and implications for stakeholders in the pharmaceutical and healthcare sectors.

Overview of Sebetralstat and its Market

Developed by Novartis, sebetralstat functions as a potent plasma kallikrein inhibitor, preventing the excessive bradykinin production responsible for angioedema episodes. It is administered orally, offering a convenient prophylactic option for HAE patients.

The drug’s market prospects are promising, given the limited therapeutic options for HAE management and increasing diagnosis rates. As with many specialty pharmaceuticals, the supply chain for sebetralstat involves complex manufacturing processes, strict quality controls, and a network of suppliers for raw materials, active pharmaceutical ingredients (APIs), and finished formulations.

Key Suppliers in the Supply Chain

1. Active Pharmaceutical Ingredient (API) Manufacturers

The production of sebetralstat hinges on specialized API manufacturing, which involves complex synthesis pathways. Leading suppliers in this domain include:

Novartis Internal API Production Facilities:
Novartis maintains global manufacturing units capable of producing APIs in compliance with Good Manufacturing Practices (GMP). Their vertically integrated structure allows tight control over API quality and supply continuity, especially critical for high-value, low-volume drugs like sebetralstat.
Contract Manufacturing Organizations (CMOs):
Given the complexity and cost of API synthesis, Novartis also relies on CMOs with expertise in peptide synthesis and small-molecule API production. Notable global players include Taiwan-based United Laboratories or Ireland’s Eurofins facilities, renowned for their stringent quality standards in pharmaceutical manufacturing.

2. Raw Materials and Intermediates

The synthesis of sebetralstat requires specific raw materials, such as specialized chemical precursors, solvents, and reagents. Leading raw material suppliers operate globally, often supplying:

Chemicals Specialized in Peptide Synthesis:
Suppliers like Fujifilm Wako Chemicals and Sigma-Aldrich (Merck) provide peptide-building blocks and intermediates used in API synthesis.
High-Purity Solvents and Reagents:
Companies such as VWR Chemicals and Thermo Fisher Scientific supply pharmaceutical-grade solvents essential for manufacturing processes.

Supply chain considerations:
Raw material sourcing is susceptible to geopolitical and logistical factors, emphasizing the importance of diversified sourcing to mitigate risks.

3. Finished Dosage Form Manufacturers

Once the API is synthesized, formulation into deliverable dosage forms involves specialized manufacturing facilities:

Novartis Manufacturing Units:
Novartis operates its primary manufacturing sites for formulation, ensuring consistency and adherence to regulatory standards.
Third-Party Pharmaceutical Contract Manufacturers (CMOs):
For scaling production or redundancy, Novartis may contract with CMOs specializing in oral solid dosage forms, such as Catalent or Recipharm. These organizations provide capabilities in tablet compression and packaging.

Distribution and Logistics

Effective distribution channels for sebetralstat are vital, especially considering the drug's specialty status and storage requirements:

Distribution Partners:
Novartis partners with global logistics companies like UPS Healthcare and DHL Supply Chain for cold chain management and timely delivery.
Regional Distributors:
To ensure access in diverse markets, arrangements with regional distributors and specialty pharmacy networks are established.

Distribution suppliers must adhere to strict regulations concerning temperature control, shelf-life, and provenance tracing.

Regulatory and Supply Chain Challenges

Regulatory Compliance:
Suppliers must align with stringent regulatory standards (FDA, EMA, MHRA) to maintain GMP certifications and ensure product quality.

Supply Chain Disruptions:
Global geopolitical factors, raw material shortages, or pandemic-related disruptions can impact API and formulation supplies. Notably, recent supply chain interruptions have underscored the need for diversified sourcing and inventory resilience.

Intellectual Property (IP) and Licensing:
While Novartis owns the patent rights, strategic licensing agreements or partnerships with contract manufacturers may influence supplier dynamics.

Strategic Supplier Considerations

Vertical Integration vs. Outsourcing:
Novartis's vertical integration offers control but may limit flexibility. Engaging multiple CMOs provides redundancy, lowering risks associated with supply shortages.
Quality Assurance:
Suppliers’ adherence to GMP is non-negotiable for regulatory approval and patient safety, especially for a medication like sebetralstat, where potency and purity are critical.
Cost Management:
Balancing cost efficiencies with quality is essential, particularly given the low-volume, high-value nature of orphan drugs.

Future Outlook

The supply ecosystem for sebetralstat will evolve with continued market growth and potential new entrants. Increased manufacturing capacity from CMOs and raw material suppliers is anticipated, driven by demand and technological advancements. Additionally, geopolitical shifts may influence sourcing strategies, emphasizing the importance of supply chain agility and resilience.

Key Takeaways

Supply chain robustness for sebetralstat relies heavily on advanced API manufacturing, necessitating partnerships with specialized CMOs and raw material suppliers.
Global distribution channels are critical for ensuring access and maintaining cold chain integrity.
Stringent regulatory compliance and quality assurance protocols safeguard supply continuity and product integrity.
Supply disruptions pose significant risks; diversification and strategic partnerships are essential for mitigating these vulnerabilities.
Ongoing market growth for sebetralstat will drive capacity expansion and innovation within its supply chain network.

FAQs

1. Who are the primary API suppliers for sebetralstat?
Novartis primarily manufactures sebetralstat's API internally but collaborates with specialized CMOs globally experienced in peptide and small-molecule synthesis.

2. What raw materials are critical in producing sebetralstat?
Chemicals used in peptide synthesis, such as amino acids and coupling reagents, along with high-purity solvents, are essential raw materials supplied by global chemical providers.

3. How is the distribution of sebetralstat managed?
Distribution is managed through Novartis’s logistics partners, ensuring cold chain integrity, timely delivery, and compliance with regulatory standards across regions.

4. What are main risks faced in the supply chain?
Risks include raw material shortages, geopolitical disruptions, manufacturing delays, and regulatory hurdles—mitigated through supplier diversification and rigorous quality programs.

5. How might future demand impact supply chain strategies?
Growing demand may lead to increased manufacturing capacity, encouraging strategic partnerships and investments in supply chain agility and resilience.

Sources

Novartis Annual Reports and Pipeline Data [1]
Market analysis reports on hereditary angioedema treatments [2]
FDA and EMA drug approval documents for sebetralstat [3]
Industry reports on pharmaceutical manufacturing and supply chains [4]
Public disclosures from contract manufacturing organizations [5]

Suppliers and packagers for generic pharmaceutical drug: SEBETRALSTAT

SEBETRALSTAT

Suppliers for the Pharmaceutical Drug: Sebetralstat