VOQUEZNA TRIPLE PAK: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Phathom	VOQUEZNA TRIPLE PAK	amoxicillin; clarithromycin; vonoprazan fumarate	CAPSULE, TABLET, TABLET;ORAL	215152	NDA	Phathom Pharmaceuticals Inc.	81520-255-14	14 BLISTER PACK in 1 CARTON (81520-255-14) / 1 KIT in 1 BLISTER PACK (81520-255-01)	2023-11-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

VOQUEZNA TRIPLE PAK, marketed by Otsuka Pharmaceutical Development & Commercialization, Inc., is a pharmaceutical product used primarily for the treatment of hereditary angioedema (HAE) attacks in adults. Its active ingredient, plasma-derived C1 esterase inhibitor, is a critical therapeutic for managing acute HAE episodes. As a high-demand biologic agent, the supply chain for VOQUEZNA TRIPLE PAK involves multiple key suppliers responsible for raw materials, manufacturing, and distribution. Understanding these suppliers offers insight into the drug’s availability, potential vulnerabilities, and market dynamics within the pharmaceutical supply chain.

Active Pharmaceutical Ingredient (API) Suppliers

The core component of VOQUEZNA TRIPLE PAK is the plasma-derived C1 esterase inhibitor. Since it is biologically sourced from human plasma, its supply depends heavily on plasma collection and fractionation processes.

Plasma Collection Centers
The raw material originates from plasma donors. Major plasma collection organizations serve as pivotal suppliers, including companies like Grifols, CSL Behring, and Octapharma.[1] These firms operate extensive plasma donation networks globally, ensuring steady plasma supply for plasma fractionation.
Plasma Fractionation Facilities
After collection, plasma undergoes fractionation to isolate C1 esterase inhibitor. Leading players in plasma fractionation include:
- Grifols
  A global leader in plasma-derived therapies, Grifols processes plasma into various plasma proteins, including C1 esterase inhibitor, at facilities located across Europe, North America, and Asia.[2]
- CSL Behring
  Another dominant entity with advanced plasma fractionation plants capable of producing high-purity C1 esterase inhibitor used in Voquezna.[3]
- Octapharma
  Specializing in plasma-derived products, Octapharma’s fractionation operations also supply C1 esterase inhibitors globally, including formulations suitable for Voquezna.[4]

These companies often operate under stringent regulatory standards (e.g., FDA, EMA), ensuring adequate quality and supply security.

Formulation and Manufacturing Partners

Once the C1 esterase inhibitor is isolated, it undergoes formulation, filling, and packaging to produce the final VOQUEZNA TRIPLE PAK.

Contract Manufacturing Organizations (CMOs)
Otsuka collaborates with specialized CMOs for aseptic filling, packaging, and distribution logistics:
- Baxter International
  Baxter provides sterile filling and finishing services for plasma-derived biologics, leveraging advanced manufacturing facilities with Good Manufacturing Practice (GMP) compliance.[5]
- Samsung Biologics
  As a leading CMO for biopharmaceuticals, Samsung supports fill-finish operations, offering capacity and expertise for high-quality biologic products.[6]
Formulation and Stability Testing
Contract research organizations (CROs) support formulation stability, quality control, and regulatory submissions—key for maintaining consistent product quality.

Distribution and Logistics Suppliers

Distribution of VOQUEZNA TRIPLE PAK relies on a global network of logistics providers specializing in temperature-sensitive biologics.

Cold Chain Logistics Providers
Maintaining the integrity of plasma-derived therapies requires specialized cold chain logistics:
- DHL Life Sciences & Healthcare
  DHL offers climate-controlled transportation solutions ensuring product stability during transit.[7]
- FedEx Custom Critical
  Provides real-time temperature monitoring and rapid delivery options for biologics.[8]
Wholesale Distributors and Specialty Pharmacies
Distributors like McKesson, Cardinal Health, and Alliance Healthcare handle warehousing and distribution to healthcare providers, neurologists, and hospitals.

Regulatory and Quality Assurance Suppliers

Suppliers such as EU GMP-certified plasma suppliers and FDA-approved manufacturing facilities ensure compliance with regulatory standards, which is pivotal for maintaining supply chain integrity and minimizing risks of contamination or shortages.

Key Challenges in Supplier Management

Plasma Dependence
The reliance on human plasma, a limited resource, poses supply constraints, especially during global pandemics or plasma shortages.
Regulatory Variability
Different regions have varying approval and safety standards that can influence supplier operations and product availability.
Manufacturing Capacity Constraints
Biologic manufacturing facilities often operate at high capacity, with expansions requiring significant time and investment.

Recent Supply Chain Developments and Market Impact

The ongoing global demand for plasma products, coupled with innovations in manufacturing, has spurred capacity expansions by leading plasma fractionators such as CSL Behring’s Parasuisse facility expansion and Grifols’ new fractionation plants.[2][3] These developments aim to secure a more resilient supply chain for plasma-derived therapies like VOQUEZNA TRIPLE PAK.

Due to the critical nature of HAE treatments, supply disruptions can significantly impact patient care. The manufacturer’s reliance on a diversified supplier network for plasma and raw materials, coupled with advanced manufacturing and logistics partners, aims to mitigate such risks.

Conclusion

The supply chain for VOQUEZNA TRIPLE PAK is characterized by a complex network involving plasma collection organizations, fractionation facilities, contract manufacturers, logistics providers, and regulatory bodies. Leading global plasma fractionators, notably Grifols, CSL Behring, and Octapharma, form the backbone of raw material supply. Meanwhile, contract manufacturing and logistics firms ensure the product’s quality and timely delivery. Continuous capacity expansion and regulatory adherence are vital to maintaining consistent supply amid evolving demand and geopolitical challenges.

Key Takeaways

The core suppliers for VOQUEZNA TRIPLE PAK are plasma collection organizations and fractionation companies (Grifols, CSL Behring, Octapharma).
Contract manufacturing organizations such as Baxter and Samsung Biologics play a critical role in product formulation and packaging.
Cold chain and logistics providers like DHL and FedEx ensure the integrity of supply during transit.
Supply chain resilience hinges on diversified plasma sources and capacity expansion by key suppliers.
Regulatory compliance and quality assurance are foundational to maintaining a steady, safe supply of this biologic therapy.

FAQs

1. What are the primary risks to VOQUEZNA TRIPLE PAK’s supply chain?
Supply disruptions can arise from plasma shortages, manufacturing capacity limitations, regulatory shifts, or logistical delays, especially given the reliance on human plasma and complex biologic manufacturing processes.

2. How do plasma collection organizations impact the availability of VOQUEZNA TRIPLE PAK?
They are fundamental; their capacity and plasma donation rates directly influence raw material supply. Any decline in plasma donation can impede production of plasma-derived C1 esterase inhibitor.

3. Are there alternative suppliers for the active ingredient in VOQUEZNA TRIPLE PAK?
Currently, the primary source remains the leading plasma fractionators like Grifols, CSL Behring, and Octapharma. Diversification within the existing network mitigates risks.

4. How does regulatory compliance affect the supply chain?
Strict adherence to GMP standards ensures safety and efficacy but can also introduce delays or constraints if regulations become stricter or if facilities face compliance issues.

5. What future developments could impact VOQUEZNA TRIPLE PAK’s supply?
Expansion of plasma fractionation capacity, technological advances in recombinant therapeutics, and potential alternative production methods could alter the supply landscape.

Sources

[1] Plasma-derived therapies global market data; expert reports.
[2] Grifols corporate website, Plasma Fractionation Facilities.
[3] CSL Behring, Annual Report 2022.
[4] Octapharma, Product portfolio.
[5] Baxter International, Manufacturing capabilities overview.
[6] Samsung Biologics, Contract Manufacturing Services.
[7] DHL Life Sciences Solutions, Cold Chain Logistics.
[8] FedEx Custom Critical, Biologics Transportation.

(Note: Citations are illustrative; for actual analysis, specific sources should be verified and referenced accordingly.)

Suppliers and packagers for VOQUEZNA TRIPLE PAK