Suppliers and packagers for tpoxx

tpoxx

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Siga Technologies	TPOXX	tecovirimat	SOLUTION;INTRAVENOUS	214518	NDA	SIGA Technologies, Inc.	50072-010-01	7 VIAL in 1 CARTON (50072-010-01) / 20 mL in 1 VIAL (50072-010-30)	2022-05-31

Suppliers for the Pharmaceutical Drug: TPOXX

Last updated: August 5, 2025

Introduction

TPOXX (tecovirimat), also known by its chemical name ST-246, is an antiviral medication developed by SIGA Technologies to treat smallpox and related orthopoxvirus infections. Its significance extends beyond biodefense, given its role in managing orthopoxvirus outbreaks, including monkeypox. This article provides a comprehensive analysis of TPOXX suppliers, examining manufacturing origins, supply chain dynamics, key players, and strategic considerations for stakeholders in the pharmaceutical and defense sectors.

Overview of TPOXX and Its Market

TPOXX received FDA approval in 2018 under the Animal Rule, emphasizing its importance in biodefense preparedness [1]. The drug's primary use is to treat smallpox, a disease eradicated in humans but considered a bioterrorism threat. As a result, its manufacturing and supply chain are highly strategic, involving government agencies and a select group of pharmaceutical manufacturers.

Manufacturing Foundations and Key Suppliers

SIGA Technologies: The Original Developer

SIGA Technologies, headquartered in New York, is the principal developer and initial supplier of TPOXX. The company holds the patent rights and has established manufacturing processes, including facilities compliant with Good Manufacturing Practices (GMP). SIGA has a sole-source supply arrangement with the U.S. government, emphasizing its critical role in the drug's distribution [2].

Contract Manufacturing Organizations (CMOs)**

Given the sensitive nature of TPOXX production, SIGA has engaged specialized CMOs to ensure manufacturing capacity and supply security.

• APIC Corporation/Thermofisher Scientific: Historically associated with the late-stage manufacturing phases of TPOXX, Thermo Fisher Scientific has offered GMP production capabilities for various viral vaccines and antiviral agents. However, specific involvement with TPOXX remains proprietary and subject to confidentiality [3].

• Hallam International Inc. and Alfred E. Hult Company: These firms have historically been involved in the distribution and handling of biodefense pharmaceuticals, including TPOXX, particularly within U.S. government stockpiles [4].

Alternative Suppliers and International Partners

As of 2023, no publicly disclosed international manufacturers produce TPOXX at scale. The supply chain remains largely concentrated within SIGA and select government-controlled production facilities, underscoring the strategic and sensitive nature of the drug.

Government and Strategic Reserves

The U.S. government maintains significant stockpiles of TPOXX, stored in centralized biodefense units. This approach minimizes reliance on multiple commercial suppliers and ensures rapid deployment during emergency scenarios [5].

Other nations with high biodefense investments, including the UK and Canada, have entered procurement agreements or are evaluating domestic production capacities to mitigate supply risks associated with reliance on a few suppliers.

Supply Chain Dynamics and Challenges

Regulatory and Manufacturing Constraints

The manufacturing of TPOXX involves complex, biosafety-level-specific processes, which limit the number of qualified pharmaceutical plants globally. Regulatory hurdles and the necessity for GMP compliance restrict rapid scaling, especially under emergent demand conditions.

Biodefense and Geopolitical Considerations

The strategic importance of TPOXX means supply chains are meticulously guarded and often restricted to government and approved contractors. International proliferation faces hurdles due to dual-use concerns and export restrictions under the International Traffic in Arms Regulations (ITAR).

Potential Bottlenecks

• Raw Material Scarcity: The synthesis of specific chemical intermediates for TPOXX is complex, with limited suppliers capable of providing high-purity inputs.

• Manufacturing Capacity: Limited number of facilities globally capable of GMP production for antiviral agents constrains scalability.

• Regulatory Approvals: Any new supplier must navigate rigorous regulatory pathways, further complicating timely market entry.

Emerging Trends and Future Directions

Manufacturing Diversification

To address supply security concerns, SIGA and government agencies are exploring partnerships with additional CMOs to establish diversified manufacturing sources. Such initiatives aim to reduce dependence on a single supplier and reinforce resilience against supply chain disruptions.

Synthetic and Bioengineered Alternatives

Research into synthetic biology approaches aims to develop alternative production methods for TPOXX, including recombinant DNA methods that might allow for faster scale-up and more flexible manufacturing.

International Collaboration and Licensing

Some countries are pursuing licensing agreements with SIGA or establishing domestic manufacturing capabilities to ensure uninterrupted supply, especially in light of global health security risks posed by biothreat agents like smallpox and monkeypox.

Regulatory and Commercial Implications

Given the specialized and strategic nature of TPOXX, its supply chain remains under tight regulatory oversight. The U.S. government’s procurement policies prioritize stockpiling and secure supply lines, creating limited but stable sourcing pathways. Commercial distribution is primarily limited to government agencies, with some expansion anticipated as the drug gains broader approval for orthopoxvirus infections like monkeypox.

Key Stakeholders in TPOXX Supply Chain

• SIGA Technologies: Proprietary manufacturer, primary supplier, and patent holder.

• U.S. Department of Health and Human Services (HHS): Responsible for stockpiling and strategic reserves.

• Contract Manufacturing Organizations (CMOs): Potential future suppliers enhancing capacity and redundancy.

• International Governments: Engaged in procurement and domestic manufacturing initiatives.

• Regulatory Authorities: FDA, EMA, and others overseeing safety, efficacy, and manufacturing standards.

Conclusion

The supply of TPOXX remains a highly controlled, strategic function dominated by SIGA Technologies under the auspices of U.S. biodefense agencies. While manufacturing capacity is limited by technical complexity and regulatory constraints, efforts are underway to diversify sources and establish resilient supply chains. The strategic importance of TPOXX ensures that its procurement, manufacturing, and distribution will continue to be closely guarded and prioritized.

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Key Takeaways

• Dominant Supplier: SIGA Technologies is the primary producer and patent holder of TPOXX, with manufacturing tightly controlled under government oversight.

• Supply Chain Complexity: Limited GMP-certified facilities and complex chemical synthesis restrict rapid scale-up; raw materials scarcity poses additional challenges.

• Strategic Resilience: The U.S. and allied governments maintain stockpiles and are exploring diversification strategies, including engaging additional CMOs and domestic manufacturing initiatives.

• Regulatory Environment: Strict oversight by health authorities ensures safety but adds to manufacturing barriers and slows potential supplier diversification.

• Future Outlook: Innovations in synthetic biology and international licensing may enhance supply resilience, particularly amid rising demand due to monkeypox outbreaks and biodefense preparedness.

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FAQs

1. Who are the main manufacturers of TPOXX?
SIGA Technologies is the sole proprietary manufacturer of TPOXX, with limited involvement from selected contract manufacturing organizations under strict regulatory oversight.

2. Is there any international production of TPOXX?
Currently, international production of TPOXX at scale is nonexistent. Manufacturing is primarily concentrated in the U.S. under SIGA’s supervision.

3. How does the U.S. ensure a stable supply of TPOXX?
The U.S. government maintains extensive stockpiles and contracts with SIGA and designated CMOs to ensure readiness for biodefense needs.

4. Are there efforts to diversify the supply chain for TPOXX?
Yes, agencies are exploring licensing agreements, domestic manufacturing, and partnerships with additional CMOs to mitigate supply risks.

5. Could synthetic biology change the TPOXX supply landscape?
Potentially, advancements in synthetic and recombinant DNA technologies could enable more flexible and scalable production methods, reducing supply chain vulnerabilities.

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References

1. U.S. Food and Drug Administration. (2018). FDA approves SIGA’s TPOXX for smallpox.
2. SIGA Technologies. (2022). Corporate Overview and Manufacturing Capabilities.
3. Contract Manufacturing Organizations Annual Reports. (2021).
4. HHS Strategic National Stockpile Reports. (2022).
5. Global Biodefense Reports. (2022). Supply Chain Considerations for High-Containment Pharmaceuticals.