Suppliers and packagers for generic pharmaceutical drug: PERAMIVIR

PERAMIVIR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Biocryst	RAPIVAB	peramivir	SOLUTION;INTRAVENOUS	206426	NDA	BioCryst Pharmaceuticals, Inc.	72769-181-03	3 VIAL, GLASS in 1 CARTON (72769-181-03) / 20 mL in 1 VIAL, GLASS (72769-181-01)	2014-12-20

Suppliers for the Pharmaceutical Drug: PERAMIVIR

Last updated: July 28, 2025

Introduction

Peramivir is an antiviral medication utilized primarily for the treatment of influenza. Marketed under various brand names including Rapivab, it is administered via intravenous infusion and is indicated for both adult and pediatric patients with uncomplicated influenza who have been symptomatic for no more than two days. As a Selective Neuraminidase Inhibitor, Peramivir plays a critical role in managing influenza outbreaks, especially in hospitalized or severely ill patients unable to tolerate oral medications. The procurement landscape is vital for healthcare providers, governments, and pharmaceutical companies aiming to ensure supply stability amid seasonal fluctuations and emerging strains.

This report explores the global suppliers manufacturing and distributing Peramivir, analyzing their production capabilities, geographic distribution, regulatory compliance, and supply chain strategies.

Global Manufacturing Landscape

Manufacturers of Peramivir

Peramivir's complex synthesis and stringent regulatory requirements restrict its production to a limited number of specialized pharmaceutical manufacturers. Major suppliers operate predominantly within Asia, North America, and Europe.

Biotech and Pharmaceutical Companies

1. BioCryst Pharmaceuticals (USA)

   BioCryst is the original developer of Peramivir, originally receiving approval from the U.S. Food and Drug Administration (FDA) in 2014. The company's manufacturing facilities are located in the United States, with a focus on high-volume production to meet domestic and international demand. BioCryst has strategic partnerships with production organizations, enhancing its distribution capacity globally.

2. Shionogi & Co., Ltd. (Japan)

   Shionogi is a significant regional supplier, primarily serving the Japanese market. They hold approvals for Peramivir and produce it either in-house or through licensed manufacturing arrangements within Japan. Shionogi’s extensive distribution channels bolster its capacity to supply domestic hospitals and clinics efficiently.

3. Zhejiang Huahai Pharmaceutical Co., Ltd. (China)

   While primarily known for generics, Zhejiang Huahai has reported manufacturing capabilities aligned with complex antiviral drugs. Their involvement in Peramivir production remains exploratory but signifies a potential increase in regional supply, especially given China's expanding biotech sector.

4. Other Manufacturers

   Due to the drug's specialized nature, several Contract Manufacturing Organizations (CMOs) in Asia and North America have entered into licensing agreements to produce Peramivir for larger pharmaceutical companies. These include firms in South Korea, India, and Europe that undertake synthesis, formulation, and quality assurance processes.

Regulatory Approvals and Licensing

Manufacturers require robust regulatory clearance to produce and distribute Peramivir. The FDA, Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and European Medicines Agency (EMA) are key regulatory bodies governing approval. BioCryst's FDA approval has facilitated distribution across North America and certain global markets through licensing agreements. Similarly, Shionogi’s approval in Japan ensures domestic availability.

Supply Chain and Distribution Channels

Peramivir’s distribution relies on a combination of direct hospital procurement, government tenders, and international health organizations. During influenza seasons, supply demand surges, necessitating scalable manufacturing capacity. Many suppliers maintain safety stock levels, and some engage third-party logistics providers to manage cold chain requirements and timely delivery.

Key Challenges in Supply

• Manufacturing Complexity: The synthesis of Peramivir involves complex chemical processes requiring specialized facilities, which limits the number of capable manufacturers.
• Regulatory Dynamics: Variations in approval status across countries can create supply bottlenecks and necessitate technical adjustments.
• Market Demand Fluctuations: Influenza outbreaks cause predictable but intense spikes in demand, exerting pressure on suppliers’ capacities.
• Trade and Intellectual Property: Licensing agreements are essential for market access, but patent protections can restrict manufacturing rights, influencing supply stability.

Emerging Trends and Strategic Considerations

• Localization of Production: Countries like China and India are expanding their biotech capabilities, potentially reducing reliance on foreign suppliers.
• Generic and Biosimilar Development: Recognizing the limited number of originator suppliers, additional manufacturers may seek to produce biosimilars or generics, expanding the supply base.
• Supply Chain Resilience: Suppliers are increasingly adopting risk mitigation strategies, including establishing multiple manufacturing sites and diversifying logistics options.

Conclusion

The supply of Peramivir hinges on a few key players, chiefly BioCryst Pharmaceuticals and Shionogi, with regional contribution from CMOs and potential emerging manufacturers in Asia. Ensuring a stable supply chain demands vigilance around manufacturing capacity, regulatory compliance, and global health dynamics.

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Key Takeaways

• The primary global suppliers of Peramivir are BioCryst Pharmaceuticals (USA) and Shionogi & Co., Ltd. (Japan), supported by regional CMOs and emerging manufacturers in Asia.
• Manufacturing complexity and regulatory hurdles limit the number of producers, emphasizing the importance of strategic licensing agreements and capacity expansion.
• Supply stability is critical during influenza seasons, requiring adaptive logistics and inventory management.
• Regional players, especially in China and India, are poised to augment supply, reducing dependency on a limited set of originators.
• Stakeholders should monitor regulatory developments and market trends to mitigate risks associated with supply shortages.

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FAQs

Q1: Is Peramivir available globally, or is it restricted to certain markets?
A1: Availability of Peramivir varies by country. It is FDA-approved in the United States and marketed under Rapivab, while in Japan, Shionogi markets it domestically. Other regions may require import licenses or rely on regional approval pathways, limiting its global distribution.

Q2: Are there generic versions of Peramivir, and who manufactures them?
A2: As of now, Peramivir remains primarily under proprietary manufacturing by BioCryst and licensed regional producers. Generic versions are limited, but biosimilar development could alter this landscape in the future.

Q3: What are the supply chain risks associated with Peramivir?
A3: Risks include manufacturing bottlenecks due to complex synthesis, regulatory delays, geopolitical factors affecting licensing agreements, and seasonal demand spikes that strain capacity.

Q4: How have recent developments in biotechnology affected Peramivir supply?
A4: Advances in biotech manufacturing, including process intensification and supply chain digitization, have improved scalability and quality control, potentially increasing supply resilience.

Q5: What strategic steps can buyers take to ensure continuous supply of Peramivir?
A5: Buyers should establish diversified sourcing agreements, maintain safety stock, engage with multiple regulatory-approved suppliers, and monitor market and production developments proactively.

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Sources

[1] U.S. Food and Drug Administration (FDA). Rapivab (Peramivir) Prescribing Information.
[2] Shionogi & Co., Ltd. Official Website. Product Portfolio.
[3] BioCryst Pharmaceuticals. Corporate Overview and Manufacturing Capabilities.
[4] World Health Organization. Influenza Antiviral Treatment Guidelines.
[5] Industry reports on antiviral manufacturing and supply chain dynamics, 2022-2023.