Suppliers and packagers for RAPIVAB

RAPIVAB

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

Rapivab (Peramivir) Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the key suppliers and manufacturing landscape for Rapivab (peramivir), an antiviral medication. The focus is on identifying active pharmaceutical ingredient (API) and finished drug product manufacturers, their geographical distribution, and potential supply chain risks.

Who Manufactures Rapivab's Active Pharmaceutical Ingredient (API)?

The primary API for Rapivab is peramivir. Manufacturing of peramivir is a complex multi-step synthesis process. Key players involved in API production or who have held related manufacturing capabilities include:

• Biocryst Pharmaceuticals, Inc. is the originator of Rapivab. While they focus on development and commercialization, they may engage contract manufacturing organizations (CMOs) for API production. Their internal capabilities or partnerships for peramivir API production are proprietary but are central to the supply chain.
• Contract Manufacturing Organizations (CMOs) specializing in complex API synthesis are likely involved. Companies with expertise in antiviral drug manufacturing and large-scale fermentation or chemical synthesis are candidates. Specific CMO names are not publicly disclosed by Biocryst due to competitive reasons. However, typical pharmaceutical API manufacturing hubs are located in India, China, and parts of Europe.

Which Companies Produce the Finished Drug Product (FDP)?

Rapivab is available as an intravenous infusion. The formulation and sterile manufacturing of the finished drug product require specialized facilities and strict regulatory compliance.

• Biocryst Pharmaceuticals, Inc. holds the marketing authorization for Rapivab in various regions. They are responsible for overseeing the final manufacturing and packaging of the drug.
• Contract Development and Manufacturing Organizations (CDMOs) with sterile injectables capabilities are essential. These CDMOs would receive the peramivir API and then formulate, fill, finish, and package the final drug product. Regions with established sterile manufacturing capacity, such as the United States, Europe, and select Asian countries, are likely locations for these CDMOs.
• Specific CDMO Partnerships: Biocryst's specific CDMO partners for Rapivab's finished drug product manufacturing are not publicly disclosed. Such information is typically considered confidential business intelligence.

What is the Geographical Distribution of Rapivab Manufacturing?

The global distribution of pharmaceutical manufacturing means that Rapivab's supply chain likely spans multiple continents.

• API Manufacturing:
  • Asia (primarily India and China): These regions are major global hubs for API production due to cost efficiencies and established chemical synthesis infrastructure. Many complex APIs, including those for antivirals, are manufactured here.
  • Europe: Some specialized API manufacturing, particularly for highly potent or complex molecules, occurs in European countries known for their robust pharmaceutical chemical industries.
• Finished Drug Product (FDP) Manufacturing:
  • North America (United States, Canada): Strong presence of CDMOs with sterile injectable manufacturing capabilities, crucial for products like Rapivab.
  • Europe: Significant sterile manufacturing capacity exists across countries like Germany, Switzerland, Ireland, and the UK.
  • Asia: Growing capabilities in high-quality sterile manufacturing, particularly in countries like Singapore and South Korea, make them potential sites for FDP production.

What are the Potential Supply Chain Risks for Rapivab?

The complexity and global nature of pharmaceutical supply chains present inherent risks that could impact the availability of Rapivab.

• Single Source API/CDMO Dependence: If a critical API supplier or FDP manufacturer faces production issues (e.g., quality control failures, natural disasters, geopolitical instability), it could lead to significant shortages. The proprietary nature of these relationships makes identifying alternative suppliers challenging.
• Geopolitical Instability and Trade Restrictions: Manufacturing sites located in regions prone to political unrest or experiencing trade disputes can face disruptions. Import/export regulations and tariffs can also affect the cost and availability of raw materials and finished products.
• Regulatory Hurdles and Compliance: Changes in manufacturing regulations or unexpected findings during facility inspections by bodies like the FDA or EMA can halt production. Maintaining Good Manufacturing Practice (GMP) compliance across all stages is paramount.
• Raw Material Sourcing: The synthesis of peramivir relies on various chemical intermediates and reagents. Disruptions in the supply of these precursor materials, which may originate from different suppliers and regions, can impact overall API production.
• Logistics and Transportation: The global movement of APIs and finished drug products is vulnerable to shipping delays, port congestion, and transportation costs. For a critical medication like an antiviral, timely delivery is essential.
• Intellectual Property (IP) and Patent Expirations: While Rapivab is protected by patents, understanding the patent landscape and potential for generic competition in the future is important for long-term supply strategy and market dynamics. Biocryst holds U.S. Patent Nos. 7,732,447, 7,595,386, and others related to peramivir and its uses [1].

Key Takeaways

The supply chain for Rapivab involves a network of specialized manufacturers, likely including a combination of proprietary production by Biocryst Pharmaceuticals and contract manufacturing organizations (CMOs/CDMOs) for both API synthesis and sterile finished drug product formulation. Manufacturing operations are geographically diversified, with significant potential for API production in Asia and FDP manufacturing in North America and Europe. Key risks include dependence on single-source suppliers, geopolitical instability, regulatory compliance, raw material availability, and logistical challenges.

Frequently Asked Questions

1. Is peramivir manufactured in-house by Biocryst Pharmaceuticals? Biocryst Pharmaceuticals is the originator of Rapivab and oversees its development and commercialization. While they may have internal capabilities, it is common practice for pharmaceutical companies to utilize contract manufacturing organizations (CMOs) for API synthesis and contract development and manufacturing organizations (CDMOs) for finished drug product manufacturing to leverage specialized expertise and capacity. Specific details of their manufacturing arrangements are proprietary.

2. What are the primary geographical regions for peramivir API production? Based on general pharmaceutical manufacturing trends for complex APIs, it is highly probable that a significant portion of peramivir API production occurs in Asia, particularly in India and China, due to their established chemical synthesis infrastructure and cost efficiencies. Specialized API manufacturing may also take place in Europe.

3. Does the FDA inspect all facilities involved in Rapivab manufacturing? Yes, the U.S. Food and Drug Administration (FDA) inspects all domestic and foreign facilities that manufacture, process, pack, or hold drug products intended for the U.S. market to ensure compliance with Current Good Manufacturing Practices (CGMP). This includes facilities producing both APIs and finished drug products for the U.S.

4. How does the patent status of peramivir affect its supply chain? Active patents for peramivir, such as U.S. Patent Nos. 7,732,447 and 7,595,386, grant exclusivity to Biocryst Pharmaceuticals, influencing who can legally manufacture and sell the drug. Upon patent expiration, generic manufacturers may enter the market, potentially increasing the number of suppliers and impacting pricing and overall supply dynamics.

5. What are the critical quality attributes (CQAs) for peramivir API and finished drug product? Critical Quality Attributes (CQAs) for peramivir API would include purity (e.g., absence of impurities and related substances), potency (assay), physical characteristics (e.g., particle size distribution if applicable to the synthesis and formulation process), and stability. For the finished intravenous drug product, CQAs would also encompass sterility, pyrogenicity, pH, osmolality, particulate matter, and content uniformity of peramivir.

Citations

[1] U.S. Patent and Trademark Office. (n.d.). Patent Center. Retrieved from USPTO Patent Center Search (Specific patent numbers like 7,732,447 and 7,595,386 can be queried for detailed information).