FOSCARNET SODIUM: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal	FOSCARNET SODIUM	foscarnet sodium	SOLUTION;INTRAVENOUS	216602	ANDA	Amneal Pharmaceuticals LLC	70121-1744-2	12 POUCH in 1 CARTON (70121-1744-2) / 1 BAG in 1 POUCH / 250 mL in 1 BAG	2024-03-04
Amneal	FOSCARNET SODIUM	foscarnet sodium	SOLUTION;INTRAVENOUS	216602	ANDA	Amneal Pharmaceuticals LLC	70121-1744-7	10 POUCH in 1 CARTON (70121-1744-7) / 1 BAG in 1 POUCH / 250 mL in 1 BAG	2024-03-04
Avet Lifesciences	FOSCARNET SODIUM	foscarnet sodium	SOLUTION;INTRAVENOUS	213807	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-771-31	1 BOTTLE, GLASS in 1 CARTON (23155-771-31) / 250 mL in 1 BOTTLE, GLASS	2023-06-05
Fresenius Kabi Usa	FOSCARNET SODIUM	foscarnet sodium	SOLUTION;INTRAVENOUS	212483	ANDA	Fresenius Kabi USA, LLC	63323-875-50	1 BOTTLE in 1 CARTON (63323-875-50) / 250 mL in 1 BOTTLE	2021-01-29
Gland	FOSCARNET SODIUM	foscarnet sodium	SOLUTION;INTRAVENOUS	213001	ANDA	Sagent Pharmaceuticals	25021-189-84	10 BAG in 1 CARTON (25021-189-84) / 250 mL in 1 BAG	2021-05-15
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: February 19, 2026

This report details the current landscape of foscarnet sodium suppliers, analyzing key manufacturers, their production capacities, and market dynamics. The analysis focuses on identifying established and emerging players, patent-related considerations, and potential supply chain vulnerabilities impacting the availability of this critical antiviral medication.

Who are the Primary Manufacturers of Foscarnet Sodium?

The global supply of foscarnet sodium is primarily concentrated among a limited number of Active Pharmaceutical Ingredient (API) manufacturers. These companies operate with varying capacities and adhere to stringent regulatory standards to meet the demand for this essential drug, primarily used in the treatment of cytomegalovirus (CMV) retinitis and acyclovir-resistant herpes simplex virus (HSV) infections.

Medac GmbH: Based in Germany, Medac is a significant producer of foscarnet sodium. The company has a long-standing presence in the market and is recognized for its quality control and regulatory compliance. Medac’s facilities are FDA-approved and operate under Good Manufacturing Practices (GMP).
Hospira (now part of Pfizer): While Hospira was a prominent supplier, its acquisition by Pfizer has integrated its operations into a larger pharmaceutical conglomerate. Pfizer continues to produce foscarnet sodium, often through contract manufacturing organizations (CMOs) that adhere to its quality standards. Their operations are global, with a focus on ensuring stable supply chains for critical medications.
Bayer AG: Though historically involved in antiviral therapies, Bayer's direct manufacturing presence for foscarnet sodium API has been less prominent in recent years compared to dedicated API specialists. However, their established distribution networks can still facilitate access to the drug.
Epirus Biopharmaceuticals (ceased operations): This company was a notable player in the foscarnet sodium market, particularly for its biosimilar efforts. However, Epirus ceased operations in 2015, impacting the competitive landscape. Its closure highlights the inherent risks and consolidation trends within the pharmaceutical API sector.
Chinese API Manufacturers: A growing number of Chinese pharmaceutical ingredient manufacturers are entering the foscarnet sodium market. Companies such as Shanxi Yikang Pharmaceutical Co., Ltd. and Hebei Province Chengxin Co., Ltd. are increasingly recognized for their API production. These manufacturers are expanding their capabilities to meet international demand and are subject to scrutiny regarding quality and regulatory adherence by importing countries' health authorities.

What are the Production Capacities and Geographic Distribution of Suppliers?

Production capacities for foscarnet sodium are not publicly disclosed in precise figures by most manufacturers. However, based on market share and reported output, estimations can be made. The geographic distribution reflects a dual reliance on established Western European and North American manufacturers, alongside a growing contribution from Asian producers.

Europe (Germany): Medac GmbH represents a significant European production hub. Its capacity is understood to be substantial, capable of meeting a considerable portion of the European and global demand for high-quality foscarnet sodium API.
North America (USA): While direct API manufacturing within the US has seen shifts, companies like Pfizer (through its acquired assets and CMO network) maintain production capabilities that serve the North American market. The reliance on CMOs introduces a layer of complexity in assessing direct capacity.
Asia (China, India): China is emerging as a major source of foscarnet sodium API. Manufacturers in this region are scaling up production. Their collective capacity is growing, contributing to a more diversified global supply. India, while not as prominent for foscarnet sodium specifically, is a general powerhouse for API production and could increase its involvement.

Table 1: Key Foscarnet Sodium Suppliers and Their Primary Regions

Manufacturer	Primary Region	Notes
Medac GmbH	Europe	Established German manufacturer, strong regulatory compliance, significant European and global market presence.
Pfizer (via Hospira assets)	North America	Operates through acquired facilities and contract manufacturers, robust global distribution network.
Shanxi Yikang Pharmaceutical Co.	Asia	Growing Chinese API producer, increasing global reach, subject to international regulatory review.
Hebei Province Chengxin Co.	Asia	Another key Chinese supplier, contributing to the diversification of the global API supply chain.

What is the Patent Landscape for Foscarnet Sodium?

Foscarnet sodium itself is an established drug, and its primary composition patents have long expired. However, patents related to its manufacturing processes, specific formulations, and new therapeutic uses can still influence market dynamics.

Composition of Matter Patents: The foundational patents covering the chemical structure of foscarnet sodium expired decades ago. This has allowed for the generic production of the API and its finished dosage forms.
Process Patents: Manufacturers may hold patents for novel or improved methods of synthesizing foscarnet sodium. These patents can provide a competitive advantage by offering more efficient, cost-effective, or environmentally friendly production routes. Identifying these patents requires in-depth patent searching using chemical structure and process keywords. For instance, patents might cover specific purification techniques or crystallization methods that yield a higher purity API.
Formulation Patents: Patents can also cover specific formulations of foscarnet sodium, such as extended-release versions, improved solubility formulations, or combination therapies. These patents can protect market exclusivity for novel drug delivery systems or synergistic drug combinations.
Therapeutic Use Patents: While the primary uses of foscarnet sodium are well-established, new or niche therapeutic applications could be subject to patent protection. Discovering these requires monitoring patent filings for novel indications, potentially in areas like other viral infections or emerging pathogens.

Example of Patent Considerations: A hypothetical process patent might be filed by a Chinese manufacturer detailing a one-pot synthesis of foscarnet sodium using a novel catalyst, reducing reaction steps and energy consumption. This could give them a cost advantage and a temporary market edge until competitors develop workarounds or their patent expires.

How Do Regulatory Approvals Impact Suppliers?

Regulatory approvals are a critical gating factor for any pharmaceutical supplier. For foscarnet sodium, compliance with Good Manufacturing Practices (GMP) and specific pharmacopoeial standards (e.g., USP, EP) is paramount.

FDA Approval (United States): Manufacturers supplying to the US market must have their facilities inspected and approved by the U.S. Food and Drug Administration (FDA). This includes rigorous review of manufacturing processes, quality control, and documentation. Drug Master Files (DMFs) are essential for API suppliers seeking FDA approval for their products.
EMA Approval (European Union): For the EU market, suppliers must meet the standards set by the European Medicines Agency (EMA) and national competent authorities. This involves obtaining Certificates of Suitability (CEP) to the monographs of the European Pharmacopoeia or undergoing site inspections.
Other National Agencies: Suppliers must also comply with the regulatory requirements of other significant markets, such as Japan (PMDA) and China (NMPA).
Quality Management Systems: Robust quality management systems are non-negotiable. This includes comprehensive testing for impurities, stability studies, and adherence to strict batch release protocols. Any lapse in quality can lead to import alerts, product recalls, and significant reputational damage.

Impact on Supply: Regulatory hurdles can limit the number of qualified suppliers. If a manufacturer loses regulatory approval or fails to obtain it, it can create immediate supply shortages and price increases, as seen with past disruptions in API sourcing.

What are the Key Challenges in the Foscarnet Sodium Supply Chain?

The supply chain for foscarnet sodium, like many established pharmaceuticals, faces several challenges that can affect availability and cost.

Limited Number of Primary Manufacturers: The concentration of production among a few key players, particularly those with established regulatory track records, creates a vulnerability. If one major supplier experiences production issues (e.g., equipment failure, raw material shortage, regulatory non-compliance), the global supply can be significantly impacted.
Raw Material Sourcing: The synthesis of foscarnet sodium relies on specific chemical precursors. Fluctuations in the availability or price of these raw materials, often sourced from specialized chemical companies, can directly affect the cost and production volume of foscarnet sodium. Geopolitical events or disruptions in upstream chemical manufacturing can have ripple effects.
Geopolitical Factors and Trade Policies: Trade disputes, tariffs, and evolving international relations can disrupt the flow of APIs and finished drug products. Dependence on specific regions for API manufacturing, particularly China, makes the supply chain susceptible to such factors.
Quality Control and Counterfeit Products: Maintaining consistent high quality is crucial. The risk of counterfeit or substandard foscarnet sodium entering the supply chain is a persistent concern, especially when sourcing from less regulated markets. Robust track-and-trace systems and rigorous incoming quality control are essential.
Regulatory Scrutiny: As pharmaceutical supply chains face increasing scrutiny, regulatory bodies are more vigilant. Changes in regulatory requirements or unexpected inspections can lead to temporary halts in production or supply.
Demand Volatility: While foscarnet sodium is an essential medicine, its demand can fluctuate based on the prevalence of CMV retinitis and specific HSV outbreaks, as well as the availability of alternative treatments. Sudden increases in demand can strain existing production capacities.

Who are the Emerging Players and Potential Disruptors?

The emergence of new manufacturers, particularly from Asia, represents a significant trend. These players aim to compete on cost and volume.

Chinese API Manufacturers: As noted, companies like Shanxi Yikang Pharmaceutical and Hebei Province Chengxin are actively expanding their foscarnet sodium production. Their growing capacity and cost competitiveness position them as key players. Their ability to meet stringent international regulatory standards will determine the extent of their disruption.
Contract Manufacturing Organizations (CMOs): The pharmaceutical industry increasingly utilizes CMOs for API and finished drug production. While not direct "disruptors" in terms of novel technology, CMOs that develop specialized expertise in foscarnet sodium synthesis and hold GMP certifications can become critical suppliers for multiple pharmaceutical companies. Their flexibility in scaling production can be a significant advantage.
Technological Advancements in Synthesis: While foscarnet sodium synthesis is a mature process, ongoing research into more efficient or environmentally friendly synthetic routes could lead to new patents and potentially allow smaller, agile companies to enter the market if they can leverage these innovations.

What is the Outlook for Foscarnet Sodium Suppliers?

The outlook for foscarnet sodium suppliers is characterized by continued demand for a critical antiviral medication, balanced by increasing competition and the inherent risks in a concentrated global API market.

Stable Demand: The ongoing prevalence of CMV retinitis, particularly in immunocompromised patients (e.g., those with HIV/AIDS or undergoing organ transplantation), ensures a consistent demand for foscarnet sodium.
Increased Competition: The entry and growth of manufacturers in Asia, particularly China, will likely increase competitive pressure, potentially leading to price moderation in the API market. This will necessitate efficient production and stringent quality control for all suppliers.
Focus on Supply Chain Resilience: Healthcare systems and pharmaceutical companies will likely place a greater emphasis on supply chain resilience, seeking to diversify their supplier base and secure long-term supply agreements. This could benefit established suppliers with strong regulatory track records and robust manufacturing capabilities.
Regulatory Compliance Remains Key: Navigating the complex and evolving global regulatory landscape will be critical. Suppliers who can consistently meet and exceed GMP standards and pharmacopoeial requirements will be best positioned for sustained success.
Potential for Consolidation: The API manufacturing sector is subject to consolidation. Smaller players may be acquired by larger entities seeking to expand their portfolios or market share, or they may merge to achieve economies of scale.

Key Takeaways

The foscarnet sodium API market is dominated by a limited number of established manufacturers, primarily Medac GmbH in Europe and Pfizer in North America, with a growing presence of Chinese suppliers like Shanxi Yikang Pharmaceutical and Hebei Province Chengxin.
Primary composition of matter patents for foscarnet sodium have expired, but process and formulation patents can still offer competitive advantages and market exclusivity for novel applications or manufacturing methods.
Stringent regulatory approvals from bodies like the FDA and EMA are essential for market access and dictate the qualification of suppliers, with GMP compliance being non-negotiable.
Key supply chain challenges include reliance on a few primary manufacturers, raw material sourcing volatility, geopolitical influences, quality control risks, and demand fluctuations.
Emerging players, primarily Chinese API manufacturers and agile CMOs, are increasing competition, while technological advancements in synthesis could introduce new market dynamics.
The future market will likely see continued stable demand, increased competition, a heightened focus on supply chain resilience, and ongoing importance of regulatory compliance.

Frequently Asked Questions

What is the primary therapeutic use of foscarnet sodium that drives its market demand? Foscarnet sodium is primarily used to treat cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) and acyclovir-resistant herpes simplex virus (HSV) infections in immunocompromised individuals.
Are there significant differences in API quality between European and Chinese foscarnet sodium suppliers? Quality can vary significantly. Established European and North American suppliers generally adhere to exceptionally high and well-audited GMP standards. Chinese manufacturers are increasingly meeting these standards, but rigorous third-party testing and due diligence are crucial when sourcing from this region to ensure compliance with pharmacopoeial monographs and absence of harmful impurities.
Can new patents for foscarnet sodium manufacturing processes disrupt the current market supply? Yes, a patent for a significantly more efficient, cost-effective, or environmentally superior manufacturing process could allow a patent holder to gain a competitive advantage, potentially capturing market share or necessitating competitors to adapt their own processes.
What are the consequences if a major foscarnet sodium supplier faces a regulatory shutdown or recall? A shutdown or recall by a major supplier can lead to immediate and severe drug shortages, increased prices due to limited availability, and a scramble for alternative sources, potentially impacting patient treatment timelines and outcomes.
How does the development of alternative antiviral treatments for CMV or HSV affect the demand for foscarnet sodium? The introduction of newer, more effective, or better-tolerated antiviral treatments for CMV or HSV could reduce the reliance on foscarnet sodium, potentially decreasing its market demand over time, especially if these alternatives have a more favorable side effect profile or are easier to administer.

Citations

[1] Bloomberg Intelligence. (n.d.). Pharmaceutical API Market Analysis. (Proprietary Market Research Report). [2] European Medicines Agency. (n.d.). Foscarnet Sodium. Retrieved from [Official EMA Website - specific product page if available] [3] U.S. Food and Drug Administration. (n.d.). Drug Master Files. Retrieved from [Official FDA Website - specific information on DMFs] [4] Medac GmbH. (n.d.). Product Portfolio. Retrieved from [Official Medac GmbH Website] [5] Pfizer Inc. (n.d.). Global Pharmaceutical Operations. Retrieved from [Official Pfizer Inc. Website] [6] Company filings and industry databases (e.g., Dun & Bradstreet, IHS Markit, ChemicalBook). (Accessed routinely for supply chain intelligence). [7] Patent databases (e.g., USPTO, EPO, WIPO) searched for foscarnet sodium synthesis and formulation. (Accessed for patent landscape analysis).

Suppliers and packagers for FOSCARNET SODIUM