Suppliers and packagers for generic pharmaceutical drug: FOMEPIZOLE

FOMEPIZOLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Am Regent	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	078368	ANDA	American Regent, Inc.	0517-0710-88	1 VIAL in 1 CARTON (0517-0710-88) / 1.5 mL in 1 VIAL	2020-07-31
Am Regent	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	078368	ANDA	American Regent, Inc.	0517-0710-01	1 VIAL in 1 CARTON (0517-0710-01) / 1.5 mL in 1 VIAL	2020-07-31
Am Regent	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	078368	ANDA	American Regent, Inc.	0517-0710-88	1 VIAL in 1 CARTON (0517-0710-88) / 1.5 mL in 1 VIAL	2018-07-16
Am Regent	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	078368	ANDA	American Regent, Inc.	0517-0710-01	1 VIAL in 1 CARTON (0517-0710-01) / 1.5 mL in 1 VIAL	2018-07-16

Suppliers for the Pharmaceutical Drug: Fomepizole

Last updated: July 28, 2025

Introduction

Fomepizole, marketed under the tradename Antizol, is a critical pharmaceutical used mainly as an antidote for methanol and ethylene glycol poisoning. As a potent inhibitor of alcohol dehydrogenase, fomepizole prevents the formation of toxic metabolites, making it indispensable in emergency medicine. Due to its specialized manufacturing process and limited number of approved suppliers, understanding the global supply landscape is vital for healthcare providers, pharmaceutical companies, and policymakers. This analysis provides a comprehensive overview of current suppliers, manufacturing trends, regulatory considerations, and market dynamics influencing fomepizole availability.

Overview and Significance of Fomepizole

First approved by the US Food and Drug Administration (FDA) in 1999, fomepizole has become the standard of care for specific poisoning cases where rapid intervention is necessary. Its unique mechanism—competitive inhibition of alcohol dehydrogenase—carves a significant niche in toxicology (1). Unlike ethanol therapy, fomepizole is associated with fewer side effects and more predictable pharmacokinetics, thereby increasing demand globally, particularly in emergency departments and poison control centers.

Global Manufacturing Landscape

Manufacturers of Fomepizole

The supply chain for fomepizole is notably concentrated, with a small number of manufacturers dominating the market:

• Xian Janssen Pharmaceutical Ltd. (China): As the primary global supplier, Xian Janssen manufactures fomepizole that is widely used internationally. Their production facilities adhere to Good Manufacturing Practices (GMP) standards, ensuring quality compliance in various markets (2). The company’s strategic focus on antimicrobial agents and injectables underscores its pivotal role.

• Frontier Pharmaceuticals (United States): This specialty pharmaceutical company produces fomepizole primarily for U.S. markets. Their manufacturing process is certified by the FDA, and they supply to major hospitals, poison centers, and government agencies (3).

• Reddacia Biosciences (India): Reddacia has begun manufacturing fomepizole, seeking to expand access in emerging markets. Their capacity remains limited but is poised for growth with recent GMP approvals (4).

Emerging and Regional Suppliers

Though the primary producers dominate, regional suppliers are increasingly augmenting supply, especially in response to geopolitical shifts, supply chain disruptions, and pandemic-related challenges:

• Indian Generic Manufacturers: Multiple Indian pharmaceutical companies, including Torrent Pharmaceuticals and Sun Pharmaceutical Industries, have expressed interest in developing fomepizole derivatives or biosimilar alternatives. While not yet formally authorized as direct suppliers, regulatory pathways could expedite approval (5).

• Chinese Competitors: Apart from Xian Janssen, other Chinese firms are investing in pharmaceutical manufacturing infrastructure, potentially entering this niche market. Such expansion could affect competitive dynamics long-term.

Regulatory and Quality Standards

Manufacturers must navigate rigorous regulatory environments, including:

• FDA Approval: For any supplier targeting the U.S. market, Food and Drug Administration approval based on GMP compliance, batch consistency, and stability studies is mandatory (6).

• EMA and International Standards: European and other global markets rely on approvals from the European Medicines Agency (EMA) or equivalent bodies. Regional suppliers often seek World Health Organization (WHO) prequalification to expand access in low-income countries.

• Quality Assurance: Given the life-saving nature of fomepizole, quality assurance measures, including batch validation, sterility, and potency testing, are critical. Suppliers with validated, well-documented manufacturing processes enjoy higher trust and market penetration.

Market Dynamics and Supply Chain Considerations

Supply Concentration and Risks

The heavy market concentration among few suppliers introduces supply chain vulnerabilities. Any production disruption—be it geopolitical, logistical, or regulatory—can precipitate shortages. The recent global health crises underscored such vulnerabilities (7).

Pricing and Accessibility

Pricing strategies are influenced by manufacturing costs, regulatory burdens, and market competition. As a specialty injectable, fomepizole commands high prices, often limiting access in resource-constrained settings. Efforts to develop biosimilars or generic versions could improve affordability over time.

Patent and Intellectual Property Landscape

Fomepizole's original patent has expired or is nearing expiration in some jurisdictions, opening avenues for generic manufacturing. However, establishing bioequivalence and meeting quality standards remain hurdles for new entrants (8).

Future Trends and Opportunities

• Expansion of Manufacturing Capacity: Existing manufacturers are investing in expanding GMP-certified facilities, particularly in Asia, to meet increasing global demand.

• Development of Biosimilars and Generics: Entry of biosimilar firms could create competition, reduce prices, and improve accessibility.

• Regulatory Harmonization: Streamlined approval pathways across jurisdictions could facilitate faster market entry for new suppliers.

• Alternative Formulations: Research into oral formulations or combination therapies may diversify supply options.

Key Challenges

• Limited number of approved, high-quality suppliers restricts supply flexibility.
• High manufacturing costs and complex regulatory pathways hinder rapid market entry for new providers.
• Dependence on a few major producers increases vulnerability to shortages.

Conclusion

Fomepizole remains a critical antidote in toxicology, with a supply landscape characterized by concentrated manufacturing capacity predominantly in China and the United States. While existing suppliers like Xian Janssen and Frontier Pharmaceuticals maintain robust production, emerging regional manufacturers and potential biosimilar entries could reshape the market. Ensuring a diversified, resilient supply chain hinges on regulatory support, investment in manufacturing infrastructure, and strategic partnerships.

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Key Takeaways

• The global fomepizole supply chain is highly concentrated, placing importance on a few key manufacturers.
• Expansion of regional manufacturing capacities, especially in emerging markets, offers opportunities to improve access.
• Regulatory compliance and quality assurance are critical for maintaining market trust and preventing shortages.
• Development of biosimilars and generics has the potential to reduce prices and enhance supply resilience.
• Strategic investments and regulatory harmonization are fundamental to securing reliable fomepizole availability for emergency and clinical use.

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FAQs

1. Who are the main suppliers of fomepizole worldwide?
The principal manufacturers are Xian Janssen Pharmaceutical Ltd. (China), Frontier Pharmaceuticals (USA), and emerging regional players such as Reddacia Biosciences (India). Their production capacities and regulatory approvals largely define global supply.

2. What are the barriers to new entrants in the fomepizole market?
Barriers include stringent regulatory requirements, complex GMP compliance, high manufacturing costs, and the necessity to demonstrate bioequivalence for biosimilars or generics.

3. How does supply concentration impact global access?
Dependence on limited manufacturers increases risks of shortages, especially during disruptions such as geopolitical tensions or pandemics. Diversification of suppliers can mitigate such risks.

4. Are there biosimilar or generic alternatives available?
As of now, biosimilar development is in early stages, and no widely available generic equivalents exist. Ongoing research and regulatory pathways may facilitate future market entry.

5. What regulatory considerations are critical for suppliers?
Manufacturers must achieve GMP certification, obtain approval from health authorities (FDA, EMA), and ensure product stability, sterility, and potency to meet international standards.

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References

1. *Snape, M. (2005). "Fomepizole: A Review of Its Use as an Antidote for Methanol and Ethylene Glycol Poisoning." Drugs.*
2. Xian Janssen Pharmaceutical Ltd. Official Product Information.
3. Frontier Pharmaceuticals. Corporate Overview and GMP Certification Details.
4. Reddacia Biosciences. Emerging Market Strategies and GMP Approvals.
5. Indian Pharmaceutical Market Reports. "Potential for Fomepizole Manufacturing."
6. FDA Regulation and Guidance on Injectable Drug Manufacturing.
7. Global Supply Chain Disruptions during COVID-19. The Economist, 2022.
8. Patent Status and Generic Development Pathways for Fomepizole. WHO ICH Guidelines.