Suppliers and packagers for generic pharmaceutical drug: flumazenil

flumazenil

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare Corp	FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	076755	ANDA	Henry Schein, Inc	0404-9859-10	1 VIAL, MULTI-DOSE in 1 BAG (0404-9859-10) / 10 mL in 1 VIAL, MULTI-DOSE	2022-01-10
Baxter Hlthcare Corp	FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	076755	ANDA	Henry Schein, Inc	0404-9860-05	1 VIAL, MULTI-DOSE in 1 BAG (0404-9860-05) / 5 mL in 1 VIAL, MULTI-DOSE	2022-01-10
Baxter Hlthcare Corp	FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	076755	ANDA	Baxter Healthcare Corporation	36000-148-10	10 VIAL, MULTI-DOSE in 1 PACKAGE (36000-148-10) / 5 mL in 1 VIAL, MULTI-DOSE	2017-10-01
Baxter Hlthcare Corp	FLUMAZENIL	flumazenil	INJECTABLE;INJECTION	076755	ANDA	Baxter Healthcare Corporation	36000-149-10	10 VIAL, MULTI-DOSE in 1 PACKAGE (36000-149-10) / 10 mL in 1 VIAL, MULTI-DOSE	2017-10-01

Suppliers for the Pharmaceutical Drug: Flumazenil

Last updated: July 29, 2025

Introduction

Flumazenil is a benzodiazepine antagonist primarily used to reverse the effects of benzodiazepine overdoses and sedation in medical settings. Its unique mechanism of action targets the GABA-A receptor complex, providing rapid reversal of benzodiazepine-induced sedation and respiratory depression. With increasing recognition of its clinical importance, the global supply chain for flumazenil has become vital for hospitals, clinics, and pharmaceutical manufacturers.

This article explores the landscape of suppliers for flumazenil, detailing manufacturing sources, leading pharmaceutical suppliers, and the regulatory considerations impacting the global distribution of this critical drug.

Manufacturers of Flumazenil

1. Major Global Pharmaceutical Manufacturers

The manufacturing of flumazenil involves complex chemical synthesis and rigorous quality control to ensure safety and efficacy. Although originally developed by well-established pharmaceutical companies, many generic drug producers now manufacture and distribute flumazenil worldwide.

• Hengdian Pharmaceutical Co., Ltd. (China)
  One of the leading Chinese pharmaceutical manufacturers, Hengdian produces a range of injectable pharmaceuticals, including flumazenil. The company's capacity to supply large volumes makes it a significant supplier in Asia and emerging markets.

• Fresenius Kabi (Germany)
  A global leader in infusion therapy and clinical nutrition, Fresenius Kabi manufactures flumazenil for markets worldwide. The company's emphasis on quality standards aligns with stringent regulatory frameworks such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

• Pfizer Inc. (United States)
  Pfizer historically produced flumazenil, although production status varies with strategic shifts. Its logistical infrastructure and robust supply chain facilitate distribution in North America and beyond.

• Local and Regional Generics Producers
  Numerous regional companies across India, Latin America, and Southeast Asia produce generic formulations of flumazenil. These are often approved through local regulatory agencies and serve markets with limited access to branded drugs.

2. Contract Manufacturing Organizations (CMOs)

Some pharmaceutical companies outsource the production of flumazenil to CMOs specializing in active pharmaceutical ingredient (API) synthesis and finished drug manufacturing.

• Recipharm (Sweden)
  Recipharm offers contract manufacturing services for injectable and generic pharmaceuticals, including flumazenil, adhering to Good Manufacturing Practices (GMP).

• Famar (Greece)
  Famar provides manufacturing and packaging services for injectable drugs, supplying flumazenil to various international markets.

Regulatory Considerations and Market Access

The distribution and approval of flumazenil depend heavily on regulatory approvals from agencies like the FDA, EMA, and other national authorities. Multiple manufacturers either hold marketing authorization or produce generic versions under approval pathways, such as the abbreviated new drug application (ANDA) in the U.S. and mutual recognition procedures in Europe.

Manufacturers seeking to enter new markets must comply with GMP standards and demonstrate bioequivalence (for generics), quality assurance, and stability. The stringent regulatory landscape influences the number of authorized suppliers and their ability to maintain consistent, high-quality production.

Market Dynamics and Supply Chain Factors

The global supply chain for flumazenil faces several challenges, including:

• Raw Material Availability: Flumazenil's synthesis requires specific intermediates often sourced from specialized chemical suppliers. Disruptions in supply chains, particularly in geopolitically sensitive regions, impact production capacity.

• Regulatory Compliance: As a critical emergency medication, any supply interruptions could have severe clinical consequences. Manufacturers maintain multiple manufacturing sites and optimize inventory management to prevent shortages.

• Patent and Generic Competition: Initially developed by proprietary companies, most markets now operate with generics, intensifying competition among suppliers. Pricing and market share are sensitive to regional patent laws and approval processes.

• Quality Standards: Ensuring consistent API purity and stability is paramount. Suppliers investing in GMP-certified facilities and rigorous testing underwrite their market credibility.

Emerging Suppliers and Regional Markets

Emerging markets continue to see the entrance of new suppliers, often driven by local demand and lower regulatory barriers. For instance:

• India and China host numerous small-to-medium pharmaceutical firms capable of producing flumazenil under local GMP standards, with some seeking export licenses for broader markets.
• Latin American countries, such as Brazil and Mexico, have local producers aligned with regional health authorities, offering more affordable options to their healthcare infrastructure.

Supply Chain Challenges and Strategic Implications

Given the critical emergency use of flumazenil, supply chain resilience is paramount. The COVID-19 pandemic highlighted vulnerabilities impacting the availability of injectable medications globally. Health authorities have emphasized the importance of diversified supply sources, strategic stockpiles, and transparent documentation to prevent shortages.

Manufacturers must navigate intellectual property considerations, especially with the rise of biosimilars and generics, which influence market access, pricing, and supply reliability.

Conclusion

The global supply of flumazenil hinges on a complex network of manufacturers ranging from established pharmaceutical giants to regional generics producers and contract manufacturers. While quality standards and regulatory compliance are paramount, market dynamics continue to evolve, influenced by patent laws, raw material availability, and geopolitical factors.

Maintaining robust production capacity, ensuring regulatory compliance, and fostering global diversification are critical for securing consistent supplies of this vital medication.

---

Key Takeaways

• Major players like Fresenius Kabi and regional manufacturers in China and India dominate the flumazenil supply landscape.
• Regulatory standards significantly influence market access and manufacturing practices, with GMP compliance being essential.
• Supply chain resilience is critical to prevent shortages, especially given flumazenil's role in emergency overdose reversal.
• Emerging markets are increasingly producing generic versions, expanding access but posing challenges for quality assurance.
• Strategic relationships with CMOs and adherence to regulatory pathways facilitate broader market penetration.

---

FAQs

1. Who are the leading global suppliers of flumazenil?
Major global suppliers include Fresenius Kabi (Germany), Hengdian Pharmaceutical (China), and regional generics producers from India, Latin America, and Southeast Asia. Contract manufacturing organizations also contribute to production capacity.

2. Are there patent restrictions on manufacturing flumazenil?
Initially developed by proprietary companies, flumazenil's patent protections have largely expired worldwide, enabling generic manufacturers to produce and distribute the drug under regulatory approvals.

3. What regions have the highest availability of flumazenil?
Availability is highest in North America and Europe, where regulatory approvals and manufacturing infrastructure are most developed. Emerging markets in Asia, Latin America, and Africa increasingly access generic versions.

4. How does regulation impact the supply of flumazenil?
Regulatory approval, GMP compliance, and quality assurance are crucial for market access. Suppliers must navigate complex registration processes, which can influence supply stability and market entry.

5. What are the risks to the global supply chain of flumazenil?
Risks include raw material shortages, geopolitical disruptions, regulatory delays, and manufacturing issues. Diversifying suppliers and maintaining strategic stockpiles mitigate these vulnerabilities.

---

Sources

[1] European Medicines Agency. (2021). Flumazenil summary.
[2] U.S. FDA. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
[3] MarketWatch. (2023). Pharmaceutical industry reports on generic drug manufacturing.
[4] IQVIA. (2022). Global pharmaceutical supply chain analysis.
[5] World Health Organization. (2020). Drug shortage and supply chain management.