XYLOCAINE W/ EPINEPHRINE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Fresenius Kabi Usa	XYLOCAINE W/ EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	006488	NDA	Henry Schein, Inc.	0404-9972-20	1 VIAL in 1 BAG (0404-9972-20) / 20 mL in 1 VIAL	2022-01-10
Fresenius Kabi Usa	XYLOCAINE W/ EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	006488	NDA	Henry Schein, Inc.	0404-9973-20	1 VIAL in 1 BAG (0404-9973-20) / 20 mL in 1 VIAL	2022-01-10
Fresenius Kabi Usa	XYLOCAINE W/ EPINEPHRINE	epinephrine; lidocaine hydrochloride	INJECTABLE;INJECTION	006488	NDA	Henry Schein, Inc.	0404-9973-50	1 VIAL in 1 BAG (0404-9973-50) / 50 mL in 1 VIAL	2022-01-10
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 3, 2025

Introduction

Xylocaine with Epinephrine ranks among the most widely utilized local anesthetic combinations in surgical, dental, and emergency medicine settings. This pairing offers effective anesthesia with prolonged duration due to vasoconstrictive properties of epinephrine, reducing bleeding and enhancing patient comfort. As demand for this combination persists globally, identifying reliable suppliers and understanding their manufacturing landscapes are critical for healthcare providers, pharmaceutical distributors, and procurement entities. This report offers a comprehensive assessment of key suppliers, their regulatory statuses, and market dynamics, supporting informed decision-making.

Overview of Xylocaine with Epinephrine

Xylocaine with Epinephrine is a trademarked formulation primarily composed of lidocaine hydrochloride—a local anesthetic—and epinephrine—vasoconstrictor—in a specified concentration. Typically, formulations range from 1% lidocaine with 1:100,000 or 1:50,000 epinephrine, depending on clinical requirements (FDA, 2021). Due to stringent quality standards, production involves stringent manufacturing controls and regulatory oversight, primarily from agencies such as the FDA, EMA, and other regional authorities.

Leading Suppliers of Xylocaine with Epinephrine

1. AstraZeneca (Innovator Supplier)

AstraZeneca holds the original patent and marketing rights for Xylocaine (lidocaine) formulations, including those combined with epinephrine. Their products dominate the global market, manufactured under rigorous regulatory protocols, ensuring high purity and consistency.

Key Details:

Manufacturing facilities: Global, with major plants in the UK, US, and Sweden.
Regulatory approvals: Approved by FDA, EMA, TGA, and other regulators.
Distribution footprint: Extensive, accessible through authorized distributors worldwide.

2. Hospira (Part of Pfizer)

Hospira, a subsidiary of Pfizer, produces a wide portfolio of generic injectables, including lidocaine with epinephrine. Their manufacturing adheres to high-quality standards, and they supply to hospitals and clinics worldwide.

Key Details:

Production: Facilities in the US and Ireland.
Regulatory status: Approved by FDA and EMA.
Market presence: Strong, especially in North America and Europe.

3. Sandoz (Novartis)

Sandoz is a reputable manufacturer of generic injectable drugs, including lidocaine with epinephrine. Their products are widely used in clinical settings, supported by extensive regulatory approvals.

Key Details:

Manufacturing: Facilities in the US, Europe, and Latin America.
Regulatory compliance: FDA, EMA, and other global agencies’ approvals.
Supply chain: Stable, with regional distribution centers.

4. TEVA Pharmaceuticals

TEVA offers a broad portfolio of generic injectables, with lidocaine with epinephrine being a critical item. Their manufacturing quality and competitive pricing make them a key supplier.

Key Details:

Facilities: Multiple manufacturing sites globally.
Regulations: Approvals from FDA, EMA, and others.
Distribution networks: Extensive worldwide.

5. Local and Regional Manufacturers

In addition to multinational corporations, numerous regional manufacturers supply Xylocaine with Epinephrine, targeting local markets or specialized healthcare providers. These manufacturers often obtain regulatory approval locally and may offer cost-effective alternatives.

Examples:

Wockhardt (India)
Laboratorios Liomont (Mexico)
Aventis (India)

Their contribution grows in emerging markets, especially where regional demand exceeds supply from large multinational firms.

Regulatory and Quality Considerations

Manufacturers of Xylocaine with Epinephrine must comply with Good Manufacturing Practices (GMP) and regulatory approval processes to ensure safety and efficacy. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) rigorously evaluate manufacturing sites, raw materials, and finished products. Additionally, suppliers should provide Certificates of Analysis (COA), stability data, and batch-specific documentation, especially in procurement of generics.

Market Dynamics and Supply Chain Risks

The global supply chain for injectable pharmaceuticals, including lidocaine with epinephrine, faces challenges such as raw material shortages, geopolitical factors, manufacturing disruptions, and regulatory hurdles (WHO, 2022). Recent geopolitical tensions and pandemic-related supply chain interruptions have emphasized the need for diversified sourcing strategies.

Major suppliers maintain inventory buffers and multiple manufacturing sites to mitigate these risks. Nonetheless, procurement entities must perform due diligence, verify supplier compliance, and monitor geopolitical and economic shifts influencing supply stability.

Emerging Trends and Future Outlook

Advancements in pharmaceutical manufacturing, such as continuous manufacturing techniques, offer potential to enhance supply reliability. Additionally, the shift toward biosimilar and generic formulations—to reduce costs—will likely expand supplier pools. Regulatory agencies are also harmonizing standards, facilitating easier approval pathways for new entrants and regional manufacturers.

Furthermore, the increasing demand for injectable anesthetics in Latin America, Asia-Pacific, and Africa fosters opportunities for regional suppliers, boosting drug accessibility.

Key Considerations for Stakeholders

Regulatory compliance: Confirm supplier approvals with relevant authorities.
Quality assurance: Obtain detailed Certificates of Analysis and batch validation data.
Supply stability: Diversify supplier base across regions and manufacturers.
Pricing strategies: Balance cost savings with quality and regulatory integrity.
Ethical sourcing: Ensure raw material sourcing meets global standards to prevent counterfeit and substandard products.

Conclusion

The supply landscape for Xylocaine with Epinephrine revolves around well-established multinationals like AstraZeneca, Pfizer (Hospira), Sandoz, and Teva, all adhering to strict regulatory standards and quality controls. Regional manufacturers also play a vital role, especially in emerging markets. Given the current geopolitical and supply chain challenges, stakeholders should prioritize supplier due diligence, regulatory compliance, and diversified sourcing strategies to ensure consistent access to this essential anesthetic product.

Key Takeaways

Major global suppliers include AstraZeneca, Pfizer (Hospira), Sandoz, and Teva, with extensive regulatory approvals and manufacturing capacity.
Regional manufacturers expand access, particularly in developing markets, often offering cost-effective alternatives.
Regulatory compliance and product quality are critical considerations—verify certifications and batch documentation before procurement.
Supply chain resilience requires diversification and proactive monitoring of geopolitical and macroeconomic developments.
Emerging manufacturing technologies and regional entrants are shaping the future of Xylocaine with Epinephrine supply, potentially enhancing availability and reducing costs.

FAQs

What are the primary manufacturers of Xylocaine with Epinephrine globally?
Major manufacturers include AstraZeneca, Pfizer (Hospira), Sandoz, and Teva, all with global distribution networks and regulatory approvals.
How can I verify the quality of a supplier’s Xylocaine with Epinephrine product?
Request Certificates of Analysis (COA), batch release documentation, and verify regulatory approvals from recognized agencies such as FDA and EMA.
Are there regional alternatives to multinational suppliers for this drug?
Yes, regional manufacturers in India, Latin America, and Asia provide approved generic formulations, often at lower costs, supporting regional healthcare needs.
What supply chain risks affect the availability of Xylocaine with Epinephrine?
Raw material shortages, geopolitical tensions, manufacturing disruptions, and regulatory delays pose significant risks.
What future trends are influencing the supply of lidocaine plus epinephrine formulations?
Emerging manufacturing technologies, regional market development, and regulatory harmonization are expanding supply options and improving access.

Sources

[1] U.S. Food and Drug Administration (FDA). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). 2021.
[2] World Health Organization (WHO). Supply Chain and Access to Medicines Report. 2022.
[3] AstraZeneca. Product information and manufacturing disclosures. 2023.
[4] Pfizer. Corporate website and product approvals. 2023.
[5] Sandoz. Product monographs and regulatory approvals. 2023.
[6] Teva Pharmaceuticals. Global supply chain overview. 2023.

Suppliers and packagers for XYLOCAINE W/ EPINEPHRINE