LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Eugia Pharma	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	203040	ANDA	Eugia US LLC	55150-158-72	10 AMPULE in 1 CARTON (55150-158-72) / 2 mL in 1 AMPULE	2013-03-14
Eugia Pharma	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	203040	ANDA	Eugia US LLC	55150-159-74	10 AMPULE in 1 CARTON (55150-159-74) / 5 mL in 1 AMPULE	2013-03-14
Eugia Pharma	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	203040	ANDA	Eugia US LLC	55150-160-72	10 AMPULE in 1 CARTON (55150-160-72) / 2 mL in 1 AMPULE	2013-03-14
Eugia Pharma	LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE	lidocaine hydrochloride	INJECTABLE;INJECTION	203040	ANDA	Medical Purchasing Solutions, LLC	71872-7190-1	1 AMPULE in 1 BAG (71872-7190-1) / 5 mL in 1 AMPULE	2013-03-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: August 5, 2025

Introduction

Lidocaine hydrochloride preservative-free (PF) is a widely utilized local anesthetic integral to various medical interventions, including surgical anesthesia, dental procedures, and diagnostic nerve blocks. The preservative-free formulation minimizes potential allergic reactions and tissue irritation, making it suitable for sensitive applications such as intrathecal or epidural injections. The global demand for preservative-free lidocaine has driven a competitive supplier landscape comprised of major pharmaceutical manufacturers, specialty chemical producers, and compounding pharmacy suppliers. Understanding these suppliers' profiles, manufacturing capacities, regulatory standards, and geographic presence facilitates informed procurement and strategic planning.

Major Pharmaceutical Suppliers

1. Hospira (now part of Pfizer Inc.)

Overview: Hospira was a leading provider of sterile injectables, including lidocaine hydrochloride preservative-free solutions, before its acquisition by Pfizer in 2015. Pfizer continues to manufacture and distribute a range of injectable anesthetics globally.
Product Portfolio: PF lidocaine 1% and 2%, supplied in various formats such as prefilled syringes and vials.
Regulatory Status: Approved by FDA, EMA, and other major health authorities with stringent cGMP compliance.
Distribution Channels: Worldwide via Pfizer's extensive distribution network, predominantly serving hospitals, clinics, and compounding pharmacies.

2. Fresenius Kabi

Overview: A global healthcare company specializing in sterile injectable medicines, including preservative-free lidocaine.
Product Portfolio: Options include lidocaine 1% and 2% solutions, in sterile vials and syringes, primarily targeted at Europe, North America, and Asia-Pacific markets.
Regulatory Status: Approved by FDA, EMA, and other regulatory bodies with adherence to high manufacturing standards.
Strengths: Known for high-quality sterile products, rapid supply chain responsiveness, and robust regulatory compliance.

3. Hikma Pharmaceuticals

Overview: A major global manufacturer of sterile injectables, Hikma supplies preservative-free lidocaine formulations across markets in the Middle East, Europe, and the US.
Product Range: Lidocaine 1% and 2% in single-use vials, with consistent batch quality.
Regulatory Compliance: Approved by USFDA, EMA, and local authorities, with emphasis on quality assurance.

4. Sagent Pharmaceuticals

Overview: Specializes in sterile, injectable pharmaceuticals including lidocaine, with a focus on US markets.
Product Quality: Provides preservative-free lidocaine in prefilled cartridges and vials, meeting USP standards.
Distribution: Serves hospitals and healthcare providers via emergency and specialty distribution channels.

Specialty and Regional Suppliers

5. BBraun Melsungen AG

Overview: A European medical device and pharmaceutical manufacturer, BBraun provides preservative-free lidocaine solutions in multiple formats.
Strengths: Emphasizes innovation, sterile manufacturing, and European regulatory compliance.

6. APP Pharmaceuticals (part of Fresenius Kabi)

Overview: Offers high-quality sterile injectables, including preservative-free lidocaine, with distribution mainly in North America.

7. Local and Compounding Pharmacy Suppliers

Many compounding pharmacies and regional suppliers produce preservative-free lidocaine solutions, often sourcing from bulk API manufacturers. These suppliers serve niche markets and facilitate customized formulations, especially in markets with limited access to large-scale pharma manufacturers.

API Manufacturers for Lidocaine Hydrochloride

Manufacturing preservative-free lidocaine begins at the active pharmaceutical ingredient (API) level. High-quality APIs are primarily produced by:

Zhejiang NHU Company (China) – A leading API manufacturer with global certifications, supplying lidocaine hydrochloride API for licensed formulations.
Hubei Tianyao Pharmaceutical (China) – Known for producing pharmaceutical-grade lidocaine APIs adhering to international standards.
BASF (Germany) – Supplies pharmaceutical intermediates and APIs, including lidocaine base, with rigorous quality standards.
Ningbo Inno Pharmchem Co., Ltd. – A reputable Chinese supplier for lidocaine APIs, with certifications suitable for pharmaceutical applications.

Quality Assurance and Regulatory Considerations

Suppliers must comply with cGMP (current Good Manufacturing Practice) standards enforced by authorities such as the FDA, EMA, or WHO, ensuring sterility, potency, and safety. Procurement should include verification of batch certificates, API purity, endotoxin levels, and compatibility with intended formulations.

European suppliers often hold ISO 13485 and ISO 9001 certifications, while US suppliers must be FDA-registered and inspected periodically. Regulatory approval for marketed products also depends on adherence to pharmacopeial standards—USP, EP, and Ph. Eur.—which stipulate specifications for preservative-free lidocaine solutions.

Supply Chain and Logistics Considerations

Global Manufacturing Hubs: Major suppliers operate facilities in North America, Europe, and Asia, enabling diversified sourcing and risk mitigation.
Lead Times: API availability and manufacturing schedules impact delivery; reputable suppliers maintain inventory buffers to support urgent needs.
Distribution Channels: Major pharmaceutical companies leverage established distribution networks to ensure timely, temperature-controlled deliveries with validated cold chain logistics where necessary.
Pricing Dynamics: Competitive markets and raw material costs influence pricing stability; long-term agreements benefit procurement strategies.

Emerging Trends and Opportunities

Local Production: To circumvent supply chain disruptions, regional manufacturers have increased investment in local API production capabilities.
Regulatory Harmonization: The global harmonization of standards simplifies cross-border procurement and compliance processes.
Innovation in Formulation: Development of preservative-free, ready-to-use formulations in prefilled syringes enhances safety and ease of administration, expanding the supplier landscape.

Conclusion

The landscape for preservative-free lidocaine hydrochloride is robust with established global manufacturers and high-quality API producers. Prominent pharmaceutical suppliers like Pfizer (Hospira), Fresenius Kabi, Hikma, and Sagent Pharmaceuticals provide certified, regulated formulations suitable for diverse healthcare settings worldwide. API manufacturers such as Zhejiang NHU and Hubei Tianyao supply the foundational materials, ensuring quality and compliance.

Procurement professionals should prioritize suppliers with robust regulatory approval, reliable supply chains, adherence to cGMP, and transparent quality documentation. Engaging with reputable partners minimizes risks associated with contamination, drug shortages, and regulatory non-compliance.

Key Takeaways

Leading pharmaceutical companies such as Pfizer, Fresenius Kabi, Hikma, and Sagent Pharmaceuticals dominate the preservative-free lidocaine market, offering high-quality, regulated products.
High-quality lidocaine API producers, primarily based in China and Germany, form the backbone of the supply chain.
Regulatory compliance, quality assurance, and temperature-controlled logistics are critical to reliable procurement.
Regional suppliers and compounding pharmacies serve niche markets and facilitate customized formulations, especially in regions with supply constraints.
Maintaining diversified sourcing, monitoring regulatory updates, and fostering relationships with vetted suppliers support risk mitigation and supply stability.

FAQs

1. Are there differences in the quality of preservative-free lidocaine from different suppliers?
Yes. Although all suppliers must meet strict regulatory standards, product quality can vary based on manufacturing practices, certification compliance, and raw material sourcing. Always verify supplier certifications and quality documentation.

2. Can preservative-free lidocaine be compounded locally, and is it as safe as commercially supplied products?
Compounded preservative-free lidocaine is safe when prepared under strict aseptic conditions by qualified pharmacists using approved APIs and sterile techniques. However, commercially supplied products typically undergo rigorous quality control, reducing contamination risk.

3. What regulations govern the import and sale of lidocaine hydrochloride preservative-free formulations?
Regulations vary by country but generally include approvals from health authorities such as the FDA in the US, EMA in Europe, or equivalent agencies, ensuring safety, efficacy, and quality standards are met.

4. How do supply disruptions impact the availability of preservative-free lidocaine?
Disruptions to API manufacturing, logistical challenges, or regulatory issues can lead to shortages. Strategic stockpiling, diversified sourcing, and regional manufacturing investments mitigate these risks.

5. Are there notable differences between preservative-free lidocaine and preservative-containing formulations in clinical outcomes?
Preservative-free formulations reduce the risk of allergic reactions and tissue irritation, making them preferable in sensitive procedures. Clinical efficacy remains comparable when formulations are properly manufactured.

Sources
[1] Pfizer Inc. Product documentation for Hospira sterile injectables.
[2] Fresenius Kabi official product catalog.
[3] Hikma Pharmaceuticals product brochure.
[4] Sagent Pharmaceuticals product data sheet.
[5] USP Monographs for Lidocaine Hydrochloride.
[6] API manufacturer certifications (Zhejiang NHU, Hubei Tianyao).

Suppliers and packagers for LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE