Last updated: July 28, 2025
Introduction
The global pharmaceutical landscape continuously evolves with an increasing demand for local anesthetics and intravenous solutions. Among these, Lidocaine Hydrochloride 0.4% combined with Dextrose 5% in plastic containers represents a critical formulation used primarily for local anesthesia, regional nerve blocks, and as a fluid supplement in clinical settings. Securing reliable suppliers for this combination ensures regulatory compliance, quality standards, and supply chain resilience. This article comprehensively examines key suppliers for this pharmaceutical formulation, highlighting sourcing options, manufacturing capabilities, and quality assurance measures.
Market Overview
Lidocaine Hydrochloride, a local anesthetic, combined with Dextrose 5%, a carbohydrate solution, is a standard formulation for disinfective and anesthetic applications. The demand is driven by hospitals, clinics, and surgical centers globally, with markets regulated through stringent pharmacopoeial standards like USP, EP, and JP. The primary requirement from manufacturers includes high purity, aseptic processing, and compliance with Good Manufacturing Practices (GMP).
Major Suppliers of Lidocaine Hydrochloride 0.4% in Plastic Containers
1. Pfizer Inc.
Overview:
Pfizer is a leading multinational pharmaceutical company with extensive experience in injectable and local anesthetic formulations. They produce Lidocaine hydrochloride in various concentrations, including 0.4%, supplied in sterile plastic bottles.
Capabilities:
- GMP-compliant manufacturing facilities worldwide
- Wide distribution network covering North America, Europe, Asia-Pacific
- Emphasis on high-quality standards and regulatory filings
Product Focus:
Pfizer’s Lidocaine solutions include ready-to-use, sterilized injections in various container types suitable for clinical and surgical use. Their robust quality assurance processes make them a preferred choice.
2. Hospira, a Pfizer Company
Overview:
Hospira specializes in injectable generic pharmaceuticals, including local anesthetics like Lidocaine. Their focus on sterile, prefilled containers aligns with hospital and clinical needs.
Capabilities:
- Extensive manufacturing footprint across North America, Europe, Asia
- Offerings include Lidocaine hydrochloride 0.4% in plastic, sterile containers
- Certified under ISO, cGMP, and other regulatory standards
Quality Assurance:
Hospira emphasizes rigorous sterilization, stability testing, and batch consistency, adhering to USP and EP standards.
3. Hikma Pharmaceuticals
Overview:
Hikma is a global pharmaceutical leader with a strong portfolio of injectable products. They manufacture Lidocaine in various formulations and container types.
Capabilities:
- Proven expertise in injectable sterile solutions
- Manufacturing plants compliant with international quality standards
- Focus on markets in Middle East, Europe, and North America
Product Offerings:
Hikma supplies Lidocaine hydrochloride solutions in sterile plastic containers, meeting regulatory requirements for hospital use.
4. Sandoz (Novartis Group)
Overview:
Sandoz is a major player in generic injectable medicines, including local anesthetics like Lidocaine. Their products emphasize affordability without compromising quality.
Capabilities:
- Global production sites with GMP certification
- Capable of providing Lidocaine in prefilled, sterile containers
- Supply chain optimized for global distribution
Regulatory Compliance:
Their formulations meet USP, EP, and JP pharmacopoeial standards.
5. Zhejiang Huahai Pharmaceutical Co., Ltd.
Overview:
A leading Chinese pharmaceutical manufacturer with extensive experience in producing local anesthetics like Lidocaine.
Capabilities:
- Large-scale manufacturing facilities sanctioned for sterile injectable products
- Competitive pricing for the Asia-Pacific market
- Certification adherence to international standards
Note:
While offering competitive prices, importers should verify regulatory approvals for specific markets.
Suppliers of Dextrose 5% in Plastic Containers
1. Baxter International Inc.
Overview:
Baxter supplies large volumes of sterile Dextrose 5% solutions in plastic bags and bottles for infusion therapy.
Capabilities:
- Extensive global manufacturing network
- Products meet stringent GMP and pharmacopoeial requirements
- Focus on high purity and sterility
2. B. Braun Melsungen AG
Overview:
B. Braun offers Dextrose 5% solutions for infusion in sterile containers, providing reliable and safe products.
Capabilities:
- Manufacturing facilities compliant with ISO and GMP standards
- Availability across hospitals and clinics worldwide
3. Fresenius Kabi
Overview:
Fresenius is a major supplier for intravenous solutions, including Dextrose 5%, supplied in plastic containers.
Capabilities:
- Wide product portfolio and geographic reach
- Products adhere to pharmacopoeial standards for safety and efficacy
4. Zhejiang Jinhua Jiuxing Medicine Co., Ltd.
Overview:
A domestic Chinese manufacturer specializing in intravenous solutions and glucose infusions.
Capabilities:
- Competitive pricing tailored for Asian markets
- Certification compliant with Chinese regulatory standards
5. Hospira (now part of Pfizer)
Overview:
Hospira’s Dextrose solutions are integrated into Pfizer’s portfolio, ensuring a consistent supply of quality products.
Key Considerations for Sourcing Pharmaceutical Ingredients
- Regulatory Compliance: Verify that suppliers possess necessary certifications (e.g., FDA, EMA, WHO GMP) and product approvals for targeted markets.
- Quality Standards: Ensure ingredients conform to pharmacopoeial standards (USP, EP, JP) and have batch-specific Certificates of Analysis (CoA).
- Supply Chain Stability: Prioritize suppliers with a proven track record of on-time delivery, inventory management, and contingency planning.
- Pricing and Contract Terms: Negotiate terms that include quality warranties, minimum order quantities, and logistics provisions.
- Customization and Packaging: Confirm the availability of plastic containers compatible with your application, including container sizes, closures, and sterilization methods.
Conclusion
The procurement of Lidocaine Hydrochloride 0.4% combined with Dextrose 5% in plastic containers involves sourcing from established global and regional suppliers. Leading pharmaceutical companies like Pfizer (including Hospira), Hikma, Sandoz, and Chinese manufacturers like Zhejiang Huahai provide high-quality options adhering to international standards. Complementing these with reliable infusion solution providers such as Baxter, B. Braun, and Fresenius ensures a robust supply chain.
Organizations should conduct due diligence, prioritize regulatory compliance, and establish long-term supplier relationships to ensure quality, cost-effectiveness, and uninterrupted supply of these critical pharmaceutical components.
Key Takeaways
- Global Leaders: Pfizer and Hospira offer highly reliable Lidocaine solutions in sterile plastic containers, widely approved and used across markets.
- Regional Options: Chinese manufacturers like Zhejiang Huahai provide cost-effective options though require thorough regulatory audits.
- Infusion Solutions Suppliers: Baxter, B. Braun, and Fresenius are trusted providers of Dextrose 5% solutions, emphasizing sterility and consistency.
- Supplier Selection: Focus on manufacturers with strong GMP credentials, regulatory approvals, and supply chain resilience.
- Strategic Sourcing: Establish long-term partnerships, perform regular quality audits, and stay updated on regulatory changes for sourcing success.
FAQs
1. What are the key regulatory standards to consider when sourcing Lidocaine Hydrochloride?
Compliance with USP, EP, and JP standards ensures pharmaceutical-grade purity and safety. Suppliers should also have certifications like FDA or EMA approval for their products.
2. Are there domestic suppliers specializing in Lidocaine solutions for specific markets?
Yes, Chinese pharmaceutical firms like Zhejiang Huahai and others cater to regional markets, often offering competitive prices but requiring careful regulatory vetting.
3. What should I verify before choosing Dextrose 5% suppliers?
Confirm sterility assurance, GMP compliance, Certificates of Analysis, and compatibility with intended containers and infusion systems.
4. How does container material impact the stability of Lidocaine and Dextrose solutions?
Plastic containers in medical-grade materials like PET or PVC are designed to be inert, maintaining solution stability. Proper sterilization and sealing are critical to prevent contamination.
5. What are the trends shaping the sourcing of pharmaceutical injectable solutions?
Increasing emphasis on supply chain transparency, regulatory harmonization, and quality assurance, alongside strategic sourcing from both multinational and regional manufacturers.
Sources
[1] U.S. Pharmacopeia (USP). "Lidocaine Hydrochloride and Dextrose Injection."
[2] European Pharmacopoeia (EP). "Injectable Solutions Standards."
[3] Pfizer Inc. Product Portfolio &Certifications.
[4] Hospira (Pfizer). Official Website and Supply Chain Data.
[5] B. Braun Melsungen AG. Product Catalog and Compliance Certificates.
