Last updated: August 1, 2025
Introduction
The combination of Lidocaine Hydrochloride 0.1% with Dextrose 5% in plastic containers is a specialized formulation used primarily for local anesthesia and diagnostic procedures. As demand for such compounded drugs increases, especially in hospitals and clinics, understanding the landscape of reliable suppliers becomes critical for pharmaceutical companies, healthcare providers, and distributors. This report delineates key global and regional suppliers, their sourcing capabilities, regulatory compliance, and market positioning.
Market Overview
Lidocaine Hydrochloride, a local anesthetic, is widely utilized due to its rapid onset and moderate duration of action. Dextrose 5% in water (D5W) serves as both a diluent and a vehicle for various medications. The combination in plastic containers offers convenience, sterility, and ease of administration, making it a favored choice in clinical settings.
The global market for injectable local anesthetics and intravenous fluids continues to expand, driven by increased surgical procedures, anesthesia needs, and supportive therapies.
Key Suppliers of Lidocaine Hydrochloride 0.1% in Plastic Containers
1. Hospira (Pfizer)
Hospira, now part of Pfizer, has a significant global footprint in injectable pharmaceuticals, including lidocaine. The company offers sterile, pre-filled plastic containers of lidocaine solutions, complying with stringent regulatory standards (USP, EP, JP).
- Product Capabilities: Various formulations, including 0.1% concentration in ready-to-use plastic containers.
- Regulatory Compliance: FDA-approved, CE-marked.
- Market Presence: Well-established in North America, Europe, and emerging markets.
2. Fresenius Kabi
A prominent provider of sterile injectables and infusion solutions, Fresenius Kabi supplies lidocaine formulations in pre-filled plastic containers.
- Advantages: Consistent quality, extensive manufacturing facilities.
- Certifications: GMP, ISO 9001, and various regional certifications.
- Regions Covered: Global, with strong presence in Europe, Asia-Pacific.
3. Hikma Pharmaceuticals
Hikma produces a broad portfolio of sterile injectables, including lidocaine hydrochloride solutions.
- Product Range: Multiple concentrations, including low-dose solutions suitable for local anesthesia.
- Supply Chain: Robust distribution channels in the Middle East, Europe, and North America.
- Regulatory Status: Compliance with EMA, FDA.
4. B. Braun
Known for their infusion and anesthesia solutions, B. Braun offers lidocaine in pre-filled plastic containers, designed for ease of use.
- Certifications: ISO, GMP.
- Market Focus: Primarily Europe, North America, Asia.
5. Local/Regional Manufacturers
In addition to global corporations, several regional producers manufacture lidocaine solutions, often approved by local regulatory bodies. For instance, Shanxi Jirai Pharmaceutical (China) and Sun Pharmaceutical Industries (India) offer competitive products compliant with regional standards.
Suppliers for Dextrose 5% in Plastic Containers
1. Baxter International
Baxter is a leader in intravenous solutions, including Dextrose 5%. Their products are known for high sterility standards and widespread availability.
- Features: Multi-dose and single-dose plastic containers.
- Regions: North America, Europe, Asia-Pacific.
2. Baxter's Regional Merges and Subsidiaries
For example, Baxter India and Baxter China supply locally manufactured Dextrose solutions with compliance to regional regulations.
3. Otsuka Pharmaceutical
Their intravenous fluids portfolio includes Dextrose 5%, mainly distributed within Asia and select export markets.
4. Fresenius Kabi
Apart from lidocaine, they supply Dextrose solutions, promoting integrated procurement.
5. Local/Regional Suppliers
Similarly, regional firms like Nantong Jiuding Pharmaceutical (China) and Sun Pharmaceutical (India) manufacture Dextrose in plastic containers, often at lower costs while maintaining quality standards.
Key Criteria for Supplier Selection
- Regulatory Compliance: Suppliers must meet regional standards (FDA, EMA, PMDA, etc.)
- Manufacturing Quality: ISO certifications, Good Manufacturing Practice (GMP)
- Product Sterility & Packaging: Confirmed sterilization processes and secure plastic container sealing
- Supply Reliability: Capacity to meet bulk orders and consistent supply timelines
- Cost Effectiveness: Competitive pricing aligned with pharmaceutical procurement budgets
- Validation & Documentation: Availability of Certificates of Analysis (CoA), stability data, and batch traceability
Regulatory Considerations
Approval status varies across regions; suppliers must provide documentation for registration with authorities such as the FDA (USA), EMA (Europe), and other national agencies. Laboratories and procurement agencies should verify product registration, sterility validation, and expiration dates before purchase.
Recent Trends and Industry Shifts
The global shift towards aseptic processing and single-use plastics bolsters demand for pre-filled solutions in sterile containers. Additionally, regional manufacturers increasingly comply with international standards to access export markets.
Supply chain resilience also gained focus following global disruptions, prompting companies to diversify sourcing and establish regional manufacturing facilities.
Conclusion
Multiple reputable global and regional manufacturers supply Lidocaine Hydrochloride 0.1% and Dextrose 5% in plastic containers. Procurement strategies should emphasize regulatory compliance, quality assurance, and supply reliability. Collaboration with established suppliers such as Pfizer (Hospira), Fresenius Kabi, Hikma, and B. Braun can ensure product integrity and consistent availability for clinical needs.
Key Takeaways
- Global Leaders Dominate Supply: Major pharmaceutical companies like Pfizer, Fresenius Kabi, Hikma, and B. Braun are key suppliers with extensive regulatory approvals.
- Regional Suppliers Play a Critical Role: Local manufacturers provide cost-effective alternatives, especially in emerging markets.
- Compliance Is Critical: Ensure suppliers meet regional and international GMP standards.
- Supply Chain Diversification Enhances Security: Relying on multiple suppliers mitigates risks associated with shortages.
- Regulatory Documentation is Essential: Verify Certificates of Analysis, registration status, and sterility validation prior to procurement.
FAQs
1. Are there approved suppliers for Lidocaine Hydrochloride 0.1% in plastic containers in the US?
Yes. Major suppliers like Pfizer (Hospira), Becton Dickinson, and B. Braun supply FDA-approved Lidocaine solutions in pre-filled plastic containers suitable for clinical use.
2. Can regional manufacturers meet international quality standards for Lidocaine and Dextrose solutions?
Many regional manufacturers now adhere to international GMP certifications, enabling them to supply products compliant with global standards, although due diligence is essential.
3. What are the typical certifications required for procurement of injectable pharmaceuticals?
Certifications include GMP, ISO 9001, ISO 13485 (medical devices), and regional approvals such as FDA approval (US), CE marking (Europe), and PMDA approval (Japan).
4. How do supplier quality variations impact clinical applications?
Inconsistent quality can lead to sterility issues, compromised efficacy, or adverse patient outcomes. Selecting reputable suppliers with robust quality controls mitigates these risks.
5. Is there a trend toward pre-filled plastic containers for these drugs?
Yes. Pre-filled containers improve safety, reduce preparation time, and minimize contamination risks, making them increasingly standard in clinical settings.
References
- [1] Pfizer. "Hospira Injectable Products," Pfizer.
- [2] Fresenius Kabi. "Injectable Solutions," Fresenius Kabi Official Site.
- [3] Hikma Pharmaceuticals. "Sterile Injectable Portfolio," Hikma Company Overview.
- [4] B. Braun. "Infusion and Injection Solutions," B. Braun Group.
- [5] Regulatory Agencies Documentation. "GMP Guidelines," FDA, EMA, and other regional authorities.
The information provided aims to assist healthcare procurement professionals and pharmaceutical entities in identifying reputable suppliers for Lidocaine Hydrochloride 0.1% and Dextrose 5% in plastic containers, fostering informed decision-making based on quality, compliance, and supply stability.
